Evaluation of a Brief Computerized and Smart Phone-based Intervention for Stress in Regular Cannabis Users

Part of paid clinical trials in Tallahassee, Florida.

Sponsor
Florida State University
Study ID
NCT06085222
Status
Recruiting
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Conditions

  • Cannabis Use Disorder

Eligibility Criteria

Sex
ALL
Age
18 Years - 30 Years
Healthy Volunteers
Not accepted

Interventions

  • Emotional Engagement Distress Tolerance Intervention — BEHAVIORAL
    2.5 hour computerized intervention with smart phone support focused on building tolerance of emotional distress
  • Health Education Intervention — BEHAVIORAL
    2.5 hour computerized intervention with smart phone support focused on building healthy habits that support stress management

Study Details

The prevalence of daily cannabis use and Cannabis Use Disorder (CUD) has increased in the United States over the past two decades. Brief, computerized harm reduction interventions that target specific high-risk CUD populations could be an efficient approach to reducing CUD. Distress intolerance , which refers to the tendency to negatively appraise and escape aversive emotional states, is a risk factor associated with stress-related cannabis use motivation and CUD severity/chronicity. Thus, a brief, accessible, low-cost intervention that reduces distress intolerance in those with CUD and elevated distress intolerance could have a significant public health impact. This proposed project aims to optimize an existing two-session computerized distress tolerance intervention and test its impact on distress intolerance and cannabis use outcomes in a randomized controlled trial. Specifically, the intervention will be condensed to one-session, its active ingredient bolstered, and augmented with smart phone-delivered therapy reminders. After obtaining feedback on the modified Emotional Engagement Distress Tolerance Intervention in a small sample, the intervention's efficacy compared to a stringent, credible, time-matched health education control intervention will be tested in a randomized controlled trial in 80 cannabis users with CUD and high distress intolerance. Distress intolerance, cannabis use, and psychosocial functioning outcomes will be evaluated. As an exploratory aim, a wristworn device will be used to measure objective stress responding in the real-world during the intervention period. Our central hypothesis is that, compared to a control intervention, the Emotional Engagement Distress Tolerance Intervention will produce superior reductions distress intolerance, stress-related cannabis use motivation, disordered cannabis use, and psychosocial functioning.

Key Dates

Start date
Jun 4, 2024
Status verified
Sep 2025
Primary completion
Oct 30, 2027
Completion
Oct 30, 2027

Study Design

Enrollment
80 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Emotional Engagement Distress Tolerance Intervention
    The experimental intervention (single 2.5 hour session) is comprised of video-delivered psychoeducation, adaptive skill practice, and emotional exposure. During exposure, a sequence of percussive sounds accompanied by a visual depiction of the participant's skin conductance level during exposure will be presented at the moment the participant's skin conductance returns to the relaxation baseline value. These images/sound will be intermittently sent to the participant's smart phone during the smart phone portion of the intervention.
  • Placebo Comparator: Health Education Intervention
    The health education control intervention is a single 2.5 hour computerized session. It is comprised of audio-narrated videos on healthy habits and self-care in the domains of sleep, nutrition, hygiene, and physical exercise. The same sequence of percussive sounds used in the Emotional Engagement Distress Tolerance Intervention is presented alongside summary slides presenting key points on healthy habits and self-care. These images/sound will be intermittently sent to the participant's smart phone during the smart phone portion of the intervention.

Primary Outcome Measure

Therapy Evaluation Questionnaire [ Time Frame: Immediately after intervention session ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
The BRAINS Lab at Florida State UniversityTallahasseeFlorida32306-4301
Zoe Howell Study Coordinator, BS
[email protected]
850-644-2445

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By research site
The BRAINS Lab at Florida State University· Tallahassee, FL

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