Computerized Intervention for Distress Intolerance

Cannabis Use Disorder Clinical Trial

Official title:

Computerized Intervention for Distress Intolerance

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04173078
• Other study ID #: 201720828
• Secondary ID: F31DA039644-01A1
• Status: Completed
• Phase: N/A
• Start date: June 1, 2016
• Est. completion date: October 30, 2017

Study information

• Verified date: November 2019
• Source: Auburn University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: October 30, 2017
• Est. primary completion date: October 30, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 30 Years

Eligibility

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

Related Conditions & MeSH terms

• Cannabis Use Disorder
• Marijuana Abuse

Intervention

Behavioral:
• Computerized Distress Intolerance Intervention

• Computerized Healthy Behaviors Intervention

Locations

Country	Name	City	State
n/a

Sponsors (3)

Lead Sponsor	Collaborator
Auburn University	Florida State University, National Institute on Drug Abuse (NIDA)

References & Publications (6)

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. — View Citation

Hjorthøj CR, Hjorthøj 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. Review. — View 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. — View 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. — View 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. — View 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. Epub 2007 Jun 9. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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)
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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	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)
Secondary	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)
Secondary	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)