Trial Outcomes & Findings for Mission Reconnect-Veterans and Their Partners to Manage Pain and PTSD (MR) (NCT NCT03593772)
NCT ID: NCT03593772
Last Updated: 2024-08-23
Results Overview
20-item questionnaire, used to assess pain, and pain-related subdomains, such as pain intensity, interference with activities, mobility, negative affect, vitality, and pain-related fear. Higher Scores associated with more adverse pain-related patient reported outcomes. Pain Range: 0 - 10 Mobility Range: 0 - 40 Activities of Daily Living Range: 0 - 40 Vitality Range: 0 - 30 Negative Affect Range: 0 - 50 Fear Range: 0 - 20 Total Range: 0-190
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
730 participants
Primary outcome timeframe
Baseline, month 1,2,4
Results posted on
2024-08-23
Participant Flow
Instruments may be administered to different individuals at different timepoints. We consented 196 Veterans (Vs) to the Treatment arm (Tx) \& 168 Vs to the Waitlist-control arm (WC). Some Partners (Ps) withdrew \& new Ps were added to the study. We consented 198 Ps to Tx, \& 168 Ps to WC. We have Baseline data for 141 Vs (Tx), 136 Vs (WC), 137 Ps (Tx), \& 133 Ps (WC). Satisfaction/utilization were only obtained after Tx initiation. The n's are the number of individuals activated (133 Vs, 133 Ps).
Participant milestones
| Measure |
Treatment Arm - Veteran
Treatment Arm: MR is an user-driven, dyadic, self-care management program developed with National Institute of Mental Health (NIMH) funding (R43/44) for use by Veterans and their selected partners, individually or together, to reduce pain and distress and support physical, mental, and relationship health. MR was designed for Veterans who face obstacles accessing formal mental health services. It can also be used to complement formal services. MR is a patient-centered intervention, allowing users to determine the pace at which to proceed in each program component. MR Content. The program provides video and audio instruction in a set of 11 evidence-based wellness.
Mission Reconnect: This four-year randomized controlled trial with one intervention arm and one wait-list control arm will utilize mixed methods to evaluate the effectiveness and perceived value of the MR program in relation to physical and psychological symptoms, global health, and social outcomes.
|
Treatment Arm - Partner
Treatment Arm: MR is an user-driven, dyadic, self-care management program developed with NIMH funding (R43/44) for use by Veterans and their selected partners, individually or together, to reduce pain and distress and support physical, mental, and relationship health. MR was designed for Veterans who face obstacles accessing formal mental health services. It can also be used to complement formal services. MR is a patient-centered intervention, allowing users to determine the pace at which to proceed in each program component. MR Content. The program provides video and audio instruction in a set of 11 evidence-based wellness.
Mission Reconnect: This four-year randomized controlled trial with one intervention arm and one wait-list control arm will utilize mixed methods to evaluate the effectiveness and perceived value of the MR program in relation to physical and psychological symptoms, global health, and social outcomes.
|
Control Arm - Veteran
Usual Care Waitlist Control Arm: For ethical reasons, this study will use a waitlist control arm to ultimately provide all participants exposure to the MR intervention. Dyads in the control arm will participate in all assessments like those in the treatment group, however, they will be asked to agree to not access the public web site during their participation. Wait-list control participants will be instructed to seek advice about treatment from their providers. Other than this initial advice, there will be no attempt by study personnel to influence condition management unless an issue (i.e., suicidal ideation) arises. The control condition will account for potential temporal effects that occur from passage of time (brief), and expectation effects associated with anticipation of MR participation. The control group will receive access to MR after they complete data collection.
Mission Reconnect: This four-year randomized controlled trial with one intervention arm and one wait-list control arm will utilize mixed methods to evaluate the effectiveness and perceived value of the MR program in relation to physical and psychological symptoms, global health, and social outcomes.
|
Control Arm - Partner
Usual Care Waitlist Control Arm: For ethical reasons, this study will use a waitlist control arm to ultimately provide all participants exposure to the MR intervention. Dyads in the control arm will participate in all assessments like those in the treatment group, however, they will be asked to agree to not access the public web site during their participation. Wait-list control participants will be instructed to seek advice about treatment from their providers. Other than this initial advice, there will be no attempt by study personnel to influence condition management unless an issue (i.e., suicidal ideation) arises. The control condition will account for potential temporal effects that occur from passage of time (brief), and expectation effects associated with anticipation of MR participation. The control group will receive access to MR after they complete data collection.
Mission Reconnect: This four-year randomized controlled trial with one intervention arm and one wait-list control arm will utilize mixed methods to evaluate the effectiveness and perceived value of the MR program in relation to physical and psychological symptoms, global health, and social outcomes.
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
196
|
198
|
168
|
168
|
|
Overall Study
Completed Baseline Data Collection
|
141
|
137
|
136
|
133
|
|
Overall Study
Activated in Protocol
|
133
|
133
|
133
|
133
|
|
Overall Study
COMPLETED
|
106
|
106
|
129
|
129
|
|
Overall Study
NOT COMPLETED
|
90
|
92
|
39
|
39
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
The total number of individuals in each arm is the number of consents. We only rec'd Baseline data from 141 Veterans in the Mission Reconnect Arm, 137 Partners in the Mission Reconnect Arm, 136 Veterans in the Waitlist Control Arm, 133 Partners in the Waitlist Control Arm.
Baseline characteristics by cohort
| Measure |
Treatment Arm - Veteran
n=196 Participants
Treatment Arm: MR is an user-driven, dyadic, self-care management program developed with NIMH funding (R43/44) for use by Veterans and their selected partners, individually or together, to reduce pain and distress and support physical, mental, and relationship health. MR was designed for Veterans who face obstacles accessing formal mental health services. It can also be used to complement formal services. MR is a patient-centered intervention, allowing users to determine the pace at which to proceed in each program component. MR Content. The program provides video and audio instruction in a set of 11 evidence-based wellness.
Mission Reconnect: This four-year randomized controlled trial with one intervention arm and one wait-list control arm will utilize mixed methods to evaluate the effectiveness and perceived value of the MR program in relation to physical and psychological symptoms, global health, and social outcomes.
|
Treatment Arm - Partner
n=198 Participants
Treatment Arm: MR is an user-driven, dyadic, self-care management program developed with NIMH funding (R43/44) for use by Veterans and their selected partners, individually or together, to reduce pain and distress and support physical, mental, and relationship health. MR was designed for Veterans who face obstacles accessing formal mental health services. It can also be used to complement formal services. MR is a patient-centered intervention, allowing users to determine the pace at which to proceed in each program component. MR Content. The program provides video and audio instruction in a set of 11 evidence-based wellness.
Mission Reconnect: This four-year randomized controlled trial with one intervention arm and one wait-list control arm will utilize mixed methods to evaluate the effectiveness and perceived value of the MR program in relation to physical and psychological symptoms, global health, and social outcomes.
|
Control Arm - Veteran
n=168 Participants
Usual Care Waitlist Control Arm: For ethical reasons, this study will use a waitlist control arm to ultimately provide all participants exposure to the MR intervention. Dyads in the control arm will participate in all assessments like those in the treatment group, however, they will be asked to agree to not access the public web site during their participation. Wait-list control participants will be instructed to seek advice about treatment from their providers. Other than this initial advice, there will be no attempt by study personnel to influence condition management unless an issue (i.e., suicidal ideation) arises. The control condition will account for potential temporal effects that occur from passage of time (brief), and expectation effects associated with anticipation of MR participation. The control group will receive access to MR after they complete data collection.
Mission Reconnect: This four-year randomized controlled trial with one intervention arm and one wait-list control arm will utilize mixed methods to evaluate the effectiveness and perceived value of the MR program in relation to physical and psychological symptoms, global health, and social outcomes.
|
Control Arm - Partner
n=168 Participants
Usual Care Waitlist Control Arm: For ethical reasons, this study will use a waitlist control arm to ultimately provide all participants exposure to the MR intervention. Dyads in the control arm will participate in all assessments like those in the treatment group, however, they will be asked to agree to not access the public web site during their participation. Wait-list control participants will be instructed to seek advice about treatment from their providers. Other than this initial advice, there will be no attempt by study personnel to influence condition management unless an issue (i.e., suicidal ideation) arises. The control condition will account for potential temporal effects that occur from passage of time (brief), and expectation effects associated with anticipation of MR participation. The control group will receive access to MR after they complete data collection.
Mission Reconnect: This four-year randomized controlled trial with one intervention arm and one wait-list control arm will utilize mixed methods to evaluate the effectiveness and perceived value of the MR program in relation to physical and psychological symptoms, global health, and social outcomes.
|
Total
n=730 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
55.80 Years
STANDARD_DEVIATION 14.13 • n=141 Participants • The total number of individuals in each arm is the number of consents. We only rec'd Baseline data from 141 Veterans in the Mission Reconnect Arm, 137 Partners in the Mission Reconnect Arm, 136 Veterans in the Waitlist Control Arm, 133 Partners in the Waitlist Control Arm.
|
52.20 Years
STANDARD_DEVIATION 13.72 • n=137 Participants • The total number of individuals in each arm is the number of consents. We only rec'd Baseline data from 141 Veterans in the Mission Reconnect Arm, 137 Partners in the Mission Reconnect Arm, 136 Veterans in the Waitlist Control Arm, 133 Partners in the Waitlist Control Arm.
|
57.28 Years
STANDARD_DEVIATION 13.35 • n=136 Participants • The total number of individuals in each arm is the number of consents. We only rec'd Baseline data from 141 Veterans in the Mission Reconnect Arm, 137 Partners in the Mission Reconnect Arm, 136 Veterans in the Waitlist Control Arm, 133 Partners in the Waitlist Control Arm.
|
52.92 Years
STANDARD_DEVIATION 14.57 • n=133 Participants • The total number of individuals in each arm is the number of consents. We only rec'd Baseline data from 141 Veterans in the Mission Reconnect Arm, 137 Partners in the Mission Reconnect Arm, 136 Veterans in the Waitlist Control Arm, 133 Partners in the Waitlist Control Arm.
|
56.54 Years
STANDARD_DEVIATION 13.74 • n=547 Participants • The total number of individuals in each arm is the number of consents. We only rec'd Baseline data from 141 Veterans in the Mission Reconnect Arm, 137 Partners in the Mission Reconnect Arm, 136 Veterans in the Waitlist Control Arm, 133 Partners in the Waitlist Control Arm.
|
|
Sex/Gender, Customized
Female
|
40 Participants
n=196 Participants
|
107 Participants
n=198 Participants
|
33 Participants
n=168 Participants
|
115 Participants
n=168 Participants
|
295 Participants
n=730 Participants
|
|
Sex/Gender, Customized
Male
|
100 Participants
n=196 Participants
|
29 Participants
n=198 Participants
|
103 Participants
n=168 Participants
|
17 Participants
n=168 Participants
|
249 Participants
n=730 Participants
|
|
Sex/Gender, Customized
Other
|
1 Participants
n=196 Participants
|
1 Participants
n=198 Participants
|
0 Participants
n=168 Participants
|
1 Participants
n=168 Participants
|
3 Participants
n=730 Participants
|
|
Sex/Gender, Customized
No Data - Did not complete Baseline Data collection
|
55 Participants
n=196 Participants
|
61 Participants
n=198 Participants
|
32 Participants
n=168 Participants
|
35 Participants
n=168 Participants
|
183 Participants
n=730 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
13 Participants
n=196 Participants
|
11 Participants
n=198 Participants
|
10 Participants
n=168 Participants
|
9 Participants
n=168 Participants
|
43 Participants
n=730 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
123 Participants
n=196 Participants
|
123 Participants
n=198 Participants
|
116 Participants
n=168 Participants
|
121 Participants
n=168 Participants
|
483 Participants
n=730 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
60 Participants
n=196 Participants
|
64 Participants
n=198 Participants
|
42 Participants
n=168 Participants
|
38 Participants
n=168 Participants
|
204 Participants
n=730 Participants
|
|
Race/Ethnicity, Customized
American Indian or Alaskan Native
|
3 Participants
n=196 Participants
|
1 Participants
n=198 Participants
|
1 Participants
n=168 Participants
|
0 Participants
n=168 Participants
|
5 Participants
n=730 Participants
|
|
Race/Ethnicity, Customized
Asian (Chinese, Filipino, Japanese, Korean etc.)
|
1 Participants
n=196 Participants
|
5 Participants
n=198 Participants
|
1 Participants
n=168 Participants
|
4 Participants
n=168 Participants
|
11 Participants
n=730 Participants
|
|
Race/Ethnicity, Customized
Black and/or African American
|
20 Participants
n=196 Participants
|
20 Participants
n=198 Participants
|
22 Participants
n=168 Participants
|
21 Participants
n=168 Participants
|
83 Participants
n=730 Participants
|
|
Race/Ethnicity, Customized
Multiracial
|
9 Participants
n=196 Participants
|
3 Participants
n=198 Participants
|
8 Participants
n=168 Participants
|
2 Participants
n=168 Participants
|
22 Participants
n=730 Participants
|
|
Race/Ethnicity, Customized
White, Caucasian
|
103 Participants
n=196 Participants
|
104 Participants
n=198 Participants
|
97 Participants
n=168 Participants
|
102 Participants
n=168 Participants
|
406 Participants
n=730 Participants
|
|
Race/Ethnicity, Customized
Missing/Decline to Respond
|
56 Participants
n=196 Participants
|
63 Participants
n=198 Participants
|
33 Participants
n=168 Participants
|
38 Participants
n=168 Participants
|
190 Participants
n=730 Participants
|
|
Race/Ethnicity, Customized
Other
|
4 Participants
n=196 Participants
|
2 Participants
n=198 Participants
|
6 Participants
n=168 Participants
|
1 Participants
n=168 Participants
|
13 Participants
n=730 Participants
|
|
Pain Outcomes Questionnaire
Total POQ
|
103.50 units on a scale
STANDARD_DEVIATION 37.13 • n=141 Participants • Pain Outcomes Questionnaire was administered only to the Veterans. Only Demographics and Relationship measures were administered to the Partners. The total number of individuals in each arm is the number of consents. We only rec'd Baseline data from 141 Veterans in the Mission Reconnect Arm, 137 Partners in the Mission Reconnect Arm, 136 Veterans in the Waitlist Control Arm, 133 Partners in the Waitlist Control Arm.
|
—
|
93.64 units on a scale
STANDARD_DEVIATION 33.08 • n=136 Participants • Pain Outcomes Questionnaire was administered only to the Veterans. Only Demographics and Relationship measures were administered to the Partners. The total number of individuals in each arm is the number of consents. We only rec'd Baseline data from 141 Veterans in the Mission Reconnect Arm, 137 Partners in the Mission Reconnect Arm, 136 Veterans in the Waitlist Control Arm, 133 Partners in the Waitlist Control Arm.
|
—
|
98.66 units on a scale
STANDARD_DEVIATION 35.48 • n=277 Participants • Pain Outcomes Questionnaire was administered only to the Veterans. Only Demographics and Relationship measures were administered to the Partners. The total number of individuals in each arm is the number of consents. We only rec'd Baseline data from 141 Veterans in the Mission Reconnect Arm, 137 Partners in the Mission Reconnect Arm, 136 Veterans in the Waitlist Control Arm, 133 Partners in the Waitlist Control Arm.
|
|
Pain Outcomes Questionnaire
Pain
|
6.25 units on a scale
STANDARD_DEVIATION 1.91 • n=141 Participants • Pain Outcomes Questionnaire was administered only to the Veterans. Only Demographics and Relationship measures were administered to the Partners. The total number of individuals in each arm is the number of consents. We only rec'd Baseline data from 141 Veterans in the Mission Reconnect Arm, 137 Partners in the Mission Reconnect Arm, 136 Veterans in the Waitlist Control Arm, 133 Partners in the Waitlist Control Arm.
|
—
|
6.07 units on a scale
STANDARD_DEVIATION 1.92 • n=136 Participants • Pain Outcomes Questionnaire was administered only to the Veterans. Only Demographics and Relationship measures were administered to the Partners. The total number of individuals in each arm is the number of consents. We only rec'd Baseline data from 141 Veterans in the Mission Reconnect Arm, 137 Partners in the Mission Reconnect Arm, 136 Veterans in the Waitlist Control Arm, 133 Partners in the Waitlist Control Arm.
|
—
|
6.16 units on a scale
STANDARD_DEVIATION 1.91 • n=277 Participants • Pain Outcomes Questionnaire was administered only to the Veterans. Only Demographics and Relationship measures were administered to the Partners. The total number of individuals in each arm is the number of consents. We only rec'd Baseline data from 141 Veterans in the Mission Reconnect Arm, 137 Partners in the Mission Reconnect Arm, 136 Veterans in the Waitlist Control Arm, 133 Partners in the Waitlist Control Arm.
|
|
Pain Outcomes Questionnaire
Mobility
|
21.63 units on a scale
STANDARD_DEVIATION 11.54 • n=141 Participants • Pain Outcomes Questionnaire was administered only to the Veterans. Only Demographics and Relationship measures were administered to the Partners. The total number of individuals in each arm is the number of consents. We only rec'd Baseline data from 141 Veterans in the Mission Reconnect Arm, 137 Partners in the Mission Reconnect Arm, 136 Veterans in the Waitlist Control Arm, 133 Partners in the Waitlist Control Arm.
|
—
|
19.78 units on a scale
STANDARD_DEVIATION 10.78 • n=136 Participants • Pain Outcomes Questionnaire was administered only to the Veterans. Only Demographics and Relationship measures were administered to the Partners. The total number of individuals in each arm is the number of consents. We only rec'd Baseline data from 141 Veterans in the Mission Reconnect Arm, 137 Partners in the Mission Reconnect Arm, 136 Veterans in the Waitlist Control Arm, 133 Partners in the Waitlist Control Arm.
|
—
|
20.72 units on a scale
STANDARD_DEVIATION 11.19 • n=277 Participants • Pain Outcomes Questionnaire was administered only to the Veterans. Only Demographics and Relationship measures were administered to the Partners. The total number of individuals in each arm is the number of consents. We only rec'd Baseline data from 141 Veterans in the Mission Reconnect Arm, 137 Partners in the Mission Reconnect Arm, 136 Veterans in the Waitlist Control Arm, 133 Partners in the Waitlist Control Arm.
|
|
Pain Outcomes Questionnaire
Activities of Daily Living
|
11.71 units on a scale
STANDARD_DEVIATION 11.24 • n=141 Participants • Pain Outcomes Questionnaire was administered only to the Veterans. Only Demographics and Relationship measures were administered to the Partners. The total number of individuals in each arm is the number of consents. We only rec'd Baseline data from 141 Veterans in the Mission Reconnect Arm, 137 Partners in the Mission Reconnect Arm, 136 Veterans in the Waitlist Control Arm, 133 Partners in the Waitlist Control Arm.
|
—
|
10.07 units on a scale
STANDARD_DEVIATION 10.09 • n=136 Participants • Pain Outcomes Questionnaire was administered only to the Veterans. Only Demographics and Relationship measures were administered to the Partners. The total number of individuals in each arm is the number of consents. We only rec'd Baseline data from 141 Veterans in the Mission Reconnect Arm, 137 Partners in the Mission Reconnect Arm, 136 Veterans in the Waitlist Control Arm, 133 Partners in the Waitlist Control Arm.
|
—
|
10.91 units on a scale
STANDARD_DEVIATION 10.70 • n=277 Participants • Pain Outcomes Questionnaire was administered only to the Veterans. Only Demographics and Relationship measures were administered to the Partners. The total number of individuals in each arm is the number of consents. We only rec'd Baseline data from 141 Veterans in the Mission Reconnect Arm, 137 Partners in the Mission Reconnect Arm, 136 Veterans in the Waitlist Control Arm, 133 Partners in the Waitlist Control Arm.
|
|
Pain Outcomes Questionnaire
Vitality
|
20.60 units on a scale
STANDARD_DEVIATION 5.74 • n=141 Participants • Pain Outcomes Questionnaire was administered only to the Veterans. Only Demographics and Relationship measures were administered to the Partners. The total number of individuals in each arm is the number of consents. We only rec'd Baseline data from 141 Veterans in the Mission Reconnect Arm, 137 Partners in the Mission Reconnect Arm, 136 Veterans in the Waitlist Control Arm, 133 Partners in the Waitlist Control Arm.
|
—
|
18.21 units on a scale
STANDARD_DEVIATION 5.71 • n=136 Participants • Pain Outcomes Questionnaire was administered only to the Veterans. Only Demographics and Relationship measures were administered to the Partners. The total number of individuals in each arm is the number of consents. We only rec'd Baseline data from 141 Veterans in the Mission Reconnect Arm, 137 Partners in the Mission Reconnect Arm, 136 Veterans in the Waitlist Control Arm, 133 Partners in the Waitlist Control Arm.
|
—
|
19.43 units on a scale
STANDARD_DEVIATION 5.84 • n=277 Participants • Pain Outcomes Questionnaire was administered only to the Veterans. Only Demographics and Relationship measures were administered to the Partners. The total number of individuals in each arm is the number of consents. We only rec'd Baseline data from 141 Veterans in the Mission Reconnect Arm, 137 Partners in the Mission Reconnect Arm, 136 Veterans in the Waitlist Control Arm, 133 Partners in the Waitlist Control Arm.
|
|
Pain Outcomes Questionnaire
Negative Affect
|
31.93 units on a scale
STANDARD_DEVIATION 11.59 • n=141 Participants • Pain Outcomes Questionnaire was administered only to the Veterans. Only Demographics and Relationship measures were administered to the Partners. The total number of individuals in each arm is the number of consents. We only rec'd Baseline data from 141 Veterans in the Mission Reconnect Arm, 137 Partners in the Mission Reconnect Arm, 136 Veterans in the Waitlist Control Arm, 133 Partners in the Waitlist Control Arm.
|
—
|
28.61 units on a scale
STANDARD_DEVIATION 11.50 • n=136 Participants • Pain Outcomes Questionnaire was administered only to the Veterans. Only Demographics and Relationship measures were administered to the Partners. The total number of individuals in each arm is the number of consents. We only rec'd Baseline data from 141 Veterans in the Mission Reconnect Arm, 137 Partners in the Mission Reconnect Arm, 136 Veterans in the Waitlist Control Arm, 133 Partners in the Waitlist Control Arm.
|
—
|
30.30 units on a scale
STANDARD_DEVIATION 11.64 • n=277 Participants • Pain Outcomes Questionnaire was administered only to the Veterans. Only Demographics and Relationship measures were administered to the Partners. The total number of individuals in each arm is the number of consents. We only rec'd Baseline data from 141 Veterans in the Mission Reconnect Arm, 137 Partners in the Mission Reconnect Arm, 136 Veterans in the Waitlist Control Arm, 133 Partners in the Waitlist Control Arm.
|
|
Pain Outcomes Questionnaire
Fear
|
11.38 units on a scale
STANDARD_DEVIATION 4.95 • n=141 Participants • Pain Outcomes Questionnaire was administered only to the Veterans. Only Demographics and Relationship measures were administered to the Partners. The total number of individuals in each arm is the number of consents. We only rec'd Baseline data from 141 Veterans in the Mission Reconnect Arm, 137 Partners in the Mission Reconnect Arm, 136 Veterans in the Waitlist Control Arm, 133 Partners in the Waitlist Control Arm.
|
—
|
10.89 units on a scale
STANDARD_DEVIATION 4.88 • n=136 Participants • Pain Outcomes Questionnaire was administered only to the Veterans. Only Demographics and Relationship measures were administered to the Partners. The total number of individuals in each arm is the number of consents. We only rec'd Baseline data from 141 Veterans in the Mission Reconnect Arm, 137 Partners in the Mission Reconnect Arm, 136 Veterans in the Waitlist Control Arm, 133 Partners in the Waitlist Control Arm.
|
—
|
11.14 units on a scale
STANDARD_DEVIATION 4.91 • n=277 Participants • Pain Outcomes Questionnaire was administered only to the Veterans. Only Demographics and Relationship measures were administered to the Partners. The total number of individuals in each arm is the number of consents. We only rec'd Baseline data from 141 Veterans in the Mission Reconnect Arm, 137 Partners in the Mission Reconnect Arm, 136 Veterans in the Waitlist Control Arm, 133 Partners in the Waitlist Control Arm.
|
PRIMARY outcome
Timeframe: Baseline, month 1,2,4Population: Multilinear model analyses were performed. Results provided are the Least Squares Mean and 95% C.I. for the two treatment arms. This is the least squares mean for the treatment variable averaged across all timepoints, after having controlled for other covariates. Instrument was administered only to Veterans activated in the protocol. Participants that opted out of responding were not included in the analyses.
