- ICH GCP
- Registro degli studi clinici negli Stati Uniti
- Sperimentazione clinica NCT04173078
Computerized Intervention for Distress Intolerance
20 novembre 2019 aggiornato da: Richard Macatee, Auburn University
This study evaluates the impact of a computerized distress intolerance intervention relative to a control intervention on cannabis use-related behavior and neurophysiology.
Panoramica dello studio
Stato
Completato
Condizioni
Descrizione dettagliata
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).
Tipo di studio
Interventistico
Iscrizione (Effettivo)
60
Fase
- Non applicabile
Criteri di partecipazione
I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.
Criteri di ammissibilità
Età idonea allo studio
Da 18 anni a 30 anni (Adulto)
Accetta volontari sani
No
Sessi ammissibili allo studio
Tutto
Descrizione
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
Piano di studio
Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Trattamento
- Assegnazione: Randomizzato
- Modello interventistico: Assegnazione parallela
- Mascheramento: Doppio
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
---|---|
Sperimentale: 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.
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Comparatore placebo: Computerized Healthy Behaviors Intervention
Two, 1-hour computerized sessions that focus on psychoeducation about the importance of a healthy lifestyle.
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Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
---|---|---|
Change in Distress Intolerance Index (DII) score from Baseline through 4-Month Follow-Up
Lasso di tempo: 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).
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Baseline, post-treatment (i.e., ~1 week following the last treatment session), 1-month follow-up, 4-month follow-up
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Change in Mirror-Tracing Persistence Task (MTPT) quit latency from Baseline to Post-Treatment
Lasso di tempo: Baseline, post-treatment (i.e., ~1 week following the last treatment session)
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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).
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Baseline, post-treatment (i.e., ~1 week following the last treatment session)
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Change in Marijuana Problems Scale (MPS) score from Baseline through 4-Month Follow-Up
Lasso di tempo: 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).
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Baseline, post-treatment (i.e., ~1 week following the last treatment session), 1-month follow-up, 4-month follow-up
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Change in Cannabis Use Disorder (CUD) diagnostic criteria from Baseline to 4-Month Follow-Up
Lasso di tempo: 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).
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Baseline, 4-month follow-up
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Change in Timeline follow-back (TLFB) cannabis use frequency from Baseline through 4-Month Follow-Up
Lasso di tempo: 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).
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Baseline, post-treatment (i.e., ~1 week following the last treatment session), 1-month follow-up, 4-month follow-up
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Change in Marijuana Motives Measure (MMM) score from Baseline through 4-Month Follow-Up
Lasso di tempo: Baseline, post-treatment (i.e., ~1 week following the last treatment session), 1-month follow-up, 4-month follow-up
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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).
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Baseline, post-treatment (i.e., ~1 week following the last treatment session), 1-month follow-up, 4-month follow-up
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Change in Marijuana Craving Questionnaire (MCQ) score from Baseline to Post-Treatment
Lasso di tempo: 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.
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Baseline, post-treatment (i.e., ~1 week following the last treatment session)
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Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
---|---|---|
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
Lasso di tempo: 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).
|
Baseline, post-treatment (i.e., ~1 week following the last treatment session)
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Change in electroencephalography (EEG) index of acute stress modulation of threat reactivity (assessed by the Late Positive Potential [LPP]) from Baseline to Post-Treatment
Lasso di tempo: 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).
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Baseline, post-treatment (i.e., ~1 week following the last treatment session)
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Change in electroencephalography (EEG) index of acute stress modulation of response inhibition (assessed by the N200 [N2]) from Baseline to Post-Treatment
Lasso di tempo: 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).
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Baseline, post-treatment (i.e., ~1 week following the last treatment session)
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Collaboratori e investigatori
Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.
Sponsor
Investigatori
- Investigatore principale: Richard J Macatee, PhD, Auburn University
Pubblicazioni e link utili
La persona responsabile dell'inserimento delle informazioni sullo studio fornisce volontariamente queste pubblicazioni. Questi possono riguardare qualsiasi cosa relativa allo studio.
Pubblicazioni generali
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
Studiare le date dei record
Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.
Studia le date principali
Inizio studio (Effettivo)
1 giugno 2016
Completamento primario (Effettivo)
30 ottobre 2017
Completamento dello studio (Effettivo)
30 ottobre 2017
Date di iscrizione allo studio
Primo inviato
13 novembre 2019
Primo inviato che soddisfa i criteri di controllo qualità
20 novembre 2019
Primo Inserito (Effettivo)
21 novembre 2019
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
21 novembre 2019
Ultimo aggiornamento inviato che soddisfa i criteri QC
20 novembre 2019
Ultimo verificato
1 novembre 2019
Maggiori informazioni
Termini relativi a questo studio
Parole chiave
Altri numeri di identificazione dello studio
- 201720828
- F31DA039644-01A1 (Sovvenzione/contratto NIH degli Stati Uniti)
Piano per i dati dei singoli partecipanti (IPD)
Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?
NO
Descrizione del piano IPD
All individual participant data will be made available upon request once primary and secondary outcome manuscripts have been published.
Informazioni su farmaci e dispositivi, documenti di studio
Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti
No
Studia un dispositivo regolamentato dalla FDA degli Stati Uniti
No
Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .
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