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

History of Changes

Tracking Information

First Received Date ^ICMJE

February 8, 2008

Last Updated Date

October 15, 2012

Start Date ^ICMJE

October 2007

Primary Completion Date

September 2012 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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 ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00618566 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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 ]

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Group Therapy Program for Women With Physical Disabilities

Official Title ^ICMJE

A Peer Implemented Cognitive Behavioral Group Therapy Intervention for Use With Women With Physical Disabilities With Secondary Depression

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 Type ^ICMJE

Interventional

Study Phase

Not Provided

Study Design ^ICMJE

Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment

Condition ^ICMJE

Depressive Symptoms

Intervention ^ICMJE

Behavioral: WPD and Depression Treatment Group

Intervention selected will depend on Phase I data analysis.

Study Arm (s)

Experimental: Oregon

Intervention: Behavioral: WPD and Depression Treatment Group

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

Completion Date

September 2012

Primary Completion Date

September 2012 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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.

Gender

Female

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States

Administrative Information

NCT Number ^ICMJE

NCT00618566

Other Study ID Numbers ^ICMJE

NIDRR, H133G060135

Has Data Monitoring Committee

Yes

Responsible Party

Dena Hassouneh, Oregon Health and Science University

Study Sponsor ^ICMJE

Oregon Health and Science University

Collaborators ^ICMJE

U.S. Department of Education

Investigators ^ICMJE

Principal Investigator:

Dena Hassouneh, PhD

Oregon Health and Science University

Information Provided By

Oregon Health and Science University

Verification Date

October 2012

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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