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

Официальное название

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

Обзор

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.

Подробное описание

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 Stage I project aims to modify an existing two-session computerized distress tolerance intervention to optimize emotion regulation learning/generalization 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 and its imaginal exposure module will be modified to shape emotional engagement with the aim of maximizing within-session habituation, which will be signaled with a novel audio/visual cue (habituation cue). Habituation cues will then be delivered in just-in-time text message reminders triggered by naturalistic distress reported via ecological momentary assessment. 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. To measure the intervention's mechanistic target engagement, multi-method distress intolerance assessments will be administered through four-month follow-up. To measure the intervention's impact on cannabis use, stress-related cannabis use motivation (lab stress- elicited craving and neurophysiological drug cue reactivity, ecological momentary assessment of stress-elicited cannabis use) will be assessed through the intervention period. Interviewer-assessed cannabis use frequency, CUD severity, and urinary THC metabolite concentration will be measured through 4-month follow-up. Quality of life and anxiety/depression symptoms will also be measured as secondary outcomes through 4-month follow-up. As an exploratory aim, a wristworn device will be used to measure ambulatory physiology during a portion of the intervention period to evaluate the feasibility of detecting heightened real- world distress based on objective indicators. Our central hypothesis is that, compared to a control intervention, the Emotional Engagement Distress Tolerance Intervention will produce superior reductions in multi-method assessments of distress intolerance, stress-related cannabis use motivation, disordered cannabis use, and psychosocial functioning. Successful completion of the proposed aims will (1) justify a subsequent Stage II trial, and (2) inform efforts to integrate the just-in-time habituation reminders with wearable technology in order to increase emotion regulation generalization opportunities and decrease participant report burden.

Вмешательства

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

Первичные конечные точки

• Therapy Evaluation Questionnaire [Срок оценки: Immediately after intervention session]
• Treatment Satisfaction Questionnaire [Срок оценки: Post-Intervention (20 days after intervention session)]
• Change in perceived distress intolerance from baseline through follow-up [Срок оценки: Baseline, Mid-Intervention (10 days after intervention session), Post-Intervention (20 days after intervention session), One-Month Follow-up, Four-Month Follow-up]
• Change in behavioral distress intolerance from baseline through follow-up [Срок оценки: Baseline, Mid-Intervention (10 days after intervention session), Post-Intervention (20 days after intervention session), One-Month Follow-up, Four-Month Follow-up]
• Change in laboratory stress-induced cannabis craving from baseline through post-intervention [Срок оценки: Baseline, Post-Intervention (20 days after intervention session)]
• Change in laboratory stress-induced neural reactivity to cannabis cues (assessed via the electroencephalography [EEG]-recorded late positive potential) from baseline through post-intervention [Срок оценки: Baseline, Post-Intervention (20 days after intervention session)]
• Change in real-world stress-elicited cannabis use from baseline to post-intervention [Срок оценки: Baseline, Mid-Intervention (10 days after intervention session), Post-Intervention (20 days after intervention session)]
• Change in cannabis use frequency from baseline through follow-up [Срок оценки: Baseline, Post-Intervention (20 days after intervention session), One-Month Follow-up, Four-Month Follow-up]
• Change in urine tetrahydrocannabinol [THC] metabolite concentration from baseline through follow-up [Срок оценки: Baseline, Mid-Intervention (10 days after intervention session), Post-Intervention (20 days after intervention session), One-Month Follow-up, Four-Month Follow-up]
• Change in self-reported cannabis use problems from baseline through follow-up [Срок оценки: Baseline, Post-Intervention (20 days after intervention session), One-Month Follow-up, Four-Month Follow-up]

Вторичные конечные точки (2)

• Change in quality of life from baseline through follow-up [Срок оценки: Baseline, Post-Intervention (20 days after intervention session), One-Month Follow-up, Four-Month Follow-up]
• Change in depression and anxiety from baseline through follow-up [Срок оценки: Baseline, Post-Intervention (20 days after intervention session), One-Month Follow-up, Four-Month Follow-up]

Критерии участия

Критерии включения

• Cannabis is the primary substance of abuse.
• Clinical-level Distress intolerance Index score.
• Current Cannabis Use Disorder diagnosis.
• Near-daily to daily cannabis use in past-month and past 3 months.
• Positive urine screen for THC
• Detectable skin conductance level
• Owns a smart phone
• Primary smoked/vaporized delta-9 or delta-8 THC user

Критерии исключения

• Presence of acute/major psychiatric disturbance
• Current pregnancy
• Change in psychotropic medication within the past month
• Concurrently receiving treatment for cannabis use
• Concurrently receiving dialectical behavior therapy or exposure-based therapy for emotional disorders
• Planning to immediately quit using cannabis
• EEG contraindications
• Kidney disease

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Двойное слепое

Основная цель

Лечение

Центры проведения

США · 1 центр

• The BRAINS Lab at Florida State University — Tallahassee

Идентификаторы

NCT: NCT06085222 · STUDY00006346 · 1R34DA057733-01A1

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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