20-item questionnaire, used to assess pain, and pain-related subdomains, such as pain intensity, interference with activities, mobility, negative affect, vitality, and pain-related fear. Higher Scores associated with more adverse pain-related patient reported outcomes. Pain Range: 0 - 10 Mobility Range: 0 - 40 Activities of Daily Living Range: 0 - 40 Vitality Range: 0 - 30 Negative Affect Range: 0 - 50 Fear Range: 0 - 20 Total Range: 0-190
Outcome measures
| Measure |
Control Arm - Veteran
n=136 Participants
Usual Care Waitlist Control Arm: For ethical reasons, this study will use a waitlist control arm to ultimately provide all participants exposure to the MR intervention. Dyads in the control arm will participate in all assessments like those in the treatment group, however, they will be asked to agree to not access the public web site during their participation. Wait-list control participants will be instructed to seek advice about treatment from their providers. Other than this initial advice, there will be no attempt by study personnel to influence condition management unless an issue (i.e., suicidal ideation) arises. The control condition will account for potential temporal effects that occur from passage of time (brief), and expectation effects associated with anticipation of MR participation. The control group will receive access to MR after they complete data collection.
|
Treatment Arm
n=141 Participants
Treatment Arm: MR is an user-driven, dyadic, self-care management program developed with NIMH funding (R43/44) for use by Veterans and their selected partners, individually or together, to reduce pain and distress and support physical, mental, and relationship health. MR was designed for Veterans who face obstacles accessing formal mental health services. It can also be used to complement formal services. MR is a patient-centered intervention, allowing users to determine the pace at which to proceed in each program component. MR Content. The program provides video and audio instruction in a set of 11 evidence-based wellness.
Mission Reconnect: This four-year randomized controlled trial with one intervention arm and one wait-list control arm will utilize mixed methods to evaluate the effectiveness and perceived value of the MR program in relation to physical and psychological symptoms, global health, and social outcomes.
|
Control Arm - Veteran
Usual Care Waitlist Control Arm: For ethical reasons, this study will use a waitlist control arm to ultimately provide all participants exposure to the MR intervention. Dyads in the control arm will participate in all assessments like those in the treatment group, however, they will be asked to agree to not access the public web site during their participation. Wait-list control participants will be instructed to seek advice about treatment from their providers. Other than this initial advice, there will be no attempt by study personnel to influence condition management unless an issue (i.e., suicidal ideation) arises. The control condition will account for potential temporal effects that occur from passage of time (brief), and expectation effects associated with anticipation of MR participation. The control group will receive access to MR after they complete data collection.
Mission Reconnect: This four-year randomized controlled trial with one intervention arm and one wait-list control arm will utilize mixed methods to evaluate the effectiveness and perceived value of the MR program in relation to physical and psychological symptoms, global health, and social outcomes.
|
Control Arm - Partner
Usual Care Waitlist Control Arm: For ethical reasons, this study will use a waitlist control arm to ultimately provide all participants exposure to the MR intervention. Dyads in the control arm will participate in all assessments like those in the treatment group, however, they will be asked to agree to not access the public web site during their participation. Wait-list control participants will be instructed to seek advice about treatment from their providers. Other than this initial advice, there will be no attempt by study personnel to influence condition management unless an issue (i.e., suicidal ideation) arises. The control condition will account for potential temporal effects that occur from passage of time (brief), and expectation effects associated with anticipation of MR participation. The control group will receive access to MR after they complete data collection.
Mission Reconnect: This four-year randomized controlled trial with one intervention arm and one wait-list control arm will utilize mixed methods to evaluate the effectiveness and perceived value of the MR program in relation to physical and psychological symptoms, global health, and social outcomes.
|
|---|---|---|---|---|
|
Pain Outcomes Questionnaire (POQ)
Total POQ
|
94.9863 Units on a scale
Interval 89.323 to 100.65
|
102.32 Units on a scale
Interval 96.6204 to 108.03
|
—
|
—
|
|
Pain Outcomes Questionnaire (POQ)
Pain Rating
|
6.1251 Units on a scale
Interval 5.833 to 6.4173
|
6.2006 Units on a scale
Interval 5.8999 to 6.5014
|
—
|
—
|
|
Pain Outcomes Questionnaire (POQ)
Mobility
|
20.2530 Units on a scale
Interval 18.5225 to 21.9835
|
21.4893 Units on a scale
Interval 19.7487 to 23.2298
|
—
|
—
|
|
Pain Outcomes Questionnaire (POQ)
Activities of Daily Living
|
10.4716 Units on a scale
Interval 8.7829 to 12.1603
|
12.1675 Units on a scale
Interval 10.4442 to 13.8908
|
—
|
—
|
|
Pain Outcomes Questionnaire (POQ)
Vitality
|
18.6968 Units on a scale
Interval 17.8919 to 19.5018
|
20.2433 Units on a scale
Interval 19.3959 to 21.0906
|
—
|
—
|
|
Pain Outcomes Questionnaire (POQ)
Negative Affect
|
28.2654 Units on a scale
Interval 26.4939 to 30.0369
|
30.7769 Units on a scale
Interval 28.9694 to 32.5843
|
—
|
—
|
|
Pain Outcomes Questionnaire (POQ)
Fear
|
11.1400 Units on a scale
Interval 10.4626 to 11.8174
|
11.5500 Units on a scale
Interval 10.8467 to 12.2533
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline, Week 1 - 8, Week 16Population: Multilinear model analyses were performed. Results provided are the Least Squares Mean and 95% C.I. for the two treatment arms. This is the least squares mean for the treatment variable averaged across all timepoints, after having controlled for other covariates. Instrument was administered only to Veterans who had been activated in the protocol. Participants who opted out of responding to certain questions were not included in the analyses.
Three items will assess pain, stress and tension using a 0 to 5-point Likert-type scale. Higher Scores associated with more adverse patient reported outcomes. Pain Range: 0 - 5 Stress Range: 0 - 5 Tension Range: 0 - 5
Outcome measures
| Measure |
Control Arm - Veteran
n=136 Participants
Usual Care Waitlist Control Arm: For ethical reasons, this study will use a waitlist control arm to ultimately provide all participants exposure to the MR intervention. Dyads in the control arm will participate in all assessments like those in the treatment group, however, they will be asked to agree to not access the public web site during their participation. Wait-list control participants will be instructed to seek advice about treatment from their providers. Other than this initial advice, there will be no attempt by study personnel to influence condition management unless an issue (i.e., suicidal ideation) arises. The control condition will account for potential temporal effects that occur from passage of time (brief), and expectation effects associated with anticipation of MR participation. The control group will receive access to MR after they complete data collection.
|
Treatment Arm
n=141 Participants
Treatment Arm: MR is an user-driven, dyadic, self-care management program developed with NIMH funding (R43/44) for use by Veterans and their selected partners, individually or together, to reduce pain and distress and support physical, mental, and relationship health. MR was designed for Veterans who face obstacles accessing formal mental health services. It can also be used to complement formal services. MR is a patient-centered intervention, allowing users to determine the pace at which to proceed in each program component. MR Content. The program provides video and audio instruction in a set of 11 evidence-based wellness.
Mission Reconnect: This four-year randomized controlled trial with one intervention arm and one wait-list control arm will utilize mixed methods to evaluate the effectiveness and perceived value of the MR program in relation to physical and psychological symptoms, global health, and social outcomes.
|
Control Arm - Veteran
Usual Care Waitlist Control Arm: For ethical reasons, this study will use a waitlist control arm to ultimately provide all participants exposure to the MR intervention. Dyads in the control arm will participate in all assessments like those in the treatment group, however, they will be asked to agree to not access the public web site during their participation. Wait-list control participants will be instructed to seek advice about treatment from their providers. Other than this initial advice, there will be no attempt by study personnel to influence condition management unless an issue (i.e., suicidal ideation) arises. The control condition will account for potential temporal effects that occur from passage of time (brief), and expectation effects associated with anticipation of MR participation. The control group will receive access to MR after they complete data collection.
Mission Reconnect: This four-year randomized controlled trial with one intervention arm and one wait-list control arm will utilize mixed methods to evaluate the effectiveness and perceived value of the MR program in relation to physical and psychological symptoms, global health, and social outcomes.
|
Control Arm - Partner
Usual Care Waitlist Control Arm: For ethical reasons, this study will use a waitlist control arm to ultimately provide all participants exposure to the MR intervention. Dyads in the control arm will participate in all assessments like those in the treatment group, however, they will be asked to agree to not access the public web site during their participation. Wait-list control participants will be instructed to seek advice about treatment from their providers. Other than this initial advice, there will be no attempt by study personnel to influence condition management unless an issue (i.e., suicidal ideation) arises. The control condition will account for potential temporal effects that occur from passage of time (brief), and expectation effects associated with anticipation of MR participation. The control group will receive access to MR after they complete data collection.
Mission Reconnect: This four-year randomized controlled trial with one intervention arm and one wait-list control arm will utilize mixed methods to evaluate the effectiveness and perceived value of the MR program in relation to physical and psychological symptoms, global health, and social outcomes.
|
|---|---|---|---|---|
|
Pain, Stress and Tension Likert
Tension (on 5-point Likert Scale)
|
3.2474 units on a scale
Interval 3.1093 to 3.3855
|
3.4061 units on a scale
Interval 3.2634 to 3.5487
|
—
|
—
|
|
Pain, Stress and Tension Likert
Pain (on 5-point Likert Scale)
|
3.3230 units on a scale
Interval 3.1909 to 3.4551
|
3.3904 units on a scale
Interval 3.2548 to 3.526
|
—
|
—
|
|
Pain, Stress and Tension Likert
Stress (on 5-point Likert Scale)
|
3.0601 units on a scale
Interval 2.9035 to 3.2168
|
3.1728 units on a scale
Interval 3.0109 to 3.3348
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline, month 1,2,4Population: Multilinear model analyses were performed. Results provided are the Least Squares Mean and 95% C.I. for the two treatment arms. This is the least squares mean for the treatment variable averaged across all timepoints, after having controlled for other covariates. Instrument was administered only to Veterans who had been activated in the protocol. Participants who opted out of responding to certain questions were not included in the analyses.
