Clinical trial NCT03589521: Adapting Alcohol Behavioral Couple Therapy for Service Members in Post-Deployment
Official title: Adapting Alcohol Behavioral Couple Therapy for Service Members in Post-Deployment
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Alcohol Abuse
Keywords: Veterans
Cognitive Therapy
Couple Therapy
Lead sponsor: University of Massachusetts, Worcester
Sponsor class: OTHER
Collaborators: name: National Institute on Alcohol Abuse and Alcoholism (NIAAA)
First posted: 2018-07-18
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Percent Drinking Days (PDD)
timeFrame: Change from baseline at 4 months post Session 1
measure: Percent Heavy Drinking Days
timeFrame: Change from baseline at 4 months post Session 1
measure: Mean Drinks Per Drinking Day
timeFrame: Change from baseline at 4 months post Session 1
measure: Couple Satisfaction Inventory 16
timeFrame: Change from baseline at 4 months post Session 1
Secondary outcomes:
measure: Coping Strategies Scale
timeFrame: Change from baseline at 4 months post Session 1
measure: World Health Quality of Life Questionnaire - Bref
timeFrame: Change from baseline at 4 months post Session 1
measure: Treatment Services Review
timeFrame: Weekly during treatment, for up to 16 weeks
measure: Working Alliance Inventory Short Form
timeFrame: Baseline and through study completion, about 16 weeks
measure: Post-Traumatic Stress Disorder (PTSD)
timeFrame: Baseline
measure: PTSD Checklist (PCL-5)
timeFrame: Baseline and through study completion, about 16 weeks
measure: Use of Treatment Skills
timeFrame: Baseline and through study completion, about 16 weeks
Other outcomes:
measure: Beck Depression Inventory II (BDI-II)
timeFrame: Change from baseline at 4 months post Session 1
measure: Copello Coping Questionnaire
timeFrame: Change from baseline at 4 months post Session 1
measure: Intimate Partner Violence (IPV)
timeFrame: Change from baseline at 4 months post Session 1
measure: Stages of Change Readiness and Treatment Eagerness Scale (SOCRATES) Short Form
timeFrame: Change from baseline at 4 months post Session 1
measure: Traumatic Brain Injury (TBI)
timeFrame: Baseline
measure: Traumatic Brain Injury (TBI) Checklist
timeFrame: Change from baseline at 4 months post Session 1
measure: Partner Quantity Frequency Questionnaire
timeFrame: Change from baseline at 4 months post Session 1
measure: Medical History Questionnaire
timeFrame: Change from baseline at 4 months post Session 1
measure: End of Treatment Questionnaire
timeFrame: 4 months post session 1
measure: Brief COPE
timeFrame: Change from baseline at 4 months post Session 1
measure: Client Satisfaction Questionnaire
timeFrame: 4 months post session 1
Locations:
city: Worcester
country: United States
facility: University of Massachusetts Medical School
state: Massachusetts
Study officials:
affiliation: University of Massachusetts, Worcester
name: Elizabeth Epstein, PhD
role: PRINCIPAL_INVESTIGATOR
References: