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Depression in Men With Physical Disabilities

Primary Purpose

Depression

Status
Unknown status
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Men's Healing Pathways
Sponsored by
Oregon Health and Science University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Depression

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)MaleDoes not accept healthy volunteers

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

Sites / Locations

  • Dena Hassouneh

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Men's Healing Pathways

Control group

Arm Description

Men with physical disabilities will receive a 15 session weekly peer implemented program

Telephone contact only

Outcomes

Primary Outcome Measures

Center for Epidemiologic Studies Depression Measure
20-item self-report measure of depressive symptoms over the past week

Secondary Outcome Measures

Full Information

First Posted
September 25, 2017
Last Updated
December 9, 2019
Sponsor
Oregon Health and Science University
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1. Study Identification

Unique Protocol Identification Number
NCT03299803
Brief Title
Depression in Men With Physical Disabilities
Official Title
Partnership to Develop and Pilot-Test a Peer Program to Reduce Depressive Symptoms in Men With Physical Disabilities
Study Type
Interventional

2. Study Status

Record Verification Date
December 2019
Overall Recruitment Status
Unknown status
Study Start Date
September 1, 2017 (Actual)
Primary Completion Date
January 1, 2021 (Anticipated)
Study Completion Date
January 1, 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Oregon Health and Science University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
This project is intended to develop an evidence-based peer group counseling program that addresses depressive symptoms in men with physical disabilities. Expanding treatment options for depressive symptoms in men with physical disabilities will improve their access to care. The benefits of men with physical disabilities receiving effective treatment for depressive symptoms include better health, independent living, and longer life.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Depression

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
31 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Men's Healing Pathways
Arm Type
Experimental
Arm Description
Men with physical disabilities will receive a 15 session weekly peer implemented program
Arm Title
Control group
Arm Type
No Intervention
Arm Description
Telephone contact only
Intervention Type
Behavioral
Intervention Name(s)
Men's Healing Pathways
Intervention Description
Peer implemented group self management program to reduce depressive symptoms in men with physical disabilities
Primary Outcome Measure Information:
Title
Center for Epidemiologic Studies Depression Measure
Description
20-item self-report measure of depressive symptoms over the past week
Time Frame
3 months

10. Eligibility

Sex
Male
Gender Based
Yes
Gender Eligibility Description
male
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Dena Hassouneh
City
Portland
State/Province
Oregon
ZIP/Postal Code
97086
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
No information will be shared

Learn more about this trial

Depression in Men With Physical Disabilities

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