CPW-D: Behavioral Couples Therapy for Female Drug-Abusing Patients

Sponsor

Harvard University (Other)

Overall Status

Completed

CT.gov ID

NCT01189305

Collaborator

National Institute on Drug Abuse (NIDA) (NIH)

185

Enrollment

Location

Arms

67.1

Duration (Months)

2.8

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

In treating drug addiction, many studies of male patients show Behavioral Couples Therapy (BCT) helps the whole family (the drug abuser, the relationship partner, and their children) and is more effective than typical individual and group counseling. Only one study of BCT has been done with female drug-abusing patients, and results were promising but not definitive. The proposed study will test with married or cohabiting female drug-abusing patients whether BCT will produce more positive outcomes for the women, their male partners, and their children than standard individual counseling for the patient alone.

Condition or Disease	Intervention/Treatment	Phase
Drug Abuse	Behavioral: Behavioral Couples Therapy Behavioral: Individual Drug Counseling	Phase 2

Study Design

Study Type:

Interventional

Actual Enrollment :

185 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

Behavioral Couples Therapy for Female Drug-Abusing Patients

Study Start Date :

Jul 1, 2009

Actual Primary Completion Date :

Feb 1, 2014

Actual Study Completion Date :

Feb 1, 2015

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Behavioral Couples Therapy	Behavioral: Behavioral Couples Therapy Behavioral Couples Therapy
Experimental: Individual Drug Counseling	Behavioral: Individual Drug Counseling Individual Drug Counseling

Arm

Intervention/Treatment

Experimental: Behavioral Couples Therapy

Behavioral: Behavioral Couples Therapy

Behavioral Couples Therapy

Experimental: Individual Drug Counseling

Behavioral: Individual Drug Counseling

Individual Drug Counseling

Outcome Measures

Primary Outcome Measures

percent days abstinent from illicit drugs [12 months]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

female patients with primary drug abuse diagnosis & their relationship partners
patient married or cohabiting with relationship partner
partner without current alcohol or drug problem

Exclusion Criteria:

both patient and partner without severe mental health disorders

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	AdCare Hospital of Worcester Inc.	Worcester	Massachusetts	United States	01605

Sponsors and Collaborators

Harvard University
National Institute on Drug Abuse (NIDA)

Investigators

Principal Investigator: Timothy J O'Farrell, PhD, Harvard University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Timothy J. O'Farrell, Professor of Psychology, Harvard University

ClinicalTrials.gov Identifier:

NCT01189305

Other Study ID Numbers:

1R01DA025618
1R01DA025618

First Posted:

Aug 26, 2010

Last Update Posted:

Mar 23, 2015

Last Verified:

Mar 1, 2015

Keywords provided by Timothy J. O'Farrell, Professor of Psychology, Harvard University

Drug Abuse

Female Patients

Additional relevant MeSH terms:

Substance-Related Disorders

Study Results

No Results Posted as of Mar 23, 2015