Adapting Alcohol Behavioral Couple Therapy for Service Members in Post-Deployment

Not Applicable

Completed

• Conditions: Alcohol Abuse

• Registration Number: NCT03589521
• Lead Sponsor: University of Massachusetts, Worcester

Brief Summary

The specific aims of the ABCT_Military project are as follows: 1) To modify the existing, Alcohol Behavioral Couple Therapy (ABCT) model to treat service members in the reconstitution (post deployment, reintegration, or separation) stage of service, and develop optional psychoeducation modules to address relevant co-morbid problems and challenges in this population in a weekly, 15 session, stand-alone outpatient format. 2) To test feasibility and preliminary efficacy of the study intervention protocol in a successive cohort design for one cohort of 8 couples and one cohort of 22 couples, with iterative manual revision.

Detailed Description

The study staff will screen potential participants over the phone, and arrange Baseline (BL) research interviews for appropriate couples. The couple will meet with the program interviewer for approximately 2 hours. After the BL interview, couples will be scheduled to attend therapy sessions. Couples will complete brief within treatment self-report assessments. Couples will complete a post treatment follow up interview four months after session 1.

Study Timeline

• Study Start: 2015-06-01
• Study First Submitted: 2018-06-08
• Study First Submitted QC: 2018-07-04
• Study First Posted: 2018-07-18
• Primary Completion: 2018-11-28
• Study Completion: 2018-11-28
• Status Verified: 2019-05
• Last Update Submitted: 2019-05-21
• Last Update Posted: 2019-05-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

• Age 18 and older;
• Married (or separated with efforts to reconcile) or in a committed relationship (cohabiting, or in an exclusive dating relationship), or significant other (SO) (first, second or third degree relative (including step relative or in-law) or close trusted friend not active in same military branch. The service member only must meet the following inclusion criteria:
• Served or serving in the U.S. Military,
• Current Alcohol Use Disorder diagnosis, or drink at high risk levels as defined by NIAAA (2010)

Exclusion Criteria

• Either individual is not fluent in the English language.

Exclusion criteria for the service member only:

• Unstabilized Psychotic disorder in past six months

Exclusion criteria for both members of the couple if SO is spouse/romantic partner:

• Either partner is fearful of participating in couple therapy OR either partner suffered severe physical abuse from partner when perpetrator not intoxicated, in past year

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Percent Drinking Days (PDD)	Change from baseline at 4 months post Session 1	Derived from Timeline Followback (TLFB)
Percent Heavy Drinking Days	Change from baseline at 4 months post Session 1	Derived from Timeline Followback (TLFB)
Mean Drinks Per Drinking Day	Change from baseline at 4 months post Session 1	Derived from Timeline Followback (TLFB)
Couple Satisfaction Inventory 16	Change from baseline at 4 months post Session 1	16 item measure assessing satisfaction in couple relationship. Scores range from 0 to 81 and higher scores indicate higher levels of relationship satisfaction. Total score is calculated by summing all values.

Secondary Outcome Measures

Name	Time	Method
Use of Treatment Skills	Baseline and through study completion, about 16 weeks	Self-report questionnaire assessing use of skills learned during treatment. Item scores range from 1-5 and a total score is calculated by summing all values. Higher scores indicate greater use of skills.
Coping Strategies Scale	Change from baseline at 4 months post Session 1	25-item brief measure assessing coping in alcohol-specific and non-alcohol situations. Scores range from 1-4 and higher scores indicate greater use of coping skills. Total score is calculated by averaging all values.
World Health Quality of Life Questionnaire - Bref	Change from baseline at 4 months post Session 1	26-item self report assessing quality of life across 4 domains/subscales: Physical health, Psychological, Social relationships, Environment. The first two items measure quality of life and overall health and are examined separately, with scores ranging from 1-5. The four domain scores are calculated by averaging values and scores range from 1-5. Higher scores indicate higher quality of life within each domain. Mean scores are then multiplied by 4 in order to make domain scores comparable with the scores used in the WHOQOL-100 (full scale measure).
Treatment Services Review	Weekly during treatment, for up to 16 weeks	Interview assessing quantity and type of services received (e.g., health, psychological) outside of study intervention. Total scores are calculated by summing the number of outside services used. Total scores have a minimum of 0 and no maximum value.
Working Alliance Inventory Short Form	Baseline and through study completion, about 16 weeks	12-item self-report measure of the therapeutic alliance. Total scales are calculated by summing all values. Values range from 1-7 with total scores ranging from 12 to 84). Higher scores indicate greater alliance.
Post-Traumatic Stress Disorder (PTSD)	Baseline	Percent of sample with a PTSD diagnosis as determined by scores on the Life Events Checklist (LEC-5) and the PTSD Checklist (PCL-5).
PTSD Checklist (PCL-5)	Baseline and through study completion, about 16 weeks	20-item self-report questionnaires assessing current symptoms of PTSD, used to assess current (past 30 days) PTSD severity. Total scores are calculated by summing all values. Scores on the PCL-5 range from 0-80 and reflect a global PTSD severity score, with higher scores indicating greater severity.

Trial Locations

Locations (1)

University of Massachusetts Medical School; 🇺🇸 Worcester, Massachusetts, United States