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| ID | Type | Description | Link |
|---|---|---|---|
| H133B050003b | Other Grant/Funding Number | Nat'l Inst on Disability & Rehab Research, US Dept of Educ |
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| Name | Class |
|---|---|
| Substance Abuse and Mental Health Services Administration (SAMHSA) | FED |
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This randomized controlled trial tests the efficacy of a mental health peer-led educational intervention called BRIDGES (Building Recovery of Individual Dreams and Goals through Education and Support). The BRIDGES program is a 10-week, manualized education course designed to provide basic information 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 study purposes, the 10-week course was modified to 8-weeks, meeting 2 1/2 hours once a week.
Hypothesis #1: Compared to wait-list controls, intervention participants will report increased feelings of psychological empowerment.
Hypothesis #2: Compared to wait-list controls, intervention participants will report increased feelings of hopefulness.
Hypothesis #3: Compared to wait-list controls, intervention participants will report enhanced coping ability.
Hypothesis #4: Compared to wait-list controls, intervention participants will report enhanced recovery.
Hypothesis #5: Compared to wait-list controls, intervention participants will report greater ability to advocate for themselves with health care providers.
Hypothesis #6: Compared to wait-list controls, those in the BRIDGES education course will report increased knowledge of the causes and treatment of mental illness and recovery principles.
Eligibility criteria included having a diagnosis of serious mental illness and experiencing severe functional impairment in one or more life roles. All study participants completed telephone interviews at three points in time: study entry (pre-intervention); 8-weeks later (immediate post-intervention); and 6-months after intervention (approximately 8 months after study entry). Blinded interviewers administered valid and reliable outcome assessments that measured changes in subjects' knowledge about mental illness; emotional well-being; empowerment; hopefulness; self-advocacy; and recovery. All study participants were compensated for their time at each interview. All BRIDGES instructors were people in recovery from serious mental illnesses who were certified and experienced BRIDGES teachers. Fidelity to the BRIDGES curriculum was assessed on an ongoing basis throughout the study.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| BRIDGES Intervention | Experimental | 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. |
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| Comparison Wait-list Group | No Intervention | 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. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BRIDGES Peer-Led Education | Behavioral | 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 week course to an 8-week course, meeting for 2 1/2 hours once a week. |
| Measure | Description | Time Frame |
|---|---|---|
| Recovery From Mental Illness | 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. | Study entry (Pre-intervention/T1), 8-weeks later (Post-Intervention 1/T2), & 6-months after T2 (Post-Intervention 2/T3) |
| Personal Empowerment | 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. | Study entry (Pre-intervention/T1), 8-weeks later (Post-Intervention 1/T2), & 6-months after T2 (Post-Intervention 2/T3) |
| Measure | Description | Time Frame |
|---|---|---|
| Hopefulness | 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Judith A Cook, PhD | Department of Psychiatry, University of Illinois at Chicago | Principal Investigator |
| Susan A Pickett, PhD | Department of Psychiatry, University of Illinois at Chicago | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| National Alliance on Mental Illness Tennessee | Nashville | Tennessee | 37217 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 20952362 | Background | Pickett SA, Diehl S, Steigman PJ, Prater JD, Fox A, Cook JA. Early outcomes and lessons learned from a study of the Building Recovery of Individual Dreams and Goals through Education and Support (BRIDGES) program in Tennessee. Psychiatr Rehabil J. 2010 Autumn;34(2):96-103. doi: 10.2975/34.2.2010.96.103. | |
| 22460927 | Result |
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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.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Recovery From Mental Illness | 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. | The "Overall Number of Participants Analyzed" reflects the number of participants at Time 1 | Posted | Mean | Standard Deviation | score on a scale | Study entry (Pre-intervention/T1), 8-weeks later (Post-Intervention 1/T2), & 6-months after T2 (Post-Intervention 2/T3) |
|
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.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Other Adverse Event | Psychiatric disorders | Other Adverse Event | Non-systematic Assessment | 1 participant became upset and threatened self-harm because his money order received for completing his Time 2 interview was not able to be cashed at the currency exchange.The study's crisis protocol was activated and issue resolved. |
Limitations include recruitment from a single state rather than a nationally representative population, and reliance on self-report rather than clinician/researcher ratings.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Judith A. Cook, Director | Center on Mental Health Services Research and Policy, University of Illinois at Chicago, Department of Psychiatry | 312-355-3921 | jcook@uic.edu |
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| ID | Term |
|---|---|
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| D010166 | Palliative Care |
| ID | Term |
|---|---|
| D005791 | Patient Care |
| D013812 | Therapeutics |
| D006296 | Health Services |
| D005159 | Health Care Facilities Workforce and Services |
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| Study entry (Pre-intervention/T1), 8-weeks later (Post-Intervention 1/T2), & 6-months after T2 (Post-Intervention 2/T3) |
| Patient Self-advocacy | 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. | Study entry (Pre-intervention/T1), 8-weeks later (Post-Intervention 1/T2), & 6-months after T2 (Post-Intervention 2/T3) |
| Coping Style | 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). | Study entry (Pre-intervention/T1), 8-weeks later (Post-Intervention 1/T2), & 6-months after T2 (Post-Intervention 2/T3) |
| Pickett SA, Diehl SM, Steigman PJ, Prater JD, Fox A, Shipley P, Grey DD, Cook JA. Consumer empowerment and self-advocacy outcomes in a randomized study of peer-led education. Community Ment Health J. 2012 Aug;48(4):420-30. doi: 10.1007/s10597-012-9507-0. Epub 2012 Mar 30. |
| 22130108 | Result | Cook JA, Steigman P, Pickett S, Diehl S, Fox A, Shipley P, MacFarlane R, Grey DD, Burke-Miller JK. Randomized controlled trial of peer-led recovery education using Building Recovery of Individual Dreams and Goals through Education and Support (BRIDGES). Schizophr Res. 2012 Apr;136(1-3):36-42. doi: 10.1016/j.schres.2011.10.016. Epub 2011 Nov 29. |
| 24566504 | Result | Steigman PJ, Pickett SA, Diehl SM, Fox A, Grey DD, Shipley P, Cook JA. Psychiatric symptoms moderate the effects of mental illness self-management in a randomized controlled trial. J Nerv Ment Dis. 2014 Mar;202(3):193-9. doi: 10.1097/NMD.0000000000000098. |
| BG001 | 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. |
| BG002 | Total | Total of all reporting groups |
| Years |
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| Sex: Female, Male | Count of Participants | Participants | No |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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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.
