NCT03589521

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jun 2015

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2015

Completed
3 years until next milestone

First Submitted

Initial submission to the registry

June 8, 2018

Completed
1 month until next milestone

First Posted

Study publicly available on registry

July 18, 2018

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 28, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 28, 2018

Completed
Last Updated

May 23, 2019

Status Verified

May 1, 2019

Enrollment Period

3.5 years

First QC Date

June 8, 2018

Last Update Submit

May 21, 2019

Conditions

Keywords

VeteransCognitive TherapyCouple Therapy

Outcome Measures

Primary Outcomes (4)

  • Percent Drinking Days (PDD)

    Derived from Timeline Followback (TLFB)

    Change from baseline at 4 months post Session 1

  • Percent Heavy Drinking Days

    Derived from Timeline Followback (TLFB)

    Change from baseline at 4 months post Session 1

  • Mean Drinks Per Drinking Day

    Derived from Timeline Followback (TLFB)

    Change from baseline at 4 months post Session 1

  • Couple Satisfaction Inventory 16

    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.

    Change from baseline at 4 months post Session 1

Secondary Outcomes (7)

  • Coping Strategies Scale

    Change from baseline at 4 months post Session 1

  • World Health Quality of Life Questionnaire - Bref

    Change from baseline at 4 months post Session 1

  • Treatment Services Review

    Weekly during treatment, for up to 16 weeks

  • Working Alliance Inventory Short Form

    Baseline and through study completion, about 16 weeks

  • Post-Traumatic Stress Disorder (PTSD)

    Baseline

  • +2 more secondary outcomes

Other Outcomes (11)

  • Beck Depression Inventory II (BDI-II)

    Change from baseline at 4 months post Session 1

  • Copello Coping Questionnaire

    Change from baseline at 4 months post Session 1

  • Intimate Partner Violence (IPV)

    Change from baseline at 4 months post Session 1

  • +8 more other outcomes

Study Arms (1)

ABCT_Military

EXPERIMENTAL

ABCT\_Military manual will address alcohol use, couple issues and military specific issues. Required interventions include: routine interventions, overview of treatment, reintegration issues, motivational techniques, patient-focused interventions for abstinence, partner-related interventions for abstinence, couple interventions, general coping skills, social skills and relapse prevention. In addition, to personalize each treatment plan, interventions from optional modules (e.g., intimate partner violence (IPV), depression, trauma, and traumatic brain injury (TBI)) will be integrated into each couple's treatment plan depending on clinical presentation.

Behavioral: ABCT_Military

Interventions

ABCT_MilitaryBEHAVIORAL

15 Weekly Couple Therapy Sessions

ABCT_Military

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age 18 and older;
  • Served or serving in the U.S. Military,
  • Current Alcohol Use Disorder diagnosis, or drink at high risk levels as defined by NIAAA (2010)

You may not qualify if:

  • Either individual is not fluent in the English language.
  • Unstabilized Psychotic disorder in past six months
  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Massachusetts Medical School

Worcester, Massachusetts, 01655, United States

Location

MeSH Terms

Conditions

Alcoholism

Condition Hierarchy (Ancestors)

Alcohol-Related DisordersSubstance-Related DisordersChemically-Induced DisordersMental Disorders

Study Officials

  • Elizabeth Epstein, PhD

    University of Massachusetts, Worcester

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

June 8, 2018

First Posted

July 18, 2018

Study Start

June 1, 2015

Primary Completion

November 28, 2018

Study Completion

November 28, 2018

Last Updated

May 23, 2019

Record last verified: 2019-05

Data Sharing

IPD Sharing
Will not share

Individual Participant Data will not be shared with investigators outside of the core study team.

Locations