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Completed

NCT Number: NCT03589521

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Massachusetts Medical School

Worcester, Massachusetts, 01655, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

ABCT_Military

Behavioral

15 Weekly Couple Therapy Sessions

Primary outcomes

  1. Percent Drinking Days (PDD)

    Time frame: Change from baseline at 4 months post Session 1

    Derived from Timeline Followback (TLFB)

  2. Percent Heavy Drinking Days

    Time frame: Change from baseline at 4 months post Session 1

    Derived from Timeline Followback (TLFB)

  3. Mean Drinks Per Drinking Day

    Time frame: Change from baseline at 4 months post Session 1

    Derived from Timeline Followback (TLFB)

  4. 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.

Secondary outcomes

  1. 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.

  2. 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).

  3. 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.

  4. 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.

  5. 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).

  6. 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.

  7. 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.

Other outcomes

  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.

  2. 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.

  3. 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.

  4. 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.

  5. Traumatic Brain Injury (TBI)

    Time frame: Baseline

    Percent of sample with a TBI as determined by scores on the TBI Checklist.

  6. 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.

  7. 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.

  8. 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.

  9. 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.

  10. 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.

  11. 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.

Sponsors and collaborators

Lead sponsor

University of Massachusetts, Worcester

Other

Collaborators

  • National Institute on Alcohol Abuse and Alcoholism (NIAAA)

Registry information

Acronym: ABCT_Mil

Important dates

Study start
2015
Primary completion
2018
Study completion
2018
First posted
Jul 18, 2018
Registry last updated
May 23, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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