Computerized Intervention for Distress Intolerance

Not Applicable

Completed

• Conditions: Cannabis Use Disorder
• Interventions: Behavioral: Computerized Distress Intolerance Intervention; Behavioral: Computerized Healthy Behaviors Intervention

• Registration Number: NCT04173078
• Lead Sponsor: Auburn University

Brief Summary

This study evaluates the impact of a computerized distress intolerance intervention relative to a control intervention on cannabis use-related behavior and neurophysiology.

Detailed Description

Distress intolerant cannabis users were randomized to a computerized distress intolerance intervention or a control intervention. Primary and secondary outcomes consist of the treatment target, cannabis use-related behavior, and theoretically-relevant neurophysiological processes (i.e., cannabis cue reactivity, response inhibition).

Study Timeline

• Study Start: 2016-06-01
• Primary Completion: 2017-10-30
• Study Completion: 2017-10-30
• Status Verified: 2019-11
• Study First Submitted: 2019-11-13
• Study First Submitted QC: 2019-11-20
• Last Update Submitted: 2019-11-20
• Study First Posted: 2019-11-21
• Last Update Posted: 2019-11-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

• Distress Intolerance Index score >= 20
• Average cannabis use frequency in the past year >= 2-3/week

Exclusion Criteria

• Current suicidal ideation
• History of psychotic symptoms
• Bipolar-spectrum disorder without stabilization on medication for >= 3 months
• Change in psychotropic medication in the past month
• Current CBT for internalizing or substance use disorders

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Computerized Distress Intolerance Intervention	Computerized Distress Intolerance Intervention	Two, 1-hour computerized sessions that include psychoeducation about emotional avoidance, idiographic emotional exposure, and construction of idiographic implementation intentions to practice distress tolerance skills outside of session.
Computerized Healthy Behaviors Intervention	Computerized Healthy Behaviors Intervention	Two, 1-hour computerized sessions that focus on psychoeducation about the importance of a healthy lifestyle.

Primary Outcome Measures

Name	Time	Method
Change in Distress Intolerance Index (DII) score from Baseline through 4-Month Follow-Up	Baseline, post-treatment (i.e., ~1 week following the last treatment session), 1-month follow-up, 4-month follow-up	Self-report measure of Distress Intolerance (Distress Intolerance Index \[DII\]; McHugh \& Otto, 2012). The DII is a self-report measure comprised of 10 items that are summed together to form a total score (minimum: 0; maximum: 40). Higher scores indicate greater distress intolerance (i.e., worse outcome).
Change in Cannabis Use Disorder (CUD) diagnostic criteria from Baseline to 4-Month Follow-Up	Baseline, 4-month follow-up	Interviewer-assessed Diagnostic and Statistical Manual of Mental Disorders (DSM)-5 Cannabis Use Disorder diagnostic criteria. DSM-5 Cannabis Use Disorder criteria were assessed via interview at baseline and again at the 4-month follow-up. Total number of Cannabis Use Disorder criteria was used to assess Cannabis Use Disorder severity (minimum score: 0; maximum score: 11). Higher scores indicate greater Cannabis Use Disorder severity (i.e., worse outcome).
Change in Timeline follow-back (TLFB) cannabis use frequency from Baseline through 4-Month Follow-Up	Baseline, post-treatment (i.e., ~1 week following the last treatment session), 1-month follow-up, 4-month follow-up	Percent cannabis use days in the past month (Timeline follow-back \[TLFB\]; Hjorthoj et al., 2012). The Timeline follow-back (TLFB) is a self-report measure that assesses cannabis use over the past 4 weeks. Percentage of days on which cannabis was used in the past four weeks was used to assess cannabis use frequency (minimum: 0%; maximum: 100%). Higher scores indicate greater cannabis use frequency (i.e., worse outcome).
Change in Mirror-Tracing Persistence Task (MTPT) quit latency from Baseline to Post-Treatment	Baseline, post-treatment (i.e., ~1 week following the last treatment session)	Behavioral measure of Distress Intolerance (Mirror-Tracing Persistence Task \[MTPT\]; Macatee \& Cougle, 2015). The MTPT is a behavioral persistence measure that assesses behavioral distress intolerance via the latency to quit a distressing task. Scores range from 0 seconds to a maximum persistence time of 7 minutes. Lower scores indicate greater distress intolerance (i.e., worse outcome).
Change in Marijuana Problems Scale (MPS) score from Baseline through 4-Month Follow-Up	Baseline, post-treatment (i.e., ~1 week following the last treatment session), 1-month follow-up, 4-month follow-up	Self-report measure of marijuana use-related problems (Marijuana Problems Scale \[MPS\]; Stephens et al., 2000). The MPS is a self-report measure of marijuana use-related problem severity in the past month. The measure is comprised of 19 items with a minimum score of 0 and a maximum score of 38. Higher scores indicate greater marijuana use-related problem severity in the past month (i.e., worse outcome).
Change in Marijuana Motives Measure (MMM) score from Baseline through 4-Month Follow-Up	Baseline, post-treatment (i.e., ~1 week following the last treatment session), 1-month follow-up, 4-month follow-up	Self-reported motives for cannabis use (Marijuana Motives Measure \[MMM\]; Zvolensky et al., 2007). The Marijuana Motives Measure (MMM) is a self-report measure that assesses different motives for marijuana use. The coping motives subscale was the subscale of interest in this project. The Coping motives subscale is comprised of 4 items that are then averaged (minimum score: 1; maximum score: 5). Greater scores indicate greater coping motives for marijuana use (i.e., worse outcome).
Change in Marijuana Craving Questionnaire (MCQ) score from Baseline to Post-Treatment	Baseline, post-treatment (i.e., ~1 week following the last treatment session)	Self-reported state craving for marijuana (Marijuana Craving Questionnaire \[MCQ\]; Heishman et al., 2009). The Marijuana Craving Questionnaire (MCQ) is a self-report measure of current craving for marijuana use. The emotionality subscale was the subscale of interest in this project. The Emotionality subscale is comprised of 5 items that are then averaged (minimum score: 1; maximum score: 7). Greater scores indicate greater marijuana craving (i.e., worse outcome). In this project, the outcome of interest is the extent to which a laboratory stress induction increases state marijuana craving.

Secondary Outcome Measures

Name	Time	Method
Change in electroencephalography (EEG) index of acute stress modulation of response inhibition (assessed by the N200 [N2]) from Baseline to Post-Treatment	Baseline, post-treatment (i.e., ~1 week following the last treatment session)	Acute stress modulation of the N2 to no-go stimuli. The N2 to no-go vs. go stimuli on a go/no-go task before and after a laboratory stress induction will be measured as a neurophysiological index of the acute stress modulation of response inhibition. More negative values indicate a larger neural response to stimuli requiring response inhibition during acute stress (i.e., better outcome).
Change in electroencephalography (EEG) index of acute stress modulation of cannabis cue reactivity (assessed by the Late Positive Potential [LPP]) from Baseline to Post-Treatment	Baseline, post-treatment (i.e., ~1 week following the last treatment session)	Acute Stress modulation of the Late Positive Potential (LPP) to Cannabis Cues. The LPP to visual cannabis cues before and after a laboratory stress induction will be measured as a neurophysiological index of acute stress modulation of cannabis cue incentive salience. Greater values indicate a larger neural response to cannabis cues during acute stress (i.e., worse outcome).
Change in electroencephalography (EEG) index of acute stress modulation of threat reactivity (assessed by the Late Positive Potential [LPP]) from Baseline to Post-Treatment	Baseline, post-treatment (i.e., ~1 week following the last treatment session)	Acute Stress modulation of the Late Positive Potential (LPP) to threat stimuli. The LPP to visual threat stimuli before and after a laboratory stress induction will be measured as a neurophysiological index of acute stress modulation of threat reactivity. Greater values indicate a larger neural response to threat during acute stress (i.e., worse outcome).