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A Brief Intervention for Alcohol Users With Interpersonal Trauma

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ClinicalTrials.gov Identifier: NCT05414344
Recruitment Status : Not yet recruiting
First Posted : June 10, 2022
Last Update Posted : September 7, 2022
Sponsor:
Information provided by (Responsible Party):
Matthew Woodward, Western Kentucky University

Brief Summary:
The current proposal aims to enhance a mobile-delivered brief intervention for young adults with heavy alcohol use and interpersonal trauma by including adaptive coping strategies for managing trauma-related distress and using peer coaches after delivery of the intervention to maintain treatment gains. Individuals will be randomized to a modified brief intervention incorporating with peer coaches, a standard brief intervention, or assessment only. Participants will be followed up at 3 and 6 months post intervention. The investigators hypothesize that the trauma-informed and peer-supported brief intervention (TIPS-BI) will show low levels of dropout, will be perceived positively by participants, and will result in greater reductions in alcohol use compared to a standard brief intervention and assessment only.

Condition or disease Intervention/treatment Phase
Heavy Drinking Alcohol Drinking Substance Use Drinking Behavior Behavioral: Standard Brief Intervention Behavioral: Trauma-Informed and Peer-Supported Brief Intervention Behavioral: Assessment only Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 165 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Participants will be randomly assigned to either 1) a standard brief intervention 2) a modified brief intervention with peer coaching and trauma-related information or 3) assessment only
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Randomized Controlled Trial of a Trauma-Informed and Peer-Supported Brief Intervention for Alcohol Users With Interpersonal Trauma
Estimated Study Start Date : September 2022
Estimated Primary Completion Date : May 2024
Estimated Study Completion Date : May 2024

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Standard Brief Intervention
Immediately following completion of the baseline assessment, participants will be texted a link to a secure website which contains the participant's personalized feedback. Personalized feedback is automatically presented via a programming algorithm that is based on the participants baseline survey responses. The personalized feedback component will include a personalized substance use profile, information on peer norms, prior substance-related consequences experienced by the participant, practical costs (e.g., money spent on substances, fees for a DUI), and standard protective behavioral strategies to limit substance-related risk.
Behavioral: Standard Brief Intervention
Immediately following completion of the baseline assessment, participants will be texted a link to a secure website which contains the participant's personalized feedback. Personalized feedback is automatically presented via a programming algorithm that is based on the participants baseline survey responses. The personalized feedback component will include a personalized substance use profile, information on peer norms, prior substance-related consequences experienced by the participant, practical costs (e.g., money spent on substances, fees for a DUI), and standard protective behavioral strategies to limit substance-related risk.

Experimental: Trauma-Informed and Peer-Supported Brief Intervention (TIPS-BI)
In addition to the components of the standard brief intervention, the TIPS-BI will include personalized feedback about participants use of substances to cope. Additionally, participants will be provided with psychoeducation about the link between substance use, trauma, and coping motives, and information highlighting the iatrogenic effects that substance use has on negative emotions. Participants will also be given a series of evidence-based alternative coping strategies for managing trauma-related distress such as anxiety, depression, and PTSD. Participants will be asked to set goals related to utilization of these alternative coping strategies. Participants will then be informed that a trained peer who is part of the research team will follow up with them via text message at the monthly time points to review adherence to their goals and offer support.
Behavioral: Trauma-Informed and Peer-Supported Brief Intervention
In addition to the components of the standard brief intervention, the TIPS-BI will include personalized feedback about participants use of substances to cope. Additionally, participants will be provided with psychoeducation about the link between substance use, trauma, and coping motives, and information highlighting the iatrogenic effects that substance use has on negative emotions. Participants will also be given a series of evidence-based alternative coping strategies for managing trauma-related distress such as anxiety, depression, and PTSD. Participants will be asked to set goals related to utilization of these alternative coping strategies. Participants will then be informed that a trained peer who is part of the research team will follow up with them via text message at the monthly time points to review adherence to their goals and offer support.

Experimental: Assessment only
Following the baseline survey, participants in the assessment only group will be texted again 3 and 6 months later to complete follow up assessments. Following the end of the 6-month follow-up, participants will be offered an opportunity to complete the TIPS-BI without peer coach follow-up.
Behavioral: Assessment only
Following the baseline survey, participants in the assessment only group will be texted again 3 and 6 months later to complete follow up assessments. Following the end of the 6-month follow-up, participants will be offered an opportunity to complete the TIPS-BI without peer coach follow-up.




