Trial Outcomes & Findings for Spouse READI (Resilience Education And Deployment Information) Post Deployment Telephone Support Groups (NCT NCT01121250)
NCT ID: NCT01121250
Last Updated: 2018-07-30
Results Overview
Anxiety symptoms from the Generalized Anxiety Disorder-7 (GAD-7) scale, measured from 0-21, higher scores indicate greater anxiety
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
228 participants
Primary outcome timeframe
Baseline, 6 months, and 12 months
Results posted on
2018-07-30
Participant Flow
Participant milestones
| Measure |
Telephone Discussion Groups
Each telephone discussion group will meet 12 times during six months. The one-hour calls will be semi-structured conference calls with education, training in coping skills and cognitive restructuring, and support. A Participant Workbook will include comprehensive materials for all sessions and topics, other resources, and red flag resources - areas that may exacerbate problems, add a level of difficulty or distress, and/or indicate a need for referrals (e.g., unsafe behaviors, substance abuse, spouse abuse, PTSD, depression, traumatic brain injury).
|
Education Sessions
Education sessions: Participants will have 12 sessions (delivered using slides and telephone) that cover the same education content, without skills building or support, over six months. They will also receive the Participant Workbook.
|
Usual Care
Participants do not receive any services.
|
|---|---|---|---|
|
Overall Study
STARTED
|
76
|
76
|
76
|
|
Overall Study
COMPLETED
|
76
|
76
|
75
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
1
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Spouse READI (Resilience Education And Deployment Information) Post Deployment Telephone Support Groups
Baseline characteristics by cohort
| Measure |
Telephone Discussion Groups
n=76 Participants
Each telephone discussion group will meet 12 times during six months. The one-hour calls will be semi-structured conference calls with education, training in coping skills and cognitive restructuring, and support. A Participant Workbook will include comprehensive materials for all sessions and topics, other resources, and red flag resources - areas that may exacerbate problems, add a level of difficulty or distress, and/or indicate a need for referrals (e.g., unsafe behaviors, substance abuse, spouse abuse, PTSD, depression, traumatic brain injury).
|
Education Sessions
n=76 Participants
Participants will have 12 sessions (delivered using slides and telephone) that cover the same education content, without skills building or support, over six months. They will also receive the Participant Workbook.
|
Usual Care
n=75 Participants
Participants do not receive any services.
|
Total
n=227 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
36.4 years
STANDARD_DEVIATION 8.6 • n=5 Participants
|
38.0 years
STANDARD_DEVIATION 8.3 • n=7 Participants
|
35.1 years
STANDARD_DEVIATION 8.7 • n=5 Participants
|
36.5 years
STANDARD_DEVIATION 8.6 • n=4 Participants
|
|
Sex: Female, Male
Female
|
74 Participants
n=5 Participants
|
75 Participants
n=7 Participants
|
75 Participants
n=5 Participants
|
224 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
10 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
27 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
66 Participants
n=5 Participants
|
69 Participants
n=7 Participants
|
65 Participants
n=5 Participants
|
200 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Black or African American
|
10 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
28 Participants
n=4 Participants
|
|
Race (NIH/OMB)
White
|
61 Participants
n=5 Participants
|
60 Participants
n=7 Participants
|
59 Participants
n=5 Participants
|
180 Participants
n=4 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
4 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
11 Participants
n=4 Participants
|
|
Region of Enrollment
United States
|
76 Participants
n=5 Participants
|
76 Participants
n=7 Participants
|
75 Participants
n=5 Participants
|
227 Participants
n=4 Participants
|
PRIMARY outcome
Timeframe: Baseline, 6 months, and 12 monthsPopulation: All participants with anxiety data at baseline, six months, and twelve months
Anxiety symptoms from the Generalized Anxiety Disorder-7 (GAD-7) scale, measured from 0-21, higher scores indicate greater anxiety
Outcome measures
| Measure |
Telephone Discussion Groups
n=76 Participants
Each telephone discussion group will meet 12 times during six months. The one-hour calls will be semi-structured conference calls with education, training in coping skills and cognitive restructuring, and support. A Participant Workbook will include comprehensive materials for all sessions and topics, other resources, and red flag resources - areas that may exacerbate problems, add a level of difficulty or distress, and/or indicate a need for referrals (e.g., unsafe behaviors, substance abuse, spouse abuse, PTSD, depression, traumatic brain injury).
|
Education Sessions
n=76 Participants
Participants will have 12 sessions (delivered using slides and telephone) that cover the same education content, without skills building or support, over six months. They will also receive the Participant Workbook.
|
Usual Care
n=75 Participants
Participants do not receive any services.