| OG001 | 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. |
|
|
|
| Primary | Personal Empowerment | 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. | The "Overall Number of Participants Analyzed" reflects the number of participants at Time 1 | Posted | Mean | Standard Deviation | score on a scale | Study entry (Pre-intervention/T1), 8-weeks later (Post-Intervention 1/T2), & 6-months after T2 (Post-Intervention 2/T3) |
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| Secondary | Hopefulness | 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. | The "Overall Number of Participants Analyzed" reflects the number of participants at Time 1 | Posted | Mean | Standard Deviation | score on a scale | Study entry (Pre-intervention/T1), 8-weeks later (Post-Intervention 1/T2), & 6-months after T2 (Post-Intervention 2/T3) |
|
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|
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| Secondary | Patient Self-advocacy | 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. | The Overall Number of Participants Analyzed reflects the number of participants at Time 1 | Posted | Mean | Standard Deviation | average score on a scale | Study entry (Pre-intervention/T1), 8-weeks later (Post-Intervention 1/T2), & 6-months after T2 (Post-Intervention 2/T3) |
|
|
|
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| Secondary | Coping Style | 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). | The "Overall Number of Participants Analyzed" reflects the number of participants at Time 1. Results are provided for the Maladaptive Coping Subcale. | Posted | Mean | Standard Deviation | units on a scale | Study entry (Pre-intervention/T1), 8-weeks later (Post-Intervention 1/T2), & 6-months after T2 (Post-Intervention 2/T3) |
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|
|
|
| 0 |
| 212 |
| 0 |
| 212 |
| 1 |
| 212 |
| EG001 | 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. | 0 | 216 | 0 | 216 | 2 | 216 |
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| Other Adverse Event | Psychiatric disorders | Other Adverse Event | Non-systematic Assessment | At baseline interview, when asked questions from the Brief Symptom Inventory, a participant reported thoughts of suicide in the past 7 days. This occurred prior to start of intervention. The study's crisis protocol was activated. |
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| Other Adverse Event | Psychiatric disorders | Other Adverse Event | Non-systematic Assessment | At baseline interview, participant reported thoughts of self-harm during past week when asked questions from the Brief Symptom Inventory. The subject stated that he shares his feelings with therapist. The study's crisis protocol was also activated. |
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| Post-intervention 1 (Time 2) |
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| Post-intervention 2 (Time 3) |
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| Superiority |
| We tested 3 moderating variables: depressive symptom, anxiety, and general symptom distress. In these three models, we hypothesized that the intervention participants with high levels of each type of symptoms would experience greater gains in empowerment over time than participants with low levels of symptoms, as well as control participants with both high and low symptom level. This model includes anxiety as the moderator (high anxiety X time X study condition) | Mixed Effects Random Regression | This analysis used Random Regression Modeling; this second model included anxiety symptoms as moderator | 0.01 | MIXREG Estimate | 0.04 | Standard Error of the Mean | .02 | 2-Sided | Superiority |
| We tested 3 moderating variables: BSI depressive symptom, anxiety, and general symptom distress. In these three models, we hypothesized that the intervention participants with high levels of each type of symptoms would experience greater gains in empowerment over time than participants with low levels of symptoms, as well as control participants with both high and low symptom level. This model includes general symptom distress as the moderator (high symptom distress X time X study condition) | Mixed Effects Random Regression | This analysis used Random Regression Modeling; this third model included the general symptom distress as moderator | .022 | MIXREG Estimate | 0.03 | Standard Error of the Mean | 0.01 | 2-Sided | Superiority |
| Post-intervention 1 (Time 2) |
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| Post-intervention 2 (Time 3) |
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| Post-intervention 1 (Time 2) |
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| Post-intervention 2 (Time 3) |
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| Post-intervention 1 (Time 2) |
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| Post-intervention 2 (Time 3) |
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