10-point scale to measure current pain intensity (past 24 hours) and pain interference (past 24 hours) with activity, sleep, mood, and stress. Higher Scores associated with more adverse pain-related patient reported outcomes. Pain Range: 0 - 10 Pain Interference with Activity Range: 0 - 10 Pain Interference with Sleep Range: 0 - 10 Pain Interference with Mood Range: 0 - 10 Pain Interference with Stress Range: 0 - 10
Outcome measures
| Measure |
Control Arm - Veteran
n=136 Participants
Usual Care Waitlist Control Arm: For ethical reasons, this study will use a waitlist control arm to ultimately provide all participants exposure to the MR intervention. Dyads in the control arm will participate in all assessments like those in the treatment group, however, they will be asked to agree to not access the public web site during their participation. Wait-list control participants will be instructed to seek advice about treatment from their providers. Other than this initial advice, there will be no attempt by study personnel to influence condition management unless an issue (i.e., suicidal ideation) arises. The control condition will account for potential temporal effects that occur from passage of time (brief), and expectation effects associated with anticipation of MR participation. The control group will receive access to MR after they complete data collection.
|
Treatment Arm
n=141 Participants
Treatment Arm: MR is an user-driven, dyadic, self-care management program developed with NIMH funding (R43/44) for use by Veterans and their selected partners, individually or together, to reduce pain and distress and support physical, mental, and relationship health. MR was designed for Veterans who face obstacles accessing formal mental health services. It can also be used to complement formal services. MR is a patient-centered intervention, allowing users to determine the pace at which to proceed in each program component. MR Content. The program provides video and audio instruction in a set of 11 evidence-based wellness.
Mission Reconnect: This four-year randomized controlled trial with one intervention arm and one wait-list control arm will utilize mixed methods to evaluate the effectiveness and perceived value of the MR program in relation to physical and psychological symptoms, global health, and social outcomes.
|
Control Arm - Veteran
Usual Care Waitlist Control Arm: For ethical reasons, this study will use a waitlist control arm to ultimately provide all participants exposure to the MR intervention. Dyads in the control arm will participate in all assessments like those in the treatment group, however, they will be asked to agree to not access the public web site during their participation. Wait-list control participants will be instructed to seek advice about treatment from their providers. Other than this initial advice, there will be no attempt by study personnel to influence condition management unless an issue (i.e., suicidal ideation) arises. The control condition will account for potential temporal effects that occur from passage of time (brief), and expectation effects associated with anticipation of MR participation. The control group will receive access to MR after they complete data collection.
Mission Reconnect: This four-year randomized controlled trial with one intervention arm and one wait-list control arm will utilize mixed methods to evaluate the effectiveness and perceived value of the MR program in relation to physical and psychological symptoms, global health, and social outcomes.
|
Control Arm - Partner
Usual Care Waitlist Control Arm: For ethical reasons, this study will use a waitlist control arm to ultimately provide all participants exposure to the MR intervention. Dyads in the control arm will participate in all assessments like those in the treatment group, however, they will be asked to agree to not access the public web site during their participation. Wait-list control participants will be instructed to seek advice about treatment from their providers. Other than this initial advice, there will be no attempt by study personnel to influence condition management unless an issue (i.e., suicidal ideation) arises. The control condition will account for potential temporal effects that occur from passage of time (brief), and expectation effects associated with anticipation of MR participation. The control group will receive access to MR after they complete data collection.
Mission Reconnect: This four-year randomized controlled trial with one intervention arm and one wait-list control arm will utilize mixed methods to evaluate the effectiveness and perceived value of the MR program in relation to physical and psychological symptoms, global health, and social outcomes.
|
|---|---|---|---|---|
|
Defense and Veterans Pain Rating Scale
Overall Pain
|
5.8431 units on a scale
Interval 5.5821 to 6.1041
|
5.8062 units on a scale
Interval 5.5361 to 6.0764
|
—
|
—
|
|
Defense and Veterans Pain Rating Scale
Pain Interference with Activity
|
6.0125 units on a scale
Interval 5.6658 to 6.3593
|
6.1319 units on a scale
Interval 5.7757 to 6.488
|
—
|
—
|
|
Defense and Veterans Pain Rating Scale
Pain Interference with Sleep
|
5.7385 units on a scale
Interval 5.337 to 6.14
|
5.9953 units on a scale
Interval 5.584 to 6.4066
|
—
|
—
|
|
Defense and Veterans Pain Rating Scale
Pain Interference with Mood
|
5.9215 units on a scale
Interval 5.5525 to 6.2905
|
6.1210 units on a scale
Interval 5.7399 to 6.5021
|
—
|
—
|
|
Defense and Veterans Pain Rating Scale
Pain Interference with Stress
|
5.8715 units on a scale
Interval 5.4825 to 6.2605
|
6.0832 units on a scale
Interval 5.6833 to 6.4831
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline, month 1,2,4Population: Multilinear model analyses were performed. Results provided are the Least Squares Mean and 95% C.I. for the two treatment arms. This is the least squares mean for the treatment variable averaged across all timepoints, after having controlled for other covariates. Instrument was administered only to Veterans who had been activated in the protocol. Participants who opted out of responding to certain questions were not included in the analyses.
20-item measure of PTSD symptoms Higher Scores associated with more adverse PTSD-related patient reported outcomes. Posttraumatic Stress Disorder Checklist (PCL-5) Range: 0 - 80
Outcome measures
| Measure |
Control Arm - Veteran
n=136 Participants
Usual Care Waitlist Control Arm: For ethical reasons, this study will use a waitlist control arm to ultimately provide all participants exposure to the MR intervention. Dyads in the control arm will participate in all assessments like those in the treatment group, however, they will be asked to agree to not access the public web site during their participation. Wait-list control participants will be instructed to seek advice about treatment from their providers. Other than this initial advice, there will be no attempt by study personnel to influence condition management unless an issue (i.e., suicidal ideation) arises. The control condition will account for potential temporal effects that occur from passage of time (brief), and expectation effects associated with anticipation of MR participation. The control group will receive access to MR after they complete data collection.
|
Treatment Arm
n=141 Participants
Treatment Arm: MR is an user-driven, dyadic, self-care management program developed with NIMH funding (R43/44) for use by Veterans and their selected partners, individually or together, to reduce pain and distress and support physical, mental, and relationship health. MR was designed for Veterans who face obstacles accessing formal mental health services. It can also be used to complement formal services. MR is a patient-centered intervention, allowing users to determine the pace at which to proceed in each program component. MR Content. The program provides video and audio instruction in a set of 11 evidence-based wellness.
Mission Reconnect: This four-year randomized controlled trial with one intervention arm and one wait-list control arm will utilize mixed methods to evaluate the effectiveness and perceived value of the MR program in relation to physical and psychological symptoms, global health, and social outcomes.
|
Control Arm - Veteran
Usual Care Waitlist Control Arm: For ethical reasons, this study will use a waitlist control arm to ultimately provide all participants exposure to the MR intervention. Dyads in the control arm will participate in all assessments like those in the treatment group, however, they will be asked to agree to not access the public web site during their participation. Wait-list control participants will be instructed to seek advice about treatment from their providers. Other than this initial advice, there will be no attempt by study personnel to influence condition management unless an issue (i.e., suicidal ideation) arises. The control condition will account for potential temporal effects that occur from passage of time (brief), and expectation effects associated with anticipation of MR participation. The control group will receive access to MR after they complete data collection.
Mission Reconnect: This four-year randomized controlled trial with one intervention arm and one wait-list control arm will utilize mixed methods to evaluate the effectiveness and perceived value of the MR program in relation to physical and psychological symptoms, global health, and social outcomes.
|
Control Arm - Partner
Usual Care Waitlist Control Arm: For ethical reasons, this study will use a waitlist control arm to ultimately provide all participants exposure to the MR intervention. Dyads in the control arm will participate in all assessments like those in the treatment group, however, they will be asked to agree to not access the public web site during their participation. Wait-list control participants will be instructed to seek advice about treatment from their providers. Other than this initial advice, there will be no attempt by study personnel to influence condition management unless an issue (i.e., suicidal ideation) arises. The control condition will account for potential temporal effects that occur from passage of time (brief), and expectation effects associated with anticipation of MR participation. The control group will receive access to MR after they complete data collection.
Mission Reconnect: This four-year randomized controlled trial with one intervention arm and one wait-list control arm will utilize mixed methods to evaluate the effectiveness and perceived value of the MR program in relation to physical and psychological symptoms, global health, and social outcomes.
|
|---|---|---|---|---|
|
PTSD: Posttraumatic Checklist
|
41.5687 units on a scale
Interval 38.907 to 44.2304
|
43.5759 units on a scale
Interval 40.8709 to 46.281
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline, month 1,2,4Population: Multilinear model analyses were performed. Results provided are the Least Squares Mean and 95% C.I. for the two treatment arms. This is the least squares mean for the treatment variable averaged across all timepoints, after having controlled for other covariates. Instrument was administered only to Veterans who had been activated in the protocol. Participants who opted out of responding to certain questions were not included in the analyses.
12-items to assess quality of life using physical status and mental health distress. Scores for the Mental Health and Physical Health domains range from 0 to 100, with higher scores indicating better physical and mental health functioning
Outcome measures
| Measure |
Control Arm - Veteran
n=136 Participants
Usual Care Waitlist Control Arm: For ethical reasons, this study will use a waitlist control arm to ultimately provide all participants exposure to the MR intervention. Dyads in the control arm will participate in all assessments like those in the treatment group, however, they will be asked to agree to not access the public web site during their participation. Wait-list control participants will be instructed to seek advice about treatment from their providers. Other than this initial advice, there will be no attempt by study personnel to influence condition management unless an issue (i.e., suicidal ideation) arises. The control condition will account for potential temporal effects that occur from passage of time (brief), and expectation effects associated with anticipation of MR participation. The control group will receive access to MR after they complete data collection.
|
Treatment Arm
n=141 Participants
Treatment Arm: MR is an user-driven, dyadic, self-care management program developed with NIMH funding (R43/44) for use by Veterans and their selected partners, individually or together, to reduce pain and distress and support physical, mental, and relationship health. MR was designed for Veterans who face obstacles accessing formal mental health services. It can also be used to complement formal services. MR is a patient-centered intervention, allowing users to determine the pace at which to proceed in each program component. MR Content. The program provides video and audio instruction in a set of 11 evidence-based wellness.
Mission Reconnect: This four-year randomized controlled trial with one intervention arm and one wait-list control arm will utilize mixed methods to evaluate the effectiveness and perceived value of the MR program in relation to physical and psychological symptoms, global health, and social outcomes.
|
Control Arm - Veteran
Usual Care Waitlist Control Arm: For ethical reasons, this study will use a waitlist control arm to ultimately provide all participants exposure to the MR intervention. Dyads in the control arm will participate in all assessments like those in the treatment group, however, they will be asked to agree to not access the public web site during their participation. Wait-list control participants will be instructed to seek advice about treatment from their providers. Other than this initial advice, there will be no attempt by study personnel to influence condition management unless an issue (i.e., suicidal ideation) arises. The control condition will account for potential temporal effects that occur from passage of time (brief), and expectation effects associated with anticipation of MR participation. The control group will receive access to MR after they complete data collection.
