Group Therapy Program for Women With Physical Disabilities (CBT-WPD)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00618566
Recruitment Status : Completed
First Posted : February 20, 2008
Last Update Posted : October 17, 2012
U.S. Department of Education
Information provided by (Responsible Party):
Dena Hassouneh, 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.

Condition or disease Intervention/treatment Phase
Depressive Symptoms Behavioral: WPD and Depression Treatment Group Not Applicable

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 Type : Interventional  (Clinical Trial)
Actual Enrollment : 82 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: A Peer Implemented Cognitive Behavioral Group Therapy Intervention for Use With Women With Physical Disabilities With Secondary Depression
Study Start Date : October 2007
Actual Primary Completion Date : September 2012
Actual Study Completion Date : September 2012

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: Oregon Behavioral: WPD and Depression Treatment Group
Intervention selected will depend on Phase I data analysis.

Primary Outcome Measures :
  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. [ Time Frame: 3 years ]

Secondary Outcome Measures :
  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. [ Time Frame: 3 years ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00618566

United States, Oregon
Oregon Health & Science University
Portland, Oregon, United States, 97239
Sponsors and Collaborators
Oregon Health and Science University
U.S. Department of Education
Principal Investigator: Dena Hassouneh, PhD Oregon Health and Science University

Responsible Party: Dena Hassouneh, Associate Professor, Oregon Health and Science University Identifier: NCT00618566     History of Changes
Other Study ID Numbers: NIDRR
First Posted: February 20, 2008    Key Record Dates
Last Update Posted: October 17, 2012
Last Verified: October 2012

Keywords provided by Dena Hassouneh, Oregon Health and Science University:
Women with physical Disabilities
Secondary Conditions
Cognitive Behavioral Therapy
Consumer Control

Additional relevant MeSH terms:
Behavioral Symptoms