Computerized Intervention for Distress Intolerance

Study Overview
=================
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).

Official Title
-----------------
Computerized Intervention for Distress Intolerance

Conditions
-----------------
Cannabis Use Disorder

Intervention / Treatment
-----------------
* Behavioral: Computerized Distress Intolerance Intervention
* Behavioral: Computerized Healthy Behaviors Intervention


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 30 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: At the end of the baseline assessment, the participant was randomized to the Computerized Distress Intolerance Intervention condition or the Computerized Healthy Behaviors condition. Participants in each condition attended two 1-hour intervention sessions followed by a post-treatment assessment. Follow-up assessments were conducted one-month and four-months after the post-treatment assessment.
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Computerized Distress Intolerance Intervention<br>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. | Behavioral: Computerized Distress Intolerance Intervention<br> <br> |
| Placebo Comparator: Computerized Healthy Behaviors Intervention<br>Two, 1-hour computerized sessions that focus on psychoeducation about the importance of a healthy lifestyle. | Behavioral: Computerized Healthy Behaviors Intervention<br> <br> |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Distress Intolerance Index (DII) score from Baseline through 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). | Baseline, post-treatment (i.e.,  1 week following the last treatment session), 1-month follow-up, 4-month follow-up | 
| Change in Mirror-Tracing Persistence Task (MTPT) quit latency from Baseline to Post-Treatment | 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). | Baseline, post-treatment (i.e.,  1 week following the last treatment session) | 
| Change in Marijuana Problems Scale (MPS) score from Baseline through 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). | Baseline, post-treatment (i.e.,  1 week following the last treatment session), 1-month follow-up, 4-month follow-up | 
| Change in Cannabis Use Disorder (CUD) diagnostic criteria from Baseline to 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). | Baseline, 4-month follow-up | 
| Change in Timeline follow-back (TLFB) cannabis use frequency from Baseline through 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). | Baseline, post-treatment (i.e.,  1 week following the last treatment session), 1-month follow-up, 4-month follow-up | 
| Change in Marijuana Motives Measure (MMM) score from Baseline through 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). | Baseline, post-treatment (i.e.,  1 week following the last treatment session), 1-month follow-up, 4-month follow-up | 
| Change in Marijuana Craving Questionnaire (MCQ) score from Baseline to Post-Treatment | 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. | Baseline, post-treatment (i.e.,  1 week following the last treatment session) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 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). | Baseline, post-treatment (i.e.,  1 week following the last treatment session) | 
| Change in electroencephalography (EEG) index of acute stress modulation of threat reactivity (assessed by the Late Positive Potential [LPP]) from Baseline to Post-Treatment | 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). | Baseline, post-treatment (i.e.,  1 week following the last treatment session) | 
| Change in electroencephalography (EEG) index of acute stress modulation of response inhibition (assessed by the N200 [N2]) from Baseline to Post-Treatment | 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). | Baseline, post-treatment (i.e.,  1 week following the last treatment session) | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
stress, distress intolerance