Mission Reconnect: This four-year randomized controlled trial with one intervention arm and one wait-list control arm will utilize mixed methods to evaluate the effectiveness and perceived value of the MR program in relation to physical and psychological symptoms, global health, and social outcomes.
|
Control Arm - Partner
Usual Care Waitlist Control Arm: For ethical reasons, this study will use a waitlist control arm to ultimately provide all participants exposure to the MR intervention. Dyads in the control arm will participate in all assessments like those in the treatment group, however, they will be asked to agree to not access the public web site during their participation. Wait-list control participants will be instructed to seek advice about treatment from their providers. Other than this initial advice, there will be no attempt by study personnel to influence condition management unless an issue (i.e., suicidal ideation) arises. The control condition will account for potential temporal effects that occur from passage of time (brief), and expectation effects associated with anticipation of MR participation. The control group will receive access to MR after they complete data collection.
Mission Reconnect: This four-year randomized controlled trial with one intervention arm and one wait-list control arm will utilize mixed methods to evaluate the effectiveness and perceived value of the MR program in relation to physical and psychological symptoms, global health, and social outcomes.
|
|---|---|---|---|---|
|
Quality of Life Short-form (SF12)
Physical Health Domain
|
24.0067 units on a scale
Interval 22.5597 to 25.4537
|
24.1845 units on a scale
Interval 22.7008 to 25.6682
|
—
|
—
|
|
Quality of Life Short-form (SF12)
Mental Health Domain
|
44.3803 units on a scale
Interval 43.22 to 45.5406
|
43.5871 units on a scale
Interval 42.3829 to 44.7914
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline, month 1,2,4Population: Multilinear model analyses were performed. Results provided are the Least Squares Mean and 95% C.I. for the two treatment arms. This is the least squares mean for the treatment variable averaged across all timepoints, after having controlled for other covariates. Instrument was administered only to Veterans who had been activated in the protocol. Participants who opted out of responding to certain questions were not included in the analyses.
19 self-rated questions from which 7 component scores are calculated and summed into a global score to assess sleep quality in the past month. Each of the domain scores range from 0 (no difficulty) to 3 (severe difficulty). The global score ranges from 0 to 21. Higher scores indicate worse sleep quality.
Outcome measures
| Measure |
Control Arm - Veteran
n=136 Participants
Usual Care Waitlist Control Arm: For ethical reasons, this study will use a waitlist control arm to ultimately provide all participants exposure to the MR intervention. Dyads in the control arm will participate in all assessments like those in the treatment group, however, they will be asked to agree to not access the public web site during their participation. Wait-list control participants will be instructed to seek advice about treatment from their providers. Other than this initial advice, there will be no attempt by study personnel to influence condition management unless an issue (i.e., suicidal ideation) arises. The control condition will account for potential temporal effects that occur from passage of time (brief), and expectation effects associated with anticipation of MR participation. The control group will receive access to MR after they complete data collection.
|
Treatment Arm
n=141 Participants
Treatment Arm: MR is an user-driven, dyadic, self-care management program developed with NIMH funding (R43/44) for use by Veterans and their selected partners, individually or together, to reduce pain and distress and support physical, mental, and relationship health. MR was designed for Veterans who face obstacles accessing formal mental health services. It can also be used to complement formal services. MR is a patient-centered intervention, allowing users to determine the pace at which to proceed in each program component. MR Content. The program provides video and audio instruction in a set of 11 evidence-based wellness.
Mission Reconnect: This four-year randomized controlled trial with one intervention arm and one wait-list control arm will utilize mixed methods to evaluate the effectiveness and perceived value of the MR program in relation to physical and psychological symptoms, global health, and social outcomes.
|
Control Arm - Veteran
Usual Care Waitlist Control Arm: For ethical reasons, this study will use a waitlist control arm to ultimately provide all participants exposure to the MR intervention. Dyads in the control arm will participate in all assessments like those in the treatment group, however, they will be asked to agree to not access the public web site during their participation. Wait-list control participants will be instructed to seek advice about treatment from their providers. Other than this initial advice, there will be no attempt by study personnel to influence condition management unless an issue (i.e., suicidal ideation) arises. The control condition will account for potential temporal effects that occur from passage of time (brief), and expectation effects associated with anticipation of MR participation. The control group will receive access to MR after they complete data collection.
Mission Reconnect: This four-year randomized controlled trial with one intervention arm and one wait-list control arm will utilize mixed methods to evaluate the effectiveness and perceived value of the MR program in relation to physical and psychological symptoms, global health, and social outcomes.
|
Control Arm - Partner
Usual Care Waitlist Control Arm: For ethical reasons, this study will use a waitlist control arm to ultimately provide all participants exposure to the MR intervention. Dyads in the control arm will participate in all assessments like those in the treatment group, however, they will be asked to agree to not access the public web site during their participation. Wait-list control participants will be instructed to seek advice about treatment from their providers. Other than this initial advice, there will be no attempt by study personnel to influence condition management unless an issue (i.e., suicidal ideation) arises. The control condition will account for potential temporal effects that occur from passage of time (brief), and expectation effects associated with anticipation of MR participation. The control group will receive access to MR after they complete data collection.
Mission Reconnect: This four-year randomized controlled trial with one intervention arm and one wait-list control arm will utilize mixed methods to evaluate the effectiveness and perceived value of the MR program in relation to physical and psychological symptoms, global health, and social outcomes.
|
|---|---|---|---|---|
|
Sleep Quality: Pittsburgh Sleep Quality Index (PSQI)
Pittsburgh Sleep Quality Index - Sleep duration
|
1.0488 units on a scale
Interval 0.8852 to 1.2124
|
0.8399 units on a scale
Interval 0.6662 to 1.0135
|
—
|
—
|
|
Sleep Quality: Pittsburgh Sleep Quality Index (PSQI)
Pittsburgh Sleep Quality Index - Sleep efficiency
|
0.3552 units on a scale
Interval 0.2606 to 0.4498
|
0.3487 units on a scale
Interval 0.2472 to 0.4502
|
—
|
—
|
|
Sleep Quality: Pittsburgh Sleep Quality Index (PSQI)
Pittsburgh Sleep Quality Index - Subjective sleep quality
|
1.8286 units on a scale
Interval 1.7189 to 1.9383
|
1.9406 units on a scale
Interval 1.8262 to 2.0549
|
—
|
—
|
|
Sleep Quality: Pittsburgh Sleep Quality Index (PSQI)
Pittsburgh Sleep Quality Index - Sleep latency
|
2.0296 units on a scale
Interval 1.8803 to 2.179
|
2.0332 units on a scale
Interval 1.8798 to 2.1867
|
—
|
—
|
|
Sleep Quality: Pittsburgh Sleep Quality Index (PSQI)
Pittsburgh Sleep Quality Index - Sleep disturbance
|
1.9507 units on a scale
Interval 1.8589 to 2.0426
|
1.9855 units on a scale
Interval 1.8898 to 2.0812
|
—
|
—
|
|
Sleep Quality: Pittsburgh Sleep Quality Index (PSQI)
Pittsburgh Sleep Quality Index - Use of sleep medication
|
1.9055 units on a scale
Interval 1.7056 to 2.1054
|
1.9685 units on a scale
Interval 1.7618 to 2.1751
|
—
|
—
|
|
Sleep Quality: Pittsburgh Sleep Quality Index (PSQI)
Pittsburgh Sleep Quality Index - Daytime dysfunction
|
1.6735 units on a scale
Interval 1.5573 to 1.7897
|
1.7602 units on a scale
Interval 1.6399 to 1.8806
|
—
|
—
|
|
Sleep Quality: Pittsburgh Sleep Quality Index (PSQI)
Pittsburgh Sleep Quality Index - Global PSQI Score
|
10.7561 units on a scale
Interval 10.2006 to 11.3116
|
10.8145 units on a scale
Interval 10.2417 to 11.3873
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline, month 1,2,4Population: Multilinear model analyses were performed. Results provided are the Least Squares Mean and 95% C.I. for the two treatment arms. This is the least squares mean for the treatment variable averaged across all timepoints, after having controlled for other covariates. Instrument was administered only to Vets and Parts who had been activated in the protocol. Participants who opted out of responding to certain questions were not included in the analyses.
26- item (CSS) and 21- item (COS) measures, that calculate an overall Compassion for Others score, an overall Compassion for Self score, and Compassion for Self subscale scores in the domains of Self-Kindness, Self-Judgment, Common Humanity, Isolation, Mindfulness, Overidentification. CSS subdomain scales and the total score (average of components) range from 0 - 5, with higher scores indicating higher self-compassion. COS score ranges from 0 - 7, with higher scores indicating higher compassion for others.
Outcome measures
| Measure |
Control Arm - Veteran
n=137 Participants
Usual Care Waitlist Control Arm: For ethical reasons, this study will use a waitlist control arm to ultimately provide all participants exposure to the MR intervention. Dyads in the control arm will participate in all assessments like those in the treatment group, however, they will be asked to agree to not access the public web site during their participation. Wait-list control participants will be instructed to seek advice about treatment from their providers. Other than this initial advice, there will be no attempt by study personnel to influence condition management unless an issue (i.e., suicidal ideation) arises. The control condition will account for potential temporal effects that occur from passage of time (brief), and expectation effects associated with anticipation of MR participation. The control group will receive access to MR after they complete data collection.
|
Treatment Arm
n=141 Participants
Treatment Arm: MR is an user-driven, dyadic, self-care management program developed with NIMH funding (R43/44) for use by Veterans and their selected partners, individually or together, to reduce pain and distress and support physical, mental, and relationship health. MR was designed for Veterans who face obstacles accessing formal mental health services. It can also be used to complement formal services. MR is a patient-centered intervention, allowing users to determine the pace at which to proceed in each program component. MR Content. The program provides video and audio instruction in a set of 11 evidence-based wellness.
Mission Reconnect: This four-year randomized controlled trial with one intervention arm and one wait-list control arm will utilize mixed methods to evaluate the effectiveness and perceived value of the MR program in relation to physical and psychological symptoms, global health, and social outcomes.
|
Control Arm - Veteran
n=136 Participants
Usual Care Waitlist Control Arm: For ethical reasons, this study will use a waitlist control arm to ultimately provide all participants exposure to the MR intervention. Dyads in the control arm will participate in all assessments like those in the treatment group, however, they will be asked to agree to not access the public web site during their participation. Wait-list control participants will be instructed to seek advice about treatment from their providers. Other than this initial advice, there will be no attempt by study personnel to influence condition management unless an issue (i.e., suicidal ideation) arises. The control condition will account for potential temporal effects that occur from passage of time (brief), and expectation effects associated with anticipation of MR participation. The control group will receive access to MR after they complete data collection.
Mission Reconnect: This four-year randomized controlled trial with one intervention arm and one wait-list control arm will utilize mixed methods to evaluate the effectiveness and perceived value of the MR program in relation to physical and psychological symptoms, global health, and social outcomes.
|
Control Arm - Partner
n=133 Participants
Usual Care Waitlist Control Arm: For ethical reasons, this study will use a waitlist control arm to ultimately provide all participants exposure to the MR intervention. Dyads in the control arm will participate in all assessments like those in the treatment group, however, they will be asked to agree to not access the public web site during their participation. Wait-list control participants will be instructed to seek advice about treatment from their providers. Other than this initial advice, there will be no attempt by study personnel to influence condition management unless an issue (i.e., suicidal ideation) arises. The control condition will account for potential temporal effects that occur from passage of time (brief), and expectation effects associated with anticipation of MR participation. The control group will receive access to MR after they complete data collection.
