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

This study has been completed.
Sponsor:
Collaborator:
U.S. Department of Education
Information provided by (Responsible Party):
Dena Hassouneh, Oregon Health and Science University
ClinicalTrials.gov Identifier:
NCT00618566
First received: February 8, 2008
Last updated: October 15, 2012
Last verified: October 2012
  Purpose

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 Intervention
Depressive Symptoms
Behavioral: WPD and Depression Treatment Group

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: A Peer Implemented Cognitive Behavioral Group Therapy Intervention for Use With Women With Physical Disabilities With Secondary Depression

Resource links provided by NLM:


Further study details as provided by Oregon Health and Science University:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: Yes ]

Enrollment: 82
Study Start Date: October 2007
Study Completion Date: September 2012
Primary Completion Date: September 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Oregon Behavioral: WPD and Depression Treatment Group
Intervention selected will depend on Phase I data analysis.

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00618566

Locations
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
Investigators
Principal Investigator: Dena Hassouneh, PhD Oregon Health and Science University
  More Information

No publications provided

Responsible Party: Dena Hassouneh, Associate Professor, Oregon Health and Science University
ClinicalTrials.gov Identifier: NCT00618566     History of Changes
Other Study ID Numbers: NIDRR, H133G060135
Study First Received: February 8, 2008
Last Updated: October 15, 2012
Health Authority: United States: Institutional Review Board

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

Additional relevant MeSH terms:
Depression
Behavioral Symptoms

ClinicalTrials.gov processed this record on April 17, 2014