Back to resultsBehavioral Couples Therapy for Female Drug-Abusing Patients (CPW-D)
Primary Purpose
Drug Abuse
Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Behavioral Couples Therapy
Individual Drug Counseling
Sponsored by
About this trial
This is an interventional treatment trial for Drug Abuse focused on measuring Drug Abuse, Female Patients
Eligibility Criteria
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
Sites / Locations
- AdCare Hospital of Worcester Inc.
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Behavioral Couples Therapy
Individual Drug Counseling
Arm Description
Outcomes
Primary Outcome Measures
percent days abstinent from illicit drugs
Secondary Outcome Measures
Full Information
NCT ID
NCT01189305
First Posted
August 16, 2010
Last Updated
March 19, 2015
Sponsor
Harvard University
Collaborators
National Institute on Drug Abuse (NIDA)
1. Study Identification
Unique Protocol Identification Number
NCT01189305
Brief Title
Behavioral Couples Therapy for Female Drug-Abusing Patients
Acronym
CPW-D
Official Title
Behavioral Couples Therapy for Female Drug-Abusing Patients
Study Type
Interventional
2. Study Status
Record Verification Date
March 2015
Overall Recruitment Status
Completed
Study Start Date
July 2009 (undefined)
Primary Completion Date
February 2014 (Actual)
Study Completion Date
February 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Harvard University
Collaborators
National Institute on Drug Abuse (NIDA)
4. Oversight
Data Monitoring Committee
No
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Drug Abuse
Keywords
Drug Abuse, Female Patients
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
185 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Behavioral Couples Therapy
Arm Type
Experimental
Arm Title
Individual Drug Counseling
Arm Type
Experimental
Intervention Type
Behavioral
Intervention Name(s)
Behavioral Couples Therapy
Intervention Description
Behavioral Couples Therapy
Intervention Type
Behavioral
Intervention Name(s)
Individual Drug Counseling
Intervention Description
Individual Drug Counseling
Primary Outcome Measure Information:
Title
percent days abstinent from illicit drugs
Time Frame
12 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Timothy J O'Farrell, PhD
Organizational Affiliation
Harvard University
Official's Role
Principal Investigator
Facility Information:
Facility Name
AdCare Hospital of Worcester Inc.
City
Worcester
State/Province
Massachusetts
ZIP/Postal Code
01605
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Behavioral Couples Therapy for Female Drug-Abusing Patients
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