Mission Reconnect: This four-year randomized controlled trial with one intervention arm and one wait-list control arm will utilize mixed methods to evaluate the effectiveness and perceived value of the MR program in relation to physical and psychological symptoms, global health, and social outcomes.
|
|---|---|---|---|---|
|
Compassion for Self and Others Scales
Overall COS
|
6.1296 units on a scale
Interval 6.0026 to 6.2565
|
5.5055 units on a scale
Interval 5.3181 to 5.693
|
5.4667 units on a scale
Interval 5.2829 to 5.6505
|
5.9148 units on a scale
Interval 5.7919 to 6.0376
|
|
Compassion for Self and Others Scales
CSS, Self-kindness Subdomain
|
3.2407 units on a scale
Interval 3.0931 to 3.3882
|
2.5769 units on a scale
Interval 2.4215 to 2.7323
|
2.7097 units on a scale
Interval 2.5581 to 2.8613
|
3.2320 units on a scale
Interval 3.0876 to 3.3765
|
|
Compassion for Self and Others Scales
Overall CSS
|
3.2624 units on a scale
Interval 3.1368 to 3.388
|
2.7177 units on a scale
Interval 2.5843 to 2.851
|
2.7983 units on a scale
Interval 2.6662 to 2.9305
|
3.2908 units on a scale
Interval 3.1662 to 3.4155
|
|
Compassion for Self and Others Scales
CSS, Self-judgment Subdomain
|
3.0189 units on a scale
Interval 2.858 to 3.1798
|
2.4873 units on a scale
Interval 2.3297 to 2.6449
|
2.5104 units on a scale
Interval 2.356 to 2.6648
|
3.0766 units on a scale
Interval 2.9186 to 3.2346
|
|
Compassion for Self and Others Scales
CSS, Common Humanity Subdomain
|
3.2938 units on a scale
Interval 3.1377 to 3.4498
|
2.7811 units on a scale
Interval 2.6305 to 2.9317
|
2.9178 units on a scale
Interval 2.7723 to 3.0634
|
3.4125 units on a scale
Interval 3.2607 to 3.5642
|
|
Compassion for Self and Others Scales
CSS, Isolation Subdomain
|
3.2216 units on a scale
Interval 3.0588 to 3.3844
|
2.6541 units on a scale
Interval 2.4834 to 2.8248
|
2.6762 units on a scale
Interval 2.5089 to 2.8436
|
3.2205 units on a scale
Interval 3.061 to 3.3799
|
|
Compassion for Self and Others Scales
CSS, Mindfulness Subdomain
|
3.5882 units on a scale
Interval 3.4454 to 3.731
|
3.0142 units on a scale
Interval 2.8653 to 3.163
|
3.1499 units on a scale
Interval 3.0052 to 3.2946
|
3.5835 units on a scale
Interval 3.4442 to 3.7228
|
|
Compassion for Self and Others Scales
CSS, Over-identification Subdomain
|
3.2191 units on a scale
Interval 3.0614 to 3.3768
|
2.7745 units on a scale
Interval 2.6027 to 2.9463
|
2.8186 units on a scale
Interval 2.6499 to 2.9874
|
3.2389 units on a scale
Interval 3.0843 to 3.3936
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline, month 1,2,4Population: Multilinear model analyses were performed. Results provided are the Least Squares Mean and 95% C.I. for the two treatment arms. This is the least squares mean for the treatment variable averaged across all timepoints, after having controlled for other covariates. Instrument was administered only to Veterans who had been activated in the protocol. Participants who opted out of responding to certain questions were not included in the analyses.
21-items, a widely used instrument for measuring depression. Respondents are asked to rate their symptoms and attitudes using a 4-point scale. Beck Depression Inventory (BDI) scores range from 0 to 63 with higher scores indicating more likely depression diagnosis, and higher prevalence of depression symptoms.
Outcome measures
| Measure |
Control Arm - Veteran
n=136 Participants
Usual Care Waitlist Control Arm: For ethical reasons, this study will use a waitlist control arm to ultimately provide all participants exposure to the MR intervention. Dyads in the control arm will participate in all assessments like those in the treatment group, however, they will be asked to agree to not access the public web site during their participation. Wait-list control participants will be instructed to seek advice about treatment from their providers. Other than this initial advice, there will be no attempt by study personnel to influence condition management unless an issue (i.e., suicidal ideation) arises. The control condition will account for potential temporal effects that occur from passage of time (brief), and expectation effects associated with anticipation of MR participation. The control group will receive access to MR after they complete data collection.
|
Treatment Arm
n=141 Participants
Treatment Arm: MR is an user-driven, dyadic, self-care management program developed with NIMH funding (R43/44) for use by Veterans and their selected partners, individually or together, to reduce pain and distress and support physical, mental, and relationship health. MR was designed for Veterans who face obstacles accessing formal mental health services. It can also be used to complement formal services. MR is a patient-centered intervention, allowing users to determine the pace at which to proceed in each program component. MR Content. The program provides video and audio instruction in a set of 11 evidence-based wellness.
Mission Reconnect: This four-year randomized controlled trial with one intervention arm and one wait-list control arm will utilize mixed methods to evaluate the effectiveness and perceived value of the MR program in relation to physical and psychological symptoms, global health, and social outcomes.
|
Control Arm - Veteran
Usual Care Waitlist Control Arm: For ethical reasons, this study will use a waitlist control arm to ultimately provide all participants exposure to the MR intervention. Dyads in the control arm will participate in all assessments like those in the treatment group, however, they will be asked to agree to not access the public web site during their participation. Wait-list control participants will be instructed to seek advice about treatment from their providers. Other than this initial advice, there will be no attempt by study personnel to influence condition management unless an issue (i.e., suicidal ideation) arises. The control condition will account for potential temporal effects that occur from passage of time (brief), and expectation effects associated with anticipation of MR participation. The control group will receive access to MR after they complete data collection.
Mission Reconnect: This four-year randomized controlled trial with one intervention arm and one wait-list control arm will utilize mixed methods to evaluate the effectiveness and perceived value of the MR program in relation to physical and psychological symptoms, global health, and social outcomes.
|
Control Arm - Partner
Usual Care Waitlist Control Arm: For ethical reasons, this study will use a waitlist control arm to ultimately provide all participants exposure to the MR intervention. Dyads in the control arm will participate in all assessments like those in the treatment group, however, they will be asked to agree to not access the public web site during their participation. Wait-list control participants will be instructed to seek advice about treatment from their providers. Other than this initial advice, there will be no attempt by study personnel to influence condition management unless an issue (i.e., suicidal ideation) arises. The control condition will account for potential temporal effects that occur from passage of time (brief), and expectation effects associated with anticipation of MR participation. The control group will receive access to MR after they complete data collection.
Mission Reconnect: This four-year randomized controlled trial with one intervention arm and one wait-list control arm will utilize mixed methods to evaluate the effectiveness and perceived value of the MR program in relation to physical and psychological symptoms, global health, and social outcomes.
|
|---|---|---|---|---|
|
Depression: Beck Depression Inventory (BDI)
|
24.6833 units on a scale
Interval 22.4713 to 26.8952
|
26.2981 units on a scale
Interval 24.0543 to 28.542
|
—
|
—
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline, month 1,2,4Population: Multilinear model analyses were performed. Results provided are the Least Squares Mean and 95% C.I. for the two treatment arms. This is the least squares mean for the treatment variable averaged across all timepoints, after having controlled for other covariates. Instrument was administered only to Veterans who had been activated in the protocol. Participants who opted out of responding to certain questions were not included in the analyses.
10 Likert-scaled items, validated and widely used, to determine perceived stress levels. Perceived Stress Scale (PSS) scaled from 0 to 40 with higher scores indicating higher perceived stress.
Outcome measures
| Measure |
Control Arm - Veteran
n=136 Participants
Usual Care Waitlist Control Arm: For ethical reasons, this study will use a waitlist control arm to ultimately provide all participants exposure to the MR intervention. Dyads in the control arm will participate in all assessments like those in the treatment group, however, they will be asked to agree to not access the public web site during their participation. Wait-list control participants will be instructed to seek advice about treatment from their providers. Other than this initial advice, there will be no attempt by study personnel to influence condition management unless an issue (i.e., suicidal ideation) arises. The control condition will account for potential temporal effects that occur from passage of time (brief), and expectation effects associated with anticipation of MR participation. The control group will receive access to MR after they complete data collection.
|
Treatment Arm
n=141 Participants
Treatment Arm: MR is an user-driven, dyadic, self-care management program developed with NIMH funding (R43/44) for use by Veterans and their selected partners, individually or together, to reduce pain and distress and support physical, mental, and relationship health. MR was designed for Veterans who face obstacles accessing formal mental health services. It can also be used to complement formal services. MR is a patient-centered intervention, allowing users to determine the pace at which to proceed in each program component. MR Content. The program provides video and audio instruction in a set of 11 evidence-based wellness.
Mission Reconnect: This four-year randomized controlled trial with one intervention arm and one wait-list control arm will utilize mixed methods to evaluate the effectiveness and perceived value of the MR program in relation to physical and psychological symptoms, global health, and social outcomes.
|
Control Arm - Veteran
Usual Care Waitlist Control Arm: For ethical reasons, this study will use a waitlist control arm to ultimately provide all participants exposure to the MR intervention. Dyads in the control arm will participate in all assessments like those in the treatment group, however, they will be asked to agree to not access the public web site during their participation. Wait-list control participants will be instructed to seek advice about treatment from their providers. Other than this initial advice, there will be no attempt by study personnel to influence condition management unless an issue (i.e., suicidal ideation) arises. The control condition will account for potential temporal effects that occur from passage of time (brief), and expectation effects associated with anticipation of MR participation. The control group will receive access to MR after they complete data collection.
Mission Reconnect: This four-year randomized controlled trial with one intervention arm and one wait-list control arm will utilize mixed methods to evaluate the effectiveness and perceived value of the MR program in relation to physical and psychological symptoms, global health, and social outcomes.
|
Control Arm - Partner
Usual Care Waitlist Control Arm: For ethical reasons, this study will use a waitlist control arm to ultimately provide all participants exposure to the MR intervention. Dyads in the control arm will participate in all assessments like those in the treatment group, however, they will be asked to agree to not access the public web site during their participation. Wait-list control participants will be instructed to seek advice about treatment from their providers. Other than this initial advice, there will be no attempt by study personnel to influence condition management unless an issue (i.e., suicidal ideation) arises. The control condition will account for potential temporal effects that occur from passage of time (brief), and expectation effects associated with anticipation of MR participation. The control group will receive access to MR after they complete data collection.
Mission Reconnect: This four-year randomized controlled trial with one intervention arm and one wait-list control arm will utilize mixed methods to evaluate the effectiveness and perceived value of the MR program in relation to physical and psychological symptoms, global health, and social outcomes.
|
|---|---|---|---|---|
|
Stress: Perceived Stress Scale (PSS)
|
21.9134 units on a scale
Interval 20.822 to 23.0049
|
22.9251 units on a scale
Interval 21.8127 to 24.0376
|
—
|
—
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline, month 1,2,4Population: Multilinear model analyses were performed. Results provided are the Least Squares Mean and 95% C.I. for the two treatment arms. This is the least squares mean for the treatment variable averaged across all timepoints, after having controlled for other covariates. Instrument was administered only to Vets and Parts who had been activated in the protocol. Participants who opted out of responding to certain questions were not included in the analyses.
14-item Likert-scaled instrument that contains domains for dyadic Consensus (sub-domain Decision Making, Values, and Affection), dyadic Satisfaction (sub-domain Stability and Conflict), and dyadic Cohesion (sub-domain Activities and Discussion). Scores on the Revised Dyadic Adjustment Scale (RDAS) range from 0 to 69 with higher scores indicating greater relationship satisfaction and lower scores indicating greater relationship distress.
