Trial Outcomes & Findings for Mechanisms of Action and Outcome (NCT NCT00555568)
NCT ID: NCT00555568
Last Updated: 2015-06-23
Results Overview
Patient activation refers to patient knowledge skill and confidence for self-management. Full name of the scale is Patient Activation Measure (PAM). Scale response options range from 1-4 and scores can range from 13-52. Higher values indicate greater activation. No subscales are used.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
298 participants
Primary outcome timeframe
3 months
Results posted on
2015-06-23
Participant Flow
Three cohorts of veterans were recruited from each of two sites. Those assigned to a peer-led group participated in the Vet-to-Vet program. Those assigned to a clinician-led group participated in a recovery-oriented group led by a clinician. Those assigned to 'treatment-as-usual' continued with their usual treatment.
Participant milestones
| Measure |
Arm 1: Peer-led Group
Arm 1 is a 3-month recovery-focused mental health education and support group led by peer facilitators
|
Arm 2: Clinician Led Group
Arm 2 is a 3-month recovery-focused mental health education and support group led by a mental health clinician
|
Arm 3: Treatment as Usual
Arm 3 is treatment as usual (no intervention)
|
|---|---|---|---|
|
Overall Study
STARTED
|
100
|
98
|
100
|
|
Overall Study
COMPLETED
|
74
|
82
|
84
|
|
Overall Study
NOT COMPLETED
|
26
|
16
|
16
|
Reasons for withdrawal
| Measure |
Arm 1: Peer-led Group
Arm 1 is a 3-month recovery-focused mental health education and support group led by peer facilitators
|
Arm 2: Clinician Led Group
Arm 2 is a 3-month recovery-focused mental health education and support group led by a mental health clinician
|
Arm 3: Treatment as Usual
Arm 3 is treatment as usual (no intervention)
|
|---|---|---|---|
|
Overall Study
Lost to Follow-up
|
26
|
16
|
16
|
Baseline Characteristics
Mechanisms of Action and Outcome
Baseline characteristics by cohort
| Measure |
Arm 1: Peer-Led Group
n=100 Participants
Arm 1 is a 3-month recovery-focused mental health education and support group led by peer facilitators
recovery oriented mental health peer support group: This is a recovery-focused mental health education and support group led by peer facilitators
|
Arm 2: Clinician-Led Group
n=98 Participants
Arm 2 is a 3-month recovery-focused mental health education and support group led by a mental health clinician
recovery-oriented mental health clinician-led group: This is a recovery-focused mental health education and support group led by a mental health clinician
|
Arm 3: Treatment as Usual
n=100 Participants
Arm 3 is treatment as usual (no intervention)
|
Total
n=298 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
12 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
28 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
88 Participants
n=5 Participants
|
90 Participants
n=7 Participants
|
92 Participants
n=5 Participants
|
270 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
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 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
|
22 Participants
n=5 Participants
|
32 Participants
n=7 Participants
|
23 Participants
n=5 Participants
|
77 Participants
n=4 Participants
|
|
Race (NIH/OMB)
White
|
66 Participants
n=5 Participants
|
58 Participants
n=7 Participants
|
66 Participants
n=5 Participants
|
190 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
|
12 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
31 Participants
n=4 Participants
|
|
Region of Enrollment
United States
|
100 participants
n=5 Participants
|
98 participants
n=7 Participants
|
100 participants
n=5 Participants
|
298 participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
95 Participants
n=5 Participants
|
88 Participants
n=7 Participants
|
93 Participants
n=5 Participants
|
276 Participants
n=4 Participants
|
|
Age, Customized
< 35 years
|
7 participants
n=5 Participants
|
8 participants
n=7 Participants
|
3 participants
n=5 Participants
|
18 participants
n=4 Participants
|
|
Age, Customized
35-50 years
|
31 participants
n=5 Participants
|
38 participants
n=7 Participants
|
24 participants
n=5 Participants
|
93 participants
n=4 Participants
|
|
Age, Customized
51-60 years
|
44 participants
n=5 Participants
|
36 participants
n=7 Participants
|
52 participants
n=5 Participants
|
132 participants
n=4 Participants
|
|
Age, Customized
>60 years
|
18 participants
n=5 Participants
|
16 participants
n=7 Participants
|
21 participants
n=5 Participants
|
55 participants
n=4 Participants
|
|
Sex: Female, Male
Female
|
5 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
22 Participants
n=4 Participants
|
PRIMARY outcome
Timeframe: 3 monthsPatient activation refers to patient knowledge skill and confidence for self-management. Full name of the scale is Patient Activation Measure (PAM). Scale response options range from 1-4 and scores can range from 13-52. Higher values indicate greater activation. No subscales are used.
