Trial Outcomes & Findings for A Randomized Controlled Trial of Mental Health Peer-Led Education (NCT NCT01297985)
NCT ID: NCT01297985
Last Updated: 2020-01-18
Results Overview
Recovery from mental illness is measured by the Recovery Assessment Scale (RAS) (Giffort et al., 1995). Recovery is a psychosocial outcome assessed via patient self-ratings on a 41-item scale using a 5-point Likert-response format ranging from "strongly disagree" to "strongly agree." The minimum value for the RAS is 41 and the maximum is 205, with higher scores indicating a better outcome. Dimensions of recovery include personal confidence and hope, willingness to ask for help, goal and success orientation, reliance on others, and no being dominated by one's residual psychiatric symptoms.
COMPLETED
NA
428 participants
Study entry (Pre-intervention/T1), 8-weeks later (Post-Intervention 1/T2), & 6-months after T2 (Post-Intervention 2/T3)
2020-01-18
Participant Flow
Recruitment was conducted collaboratively with the statewide consumer coalition, Tennessee Mental Health Consumer's Association (TMHCA), and the statewide National Alliance for Mental Illness (NAMI), NAMI Tennessee. Recruitment took place from March 2007 through March 2009 at local mental health agencies, and at residential and peer-run programs.
Participant milestones
| Measure |
BRIDGES Intervention
BRIDGES Peer-Led Education: The BRIDGES program is a 10-week, manualized education course designed to provide basic education about the etiology and treatment of mental illness, self-help skills, and recovery principles in order to empower participants to return to valued social roles within their communities. BRIDGES is a peer-led program and all instructors are adults with mental illnesses. For this intervention study, the BRIDGES curriculum was modified from a 10-week course to an 8-week course, meeting for 2 1/2 hours once a week.
|
Comparison Wait-list Group
Participants assigned to the comparison group were in a delayed treatment condition in which they continued in public services as usual, but were offered the chance to attend the BRIDGES program after their final research interview.
|
|---|---|---|
|
Overall Study
STARTED
|
212
|
216
|
|
Overall Study
COMPLETED
|
157
|
163
|
|
Overall Study
NOT COMPLETED
|
55
|
53
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
A Randomized Controlled Trial of Mental Health Peer-Led Education
Baseline characteristics by cohort
| Measure |
BRIDGES Intervention
n=212 Participants
BRIDGES Peer-Led Education: The BRIDGES program is a 10-week, manualized education course designed to provide basic education about the etiology and treatment of mental illness, self-help skills, and recovery principles in order to empower participants to return to valued social roles within their communities. BRIDGES is a peer-led program and all instructors are adults with mental illnesses. For this intervention study, the BRIDGES curriculum was modified from a 10-week course to an 8-week course, meeting for 2 1/2 hours once a week.
|
Comparison Wait-list Group
n=216 Participants
Participants assigned to the comparison group were in a delayed treatment condition in which they continued in public services as usual, but were offered the chance to attend the BRIDGES program after their final research interview.
|
Total
n=428 Participants
Total of all reporting groups
|
|---|---|---|---|
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Age, Continuous
|
42.7 Years
STANDARD_DEVIATION 9.9 • n=5 Participants
|
43.0 Years
STANDARD_DEVIATION 11.8 • n=7 Participants
|
42.8 Years
STANDARD_DEVIATION 10.9 • n=5 Participants
|
|
Sex: Female, Male
Female
|
114 Participants
n=5 Participants
|
124 Participants
n=7 Participants
|
238 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
98 Participants
n=5 Participants
|
92 Participants
n=7 Participants
|
190 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
75 Participants
n=5 Participants
|
71 Participants
n=7 Participants
|
146 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
137 Participants
n=5 Participants
|
145 Participants
n=7 Participants
|
282 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
10 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
25 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 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
|
|
Race (NIH/OMB)
Black or African American
|
75 Participants
n=5 Participants
|
71 Participants
n=7 Participants
|
146 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
112 Participants
n=5 Participants
|
117 Participants
n=7 Participants
|
229 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
3 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
11 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
20 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
212 participants
n=5 Participants
|
216 participants
n=7 Participants
|
428 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Study entry (Pre-intervention/T1), 8-weeks later (Post-Intervention 1/T2), & 6-months after T2 (Post-Intervention 2/T3)Population: The "Overall Number of Participants Analyzed" reflects the number of participants at Time 1
Recovery from mental illness is measured by the Recovery Assessment Scale (RAS) (Giffort et al., 1995). Recovery is a psychosocial outcome assessed via patient self-ratings on a 41-item scale using a 5-point Likert-response format ranging from "strongly disagree" to "strongly agree." The minimum value for the RAS is 41 and the maximum is 205, with higher scores indicating a better outcome. Dimensions of recovery include personal confidence and hope, willingness to ask for help, goal and success orientation, reliance on others, and no being dominated by one's residual psychiatric symptoms.
