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

Alcohol Abuse Clinical Trial

— ABCT_Mil  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03589521
• Other study ID #: AA023027
• Secondary ID: 5R34AA023027
• Status: Completed
• Phase: N/A
• Start date: June 1, 2015
• Est. completion date: November 28, 2018

Study information

• Verified date: May 2019
• Source: University of Massachusetts, Worcester
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: November 28, 2018
• Est. primary completion date: November 28, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Alcohol Abuse
• Alcoholism

Intervention

Behavioral:
• ABCT_Military
15 Weekly Couple Therapy Sessions

Locations

Country	Name	City	State
United States	University of Massachusetts Medical School	Worcester	Massachusetts

Sponsors (2)

Lead Sponsor	Collaborator
University of Massachusetts, Worcester	National Institute on Alcohol Abuse and Alcoholism (NIAAA)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Beck Depression Inventory II (BDI-II)	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
Other	Copello Coping Questionnaire	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
Other	Intimate Partner Violence (IPV)	Percent of sample with IPV as determined by scores on the Conflict Screener Form H.	Change from baseline at 4 months post Session 1
Other	Stages of Change Readiness and Treatment Eagerness Scale (SOCRATES) Short Form	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
Other	Traumatic Brain Injury (TBI)	Percent of sample with a TBI as determined by scores on the TBI Checklist.	Baseline
Other	Traumatic Brain Injury (TBI) Checklist	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
Other	Partner Quantity Frequency Questionnaire	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
Other	Medical History Questionnaire	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
Other	End of Treatment Questionnaire	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
Other	Brief COPE	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
Other	Client Satisfaction Questionnaire	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
Primary	Percent Drinking Days (PDD)	Derived from Timeline Followback (TLFB)	Change from baseline at 4 months post Session 1
Primary	Percent Heavy Drinking Days	Derived from Timeline Followback (TLFB)	Change from baseline at 4 months post Session 1
Primary	Mean Drinks Per Drinking Day	Derived from Timeline Followback (TLFB)	Change from baseline at 4 months post Session 1
Primary	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	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.	Change from baseline at 4 months post Session 1
Secondary	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).	Change from baseline at 4 months post Session 1
Secondary	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.	Weekly during treatment, for up to 16 weeks
Secondary	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.	Baseline and through study completion, about 16 weeks
Secondary	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).	Baseline
Secondary	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.	Baseline and through study completion, about 16 weeks
Secondary	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.	Baseline and through study completion, about 16 weeks