Primary Outcome Measures :
  1. Alcohol use [ Time Frame: Change from Baseline to 3 month follow-up ]
    The Daily Drinking Questionnaire

  2. Alcohol use [ Time Frame: Change from Baseline to 6 month follow-up ]
    The Daily Drinking Questionnaire

  3. Alcohol use [ Time Frame: Change from Baseline to 3 month follow-up ]
    The Brief Young Adult Alcohol Consequences Questionnaire

  4. Alcohol use [ Time Frame: Change from Baseline to 6 month follow-up ]
    The Brief Young Adult Alcohol Consequences Questionnaire

  5. Cannabis use [ Time Frame: Change from baseline to 3-month follow-up ]
    The Daily Sessions, Frequency, Age of Onset, Quantity of Cannabis Use Inventory (DFAQ-CU)

  6. Cannabis use [ Time Frame: Change from baseline to 6-month follow-up ]
    The Daily Sessions, Frequency, Age of Onset, Quantity of Cannabis Use Inventory (DFAQ-CU)

  7. Cannabis-related problems [ Time Frame: Change from baseline to 3-month follow-up ]
    The Marijuana Problems Scale; scores range from 0-38; higher scores reflect greater problems

  8. Cannabis-related problems [ Time Frame: Change from baseline to 6-month follow-up ]
    The Marijuana Problems Scale; scores range from 0-38; higher scores reflect greater problems

  9. Intervention Feasibility [ Time Frame: 6 month follow-up ]
    Percentage of drop out in the interventions

  10. Intervention Acceptability [ Time Frame: 6 month follow-up ]
    Participants in both the standard and modified brief interventions will be asked to rate on a Likert scale how satisfied they were with the intervention.

  11. Intervention Helpfulness [ Time Frame: 6 month follow-up ]
    Participants in both the standard and modified brief interventions will be asked to rate on a Likert scale how how helpful they found the intervention.


Secondary Outcome Measures :
  1. Marijuana use motives [ Time Frame: Change from baseline to 3-month follow-up ]
    The Comprehensive Marijuana Motives Questionnaire; scores range from 3 to 15; higher scores reflect greater endorsement of motives

  2. Marijuana use motives [ Time Frame: Change from baseline to 6-month follow-up ]
    The Comprehensive Marijuana Motives Questionnaire; scores range from 3 to 15; higher scores reflect greater endorsement of motives

  3. Alcohol use motives [ Time Frame: Change from baseline to 3-month follow-up ]
    Modified Drinking Motives Questionnaire - Revised

  4. Alcohol use motives [ Time Frame: Change from baseline to 6-month follow-up ]
    Modified Drinking Motives Questionnaire - Revised

  5. Substance-related coping [ Time Frame: Change from baseline to 3-month follow-up ]
    The Brief Cope Inventory; scores range from 2 to 8; higher scores reflected greater use of the specified coping method

  6. Substance-related coping [ Time Frame: Change from baseline to 6-month follow-up ]
    The Brief Cope Inventory; scores range from 2 to 8; higher scores reflected greater use of the specified coping method

  7. Coping self-efficacy [ Time Frame: Change from baseline to 3-month follow-up ]
    The Coping Self-Efficacy Scale; scores range from 0-260; higher scores reflect greater coping self-efficacy

  8. Coping self-efficacy [ Time Frame: Change from baseline to 6-month follow-up ]
    The Coping Self-Efficacy Scale; scores range from 0-260; higher scores reflect greater coping self-efficacy



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 25 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Age 18 to 25
  2. Part-time or full-time college student
  3. Ability to speak and understand English
  4. Access to a cell phone
  5. Lifetime history of interpersonal trauma exposure
  6. Heavy alcohol use

Exclusion Criteria:

1) Currently receiving psychological therapy or psychotropic medication for substance use.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05414344


Contacts
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Contact: Matt Woodward, Ph.D. 270-745-3919 matthew.woodward@wku.edu

Sponsors and Collaborators
Western Kentucky University
Publications of Results:
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Responsible Party: Matthew Woodward, Assistant Professor, Western Kentucky University
ClinicalTrials.gov Identifier: NCT05414344    
Other Study ID Numbers: 22-132
First Posted: June 10, 2022    Key Record Dates
Last Update Posted: September 7, 2022
Last Verified: September 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Matthew Woodward, Western Kentucky University:
Brief intervention
Cannabis
Trauma
Alcohol
Drinking
Peer coach
Additional relevant MeSH terms:
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Substance-Related Disorders
Alcohol Drinking
Drinking Behavior
Chemically-Induced Disorders
Mental Disorders