INSIGHT-WPD: A CBT Group Therapy Program - Full Text View

Sponsors and Collaborators:	Oregon Health and Science University National Institute of Disability and Rehabilitation Research
Information provided by:	Oregon Health and Science University
ClinicalTrials.gov Identifier:	NCT00618566

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. Modify an existing 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

MedlinePlus related topics: Depression

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Investigator), Historical Control, Parallel Assignment, Efficacy Study
Official Title:	INSIGHT-WPD: A Cognitive Behavioral Group Therapy Intervention for Use With Women With Physical Disabilities Who Experience Depression

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 ]

Estimated Enrollment:	114
Study Start Date:	October 2007
Estimated Study Completion Date:	September 2010
Estimated Primary Completion Date:	May 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Oregon: Experimental	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 modification of INSIGHT - a cognitive behavioral group therapy program. Phase II will evaluate the efficacy of the modified 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 signficant depressive symptoms as defined by a cut off score of 16 or greater on the CES-D.

Exclusion Criteria:

Women currently receiving other psychotherpy treatment
Women who are pscyhotic 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

Contacts

Contact: Dena M Hassouneh, PhD	503 494 2714	phillide@ohsu.edu
Contact: Elizabeth McNeff, MPHA	503 725 4160	mcneff@pdx.edu

Locations

United States, Oregon
Oregon Health & Science University	Not yet recruiting
Portland, Oregon, United States, 97239
Contact: Dena M Hassouneh, PhD 503-494-2714 phillide@ohsu.edu
Contact: Elizabeth McNeff, MPHA 503 725 4160 mcneff@pdx.edu
Principal Investigator: Dena M Hassouneh, PhD
Oregon Health & Science University	Recruiting
Portland, Oregon, United States, 97239
Contact: Dena Hassouneh, PhD 503-494-2714 phillide@ohsu.edu
Principal Investigator: Dena Hassouneh, PhD

Sponsors and Collaborators

Oregon Health and Science University

National Institute of Disability and Rehabilitation Research

Investigators

Principal Investigator:

Dena Hassouneh, PhD

Oregon Health and Science University

More Information

Responsible Party:	Associate Professor ( Dr. Dena Hassouneh )
Study ID Numbers:	NIDRR, H133G060135
Study First Received:	February 8, 2008
Last Updated:	February 8, 2008
ClinicalTrials.gov Identifier:	NCT00618566
Health Authority:	United States: Institutional Review Board

Keywords provided by Oregon Health and Science University:

Women with physical Disabilities
Seconcary Conditoins
Depression
Cognitive Behavioral Therapy
Consumer Control

Study placed in the following topic categories:

Depression
Depressive Disorder
Behavioral Symptoms

ClinicalTrials.gov processed this record on January 16, 2009