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Alcohol AbuseABCT_MilNCT03589521

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

A study testing ABCT_Military in people with Alcohol Abuse, run by University of Massachusetts, Worcester at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Alcohol Abuse
What is being tested?
ABCT_Military
Could I receive a placebo?
No, everyone receives an active treatment
How many people
60 participants
Where
1 siteUnited States
Study dates
1 Jun 2015to 28 Nov 2018
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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)

Who cannot join

  • Either individual is not fluent in the English language.
  • 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

Trial locations and contacts

1 site in 1 country.

United States1 site

  • University of Massachusetts Medical School

    Worcester, Massachusetts, 01655

Other trials in United States

About this study

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.

Read the 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.

Conditions
Alcohol Abuse
Being tested
ABCT_Military
Keywords
Veterans, Cognitive Therapy, Couple Therapy
Medical subject headings
Alcoholism

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • ABCT_MilitaryBehavioural

    15 Weekly Couple Therapy Sessions

Study groups in NCT03589521
Study groupRoleWhat they receive
ABCT_MilitaryExperimentalABCT_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.
Receives: Behavioral: ABCT_Military

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Percent Drinking Days (PDD)

    Derived from Timeline Followback (TLFB)

    Measured: Change from baseline at 4 months post Session 1

  2. Percent Heavy Drinking Days

    Derived from Timeline Followback (TLFB)

    Measured: Change from baseline at 4 months post Session 1

  3. Mean Drinks Per Drinking Day

    Derived from Timeline Followback (TLFB)

    Measured: Change from baseline at 4 months post Session 1

  4. 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.

    Measured: Change from baseline at 4 months post Session 1

Secondary outcomes (7)

  1. Coping Strategies Scale

    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.

    Measured: Change from baseline at 4 months post Session 1

  2. World Health Quality of Life Questionnaire - Bref

    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).

    Measured: Change from baseline at 4 months post Session 1

  3. Treatment Services Review

    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.

    Measured: Weekly during treatment, for up to 16 weeks

  4. Working Alliance Inventory Short Form

    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.

    Measured: Baseline and through study completion, about 16 weeks

  5. Post-Traumatic Stress Disorder (PTSD)

    Percent of sample with a PTSD diagnosis as determined by scores on the Life Events Checklist (LEC-5) and the PTSD Checklist (PCL-5).

    Measured: Baseline

  6. PTSD Checklist (PCL-5)

    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.

    Measured: Baseline and through study completion, about 16 weeks

  7. Use of Treatment Skills

    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.

    Measured: Baseline and through study completion, about 16 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted18 Jul 2018
  2. Study start1 Jun 2015
  3. Primary completion28 Nov 2018
  4. Study completion28 Nov 2018

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
60 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03589521
Sponsor's protocol ID
AA023027
Other IDs
5R34AA023027
Acronym
ABCT_Mil
Status last verified
May 2019
First submitted
8 Jun 2018
Last updated
23 May 2019
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: Individual Participant Data will not be shared with investigators outside of the core study team.

Questions about this trial

What is this clinical trial studying?

A study testing ABCT_Military in people with Alcohol Abuse, run by University of Massachusetts, Worcester at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 23 May 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percent Drinking Days (PDD) (time frame: Change from baseline at 4 months post Session 1). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03589521.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 May 2019.

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