Outcome measures
| Measure |
BRIDGES Intervention
n=212 Participants
BRIDGES Peer-Led Education: The BRIDGES program is a 10-week, manualized education course designed to provide basic education about the etiology and treatment of mental illness, self-help skills, and recovery principles in order to empower participants to return to valued social roles within their communities. BRIDGES is a peer-led program and all instructors are adults with mental illnesses. For this intervention study, the BRIDGES curriculum was modified from a 10-week course to an 8-week course, meeting for 2 1/2 hours once a week.
|
Comparison Wait-list Group
n=216 Participants
Participants assigned to the comparison group were in a delayed treatment condition in which they continued in public services as usual, but were offered the chance to attend the BRIDGES program after their final research interview.
|
|---|---|---|
|
Recovery From Mental Illness
Baseline
|
91.90 score on a scale
Standard Deviation 13.65
|
90.72 score on a scale
Standard Deviation 13.33
|
|
Recovery From Mental Illness
Post-intervention 1 (Time 2)
|
94.84 score on a scale
Standard Deviation 12.83
|
91.01 score on a scale
Standard Deviation 14.35
|
|
Recovery From Mental Illness
Post-intervention 2 (Time 3)
|
96.13 score on a scale
Standard Deviation 12.76
|
91.97 score on a scale
Standard Deviation 14.58
|
PRIMARY outcome
Timeframe: Study entry (Pre-intervention/T1), 8-weeks later (Post-Intervention 1/T2), & 6-months after T2 (Post-Intervention 2/T3)Population: The "Overall Number of Participants Analyzed" reflects the number of participants at Time 1
Personal psychological empowerment is measured via the Boston University Empowerment Scale (Rogers et al.,1997). This 28-item instrument designed to measure subjective feelings of empowerment via self-report in which respondents answer questions on a four-point scale ranging from Strongly Agree to Strongly Disagree. The minimum score is 28 and the maximum is 112, with higher scores indicating a better outcome.
Outcome measures
| Measure |
BRIDGES Intervention
n=212 Participants
BRIDGES Peer-Led Education: The BRIDGES program is a 10-week, manualized education course designed to provide basic education about the etiology and treatment of mental illness, self-help skills, and recovery principles in order to empower participants to return to valued social roles within their communities. BRIDGES is a peer-led program and all instructors are adults with mental illnesses. For this intervention study, the BRIDGES curriculum was modified from a 10-week course to an 8-week course, meeting for 2 1/2 hours once a week.
|
Comparison Wait-list Group
n=216 Participants
Participants assigned to the comparison group were in a delayed treatment condition in which they continued in public services as usual, but were offered the chance to attend the BRIDGES program after their final research interview.
