DepressionNCT03299803
Depression in Men With Physical Disabilities
A study testing Men's Healing Pathways in people with Depression, run by Oregon Health and Science University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Depression
- What is being tested?
- Men's Healing Pathways
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 31 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Sep 2017to 1 Jan 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Self-identifies as having a physical disability
- Diagnosis of Depression
- Must be able to participate and attend all intervention sessions
Who cannot join
- Currently suicidal with intent and plan
- Diagnosis of schizophrenia or schizoaffective disorder
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Partnership to Develop and Pilot-Test a Peer Program to Reduce Depressive Symptoms in Men With Physical Disabilities
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.
Read the 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.
- Conditions
- Depression
- Being tested
- Men's Healing Pathways
- Medical subject headings
- Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Men's Healing PathwaysBehavioural
Peer implemented group self management program to reduce depressive symptoms in men with physical disabilities
| Study group | Role | What they receive |
|---|---|---|
| Men's Healing Pathways | Experimental | Men with physical disabilities will receive a 15 session weekly peer implemented program Receives: Behavioral: Men's Healing Pathways |
| Control group | No intervention | Telephone contact only |
What is being measured
The primary outcome is the main question the study is designed to answer.
Center for Epidemiologic Studies Depression Measure
20-item self-report measure of depressive symptoms over the past week
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Oct 2017
- Study start1 Sep 2017
- Primary completion1 Jan 2021 (estimated)
- Study completion1 Jan 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DepressionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 31 participants (actual)
Sponsor and investigators
- Lead sponsor
- Oregon Health and Science University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dena Hassouneh, Oregon Health and Science University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03299803
- Sponsor's protocol ID
- R15NR016362
- Status last verified
- Dec 2019
- First submitted
- 25 Sep 2017
- Last updated
- 11 Dec 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: No information will be shared
Study at a glance
From the registry record, last updated by the sponsor on 11 Dec 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Partnership to Develop and Pilot-Test a Peer Program to Reduce Depressive Symptoms in Men With Physical Disabilities
- ClinicalTrials.gov ID
- NCT03299803
- Acronym / sponsor ID
- R15NR016362
- Conditions
- Depression
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 31 participants (actual)
- Lead sponsor
- Oregon Health and Science UniversityUniversity, hospital or other
- Study start
- 1 Sep 2017 (actual)
- Primary completion
- 1 Jan 2021 (estimated)
- Study completion
- 1 Jan 2021 (estimated)
- First posted
- 3 Oct 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Men's Healing Pathways | Experimental | Behavioral: Men's Healing PathwaysMen with physical disabilities will receive a 15 session weekly peer implemented program |
| Control group | No intervention | –Telephone contact only |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Self-identifies as having a physical disability
- Diagnosis of Depression
- Must be able to participate and attend all intervention sessions
Key exclusion criteria (2 listed)
- Currently suicidal with intent and plan
- Diagnosis of schizophrenia or schizoaffective disorder
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Men's Healing PathwaysPeer implemented group self management program to reduce depressive symptoms in men with physical disabilities | Behavioural | Men's Healing Pathways |
Primary outcome
Center for Epidemiologic Studies Depression Measure
Time frame: 3 months
20-item self-report measure of depressive symptoms over the past week
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Dec 2019.
- Individual participant dataSharing planned: No. No information will be shared
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Men's Healing Pathways in people with Depression, run by Oregon Health and Science University 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 3 inclusion and 2 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: status not confirmed, as of the sponsor's last update on 11 Dec 2019. 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?
Results are not available in the source record.
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?
Center for Epidemiologic Studies Depression Measure (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 11 Dec 2019.