University of Massachusetts Medical School
Worcester, Massachusetts, 01655, United States
NCT Number: NCT03589521
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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Notify Me18 year and older
All sexes
Interventional
Not applicable
Worcester, Massachusetts, 01655, United States
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Exclusion criteria
for the service member only:
Exclusion criteria
for both members of the couple if SO is spouse/romantic partner:
15 Weekly Couple Therapy Sessions
Time frame: Change from baseline at 4 months post Session 1
Derived from Timeline Followback (TLFB)
Time frame: Change from baseline at 4 months post Session 1
Derived from Timeline Followback (TLFB)
Time frame: Change from baseline at 4 months post Session 1
Derived from Timeline Followback (TLFB)
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.
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.
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).
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.
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.
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).
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.
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.
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.
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.
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.
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.
Time frame: Baseline
Percent of sample with a TBI as determined by scores on the 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.
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.
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.
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.
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.
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.
University of Massachusetts, Worcester
Other
Acronym: ABCT_Mil
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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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