- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03299803
Depression in Men With Physical Disabilities
Partnership to Develop and Pilot-Test a Peer Program to Reduce Depressive Symptoms in Men With Physical Disabilities
Study Overview
Detailed Description
Previously the investigators developed, tested and disseminated a highly effective peer counseling program to reduce depressive symptoms in women with physical disabilities (WPDs) in partnership with Oregon Centers for Independent Living (CILs). WPDs with baseline Center for Epidemiologic Depression (CES-D) scores >16 demonstrated significant improvement in depressive symptoms that were sustained over a three month follow-up period (ES partial eta2=.10). The program is offered by two peers in 14 weekly 2.5 hour group sessions. Our academic-disability community partnership created Healing Pathways using community-based participatory research (CBPR) methods and the investigators have sustained our partnership over 9 years. Healing Pathways is currently publicly funded and offered by four of the seven CILs in Oregon. The success of Healing Pathways is a direct result of community investment in and ownership of the program. This project intends to replicate this model to address depression in men with physical disabilities (MPDs).
Depression is a common secondary condition in MPDs, occurring at rates between 37-64%.This is 2-6 times the rate of depression found in non-disabled men. MPDs who work in CILs or other consumer-controlled non-profit agencies are uniquely situated to address depression in their peer group. The Rehabilitation Act of 1973 mandated the formation of CILs to maximize the leadership, empowerment, independence, and productivity of people with disabilities and to integrate them into mainstream society by providing four core independent living services. The core services are: information and referral, independent living skills training, peer counseling, and individual and systems advocacy. CILs are grounded in Independent Living (IL) philosophy, promulgating inclusion across disability-types, de-medicalization and de-institutionalization, and the belief that people with disabilities are the best experts on their own health. There are 403 CILs across the nation, a largely untapped infrastructure with great potential to augment health services for people with disabilities using a peer-to-peer model. The sweeping nature of mental health reforms occurring in the span of a lifetime has given rise to consumer-run peer programs and there is mounting evidence, including randomized controlled trials, that they are efficacious in improving well-being and psychiatric symptoms. Many persons with chronic mental illness prefer peer programs, finding them more relatable and empowering than traditional services. Although many MPDs may also prefer the option of peer counseling compared to traditional psychotherapy, to our knowledge there are no peer programs that address the co-occurrence of physical disability and depression in men. The long-term goal of this program of research is to improve mental health outcomes in people with physical disabilities by partnering with members of this community. This approach recognizes disability communities as cultural entities, respects the values of IL philosophy, and emphasizes the interconnection between mental and physical health. The objective here, the investigators' next step in pursuit of that goal, is to develop and pilot-test a peer program for MPDs with depression. Using a community-engaged, exploratory sequential, mixed methods design, this study intends to achieve the following three specific aims:
- Adapt the Healing Pathways program to meet the needs of MPDs with depressive symptoms.
- Conduct a pilot study to assess the feasibility and acceptability of the peer program.
- Estimate the effect size of the peer program for depressive symptoms. The outcomes of this study will collectively inform the development of a future randomized controlled trial of a program designed to treat depressive symptoms in MPDs. Further, the proposed study addresses several public health goals including Healthy People 2020 goal DH18 to reduce the proportion of people with disabilities who report serious emotional distress,24 and the President's New Freedom Commission on Mental Health goals 1-3, to understand that mental health is essential to overall health, promote mental health treatments that are consumer-driven, and eliminate disparities in mental health care. Because bias against people with disabilities is common among health care providers, education of future health researchers is also necessary to help meet these goals. As part of the proposed project, nursing students will received a mentored experience to support culturally appropriate research with members of the disability community. Experiences will include didactic instruction, community immersion, and research training. Development of a cadre of future researchers who have the knowledge, abilities, and skills to advance the health of people with disabilities through community partnerships is a goal of the project.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Oregon
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Portland, Oregon, United States, 97086
- Dena Hassouneh
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Self-identifies as having a physical disability
- Diagnosis of Depression
- Must be able to participate and attend all intervention sessions
Exclusion Criteria:
- Currently suicidal with intent and plan
- Diagnosis of schizophrenia or schizoaffective disorder
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Men's Healing Pathways
Men with physical disabilities will receive a 15 session weekly peer implemented program
|
Peer implemented group self management program to reduce depressive symptoms in men with physical disabilities
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No Intervention: Control group
Telephone contact only
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Center for Epidemiologic Studies Depression Measure
Time Frame: 3 months
|
20-item self-report measure of depressive symptoms over the past week
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3 months
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- R15NR016362 (U.S. NIH Grant/Contract)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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