Group Therapy Program for Women With Physical Disabilities

Not Applicable

Completed

• Conditions: Depressive Symptoms
• Interventions: Behavioral: WPD and Depression Treatment Group

• Registration Number: NCT00618566
• Lead Sponsor: Oregon Health and Science University

Brief Summary

More women with disabilities (30%) report "feelings such as sadness, unhappiness, or depression that prevent them from being active" compared to women without disabilities (8%). The contexts of the lives of WPD, which often include high rates of poverty, architectural and attitudinal barriers, and higher vulnerability to violence and abuse, contribute to this mental health disparity. To help address this disparity, the overall goals of this pilot study are to: 1)1. Develop a cognitive behavioral group therapy intervention to address the specific needs of WPD who experience depressive symptoms; and 2. Pilot-test the intervention to preliminarily evaluate its efficacy using a mixed-methods approach. The proposed and revised study outcomes were derived from our previous work with WPD as well as from feedback obtained from community meetings conducted since our last submission of this proposal. A pilot of the modified intervention with a total of 90 participants will be conducted using a using a wait list control design. The decision to use a wait list control design was made jointly with our community partners to ensure that all WPD participating in the study have access to the intervention.

Detailed Description

The project will use a longitudinal mixed method research design. Phase I will utilize focus groups conducted with WPD to support development of the group therapy program. Phase II will evaluate the efficacy of the intervention using a randomized design. Measures to protect human subjects include development of detailed safety and referral protocols including 24 hour access to emergency mental health assessment and intervention as needed.

Study Timeline

• Study Start: 2007-10
• Study First Submitted: 2008-02-08
• Study First Submitted QC: 2008-02-08
• Study First Posted: 2008-02-20
• Primary Completion: 2012-09
• Study Completion: 2012-09
• Status Verified: 2012-10
• Last Update Submitted: 2012-10-15
• Last Update Posted: 2012-10-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 82

Inclusion Criteria

• Women with physical disabilities age 18 and older who require some form of accommodation and experience significant depressive symptoms as defined by a cut off score of 16 or greater on the CES-D.

Exclusion Criteria

• Women currently receiving other psychotherapy treatment
• Women who are psychotic or have significant cognitive impairment
• Women who are actively suicidal with intent and plan
• Women who have discontinued or initiated antidepressant medications within an 4 week time period.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Oregon	WPD and Depression Treatment Group	-

Primary Outcome Measures

Name	Time	Method
The following hypothesis is specific to the primary outcome: Hypotheses: 1. WPD receiving the intervention will demonstrate a greater improvement in depressive symptom scores compared to participants in the wait-list control groups.	3 years

Secondary Outcome Measures

Name	Time	Method
Secondary Outcomes: Hypothesis 2: the intervention group will demonstrate a greater improvement in coping and problem-solving skills, health behavior, body image and sexual self-esteem and loneliness compared to wait-listed controls.	3 years

Trial Locations

Locations (1)

Oregon Health & Science University; 🇺🇸 Portland, Oregon, United States