Clinical trial NCT05414344: A Brief Intervention for Alcohol Users With Interpersonal Trauma
Official title: A Randomized Controlled Trial of a Trauma-Informed and Peer-Supported Brief Intervention for Alcohol Users With Interpersonal Trauma
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Heavy Drinking
Alcohol Drinking
Substance Use
Drinking Behavior
Keywords: Brief intervention
Cannabis
Trauma
Alcohol
Drinking
Peer coach
Lead sponsor: Western Kentucky University
Sponsor class: OTHER
First posted: 2022-06-10
Enrollment: 225
Sex: ALL
Minimum age (years): 18
Maximum age (years): 25
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
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
Primary purpose: TREATMENT

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.

Detailed description: Alcohol is the most frequently used substances in the United States, and emerging adults (EAs) ages 18-25 have the highest rates of heavy substance use of any age group. Heavy and persistent alcohol is linked with a host of negative outcomes in EAs, including poor mental health, lower life satisfaction, cognitive impairments, poor academic performance, increased risk for motor vehicle accidents, and substance use disorders.

Brief interventions (BIs) for substance use typically consist of one to two individual sessions with personalized feedback about substance use. BIs aim to correct inaccurate normative beliefs and highlight personal consequences of substance use. BIs for alcohol use have demonstrated reductions in drinking and alcohol-related problems in numerous clinical trials. However, problems with BIs include 1) effect sizes are typically small and dissipate over time and 2) BIs for substance use demonstrate little to no effectiveness in individuals with interpersonal trauma (i.e., human-perpetrated violence) and interpersonal trauma-related distress. A potential reason for small or null effects of BIs for substance use in EAs are that existing interventions fail to tailor components to specific groups at high risk for substance issues, such as interpersonal trauma survivors. This limited effectiveness may be enhanced by 1) targeting coping motives, a consistent predictor of heavy and persistent alcohol use for interpersonal trauma survivors that is omitted from traditional BIs and 2) use of peer coaches to enhance outcomes following BI delivery.

There are many reasons that greater focus on trauma, coping, and peer influence in BIs could improve outcomes among substance using EAs. Individuals are most likely to experience interpersonal trauma during emerging adulthood, which in turn has been linked to worse mental health, lower social support, and higher rates of alcohol and cannabis use and problems. Studies on alcohol and cannabis use motives suggest that coping with negative emotions are common reasons for substance use among EAs, particularly for EAs with interpersonal trauma, driving heavy use. However, the connections between negative emotions, trauma, substance use, and coping are not addressed in standard BIs. Furthermore, traditional BIs do not provide healthy coping strategies for managing trauma-related negative emotions, despite many empirically supported and adaptive coping strategies that have been identified. Additionally, peer influence has a strong effect on initiation and maintenance of alcohol and cannabis use in EAs, and inclusion of affiliated peers in in-person BIs has been found to enhance treatment efficacy. However, studies have yet to incorporate peers into follow-up of BIs for substance use, despite the demonstrated utility of peer coaches in health interventions for other outcomes (e.g., weight loss).

Importantly, in-person, counselor-delivered BIs have been critiqued as being costly and impractical to implement in real-world settings, inhibiting widespread dissemination. Given that few EAs seek out substance prevention or treatment services, highly accessible, low-cost ways of delivering BIs to this population are needed. Mobile phones are now ubiquitous and represent a particularly advantageous way to provide BIs. Recent research indicates that mobile-delivered substance use interventions show promise in this age group, but given poor treatment engagement often exhibited in many digital health interventions, these approaches may benefit from inclusion of peer coaches following intervention delivery.

The primary goal of the proposed study is to examine the feasibility and efficacy of a mobile-delivered, trauma-informed and peer-supported BI (TIPS-BI) in a sample of EAs with interpersonal trauma histories. The study will enhance and extend research on BIs by: (a) providing intervention content focused on understanding the connection between trauma and substance use and teaching emotion regulation coping skills and (b) incorporating trained peer coaches into text-message-based follow-up. We will conduct a 3-group randomized controlled trial with 165 EAs (ages 18-25; project 60% female) with interpersonal trauma and recent heavy alcohol use. Groups will include Group 1: Mobile-delivered, TIPS-BI with peer coach follow-up (N=55), Group 2: Mobile-delivered standard substance use BI (N=55), and Group 3: Assessment only (N=55)

Aim 1: Examine the feasibility and acceptability of the TIPS-BI. The investigators hypothesize that TIPS-BI will exhibit relatively low levels of dropout (\<10%) at follow-up and will be similar to dropout rates shown in the standard BI. The investigators also believe that the TIPS-BI will be perceived by participants as satisfactory, relevant, helpful, and a low burden.

Aims 2 \& 3: Evaluate the efficacy of the TIPS-BI in a randomized controlled trial. The investigators hypothesize that the TIPS-BI will be associated with greater reductions in alcohol/cannabis use, alcohol/cannabis problems, and coping motives at 3 and 6-month follow-ups relative to the standard BI and assessment only. The investigators also hypothesize that the TIPS-BI will result in greater increases in coping self-efficacy at 3 and 6-month follow-ups relative to the standard BI and assessment only.

Eligibility 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.

Primary outcomes:
measure: Alcohol use
timeFrame: Change from Baseline to 3 month follow-up
measure: Alcohol use
timeFrame: Change from Baseline to 6 month follow-up
measure: Alcohol use
timeFrame: Change from Baseline to 3 month follow-up
measure: Alcohol use
timeFrame: Change from Baseline to 6 month follow-up
measure: Cannabis use
timeFrame: Change from baseline to 3-month follow-up
measure: Cannabis use
timeFrame: Change from baseline to 6-month follow-up
measure: Cannabis-related problems
timeFrame: Change from baseline to 3-month follow-up
measure: Cannabis-related problems
timeFrame: Change from baseline to 6-month follow-up
measure: Intervention Feasibility
timeFrame: 6 month follow-up
measure: Intervention Acceptability
timeFrame: 6 month follow-up
measure: Intervention Helpfulness
timeFrame: 6 month follow-up
Secondary outcomes:
measure: Marijuana use motives
timeFrame: Change from baseline to 3-month follow-up
measure: Marijuana use motives
timeFrame: Change from baseline to 6-month follow-up
measure: Alcohol use motives
timeFrame: Change from baseline to 3-month follow-up
measure: Alcohol use motives
timeFrame: Change from baseline to 6-month follow-up
measure: Substance-related coping
timeFrame: Change from baseline to 3-month follow-up
measure: Substance-related coping
timeFrame: Change from baseline to 6-month follow-up
measure: Coping self-efficacy
timeFrame: Change from baseline to 3-month follow-up
measure: Coping self-efficacy
timeFrame: Change from baseline to 6-month follow-up
Other outcomes:
Locations:
city: Bowling Green
country: United States
facility: Western Kentucky University
state: Kentucky
Study officials:
References:
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