MET-SAH: Adjunctive Motivational Alcohol Intervention to Prevent IPV

Sponsor
VA Office of Research and Development (U.S. Fed)
Overall Status
Not yet recruiting
CT.gov ID
NCT05287711
Collaborator
(none)
300
4
3
49
75
1.5

Study Details

Study Description

Brief Summary

This is a study to provide much-needed experimental data on the efficacy of a brief alcohol Motivational Enhancement Therapy (MET) pre-group intervention for Veterans receiving group treatment for IPV perpetration. The investigators will compare those assigned to receive this MET intervention to those receiving a 4-session Alcohol Education (AE) intervention or a standard treatment as usual (TAU) telephone monitoring intervention. The investigators will examine whether MET leads to greater reductions in alcohol use problems and IPV perpetration, and increased help-seeking behavior for alcohol use problems. Participants will be 300 male Veterans drawn from the Strength at Home IPV intervention program at three locations: the Minneapolis VA Medical Center, the Phoenix VA Healthcare System, and VA Ann Arbor Healthcare System.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Motivational Enhancement Therapy
  • Behavioral: Alcohol Education Control
  • Behavioral: Treatment as Usual
  • Behavioral: Strength at Home
N/A

Detailed Description

Veterans exposed to trauma are at elevated risk for perpetration of intimate partner violence (IPV) and for the development of alcohol-related problems. Despite commonly found associations between alcohol misuse and IPV, the investigators are aware of no prior research in Veterans examining the impact of adjunctive alcohol interventions for those receiving IPV intervention. The investigators propose to provide much-needed experimental data on the efficacy of a brief alcohol Motivational Enhancement Therapy (MET) pre-group intervention for Veterans receiving group treatment for IPV perpetration. More specifically, the investigators propose to examine whether those assigned to receive this MET intervention, relative to those receiving a 4-session Alcohol Education (AE) intervention or a standard treatment as usual (TAU) telephone monitoring intervention, evidence greater reductions in alcohol use problems and IPV perpetration, and increased help-seeking behavior for alcohol use problems. Participants will be 300 male Veterans drawn from the Strength at Home IPV intervention program at three locations: the Minneapolis VA Medical Center, the Phoenix VA Healthcare System, and VA Ann Arbor Healthcare System. Participants will be randomized to their pre-group conditions and then assigned to Strength at Home groups for IPV, and will receive referrals for substance use treatment in the VA system or the community. Participants with clinically relevant alcohol use problems, as determined by baseline screening measures, will complete assessments of alcohol use, readiness to change, IPV and help-seeking behavior at baseline, post IPV intervention group (3 months after completion of 4-session alcohol intervention), and four separate 3-month follow-ups after the post-treatment assessment. Differences between conditions on the major outcome variables involving alcohol use, IPV, help-seeking, and treatment engagement will be examined with random-effects regression models using an intent-to-treat approach. Study findings may assist in enhancing the efficacy of IPV interventions for the Veteran population to help ensure the safety and well-being of Veterans and their families.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
300 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
Participants will receive motivational enhancement therapy for alcohol use problems and this will be compared to an alcohol psychoeducational intervention.Participants will receive motivational enhancement therapy for alcohol use problems and this will be compared to an alcohol psychoeducational intervention.
Masking:
Single (Outcomes Assessor)
Masking Description:
Assessors will be masked.
Primary Purpose:
Treatment
Official Title:
Adjunctive Motivational Alcohol Intervention to Prevent Intimate Partner Violence
Anticipated Study Start Date :
Oct 1, 2022
Anticipated Primary Completion Date :
Nov 1, 2026
Anticipated Study Completion Date :
Nov 1, 2026

Arms and Interventions

Arm Intervention/Treatment
Experimental: Motivational Enhancement Therapy

Motivational enhancement therapy for alcohol use problems, which includes empathic support, feedback and advice, strategies for enhancing self-efficacy, techniques for eliciting self-motivational statements from the participant, strategies for addressing participant ambivalence about change and participant resistance to change, and methods for eliciting and affirming commitment to a specific change plan (active intervention).

Behavioral: Motivational Enhancement Therapy
In Session 1, the therapist provides personalized feedback on a range of assessment variables, including alcohol consumption levels, negative consequences from alcohol use, and family risk of alcoholism. Sessions 2-4 are follow-through sessions in which the therapist attempts to help the Veteran participant establish or reaffirm a commitment to an action plan for addressing alcohol concerns.
Other Names:
  • MET
  • Behavioral: Strength at Home
    IPV intervention which consists of 12 weekly, 2-hour cognitive-behavioral sessions offered in a closed group format and co-led by doctoral level male and female therapists. Strength at Home is based on a social information processing model of trauma and IPV and provides material covering psychoeducation regarding trauma and IPV, conflict and anger management skills, assertiveness training, and skills in stress management and communication.
    Other Names:
  • SAH
  • Experimental: Alcohol Education Control

    Psychoeducational intervention intended to: (1) dispel myths about the effects of alcohol, (2) provide information about the general risks of drinking and process of recovery from alcohol problems, (3) provide information about the specific risks related to family relationships and IPV, (4) offer self-help program information and related strategies to address drinking problems, (5) promote and encourage healthy decision-making, and (6) reinforce the benefits of abstinence or controlled drinking.

