Back to resultsAdapting Alcohol Behavioral Couple Therapy for Service Members in Post-Deployment (ABCT_Mil)
Primary Purpose
Alcohol Abuse
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
ABCT_Military
Sponsored by
About this trial
This is an interventional treatment trial for Alcohol Abuse focused on measuring Veterans, Cognitive Therapy, Couple Therapy
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
Sites / Locations
- University of Massachusetts Medical School
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
ABCT_Military
Arm Description
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.
Outcomes
Primary Outcome Measures
Percent Drinking Days (PDD)
Derived from Timeline Followback (TLFB)
Percent Heavy Drinking Days
Derived from Timeline Followback (TLFB)
Mean Drinks Per Drinking Day
Derived from Timeline Followback (TLFB)
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.
Secondary Outcome Measures
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.
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).
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.
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.
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).
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.
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.
Full Information
NCT ID
NCT03589521
First Posted
June 8, 2018
Last Updated
May 21, 2019
Sponsor
University of Massachusetts, Worcester
Collaborators
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
1. Study Identification
Unique Protocol Identification Number
NCT03589521
Brief Title
Adapting Alcohol Behavioral Couple Therapy for Service Members in Post-Deployment
Acronym
ABCT_Mil
Official Title
Adapting Alcohol Behavioral Couple Therapy for Service Members in Post-Deployment
Study Type
Interventional
2. Study Status
Record Verification Date
May 2019
Overall Recruitment Status
Completed
Study Start Date
June 1, 2015 (Actual)
Primary Completion Date
November 28, 2018 (Actual)
Study Completion Date
November 28, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Massachusetts, Worcester
Collaborators
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alcohol Abuse
Keywords
Veterans, Cognitive Therapy, Couple Therapy
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
60 (Actual)
8. Arms, Groups, and Interventions
Arm Title
ABCT_Military
Arm Type
Experimental
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
ABCT_Military
Intervention Description
15 Weekly Couple Therapy Sessions
Primary Outcome Measure Information:
Title
Percent Drinking Days (PDD)
Description
Derived from Timeline Followback (TLFB)
Time Frame
Change from baseline at 4 months post Session 1
Title
Percent Heavy Drinking Days
Description
Derived from Timeline Followback (TLFB)
Time Frame
Change from baseline at 4 months post Session 1
Title
Mean Drinks Per Drinking Day
Description
Derived from Timeline Followback (TLFB)
Time Frame
Change from baseline at 4 months post Session 1
Title
Couple Satisfaction Inventory 16
Description
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.
Time Frame
Change from baseline at 4 months post Session 1
Secondary Outcome Measure Information:
Title
Coping Strategies Scale
Description
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.
Time Frame
Change from baseline at 4 months post Session 1
Title
World Health Quality of Life Questionnaire - Bref
Description
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).
Time Frame
Change from baseline at 4 months post Session 1
Title
Treatment Services Review
Description
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.
Time Frame
Weekly during treatment, for up to 16 weeks
Title
Working Alliance Inventory Short Form
Description
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.
Time Frame
Baseline and through study completion, about 16 weeks
Title
Post-Traumatic Stress Disorder (PTSD)
Description
Percent of sample with a PTSD diagnosis as determined by scores on the Life Events Checklist (LEC-5) and the PTSD Checklist (PCL-5).
Time Frame
Baseline
Title
PTSD Checklist (PCL-5)
Description
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.
Time Frame
Baseline and through study completion, about 16 weeks
Title
Use of Treatment Skills
Description
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.
Time Frame
Baseline and through study completion, about 16 weeks
Other Pre-specified Outcome Measures:
Title
Beck Depression Inventory II (BDI-II)
Description
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.
Time Frame
Change from baseline at 4 months post Session 1
Title
Copello Coping Questionnaire
Description
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.
Time Frame
Change from baseline at 4 months post Session 1
Title
Intimate Partner Violence (IPV)
Description
Percent of sample with IPV as determined by scores on the Conflict Screener Form H.
Time Frame
Change from baseline at 4 months post Session 1
Title
Stages of Change Readiness and Treatment Eagerness Scale (SOCRATES) Short Form
Description
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.
Time Frame
Change from baseline at 4 months post Session 1
Title
Traumatic Brain Injury (TBI)
Description
Percent of sample with a TBI as determined by scores on the TBI Checklist.
Time Frame
Baseline
Title
Traumatic Brain Injury (TBI) Checklist
Description
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.
Time Frame
Change from baseline at 4 months post Session 1
Title
Partner Quantity Frequency Questionnaire
Description
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.
Time Frame
Change from baseline at 4 months post Session 1
Title
Medical History Questionnaire
Description
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.
Time Frame
Change from baseline at 4 months post Session 1
Title
End of Treatment Questionnaire
Description
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.
Time Frame
4 months post session 1
Title
Brief COPE
Description
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.
Time Frame
Change from baseline at 4 months post Session 1
Title
Client Satisfaction Questionnaire
Description
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.
Time Frame
4 months post session 1
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Elizabeth Epstein, PhD
Organizational Affiliation
University of Massachusetts, Worcester
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Massachusetts Medical School
City
Worcester
State/Province
Massachusetts
ZIP/Postal Code
01655
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
Individual Participant Data will not be shared with investigators outside of the core study team.
Learn more about this trial
Adapting Alcohol Behavioral Couple Therapy for Service Members in Post-Deployment
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