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Mental DisordersBRIDGESNCT01297985

A Randomized Controlled Trial of Mental Health Peer-Led Education

A study testing BRIDGES Peer-Led Education in people with Mental Disorders, run by University of Illinois Chicago at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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). Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for
Mental Disorders
What is being tested?
BRIDGES Peer-Led Education
Could I receive a placebo?
No, everyone receives an active treatment
How many people
428 participants
Where
1 siteUnited States
Study dates
Jan 2006to Feb 2010
Phase
Interventional
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • Clinical diagnosis of mental illness
  • Disability due to mental illness
  • Age 18 years or older
  • Willingness to receive the intervention

Who cannot join

  • Inability to understand spoken English

Trial locations and contacts

1 site in 1 country.

United States1 site

  • National Alliance on Mental Illness Tennessee

    Nashville, Tennessee, 37217

Other trials in United States

About this study

Official title: Efficacy of Peer-Led Education in Improving Mental Health Recovery Outcomes in Tennessee

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.

Read more

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.

Read the detailed 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.

Being tested
BRIDGES Peer-Led Education
Keywords
Serious mental illness, Psychiatric disability, Mental health peer-led, Mental illness education, Illness self-management
Medical subject headings
Mental Disorders

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • BRIDGES Peer-Led EducationBehavioural

    Also called 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 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.

Study groups in NCT01297985
Study groupRoleWhat they receive
BRIDGES InterventionExperimentalThe 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.
Receives: Behavioral: BRIDGES Peer-Led Education
Comparison Wait-list GroupNo interventionParticipants 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.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: Study entry (Pre-intervention/T1), 8-weeks later (Post-Intervention 1/T2), & 6-months after T2 (Post-Intervention 2/T3)

  2. 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.

    Measured: Study entry (Pre-intervention/T1), 8-weeks later (Post-Intervention 1/T2), & 6-months after T2 (Post-Intervention 2/T3)

Secondary outcomes (3)

  1. 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.

    Measured: Study entry (Pre-intervention/T1), 8-weeks later (Post-Intervention 1/T2), & 6-months after T2 (Post-Intervention 2/T3)

  2. 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.

    Measured: Study entry (Pre-intervention/T1), 8-weeks later (Post-Intervention 1/T2), & 6-months after T2 (Post-Intervention 2/T3)

  3. 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).

    Measured: Study entry (Pre-intervention/T1), 8-weeks later (Post-Intervention 1/T2), & 6-months after T2 (Post-Intervention 2/T3)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted17 Feb 2011 (estimated)
  2. Study startJan 2006
  3. Primary completionFeb 2010
  4. Study completionFeb 2010

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Health services research
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
428 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01297985
Sponsor's protocol ID
2006-0024
Other IDs
H133B050003b
Acronym
BRIDGES
Status last verified
Jan 2020
First submitted
16 Feb 2011
Last updated
18 Jan 2020
Data monitoring committee
No

Publications

  • 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.

    PubMed 20952362

  • 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.

    PubMed 22460927

  • 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.

    PubMed 22130108

  • 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.

    PubMed 24566504

Questions about this trial

What is this clinical trial studying?

A study testing BRIDGES Peer-Led Education in people with Mental Disorders, run by University of Illinois Chicago at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 18 Jan 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 18 Jan 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Recovery From Mental Illness (time frame: Study entry (Pre-intervention/T1), 8-weeks later (Post-Intervention 1/T2), & 6-months after T2 (Post-Intervention 2/T3)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01297985, which also lists 4 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jan 2020.

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