    Behavioral: Alcohol Education Control
    Will consist of 4 weekly individual sessions, approximately 60 minutes each. AE therapists will explain that their job is to provide the Veteran participants with information and education about the effects of alcohol, and that it is up to the Veteran participant to use this information as he sees fit. In each session, the Veteran participant will watch an educational videotape in a comfortable consulting room and will be given an opportunity to discuss the videotape with the project therapist for approximately 10 minutes. Written educational materials will supplement the information provided in the videos, and the therapist will ask several structured questions to determine whether the Veteran participant understood the material presented in the video.
    Other Names:
  • AE
  • Behavioral: Strength at Home
    IPV intervention which consists of 12 weekly, 2-hour cognitive-behavioral sessions offered in a closed group format and co-led by doctoral level male and female therapists. Strength at Home is based on a social information processing model of trauma and IPV and provides material covering psychoeducation regarding trauma and IPV, conflict and anger management skills, assertiveness training, and skills in stress management and communication.
    Other Names:
  • SAH
  • Other: Telephone Monitoring

    Brief supportive telephone monitoring sessions that are commonly delivered while Veterans wait to begin their groups (treatment as usual).

    Behavioral: Treatment as Usual
    Supportive telephone monitoring sessions that ensure equal spacing between assessments across conditions and equal number of therapist contacts.
    Other Names:
  • TAU
  • Behavioral: Strength at Home
    IPV intervention which consists of 12 weekly, 2-hour cognitive-behavioral sessions offered in a closed group format and co-led by doctoral level male and female therapists. Strength at Home is based on a social information processing model of trauma and IPV and provides material covering psychoeducation regarding trauma and IPV, conflict and anger management skills, assertiveness training, and skills in stress management and communication.
    Other Names:
  • SAH
  • Outcome Measures

    Primary Outcome Measures

    1. Quantity/Frequency of Alcohol Consumption, Self-Report (QFV) [Baseline, post-treatment, three-month, six-month, nine-month, and twelve-month follow-ups]

      Participants will be shown a standard drink equivalent chart and will answer questions about their typical alcohol consumption quantity (in standard drink units) on weekdays and weekend days, typical drinking frequency (number of consumption days per week) on weekdays and weekend days, and the highest number of standard drinks consumed at a single occasion during the prior 3 months. If participants work unusual schedules, they will be asked to define the weekend as their day or days off from work. If participants report periods of abstinence and periods of drinking in the previous 3 months, the questions will pertain to periods of drinking. Scores will not be reported on a scale, so there are no minimum and maximum values to report.

    Secondary Outcome Measures

    1. Revised Conflict Tactics Scales (CTS2) [Baseline, post-treatment, three-month, six-month, nine-month, and twelve-month follow-ups]

      Intimate partner violence (IPV) will be measured using the CTS2, administered to the client regarding their IPV at baseline and follow-up assessments. We will administer only the Physical Assault (12 items) and Psychological Aggression (8 items) subscales to limit respondent burden and because these are most relevant to study hypotheses. The minimum value is 0 and the maximum value is 8. Higher scores represent higher rates of IPV, except for 7 and 8, which represent year and lifetime use and experience of IPV. Variety scores will be calculated for the CTS2 so that scores reflect the number of positively endorsed IPV behaviors (rather than estimates of IPV frequency). This scoring method is considered more reliable, less skewed, more balanced (since high frequency, less severe aggressive behaviors may outweigh the influence of more severe but less frequent violence), and less influenced by recall errors than other methods.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    Male
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    All male Veteran participants must meet the following eligibility criteria:
    • participant is a Veteran

    • minimum age 18

    • participant is enrolled in the Strength at Home program following program intake

    • participant displays evidence of alcohol-related problems during program intake, as indicated by any of the following:

    • a report of physical IPV while under the influence of alcohol in the past year

    • a score of 8 or greater on the Alcohol Use Disorders Identification Test (AUDIT)

    • consumption of 6 or more standard drinks per occasion on one or more occasions in the previous 6 months

    • average weekly consumption of 14 or more standard drinks in the prior 6 months

    • participant provides written consent to participate in the study

    • inclusion for this study is broad because this is a population who possesses a number of comorbid problems and exclusion for those based on psychopathology or risk for aggression could potentially lead to a biased sample

    Exclusion Criteria:
    • None

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Phoenix VA Health Care System, Phoenix, AZ Phoenix Arizona United States 85012
    2 VA Boston Healthcare System Jamaica Plain Campus, Jamaica Plain, MA Boston Massachusetts United States 02130
    3 VA Ann Arbor Healthcare System, Ann Arbor, MI Ann Arbor Michigan United States 48105
    4 Minneapolis VA Health Care System, Minneapolis, MN Minneapolis Minnesota United States 55417

    Sponsors and Collaborators

    • VA Office of Research and Development

    Investigators

    • Principal Investigator: Casey Tyler Taft, PhD, VA Boston Healthcare System Jamaica Plain Campus, Jamaica Plain, MA

    Study Documents (Full-Text)

    None provided.

    More Information

    Additional Information:

    Publications

    None provided.
    Responsible Party:
    VA Office of Research and Development
    ClinicalTrials.gov Identifier:
    NCT05287711
    Other Study ID Numbers:
    • NURA-007-20F
    First Posted:
    Mar 18, 2022
    Last Update Posted:
    Jul 18, 2022
    Last Verified:
    Jul 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Product Manufactured in and Exported from the U.S.:
    No
    Keywords provided by VA Office of Research and Development
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Jul 18, 2022