Computerized Intervention for Distress Intolerance

NCT ID: NCT04173078

Last Updated: 2019-11-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-06-01

Study Completion Date

2017-10-30

Brief Summary

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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

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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).

Conditions

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Cannabis Use Disorder

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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 Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors
Participants were blind to whether they were in the experimental (Distress Intolerance Intervention) or control (Healthy Behaviors Intervention) condition. All outcome measures were self-report except for the four-month follow-up Cannabis Use Diagnostic interview which was conducted by an interviewer blind to the participant's treatment condition.

Study Groups

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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.

Group Type EXPERIMENTAL

Computerized Distress Intolerance Intervention

Intervention Type BEHAVIORAL

Computerized Healthy Behaviors Intervention

Two, 1-hour computerized sessions that focus on psychoeducation about the importance of a healthy lifestyle.

Group Type PLACEBO_COMPARATOR

Computerized Healthy Behaviors Intervention

Intervention Type BEHAVIORAL

Interventions

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Computerized Distress Intolerance Intervention

Intervention Type BEHAVIORAL

Computerized Healthy Behaviors Intervention

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

30 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Institute on Drug Abuse (NIDA)

NIH

Sponsor Role collaborator

Florida State University

OTHER

Sponsor Role collaborator

Auburn University

OTHER

Sponsor Role lead

Responsible Party

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Richard Macatee

Assistant Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Richard J Macatee, PhD

Role: PRINCIPAL_INVESTIGATOR

Auburn University

References

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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.

Reference Type BACKGROUND
PMID: 22697451 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 25681579 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 11068976 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 22143002 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 17602842 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 19217724 (View on PubMed)

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.

Reference Type DERIVED
PMID: 35129994 (View on PubMed)

Other Identifiers

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F31DA039644-01A1

Identifier Type: NIH

Identifier Source: secondary_id

View Link

201720828

Identifier Type: -

Identifier Source: org_study_id

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