Outcome measures
| Measure |
Arm 1: Peer-led Group
n=74 Participants
Arm 1 is a 3-month recovery-focused mental health education and support group led by peer facilitators
|
Arm 2: Clinician-led Group
n=82 Participants
Arm 2 is a 3-month recovery-focused mental health education and support group led by a mental health clinician
|
Arm 3: Treatment as Usual
n=84 Participants
Arm 3 is treatment as usual (no intervention)
|
|---|---|---|---|
|
Patient Activation
|
29.12 units on a scale
Standard Deviation 5.91
|
28.82 units on a scale
Standard Deviation 6.48
|
29.21 units on a scale
Standard Deviation 5.80
|
PRIMARY outcome
Timeframe: 3 monthsEmpowerment is measured by the "Making Decisions" instrument. Response options range from 1-4 and scores can range from 28-112. Higher scores indicate more empowerment.
Outcome measures
| Measure |
Arm 1: Peer-led Group
n=74 Participants
Arm 1 is a 3-month recovery-focused mental health education and support group led by peer facilitators
|
Arm 2: Clinician-led Group
n=82 Participants
Arm 2 is a 3-month recovery-focused mental health education and support group led by a mental health clinician
|
Arm 3: Treatment as Usual
n=84 Participants
Arm 3 is treatment as usual (no intervention)
|
|---|---|---|---|
|
Empowerment
|
80.20 units on a scale
Standard Deviation 6.66
|
80.85 units on a scale
Standard Deviation 8.00
|
81.15 units on a scale
Standard Deviation 8.37
|
PRIMARY outcome
Timeframe: 3 monthsSocial Support was assessed by the Medical Outcomes Study Social Support Survey. Response options range from 1-5 and scores range from 19-95. Higher scores indicate greater social support
Outcome measures
| Measure |
Arm 1: Peer-led Group
n=74 Participants
Arm 1 is a 3-month recovery-focused mental health education and support group led by peer facilitators
|
Arm 2: Clinician-led Group
n=82 Participants
Arm 2 is a 3-month recovery-focused mental health education and support group led by a mental health clinician
|
Arm 3: Treatment as Usual
n=84 Participants
Arm 3 is treatment as usual (no intervention)
|
|---|---|---|---|
|
Social Support
|
63.18 units on a scale
Standard Deviation 16.59
|
58.21 units on a scale
Standard Deviation 19.00
|
64.30 units on a scale
Standard Deviation 16.31
|
PRIMARY outcome
Timeframe: 3 monthsVR-12 MCS refers to the Mental Health Component of the SF-12. The rating scale varies depending on the item. Scores range from 0-100; higher values indicate better mental health;
Outcome measures
| Measure |
Arm 1: Peer-led Group
n=74 Participants
Arm 1 is a 3-month recovery-focused mental health education and support group led by peer facilitators
|
Arm 2: Clinician-led Group
n=82 Participants
Arm 2 is a 3-month recovery-focused mental health education and support group led by a mental health clinician
|
Arm 3: Treatment as Usual
n=84 Participants
Arm 3 is treatment as usual (no intervention)
|
|---|---|---|---|
|
VR-12 MCS
|
47.16 units on a scale
Standard Deviation 12.41
|
44.57 units on a scale
Standard Deviation 13.30
|
47.18 units on a scale
Standard Deviation 12.80
|
PRIMARY outcome
Timeframe: 3 monthsBASIS-24 refers to the 24-item Behavior and Symptom Identification Scale. Responses range from 0-4; scores range from 0-4; higher values indicate greater symptom severity.
Outcome measures
| Measure |
Arm 1: Peer-led Group
n=74 Participants
Arm 1 is a 3-month recovery-focused mental health education and support group led by peer facilitators
|
Arm 2: Clinician-led Group
n=82 Participants
Arm 2 is a 3-month recovery-focused mental health education and support group led by a mental health clinician
|
Arm 3: Treatment as Usual
n=84 Participants
Arm 3 is treatment as usual (no intervention)
|
|---|---|---|---|
|
Overall Mental Health (BASIS-24 Summary Score)
|
1.09 units on a scale
Standard Deviation 0.65
|
1.24 units on a scale
Standard Deviation 0.66
|
1.08 units on a scale
Standard Deviation 0.65
|
Adverse Events
Arm 1: Peer-led Group
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Arm 2: Clinician-led Group
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Arm 3: Treatment as Usual
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
Susan V. Eisen
CHOIR (Center for Healthcare Organization & Implementation Research
Phone: 781-687-2858
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place