Group Therapy Program for Women With Physical Disabilities

NCT00618566 | Completed DMC

• 2 other identifiers: NIDRRH133G060135
• Study Type: interventional
• Target: 82
• Locations: 1 country
• Sites: 1

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.

Conditions

Depressive Symptoms

Keywords

Women with physical Disabilities; Secondary Conditions; Depression; Cognitive Behavioral Therapy; Consumer Control

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• 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

Study Arms (1)

Oregon

EXPERIMENTAL

Behavioral: WPD and Depression Treatment Group

Interventions

WPD and Depression Treatment Group BEHAVIORAL

Intervention selected will depend on Phase I data analysis.

Oregon

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Oregon Health and Science University: lead
• U.S. Department of Education: collaborator

Study Sites (1)

Oregon Health & Science University

Portland, Oregon, 97239, United States

Location

MeSH Terms

Conditions

Depression

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior

Study Officials

• Dena Hassouneh, PhD

  Oregon Health and Science University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: February 8, 2008
• First Posted: February 20, 2008
• Study Start: October 1, 2007
• Primary Completion: September 1, 2012
• Study Completion: September 1, 2012
• Last Updated: October 17, 2012

Record last verified: 2012-10

Locations

US (1)