Clinical trial NCT04173078: Computerized Intervention for Distress Intolerance
Official title: Computerized Intervention for Distress Intolerance
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cannabis Use Disorder
Keywords: distress intolerance
stress
Lead sponsor: Auburn University
Sponsor class: OTHER
Collaborators: name: National Institute on Drug Abuse (NIDA)
name: Florida State University
First posted: 2019-11-21
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 30
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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.
Primary purpose: TREATMENT

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).

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

Primary outcomes:
measure: Change in Distress Intolerance Index (DII) score from Baseline through 4-Month Follow-Up
timeFrame: Baseline, post-treatment (i.e., ~1 week following the last treatment session), 1-month follow-up, 4-month follow-up
measure: Change in Mirror-Tracing Persistence Task (MTPT) quit latency from Baseline to Post-Treatment
timeFrame: Baseline, post-treatment (i.e., ~1 week following the last treatment session)
measure: Change in Marijuana Problems Scale (MPS) score from Baseline through 4-Month Follow-Up
timeFrame: Baseline, post-treatment (i.e., ~1 week following the last treatment session), 1-month follow-up, 4-month follow-up
measure: Change in Cannabis Use Disorder (CUD) diagnostic criteria from Baseline to 4-Month Follow-Up
timeFrame: Baseline, 4-month follow-up
measure: Change in Timeline follow-back (TLFB) cannabis use frequency from Baseline through 4-Month Follow-Up
timeFrame: Baseline, post-treatment (i.e., ~1 week following the last treatment session), 1-month follow-up, 4-month follow-up
measure: Change in Marijuana Motives Measure (MMM) score from Baseline through 4-Month Follow-Up
timeFrame: Baseline, post-treatment (i.e., ~1 week following the last treatment session), 1-month follow-up, 4-month follow-up
measure: Change in Marijuana Craving Questionnaire (MCQ) score from Baseline to Post-Treatment
timeFrame: Baseline, post-treatment (i.e., ~1 week following the last treatment session)
Secondary outcomes:
measure: 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
timeFrame: Baseline, post-treatment (i.e., ~1 week following the last treatment session)
measure: Change in electroencephalography (EEG) index of acute stress modulation of threat reactivity (assessed by the Late Positive Potential [LPP]) from Baseline to Post-Treatment
timeFrame: Baseline, post-treatment (i.e., ~1 week following the last treatment session)
measure: Change in electroencephalography (EEG) index of acute stress modulation of response inhibition (assessed by the N200 [N2]) from Baseline to Post-Treatment
timeFrame: Baseline, post-treatment (i.e., ~1 week following the last treatment session)
Other outcomes:
Locations:
Study officials:
affiliation: Auburn University
name: Richard J Macatee, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: McHugh RK, Otto MW. Refining the measurement of distress intolerance. Behav Ther. 2012 Sep;43(3):641-51. doi: 10.1016/j.beth.2011.12.001. Epub 2011 Dec 20.
citation: Macatee RJ, Cougle JR. Development and evaluation of a computerized intervention for low distress tolerance and its effect on performance on a neutralization task. J Behav Ther Exp Psychiatry. 2015 Sep;48:33-9. doi: 10.1016/j.jbtep.2015.01.007. Epub 2015 Jan 26.
citation: Stephens RS, Roffman RA, Curtin L. Comparison of extended versus brief treatments for marijuana use. J Consult Clin Psychol. 2000 Oct;68(5):898-908.
citation: Hjorthoj CR, Hjorthoj AR, Nordentoft M. Validity of Timeline Follow-Back for self-reported use of cannabis and other illicit substances--systematic review and meta-analysis. Addict Behav. 2012 Mar;37(3):225-33. doi: 10.1016/j.addbeh.2011.11.025. Epub 2011 Nov 26.
citation: Zvolensky MJ, Vujanovic AA, Bernstein A, Bonn-Miller MO, Marshall EC, Leyro TM. Marijuana use motives: A confirmatory test and evaluation among young adult marijuana users. Addict Behav. 2007 Dec;32(12):3122-30. doi: 10.1016/j.addbeh.2007.06.010. Epub 2007 Jun 9.
citation: Heishman SJ, Evans RJ, Singleton EG, Levin KH, Copersino ML, Gorelick DA. Reliability and validity of a short form of the Marijuana Craving Questionnaire. Drug Alcohol Depend. 2009 Jun 1;102(1-3):35-40. doi: 10.1016/j.drugalcdep.2008.12.010. Epub 2009 Feb 13.
citation: Macatee RJ, Preston TJ, Afshar K, Schmidt NB, Cougle JR. Impact of a computerized distress intolerance intervention on electrocortical reactivity to cannabis and threat cues: A randomized controlled trial. Psychol Addict Behav. 2022 Nov;36(7):920-929. doi: 10.1037/adb0000815. Epub 2022 Feb 7.