|
|---|---|---|
|
Personal Empowerment
Baseline (Time 1)
|
78.82 score on a scale
Standard Deviation 9.29
|
78.58 score on a scale
Standard Deviation 10.04
|
|
Personal Empowerment
Post-intervention 1 (Time 2)
|
82.31 score on a scale
Standard Deviation 9.12
|
79.91 score on a scale
Standard Deviation 9.88
|
|
Personal Empowerment
Post-intervention 2 (Time 3)
|
81.19 score on a scale
Standard Deviation 9.21
|
79.57 score on a scale
Standard Deviation 10.31
|
SECONDARY outcome
Timeframe: Study entry (Pre-intervention/T1), 8-weeks later (Post-Intervention 1/T2), & 6-months after T2 (Post-Intervention 2/T3)Population: The "Overall Number of Participants Analyzed" reflects the number of participants at Time 1
Hopefulness is measured by the State Hope Scale (Snyder et al., 1991). Hopefulness as a cross-situational long-term trait is assessed via patient self-report using a 12-item scale assessed on a 4-point Likert response scale with options ranging from "definitely false" to "definitely true" and summed to produce a total score and sub-scale scores. The minimum value for this scale is 12 and the maximum value is 48. Higher scores indicate a better income.
Outcome measures
| Measure |
BRIDGES Intervention
n=212 Participants
BRIDGES Peer-Led Education: The BRIDGES program is a 10-week, manualized education course designed to provide basic education about the etiology and treatment of mental illness, self-help skills, and recovery principles in order to empower participants to return to valued social roles within their communities. BRIDGES is a peer-led program and all instructors are adults with mental illnesses. For this intervention study, the BRIDGES curriculum was modified from a 10-week course to an 8-week course, meeting for 2 1/2 hours once a week.
|
Comparison Wait-list Group
n=211 Participants
Participants assigned to the comparison group were in a delayed treatment condition in which they continued in public services as usual, but were offered the chance to attend the BRIDGES program after their final research interview.
|
|---|---|---|
|
Hopefulness
Baseline
|
22.64 score on a scale
Standard Deviation 4.31
|
22.68 score on a scale
Standard Deviation 4.77
|
|
Hopefulness
Post-intervention 1 (Time 2)
|
23.12 score on a scale
Standard Deviation 3.73
|
22.77 score on a scale
Standard Deviation 4.80
|
|
Hopefulness
Post-intervention 2 (Time 3)
|
23.24 score on a scale
Standard Deviation 3.92
|
22.66 score on a scale
Standard Deviation 4.73
|
SECONDARY outcome
Timeframe: Study entry (Pre-intervention/T1), 8-weeks later (Post-Intervention 1/T2), & 6-months after T2 (Post-Intervention 2/T3)Population: The Overall Number of Participants Analyzed reflects the number of participants at Time 1
The ability to advocate for oneself with medical care providers is assessed via self-report using The Patient Self-Advocacy Scale (Brashers et al., 1999), an 18-item scale with a 5-point Likert response set ranging from "strongly disagree" to "strongly agree." Dimensions include in patient knowledge, assertiveness, and potential for mindful non-adherence to treatment. Scoring involves computing the mean scale score, so therefore values range from a minimum of 1 to a maximum of 5, with higher scores indicating a better outcome. Reported below are findings for the assertiveness sub-scale.
Outcome measures
| Measure |
BRIDGES Intervention
n=212 Participants
BRIDGES Peer-Led Education: The BRIDGES program is a 10-week, manualized education course designed to provide basic education about the etiology and treatment of mental illness, self-help skills, and recovery principles in order to empower participants to return to valued social roles within their communities. BRIDGES is a peer-led program and all instructors are adults with mental illnesses. For this intervention study, the BRIDGES curriculum was modified from a 10-week course to an 8-week course, meeting for 2 1/2 hours once a week.
|
Comparison Wait-list Group
n=216 Participants
Participants assigned to the comparison group were in a delayed treatment condition in which they continued in public services as usual, but were offered the chance to attend the BRIDGES program after their final research interview.
|
|---|---|---|
|
Patient Self-advocacy
Baseline
|
3.68 average score on a scale
Standard Deviation 0.71
|
3.72 average score on a scale
Standard Deviation 0.71
|
|
Patient Self-advocacy
Post-intervention 1 (Time 2)
|
3.82 average score on a scale
Standard Deviation 0.72
|
3.73 average score on a scale
Standard Deviation 0.76
|
|
Patient Self-advocacy
Post-intervention 2 (Time 3)
|
3.82 average score on a scale
Standard Deviation 0.73
|
3.79 average score on a scale
Standard Deviation 0.75
|
SECONDARY outcome
Timeframe: Study entry (Pre-intervention/T1), 8-weeks later (Post-Intervention 1/T2), & 6-months after T2 (Post-Intervention 2/T3)Population: The "Overall Number of Participants Analyzed" reflects the number of participants at Time 1. Results are provided for the Maladaptive Coping Subcale.