Outcome measures
| Measure |
Control Arm - Veteran
n=136 Participants
Usual Care Waitlist Control Arm: For ethical reasons, this study will use a waitlist control arm to ultimately provide all participants exposure to the MR intervention. Dyads in the control arm will participate in all assessments like those in the treatment group, however, they will be asked to agree to not access the public web site during their participation. Wait-list control participants will be instructed to seek advice about treatment from their providers. Other than this initial advice, there will be no attempt by study personnel to influence condition management unless an issue (i.e., suicidal ideation) arises. The control condition will account for potential temporal effects that occur from passage of time (brief), and expectation effects associated with anticipation of MR participation. The control group will receive access to MR after they complete data collection.
|
Treatment Arm
n=141 Participants
Treatment Arm: MR is an user-driven, dyadic, self-care management program developed with NIMH funding (R43/44) for use by Veterans and their selected partners, individually or together, to reduce pain and distress and support physical, mental, and relationship health. MR was designed for Veterans who face obstacles accessing formal mental health services. It can also be used to complement formal services. MR is a patient-centered intervention, allowing users to determine the pace at which to proceed in each program component. MR Content. The program provides video and audio instruction in a set of 11 evidence-based wellness.
Mission Reconnect: This four-year randomized controlled trial with one intervention arm and one wait-list control arm will utilize mixed methods to evaluate the effectiveness and perceived value of the MR program in relation to physical and psychological symptoms, global health, and social outcomes.
|
Control Arm - Veteran
n=136 Participants
Usual Care Waitlist Control Arm: For ethical reasons, this study will use a waitlist control arm to ultimately provide all participants exposure to the MR intervention. Dyads in the control arm will participate in all assessments like those in the treatment group, however, they will be asked to agree to not access the public web site during their participation. Wait-list control participants will be instructed to seek advice about treatment from their providers. Other than this initial advice, there will be no attempt by study personnel to influence condition management unless an issue (i.e., suicidal ideation) arises. The control condition will account for potential temporal effects that occur from passage of time (brief), and expectation effects associated with anticipation of MR participation. The control group will receive access to MR after they complete data collection.
Mission Reconnect: This four-year randomized controlled trial with one intervention arm and one wait-list control arm will utilize mixed methods to evaluate the effectiveness and perceived value of the MR program in relation to physical and psychological symptoms, global health, and social outcomes.
|
Control Arm - Partner
n=133 Participants
Usual Care Waitlist Control Arm: For ethical reasons, this study will use a waitlist control arm to ultimately provide all participants exposure to the MR intervention. Dyads in the control arm will participate in all assessments like those in the treatment group, however, they will be asked to agree to not access the public web site during their participation. Wait-list control participants will be instructed to seek advice about treatment from their providers. Other than this initial advice, there will be no attempt by study personnel to influence condition management unless an issue (i.e., suicidal ideation) arises. The control condition will account for potential temporal effects that occur from passage of time (brief), and expectation effects associated with anticipation of MR participation. The control group will receive access to MR after they complete data collection.
Mission Reconnect: This four-year randomized controlled trial with one intervention arm and one wait-list control arm will utilize mixed methods to evaluate the effectiveness and perceived value of the MR program in relation to physical and psychological symptoms, global health, and social outcomes.
|
|---|---|---|---|---|
|
Revised Dyadic Adjustment Scale (RDAS)
Total Consensus Domain, RDAS
|
21.5715 units on a scale
Interval 20.7299 to 22.413
|
21.2171 units on a scale
Interval 20.3318 to 22.1025
|
22.0963 units on a scale
Interval 21.4122 to 22.7805
|
22.5988 units on a scale
Interval 21.9356 to 23.262
|
|
Revised Dyadic Adjustment Scale (RDAS)
Subdomain: Discussion. Cohesion Domain, RDAS
|
6.8995 units on a scale
Interval 6.5375 to 7.2614
|
6.5337 units on a scale
Interval 6.1557 to 6.9117
|
6.9106 units on a scale
Interval 6.5682 to 7.253
|
6.5975 units on a scale
Interval 6.2667 to 6.9284
|
|
Revised Dyadic Adjustment Scale (RDAS)
Total RDAS
|
47.8727 units on a scale
Interval 46.171 to 49.5745
|
46.5186 units on a scale
Interval 44.7637 to 48.2734
|
48.4518 units on a scale
Interval 46.936 to 49.9676
|
48.4138 units on a scale
Interval 46.9186 to 49.9091
|
|
Revised Dyadic Adjustment Scale (RDAS)
Subdomain: Decision Making. Consensus Domain, RDAS
|
7.5229 units on a scale
Interval 7.2281 to 7.8177
|
7.4194 units on a scale
Interval 7.109 to 7.7298
|
7.6760 units on a scale
Interval 7.4422 to 7.9098
|
7.7975 units on a scale
Interval 7.5747 to 8.0202
|
|
Revised Dyadic Adjustment Scale (RDAS)
Subdomain: Values. Consensus Domain, RDAS
|
7.3515 units on a scale
Interval 7.0774 to 7.6256
|
7.4926 units on a scale
Interval 7.2021 to 7.783
|
7.3577 units on a scale
Interval 7.099 to 7.6163
|
7.5449 units on a scale
Interval 7.2967 to 7.7931
|
|
Revised Dyadic Adjustment Scale (RDAS)
Subdomain: Affection. Consensus Domain, RDAS
|
6.7036 units on a scale
Interval 6.3005 to 7.1066
|
6.3686 units on a scale
Interval 5.9426 to 6.7947
|
7.0612 units on a scale
Interval 6.7448 to 7.3776
|
7.2958 units on a scale
Interval 6.9897 to 7.602
|
|
Revised Dyadic Adjustment Scale (RDAS)
Subdomain: Stability. Satisfaction Domain, RDAS
|
8.1900 units on a scale
Interval 7.8844 to 8.4957
|
8.1158 units on a scale
Interval 7.7955 to 8.436
|
8.3706 units on a scale
Interval 8.0901 to 8.6511
|
8.2289 units on a scale
Interval 7.952 to 8.5058
|
|
Revised Dyadic Adjustment Scale (RDAS)
Subdomain: Conflict. Satisfaction Domain, RDAS
|
6.5229 units on a scale
Interval 6.2323 to 6.8136
|
6.5146 units on a scale
Interval 6.2132 to 6.8161
|
6.4356 units on a scale
Interval 6.1667 to 6.7045
|
6.3987 units on a scale
Interval 6.1332 to 6.6643
|
|
Revised Dyadic Adjustment Scale (RDAS)
Total Satisfaction Domain, RDAS
|
14.7285 units on a scale
Interval 14.2022 to 15.2547
|
14.6541 units on a scale
Interval 14.1082 to 15.1999
|
14.8108 units on a scale
Interval 14.31 to 15.3117
|
14.6276 units on a scale
Interval 14.1307 to 15.1244
|
|
Revised Dyadic Adjustment Scale (RDAS)
Subdomain: Activities. Cohesion Domain, RDAS
|
4.6511 units on a scale
Interval 4.3443 to 4.9579
|
4.1842 units on a scale
Interval 3.8649 to 4.5035
|
4.6317 units on a scale
Interval 4.3504 to 4.9129
|
4.6058 units on a scale
Interval 4.3346 to 4.8771
|
|
Revised Dyadic Adjustment Scale (RDAS)
Total Cohesion Domain, RDAS
|
11.5612 units on a scale
Interval 10.9506 to 12.1718
|
10.7219 units on a scale
Interval 10.09 to 11.3537
|
11.5357 units on a scale
Interval 10.9654 to 12.106
|
11.2067 units on a scale
Interval 10.6549 to 11.7586
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Month 4Population: Instrument requests experiences with treatment. Instrument only administered to Veterans and Partners in the Treatment Arm who were activated in the protocol. Participants who opted out of responding to certain questions were not included in the analyses for the instrument.
11 eleven-point Likert-type items (i.e., 0-10) assess satisfaction using MR components, whether they would recommend MR, and massage satisfaction. Higher scores refer to higher satisfaction with MR.
Outcome measures
| Measure |
Control Arm - Veteran
n=133 Participants
Usual Care Waitlist Control Arm: For ethical reasons, this study will use a waitlist control arm to ultimately provide all participants exposure to the MR intervention. Dyads in the control arm will participate in all assessments like those in the treatment group, however, they will be asked to agree to not access the public web site during their participation. Wait-list control participants will be instructed to seek advice about treatment from their providers. Other than this initial advice, there will be no attempt by study personnel to influence condition management unless an issue (i.e., suicidal ideation) arises. The control condition will account for potential temporal effects that occur from passage of time (brief), and expectation effects associated with anticipation of MR participation. The control group will receive access to MR after they complete data collection.
|
Treatment Arm
n=133 Participants
Treatment Arm: MR is an user-driven, dyadic, self-care management program developed with NIMH funding (R43/44) for use by Veterans and their selected partners, individually or together, to reduce pain and distress and support physical, mental, and relationship health. MR was designed for Veterans who face obstacles accessing formal mental health services. It can also be used to complement formal services. MR is a patient-centered intervention, allowing users to determine the pace at which to proceed in each program component. MR Content. The program provides video and audio instruction in a set of 11 evidence-based wellness.
Mission Reconnect: This four-year randomized controlled trial with one intervention arm and one wait-list control arm will utilize mixed methods to evaluate the effectiveness and perceived value of the MR program in relation to physical and psychological symptoms, global health, and social outcomes.
|
Control Arm - Veteran
Usual Care Waitlist Control Arm: For ethical reasons, this study will use a waitlist control arm to ultimately provide all participants exposure to the MR intervention. Dyads in the control arm will participate in all assessments like those in the treatment group, however, they will be asked to agree to not access the public web site during their participation. Wait-list control participants will be instructed to seek advice about treatment from their providers. Other than this initial advice, there will be no attempt by study personnel to influence condition management unless an issue (i.e., suicidal ideation) arises. The control condition will account for potential temporal effects that occur from passage of time (brief), and expectation effects associated with anticipation of MR participation. The control group will receive access to MR after they complete data collection.
Mission Reconnect: This four-year randomized controlled trial with one intervention arm and one wait-list control arm will utilize mixed methods to evaluate the effectiveness and perceived value of the MR program in relation to physical and psychological symptoms, global health, and social outcomes.
|
Control Arm - Partner
Usual Care Waitlist Control Arm: For ethical reasons, this study will use a waitlist control arm to ultimately provide all participants exposure to the MR intervention. Dyads in the control arm will participate in all assessments like those in the treatment group, however, they will be asked to agree to not access the public web site during their participation. Wait-list control participants will be instructed to seek advice about treatment from their providers. Other than this initial advice, there will be no attempt by study personnel to influence condition management unless an issue (i.e., suicidal ideation) arises. The control condition will account for potential temporal effects that occur from passage of time (brief), and expectation effects associated with anticipation of MR participation. The control group will receive access to MR after they complete data collection.
