Alcoholism Clinical Trial
Official title:
Behavioral Couples Group Therapy for Alcholic Patients: Clinical and Cost Outcomes
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.
Multiple studies indicate that participation in Behavioral Couples Therapy (BCT) is
associated with robust positive outcomes for alcoholic and drug-abusing patients, in terms
of reduced substance use and improved relationship functioning. Yet, community-based
treatment programs rarely offer BCT to incoming eligible patients. As reported by providers
and administrators in a national survey of treatment programs in the U.S., BCT was viewed as
prohibitively labor intensive, due in large measure to its standard conjoint
one-couple-at-a-time delivery format. Given the public policy climate that is now
emphasizing not only clinical effectiveness, but also economic accountability, an
intervention's efficiency (i.e., the ratio of effectiveness to program resources used to
provide the service) is a critical factor in decisions by treatment programs to adopt new
interventions. Although BCT has well-proven efficacy, the consensus of providers and
administrators is that BCT is not efficient.
To address these issues, we have studied couples group formats to deliver BCT. First, in
earlier work the PI developed a 10-week BCT group with a number of conjoint sessions added
before to prepare couples and afterwards to prevent relapse. While the outcomes were
favorable, the added conjoint sessions and the closed group that once begun did not add
additional members made it a hard sell for community agencies looking for briefer treatments
and typically running ongoing groups with new members added regularly. Second, to overcome
these problems, the PI and Co-PI developed a 10-session ongoing BCT group format that has
rotating content and rolling admissions in which couples join the group, complete 10
sessions, and "graduate". A major advantage of this ongoing group format for BCT is that it
fits with the way other types of groups generally are run in substance abuse programs. It
got favorable reviews in provider focus groups and showed promise in a pilot study.
The pilot study with married or cohabiting male drug-abusing patients examined the efficacy
of a multi-couple group therapy version of BCT (G-BCT) compared to standard conjoint BCT
(S-BCT), and individual-based treatment (group and individual counseling) for the patient
only. Results showed G-BCT yielded equivalent outcomes when compared to S-BCT, in terms of
reduction in substance use and improved relationship adjustment, but GBCT was less costly to
deliver and had superior cost-benefit and cost-effectiveness. Both G-BCT and S-BCT yielded
better clinical and cost-outcomes than individual-based treatment. Also, a small-scale
evaluation study indicated G-BCT was more likely to be used in community-based treatment
programs than S-BCT.
Thus, this proposed study will conduct a randomized clinical trial to examine the clinical
effectiveness, in terms of substance use, relationship functioning, and psychosocial
adjustment, of Group BCT (G-BCT) versus Standard BCT (S-BCT) for 160 alcoholic patients and
their nonsubtance-abusing partners. Given the likely differences in cost of treatment
delivery between the 2 interventions, we will also examine the comparative cost-benefit and
cost-effectiveness of the 2 intervention packages.
;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Recruiting |
NCT05054738 -
CRP and S&A for Inpatient Veterans
|
N/A | |
| Completed |
NCT02233738 -
Group Motivational Interviewing (GMI) For Homeless Veterans In VA Services
|
N/A | |
| Completed |
NCT05877807 -
Effect of Baclofen to Prevent Post-Traumatic Stress Disorder
|
||
| Completed |
NCT00000437 -
Tobacco Dependence in Alcoholism Treatment (Nicotine Patch/Naltrexone)
|
Phase 4 | |
| Completed |
NCT00536146 -
The Stress-Hormone System in Alcohol-Dependent Subjects
|
N/A | |
| Terminated |
NCT00890149 -
Ondansetron for the Treatment of Heavy Drinking Among Emerging Adults
|
Phase 2 | |
| Completed |
NCT02939352 -
The Effects of Theta Burst Stimulation on the Brain Response to Drug and Alcohol Cues
|
Early Phase 1 | |
| Completed |
NCT02179749 -
Mifepristone Treatment of Alcohol Use Disorder
|
Phase 2 | |
| Completed |
NCT01553136 -
Varenicline Treatment of Alcohol Dependence in Smokers
|
Phase 2 | |
| Terminated |
NCT01408641 -
Topiramate for Alcohol Use in Posttraumatic Stress Disorder
|
N/A | |
| Completed |
NCT01389297 -
Overcoming Addictions: A Randomized Clinical Trial of a Web Application Based on SMART Recovery
|
N/A | |
| Completed |
NCT00768508 -
Combined Pharmacotherapies for Alcoholism
|
Phase 3 | |
| Completed |
NCT01760785 -
Valproate for Mood Swings and Alcohol Use Following Head Injury
|
N/A | |
| Completed |
NCT01113164 -
Matching Genotypes and Serotonergic Medications for Alcoholism
|
Phase 1 | |
| Completed |
NCT00127231 -
Brief Therapy Intervention for Heavy/Hazardous Drinking in HIV-Positive Women
|
N/A | |
| Terminated |
NCT02842528 -
Cognitive Vulnerability Factors in Alcohol-dependence
|
N/A | |
| Completed |
NCT00367575 -
An Internet-based Intervention for Problem Drinking
|
N/A | |
| Completed |
NCT00167687 -
Prazosin Alcohol Dependence IVR Study
|
Phase 4 | |
| Completed |
NCT00223639 -
New Medications to Treat Alcohol Dependence
|
Phase 2 | |
| Completed |
NCT00583440 -
12-step Facilitation for the Dually Diagnosed
|
Phase 1/Phase 2 |