Coping is measured via patient self-report using The Brief COPE Inventory (Carver, 1997), a 28-item instrument with 4-point Likert responses ranging from 1-"I haven't been doing this at all" to 4-"I have been doing this a lot." This measure includes two subscales that assess participants' adaptive coping skills (e.g., planning and using emotional support to deal with problems) and maladaptive coping skills (e.g., self-blame and denial). Scoring involves computing the means for each subscale, with a minimum value of 1 and a maximum value of 4. Higher adaptive coping scores indicate a greater use of positive coping styles; higher maladaptive coping scores indicate a greater use of negative coping styles (in other words, lower maladative coping scores indicate a better outcome).
Outcome measures
| Measure |
BRIDGES Intervention
n=212 Participants
BRIDGES Peer-Led Education: The BRIDGES program is a 10-week, manualized education course designed to provide basic education about the etiology and treatment of mental illness, self-help skills, and recovery principles in order to empower participants to return to valued social roles within their communities. BRIDGES is a peer-led program and all instructors are adults with mental illnesses. For this intervention study, the BRIDGES curriculum was modified from a 10-week course to an 8-week course, meeting for 2 1/2 hours once a week.
|
Comparison Wait-list Group
n=216 Participants
Participants assigned to the comparison group were in a delayed treatment condition in which they continued in public services as usual, but were offered the chance to attend the BRIDGES program after their final research interview.
|
|---|---|---|
|
Coping Style
Baseline (Time 1)
|
2.14 units on a scale
Standard Deviation 0.53
|
2.14 units on a scale
Standard Deviation 0.54
|
|
Coping Style
Post-intervention 1 (Time 2)
|
2.01 units on a scale
Standard Deviation 0.51
|
2.13 units on a scale
Standard Deviation 0.53
|
|
Coping Style
Post-intervention 2 (Time 3)
|
2.04 units on a scale
Standard Deviation 0.48
|
2.06 units on a scale
Standard Deviation 0.52
|
Adverse Events
BRIDGES Intervention
Comparison Wait-list Group
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
BRIDGES Intervention
n=212 participants at risk
BRIDGES Peer-Led Education: The BRIDGES program is a 10-week, manualized education course designed to provide basic education about the etiology and treatment of mental illness, self-help skills, and recovery principles in order to empower participants to return to valued social roles within their communities. BRIDGES is a peer-led program and all instructors are adults with mental illnesses. For this intervention study, the BRIDGES curriculum was modified from a 10-week course to an 8-week course, meeting for 2 1/2 hours once a week.
|
Comparison Wait-list Group
n=216 participants at risk
Participants assigned to the comparison group were in a delayed treatment condition in which they continued in public services as usual, but were offered the chance to attend the BRIDGES program after their final research interview.
|
|---|---|---|
|
Psychiatric disorders
Other Adverse Event
|
0.00%
0/212 • Adverse event data were collected over a 2 year period.
Adverse events in our behavioral health research study are indicated when participants report recent feelings of self-harm or harm to others either during the research interview assessments or at the time of an intervention.
|
0.46%
1/216 • Number of events 1 • Adverse event data were collected over a 2 year period.
Adverse events in our behavioral health research study are indicated when participants report recent feelings of self-harm or harm to others either during the research interview assessments or at the time of an intervention.
|
Additional Information
Dr. Judith A. Cook, Director
Center on Mental Health Services Research and Policy, University of Illinois at Chicago, Department of Psychiatry
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place