Mission Reconnect: This four-year randomized controlled trial with one intervention arm and one wait-list control arm will utilize mixed methods to evaluate the effectiveness and perceived value of the MR program in relation to physical and psychological symptoms, global health, and social outcomes.
|
|---|---|---|---|---|
|
MR Program Satisfaction Items
Response to "I am satisfied with the Mission Reconnect program."
|
8 units on a scale
Interval 7.0 to 10.0
|
8 units on a scale
Interval 6.0 to 10.0
|
—
|
—
|
|
MR Program Satisfaction Items
Response to "I would recommend Mission Reconnect to other Veterans and their partners."
|
8 units on a scale
Interval 7.0 to 10.0
|
9 units on a scale
Interval 7.0 to 10.0
|
—
|
—
|
|
MR Program Satisfaction Items
Response to "I am satisfied with the "Connecting to Yourself" activities."
|
8 units on a scale
Interval 7.0 to 10.0
|
8 units on a scale
Interval 6.5 to 9.5
|
—
|
—
|
|
MR Program Satisfaction Items
Response to "I am satisfied with my ability to connect with myself."
|
8 units on a scale
Interval 7.0 to 10.0
|
8 units on a scale
Interval 6.0 to 9.0
|
—
|
—
|
|
MR Program Satisfaction Items
Response to "I am satisfied with the "Connecting with Quiet" activities."
|
8 units on a scale
Interval 7.0 to 10.0
|
8 units on a scale
Interval 6.0 to 10.0
|
—
|
—
|
|
MR Program Satisfaction Items
Response to "I am satisfied with my ability to connect with quiet."
|
8 units on a scale
Interval 6.0 to 10.0
|
8 units on a scale
Interval 6.0 to 10.0
|
—
|
—
|
|
MR Program Satisfaction Items
Response to "I am satisfied with the "Connecting with Your Partner" activities."
|
8 units on a scale
Interval 6.0 to 10.0
|
8 units on a scale
Interval 6.0 to 10.0
|
—
|
—
|
|
MR Program Satisfaction Items
Response to "I am satisfied with my ability to connect with my partner."
|
7.5 units on a scale
Interval 6.0 to 10.0
|
8 units on a scale
Interval 5.0 to 10.0
|
—
|
—
|
|
MR Program Satisfaction Items
Response to "I am satisfied with receiving massage from my partner."
|
9 units on a scale
Interval 6.0 to 10.0
|
8 units on a scale
Interval 6.0 to 10.0
|
—
|
—
|
|
MR Program Satisfaction Items
Response to "I am satisfied with my ability to give my partner massage."
|
8 units on a scale
Interval 7.0 to 10.0
|
8 units on a scale
Interval 5.0 to 10.0
|
—
|
—
|
|
MR Program Satisfaction Items
Response to "I am satisfied with the Mission Reconnect Support Materials activities."
|
8 units on a scale
Interval 6.0 to 10.0
|
8 units on a scale
Interval 6.0 to 10.0
|
—
|
—
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Month 4Population: Instrument requests experiences with treatment. Instrument only administered to Veterans and Partners in the Treatment Arm who were activated in the protocol. Participants who opted out of responding to certain questions were not included in the analyses for the instrument.
Treatment group: weekly report 11-items will assess frequency of use and compliance of the MR mind/body \& massage practices. Measure calculated in number of minutes per week the participant performed the activity.
Outcome measures
| Measure |
Control Arm - Veteran
n=133 Participants
Usual Care Waitlist Control Arm: For ethical reasons, this study will use a waitlist control arm to ultimately provide all participants exposure to the MR intervention. Dyads in the control arm will participate in all assessments like those in the treatment group, however, they will be asked to agree to not access the public web site during their participation. Wait-list control participants will be instructed to seek advice about treatment from their providers. Other than this initial advice, there will be no attempt by study personnel to influence condition management unless an issue (i.e., suicidal ideation) arises. The control condition will account for potential temporal effects that occur from passage of time (brief), and expectation effects associated with anticipation of MR participation. The control group will receive access to MR after they complete data collection.
|
Treatment Arm
n=133 Participants
Treatment Arm: MR is an user-driven, dyadic, self-care management program developed with NIMH funding (R43/44) for use by Veterans and their selected partners, individually or together, to reduce pain and distress and support physical, mental, and relationship health. MR was designed for Veterans who face obstacles accessing formal mental health services. It can also be used to complement formal services. MR is a patient-centered intervention, allowing users to determine the pace at which to proceed in each program component. MR Content. The program provides video and audio instruction in a set of 11 evidence-based wellness.
Mission Reconnect: This four-year randomized controlled trial with one intervention arm and one wait-list control arm will utilize mixed methods to evaluate the effectiveness and perceived value of the MR program in relation to physical and psychological symptoms, global health, and social outcomes.
|
Control Arm - Veteran
Usual Care Waitlist Control Arm: For ethical reasons, this study will use a waitlist control arm to ultimately provide all participants exposure to the MR intervention. Dyads in the control arm will participate in all assessments like those in the treatment group, however, they will be asked to agree to not access the public web site during their participation. Wait-list control participants will be instructed to seek advice about treatment from their providers. Other than this initial advice, there will be no attempt by study personnel to influence condition management unless an issue (i.e., suicidal ideation) arises. The control condition will account for potential temporal effects that occur from passage of time (brief), and expectation effects associated with anticipation of MR participation. The control group will receive access to MR after they complete data collection.
Mission Reconnect: This four-year randomized controlled trial with one intervention arm and one wait-list control arm will utilize mixed methods to evaluate the effectiveness and perceived value of the MR program in relation to physical and psychological symptoms, global health, and social outcomes.
|
Control Arm - Partner
Usual Care Waitlist Control Arm: For ethical reasons, this study will use a waitlist control arm to ultimately provide all participants exposure to the MR intervention. Dyads in the control arm will participate in all assessments like those in the treatment group, however, they will be asked to agree to not access the public web site during their participation. Wait-list control participants will be instructed to seek advice about treatment from their providers. Other than this initial advice, there will be no attempt by study personnel to influence condition management unless an issue (i.e., suicidal ideation) arises. The control condition will account for potential temporal effects that occur from passage of time (brief), and expectation effects associated with anticipation of MR participation. The control group will receive access to MR after they complete data collection.
Mission Reconnect: This four-year randomized controlled trial with one intervention arm and one wait-list control arm will utilize mixed methods to evaluate the effectiveness and perceived value of the MR program in relation to physical and psychological symptoms, global health, and social outcomes.
|
|---|---|---|---|---|
|
MR Program Utilization
Utilization in the "Connecting with Yourself" Domain
|
55 minutes per week
Interval 15.0 to 98.0
|
30 minutes per week
Interval 0.0 to 110.0
|
—
|
—
|
|
MR Program Utilization
Utilization in the "Connecting with the Quiet" Domain
|
42 minutes per week
Interval 10.0 to 95.0
|
40 minutes per week
Interval 0.0 to 98.0
|
—
|
—
|
|
MR Program Utilization
Utilization in the "Connecting with your Partner" Domain
|
43 minutes per week
Interval 9.0 to 140.0
|
60 minutes per week
Interval 0.0 to 240.0
|
—
|
—
|
|
MR Program Utilization
Total Utilization
|
190 minutes per week
Interval 70.0 to 360.0
|
201 minutes per week
Interval 0.0 to 565.0
|
—
|
—
|
Adverse Events
Treatment Arm - Veteran
Serious events: 0 serious events
Other events: 7 other events
Deaths: 0 deaths
Treatment Arm - Partner
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Control Arm - Veteran
Serious events: 0 serious events
Other events: 7 other events
Deaths: 0 deaths
Control Arm - Partner
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Treatment Arm - Veteran
n=196 participants at risk
Treatment Arm: MR is an user-driven, dyadic, self-care management program developed with NIMH funding (R43/44) for use by Veterans and their selected partners, individually or together, to reduce pain and distress and support physical, mental, and relationship health. MR was designed for Veterans who face obstacles accessing formal mental health services. It can also be used to complement formal services. MR is a patient-centered intervention, allowing users to determine the pace at which to proceed in each program component. MR Content. The program provides video and audio instruction in a set of 11 evidence-based wellness.
Mission Reconnect: This four-year randomized controlled trial with one intervention arm and one wait-list control arm will utilize mixed methods to evaluate the effectiveness and perceived value of the MR program in relation to physical and psychological symptoms, global health, and social outcomes.
|
Treatment Arm - Partner
n=198 participants at risk
Treatment Arm: MR is an user-driven, dyadic, self-care management program developed with NIMH funding (R43/44) for use by Veterans and their selected partners, individually or together, to reduce pain and distress and support physical, mental, and relationship health. MR was designed for Veterans who face obstacles accessing formal mental health services. It can also be used to complement formal services. MR is a patient-centered intervention, allowing users to determine the pace at which to proceed in each program component. MR Content. The program provides video and audio instruction in a set of 11 evidence-based wellness.
Mission Reconnect: This four-year randomized controlled trial with one intervention arm and one wait-list control arm will utilize mixed methods to evaluate the effectiveness and perceived value of the MR program in relation to physical and psychological symptoms, global health, and social outcomes.
|
Control Arm - Veteran
n=168 participants at risk
Usual Care Waitlist Control Arm: For ethical reasons, this study will use a waitlist control arm to ultimately provide all participants exposure to the MR intervention. Dyads in the control arm will participate in all assessments like those in the treatment group, however, they will be asked to agree to not access the public web site during their participation. Wait-list control participants will be instructed to seek advice about treatment from their providers. Other than this initial advice, there will be no attempt by study personnel to influence condition management unless an issue (i.e., suicidal ideation) arises. The control condition will account for potential temporal effects that occur from passage of time (brief), and expectation effects associated with anticipation of MR participation. The control group will receive access to MR after they complete data collection.
Mission Reconnect: This four-year randomized controlled trial with one intervention arm and one wait-list control arm will utilize mixed methods to evaluate the effectiveness and perceived value of the MR program in relation to physical and psychological symptoms, global health, and social outcomes.
|
Control Arm - Partner
n=168 participants at risk
Usual Care Waitlist Control Arm: For ethical reasons, this study will use a waitlist control arm to ultimately provide all participants exposure to the MR intervention. Dyads in the control arm will participate in all assessments like those in the treatment group, however, they will be asked to agree to not access the public web site during their participation. Wait-list control participants will be instructed to seek advice about treatment from their providers. Other than this initial advice, there will be no attempt by study personnel to influence condition management unless an issue (i.e., suicidal ideation) arises. The control condition will account for potential temporal effects that occur from passage of time (brief), and expectation effects associated with anticipation of MR participation. The control group will receive access to MR after they complete data collection.
Mission Reconnect: This four-year randomized controlled trial with one intervention arm and one wait-list control arm will utilize mixed methods to evaluate the effectiveness and perceived value of the MR program in relation to physical and psychological symptoms, global health, and social outcomes.
|
|---|---|---|---|---|
|
Social circumstances
Suicide Ideation
|
3.6%
7/196 • Number of events 16 • Baseline (before the start of the study activities) and 1, 2 & 4 months after study activities)
While all participants are given a baseline coverage of resources to deal with suicidal ideation, domestic violence issues, and/or severe depression/mental health issues, the Veteran participants are also directly asked at Baseline and at the monthly time points if they specifically have suicidal ideation. An affirmative response of any suicidal ideation with intent and/or plan of action.
|
0.00%
0/198 • Baseline (before the start of the study activities) and 1, 2 & 4 months after study activities)
While all participants are given a baseline coverage of resources to deal with suicidal ideation, domestic violence issues, and/or severe depression/mental health issues, the Veteran participants are also directly asked at Baseline and at the monthly time points if they specifically have suicidal ideation. An affirmative response of any suicidal ideation with intent and/or plan of action.
|
4.2%
7/168 • Number of events 8 • Baseline (before the start of the study activities) and 1, 2 & 4 months after study activities)
While all participants are given a baseline coverage of resources to deal with suicidal ideation, domestic violence issues, and/or severe depression/mental health issues, the Veteran participants are also directly asked at Baseline and at the monthly time points if they specifically have suicidal ideation. An affirmative response of any suicidal ideation with intent and/or plan of action.
|
0.00%
0/168 • Baseline (before the start of the study activities) and 1, 2 & 4 months after study activities)
While all participants are given a baseline coverage of resources to deal with suicidal ideation, domestic violence issues, and/or severe depression/mental health issues, the Veteran participants are also directly asked at Baseline and at the monthly time points if they specifically have suicidal ideation. An affirmative response of any suicidal ideation with intent and/or plan of action.
|
Additional Information
Dr. Jolie Haun
James A. Haley Veteran Hospital Research Service
Phone: 904-377-6796
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place