|
|---|---|---|---|
|
Spouse Self-report of Anxiety
Anxiety score at baseline
|
7.9 units on a scale
Standard Deviation 5.5
|
7.1 units on a scale
Standard Deviation 5.1
|
7.9 units on a scale
Standard Deviation 4.8
|
|
Spouse Self-report of Anxiety
Anxiety score at 6 months
|
5.5 units on a scale
Standard Deviation 4.0
|
5.2 units on a scale
Standard Deviation 4.4
|
6.2 units on a scale
Standard Deviation 4.4
|
|
Spouse Self-report of Anxiety
Anxiety score at 12 months
|
6.0 units on a scale
Standard Deviation 4.8
|
6.1 units on a scale
Standard Deviation 4.9
|
5.5 units on a scale
Standard Deviation 4.8
|
PRIMARY outcome
Timeframe: Baseline, 6 months, and 12 monthsPopulation: All participations with depression data at baseline, six and 12 months
Depression symptoms as measured on the Patient Health Questionnaire (PHQ-9), measured from 0-27, with higher numbers indicating more depression
Outcome measures
| Measure |
Telephone Discussion Groups
n=76 Participants
Each telephone discussion group will meet 12 times during six months. The one-hour calls will be semi-structured conference calls with education, training in coping skills and cognitive restructuring, and support. A Participant Workbook will include comprehensive materials for all sessions and topics, other resources, and red flag resources - areas that may exacerbate problems, add a level of difficulty or distress, and/or indicate a need for referrals (e.g., unsafe behaviors, substance abuse, spouse abuse, PTSD, depression, traumatic brain injury).
|
Education Sessions
n=76 Participants
Participants will have 12 sessions (delivered using slides and telephone) that cover the same education content, without skills building or support, over six months. They will also receive the Participant Workbook.
|
Usual Care
n=75 Participants
Participants do not receive any services.
|
|---|---|---|---|
|
Spouse Self-report of Depression
Depression symptoms at baseline
|
6.6 units on a scale
Standard Deviation 5.8
|
5.8 units on a scale
Standard Deviation 5.2
|
6.4 units on a scale
Standard Deviation 4.7
|
|
Spouse Self-report of Depression
Depression symptoms at 6 months
|
4.5 units on a scale
Standard Deviation 4.6
|
4.4 units on a scale
Standard Deviation 4.8
|
5.3 units on a scale
Standard Deviation 4.1
|
|
Spouse Self-report of Depression
Depression symptoms at 12 months
|
4.8 units on a scale
Standard Deviation 5.1
|
5.3 units on a scale
Standard Deviation 4.8
|
5.0 units on a scale
Standard Deviation 4.7
|
PRIMARY outcome
Timeframe: Baseline, 6 months, and 12 monthsPopulation: All participants with resilience data at baseline, 6 and 12 months
Resilience as measured on the Connor-Davidson Resilience Scale, measured from 0-100; higher scores show greater resilience
Outcome measures
| Measure |
Telephone Discussion Groups
n=76 Participants
Each telephone discussion group will meet 12 times during six months. The one-hour calls will be semi-structured conference calls with education, training in coping skills and cognitive restructuring, and support. A Participant Workbook will include comprehensive materials for all sessions and topics, other resources, and red flag resources - areas that may exacerbate problems, add a level of difficulty or distress, and/or indicate a need for referrals (e.g., unsafe behaviors, substance abuse, spouse abuse, PTSD, depression, traumatic brain injury).
|
Education Sessions
n=76 Participants
Participants will have 12 sessions (delivered using slides and telephone) that cover the same education content, without skills building or support, over six months. They will also receive the Participant Workbook.
|
Usual Care
n=75 Participants
Participants do not receive any services.
|
|---|---|---|---|
|
Spouse Self-report of Resilience
Resilience scores at 12 months
|
78.1 units on a scale
Standard Deviation 11.0
|
76.3 units on a scale
Standard Deviation 12.5
|
78.0 units on a scale
Standard Deviation 10.2
|
|
Spouse Self-report of Resilience
Resilience scores at baseline
|
75.8 units on a scale
Standard Deviation 10.0
|
78.8 units on a scale
Standard Deviation 10.6
|
76.4 units on a scale
Standard Deviation 9.5
|
|
Spouse Self-report of Resilience
Resilience scores at 6 months
|
78.1 units on a scale
Standard Deviation 12.4
|
77.9 units on a scale
Standard Deviation 13.0
|
77.7 units on a scale
Standard Deviation 10.7
|
Adverse Events
Telephone Discussion Groups
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Education Sessions
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Usual Care
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place