NCT03299803

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
31

participants targeted

Target at below P25 for not_applicable depression

Timeline
Completed

Started Sep 2017

Typical duration for not_applicable depression

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2017

Completed
24 days until next milestone

First Submitted

Initial submission to the registry

September 25, 2017

Completed
8 days until next milestone

First Posted

Study publicly available on registry

October 3, 2017

Completed
3.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2021

Completed
Last Updated

December 11, 2019

Status Verified

December 1, 2019

Enrollment Period

3.3 years

First QC Date

September 25, 2017

Last Update Submit

December 9, 2019

Conditions

Depression

Outcome Measures

Primary Outcomes (1)

  • Center for Epidemiologic Studies Depression Measure

    20-item self-report measure of depressive symptoms over the past week

    3 months

Study Arms (2)

Men's Healing Pathways

EXPERIMENTAL

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

Behavioral: Men's Healing Pathways

Control group

NO INTERVENTION

Telephone contact only

Interventions

Men's Healing PathwaysBEHAVIORAL

Peer implemented group self management program to reduce depressive symptoms in men with physical disabilities

Men's Healing Pathways

Eligibility Criteria

Age18 Years+
Sexmale(Gender-based eligibility)
Gender Eligibility Detailsmale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Self-identifies as having a physical disability
  • Diagnosis of Depression
  • Must be able to participate and attend all intervention sessions

You may not qualify if:

  • Currently suicidal with intent and plan
  • Diagnosis of schizophrenia or schizoaffective disorder

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Dena Hassouneh

Portland, Oregon, 97086, United States

Location

MeSH Terms

Conditions

Depression

Condition Hierarchy (Ancestors)

Behavioral SymptomsBehavior

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

September 25, 2017

First Posted

October 3, 2017

Study Start

September 1, 2017

Primary Completion

January 1, 2021

Study Completion

January 1, 2021

Last Updated

December 11, 2019

Record last verified: 2019-12

Data Sharing

IPD Sharing
Will not share

No information will be shared

Locations

US(1)