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

May 21, 2019 updated by: Elizabeth Epstein, University of Massachusetts, Worcester
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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
60

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Massachusetts
      • Worcester, Massachusetts, United States, 01655
        • University of Massachusetts Medical School

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: ABCT_Military
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
15 Weekly Couple Therapy Sessions

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Percent Drinking Days (PDD)
Time Frame: Change from baseline at 4 months post Session 1
Derived from Timeline Followback (TLFB)
Change from baseline at 4 months post Session 1
Percent Heavy Drinking Days
Time Frame: Change from baseline at 4 months post Session 1
Derived from Timeline Followback (TLFB)
Change from baseline at 4 months post Session 1
Mean Drinks Per Drinking Day
Time Frame: Change from baseline at 4 months post Session 1
Derived from Timeline Followback (TLFB)
Change from baseline at 4 months post Session 1
Couple Satisfaction Inventory 16
Time Frame: 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.
Change from baseline at 4 months post Session 1

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Coping Strategies Scale
Time Frame: 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.
Change from baseline at 4 months post Session 1
World Health Quality of Life Questionnaire - Bref
Time Frame: 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).
Change from baseline at 4 months post Session 1
Treatment Services Review
Time Frame: 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.
Weekly during treatment, for up to 16 weeks
Working Alliance Inventory Short Form
Time Frame: 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.
Baseline and through study completion, about 16 weeks
Post-Traumatic Stress Disorder (PTSD)
Time Frame: 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).
Baseline
PTSD Checklist (PCL-5)
Time Frame: 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.
Baseline and through study completion, about 16 weeks
Use of Treatment Skills
Time Frame: 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.
Baseline and through study completion, about 16 weeks

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Traumatic Brain Injury (TBI)
Time Frame: Baseline
Percent of sample with a TBI as determined by scores on the TBI Checklist.
Baseline
Traumatic Brain Injury (TBI) Checklist
Time Frame: Change from baseline at 4 months post Session 1
Severity of TBI as determined by total scores on the TBI Checklist. Scores are calculated by summing individual item scores with possible scores ranging from 8 to 88.
Change from baseline at 4 months post Session 1
Beck Depression Inventory II (BDI-II)
Time Frame: Change from baseline at 4 months post Session 1
self-report questionnaire assessing depression symptoms over the prior two weeks (scores range 0-63) and higher scores indicate greater depression symptomatology. All item scores are summed to attain a total score.
Change from baseline at 4 months post Session 1
Copello Coping Questionnaire
Time Frame: Change from baseline at 4 months post Session 1
30 item self-report assessing partner alcohol-related coping skill use. Total score is calculated by summing the values from each item and scores range from 0-90 with higher scored indicating greater use of coping strategies.
Change from baseline at 4 months post Session 1
Intimate Partner Violence (IPV)
Time Frame: Change from baseline at 4 months post Session 1
Percent of sample with IPV as determined by scores on the Conflict Screener Form H.
Change from baseline at 4 months post Session 1
Stages of Change Readiness and Treatment Eagerness Scale (SOCRATES) Short Form
Time Frame: Change from baseline at 4 months post Session 1
19 item self-report questionnaire assessing client readiness for change. An additional item assesses the client's motivation for coming to therapy. There are three sub scales (Recognition, Ambivalence, and Taking Steps) which are derived from individual items. Higher scores indicate greater recognition, ambivalence and taking steps and scores range from 7 to 35, 4 to 20, and 8-40, respectively.
Change from baseline at 4 months post Session 1
Partner Quantity Frequency Questionnaire
Time Frame: Change from baseline at 4 months post Session 1
Self-report questionnaire assessing frequency and quantity of current and lifetime substance use. Measure is used to provide descriptive data about partner substance use. Total scores are not used.
Change from baseline at 4 months post Session 1
Medical History Questionnaire
Time Frame: Change from baseline at 4 months post Session 1
40 item self-report assessing presence of medical conditions currently and in the past. Scores are calculated by summing individual item scores with possible scores ranging from 0 to 40. Higher scores indicate greater number of medical problems.
Change from baseline at 4 months post Session 1
End of Treatment Questionnaire
Time Frame: 4 months post session 1
Self-report questionnaire of helpfulness of therapy elements on a 7 point scale of -3 (greatly harmful), -2, -1, 0 (neutral), +1, +2, +3 (greatly helpful). Total scores are calculated by averaging scores across individual items.
4 months post session 1
Brief COPE
Time Frame: Change from baseline at 4 months post Session 1
28 item self-report assessing general coping skill use. Sub scale scores are calculated by summing individual items (2 items per sub scale) with possible scores of 2 to 8. The sub scales are: Self-distraction, Active coping, Denial, Substance use, Use of emotional support, Use of instrumental support, Behavioral disengagement, Venting, Positive reframing, Planning, Humor, Acceptance, Religion, and Self-blame. Higher scores reflect greater use of each category of coping skills.
Change from baseline at 4 months post Session 1
Client Satisfaction Questionnaire
Time Frame: 4 months post session 1
8 item self-report assessing satisfaction with treatment. Individual item scores are averaged to calculate a total score with possible scores ranging from 0 to 4. Two additional items assessed the client's ideal number of sessions and length of treatment, with scores ranging from 1 to 24 sessions and 1-12 months.
4 months post session 1

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Massachusetts, Worcester

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
National Institute on Alcohol Abuse and Alcoholism (NIAAA)

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 1, 2015

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
November 28, 2018

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
November 28, 2018

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 8, 2018

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 4, 2018

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 18, 2018

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 23, 2019

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 21, 2019

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • AA023027
  • 5R34AA023027 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

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

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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