Couples Therapy for Alcoholic Patients

NCT01659957 | Completed Phase 2 DMC

• 1 other identifier: R01AA017865
• Study Type: interventional
• Target: 285
• Locations: 1 country
• Sites: 1

Brief Summary

In treating alcoholism, many studies show Behavioral Couples Therapy (BCT) is more effective than typical counseling, but BCT is not widely used because standard BCT delivered one couple at a time is costly to deliver and does not fit with the primary group therapy focus of most community clinics. The proposed study will test with married or cohabiting alcoholic patients whether a group format for BCT will produce similar positive outcomes as standard BCT, and deliver these results at a lower cost. If outcomes are favorable, this could prompt clinics to start using group BCT and improve outcomes for alcoholic patients and their families.

Conditions

Alcoholism

Keywords

Alcoholism; Couples

Outcome Measures

Primary Outcomes (1)

• Percent days abstinent from alcohol or illicit drugs

  12 months

Study Arms (2)

Group Couples Couseling

EXPERIMENTAL

Patients randomized to this arm will receive group couples counseling plus 12-step oriented alcoholism counseling.

Behavioral: Group Couples Counseling

One-on-One Couples Couseling

EXPERIMENTAL

Patients randomized to this arm will receive one-on-one couples counseling plus 12-step oriented alcoholism counseling.

Behavioral: One-on-One Couples Counseling

Interventions

Group Couples Counseling BEHAVIORAL

Group Couples Couseling

One-on-One Couples Counseling BEHAVIORAL

One-on-One Couples Couseling

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• (a) both members of the couple must be between 18 and 65 years of age; (b) patient must meet Diagnostic and Statistical Manual of Mental Disorders (DSM-IV; American Psychiatric Association, 1994) criteria for current (past 12 months) alcohol dependence and alcohol must be the patient's primary substance of abuse as determined by a clinical algorithm (Fals-Stewart, Stappenbeck et al, 2004); (c) be married to their current partner for at least 1 year or be cohabiting in a stable common-law relationship for 2 years; (d) patient agrees to a goal of abstinence from alcohol and drugs at least for the duration of the 12-week study-based treatment; (e) patient drank in past 60 days; (f) patient agrees to forego other alcoholism counseling except for self-help meetings (e.g., AA) or treatment required for a clinical emergency or clinical deterioration for the duration of the 12-week study-based treatment; (g) no more than 4 months living apart in past year; (h) alcohol dependent patient and partner currently living with each other, i.e., not separated or planning divorce; and (i) both alcohol dependent patient and the relationship partner are willing to participate.

You may not qualify if:

• a) partner meets DSM-IV criteria for a substance use disorder (other than nicotine) in the last 12 months; (b) patient has dependence on alcohol or other drugs that requires inpatient treatment or medical detoxification (as indicated by daily heavy use or use to prevent or deal with withdrawal symptoms) - after patient has completed detoxification, he or she may be eligible for the study; (c) patient or partner are at immediate risk for suicide or homicide or either made a suicide attempt in past 30 days; and (d) patient or partner meets DSM-IV criteria for a current organic mental disorder, schizophrenia, delusional (paranoid) disorder, or any of the other psychotic disorders. The SCID-IV (SCID; First, Spitzer, Gibbon, \& Williams, 1995) will be used to screen out participants with psychosis or thought disorder. Subjects with other disorders, however, will not be excluded. Consistent with general AdCare Hospital services, the AdCare physician can prescribe psychiatric medication (e.g., antidepressants) if necessary. Finally, we also will exclude couples with a recent history (past 3 years) of severe partner violence on a day when drinking or drug use did not occur or if either member of the couple expresses fear that couples therapy may put him or her at risk of violence.

Sponsors & Collaborators

• Harvard University: lead

Study Sites (1)

AdCare Hospital of Worcester, Inc.

Worcester, Massachusetts, 01605, United States

Location

MeSH Terms

Conditions

Alcoholism

Condition Hierarchy (Ancestors)

Alcohol-Related Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders

Study Officials

• Timothy J O'Farrell, PhD

  Harvard Medical School (HMS and HSDM)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Psychology

Study Record Dates

• First Submitted: August 6, 2012
• First Posted: August 8, 2012
• Study Start: November 1, 2010
• Primary Completion: November 1, 2013
• Study Completion: November 1, 2014
• Last Updated: March 23, 2015

Record last verified: 2015-03

Locations

US (1)