Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01297985
Other study ID # 2006-0024
Secondary ID H133B050003b
Status Completed
Phase N/A
First received
Last updated
Start date January 2006
Est. completion date February 2010

Study information

Verified date January 2020
Source University of Illinois at Chicago
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.


Description:

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.


Recruitment information / eligibility

Status Completed
Enrollment 428
Est. completion date February 2010
Est. primary completion date February 2010
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria:

- Clinical diagnosis of mental illness

- Disability due to mental illness

- Age 18 years or older

- Willingness to receive the intervention

Exclusion Criteria:

- Inability to understand spoken English

Study Design


Related Conditions & MeSH terms


Intervention

Behavioral:
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 week course to an 8-week course, meeting for 2 1/2 hours once a week.

Locations

Country Name City State
United States National Alliance on Mental Illness Tennessee Nashville Tennessee

Sponsors (2)

Lead Sponsor Collaborator
University of Illinois at Chicago Substance Abuse and Mental Health Services Administration (SAMHSA)

Country where clinical trial is conducted

United States, 

References & Publications (4)

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). S — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
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. Study entry (Pre-intervention/T1), 8-weeks later (Post-Intervention 1/T2), & 6-months after T2 (Post-Intervention 2/T3)
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. Study entry (Pre-intervention/T1), 8-weeks later (Post-Intervention 1/T2), & 6-months after T2 (Post-Intervention 2/T3)
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. Study entry (Pre-intervention/T1), 8-weeks later (Post-Intervention 1/T2), & 6-months after T2 (Post-Intervention 2/T3)
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. Study entry (Pre-intervention/T1), 8-weeks later (Post-Intervention 1/T2), & 6-months after T2 (Post-Intervention 2/T3)
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). Study entry (Pre-intervention/T1), 8-weeks later (Post-Intervention 1/T2), & 6-months after T2 (Post-Intervention 2/T3)
See also
  Status Clinical Trial Phase
Completed NCT05321602 - Study to Evaluate the PK Profiles of LY03010 in Patients With Schizophrenia or Schizoaffective Disorder Phase 1
Completed NCT05080777 - Pilot Pragmatic Clinical Trial to Embed Tele-Savvy Into Health Care Systems N/A
Recruiting NCT06012149 - Braining: Implementation of Physical Exercise for Patients in Specialist Psychiatry N/A
Recruiting NCT03222375 - SQUEDâ„¢ Series 28.1 Home-use and Treatment of Autowave Reverberator of Autism N/A
Active, not recruiting NCT02836080 - Integrated Collaborative Care Teams for Youth With Mental Health and/or Addiction Challenges (YouthCan IMPACT) N/A
Active, not recruiting NCT02907658 - Efficacy of Internet Use Disorder Prevention N/A
Completed NCT02710344 - Using Telehealth to Improve Psychiatric Symptom Management N/A
Enrolling by invitation NCT02487888 - A Study of the Impact of Genetic Testing on Clinical Decision Making and Patient Care N/A
Recruiting NCT02292056 - Medication Safety and Contraceptive Counseling for Reproductive Aged Women With Psychiatric Conditions N/A
Active, not recruiting NCT02761733 - The Effectiveness of a Decision-Support Tool for Adult Consumers With Mental Health Needs and Their Care Managers N/A
Completed NCT01947283 - Effectiveness of DECIDE in Patient-Provider Communication, Therapeutic Alliance & Care Continuation N/A
Completed NCT01690013 - Life Quality and Health in Patients With Klinefelter Syndrome N/A
Completed NCT01633138 - Performance-based Reinforcement to Enhance Cognitive Remediation Therapy N/A
Completed NCT01656707 - Adaptive Treatment for Adolescent Cannabis Use Disorders N/A
Completed NCT01415323 - Agitation in the Acute Psychiatric Department
Completed NCT01701765 - Outcomes and Discharge of Long-stay Psychiatric Patients N/A
Completed NCT00375167 - Efficacy of the Recovery Workbook as a Psychoeducational Tool for Facilitating Recovery N/A
Terminated NCT00757497 - Transcranial Direct Current Brain Stimulation to Treat Patients With Childhood-Onset Schizophrenia Phase 1
Terminated NCT03527550 - Cognitive Control Training for Urgency in a Naturalistic Clinical Setting N/A
Withdrawn NCT03518996 - Non-Invasive Brain Stimulation and Delirium N/A