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Computerized Intervention for Distress Intolerance

20 novembre 2019 mis à jour par: 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.

Aperçu de l'étude

Description détaillée

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).

Type d'étude

Interventionnel

Inscription (Réel)

60

Phase

  • N'est pas applicable

Critères de participation

Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.

Critère d'éligibilité

Âges éligibles pour étudier

18 ans à 30 ans (Adulte)

Accepte les volontaires sains

Non

Sexes éligibles pour l'étude

Tout

La description

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

Plan d'étude

Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.

Comment l'étude est-elle conçue ?

Détails de conception

  • Objectif principal: Traitement
  • Répartition: Randomisé
  • Modèle interventionnel: Affectation parallèle
  • Masquage: Double

Armes et Interventions

Groupe de participants / Bras
Intervention / Traitement
Expérimental: 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.
Comparateur placebo: Computerized Healthy Behaviors Intervention
Two, 1-hour computerized sessions that focus on psychoeducation about the importance of a healthy lifestyle.

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats
Description de la mesure
Délai
Change in Distress Intolerance Index (DII) score from Baseline through 4-Month Follow-Up
Délai: 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).
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
Délai: Baseline, post-treatment (i.e., ~1 week following the last treatment session)
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
Délai: 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).
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
Délai: 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).
Baseline, 4-month follow-up
Change in Timeline follow-back (TLFB) cannabis use frequency from Baseline through 4-Month Follow-Up
Délai: 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).
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
Délai: Baseline, post-treatment (i.e., ~1 week following the last treatment session), 1-month follow-up, 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
Délai: 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.
Baseline, post-treatment (i.e., ~1 week following the last treatment session)

Mesures de résultats secondaires

Mesure des résultats
Description de la mesure
Délai
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
Délai: 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)
Change in electroencephalography (EEG) index of acute stress modulation of threat reactivity (assessed by the Late Positive Potential [LPP]) from Baseline to Post-Treatment
Délai: 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).
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
Délai: 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).
Baseline, post-treatment (i.e., ~1 week following the last treatment session)

Collaborateurs et enquêteurs

C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.

Parrainer

Les enquêteurs

  • Chercheur principal: Richard J Macatee, PhD, Auburn University

Publications et liens utiles

La personne responsable de la saisie des informations sur l'étude fournit volontairement ces publications. Il peut s'agir de tout ce qui concerne l'étude.

Publications générales

Dates d'enregistrement des études

Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.

Dates principales de l'étude

Début de l'étude (Réel)

1 juin 2016

Achèvement primaire (Réel)

30 octobre 2017

Achèvement de l'étude (Réel)

30 octobre 2017

Dates d'inscription aux études

Première soumission

13 novembre 2019

Première soumission répondant aux critères de contrôle qualité

20 novembre 2019

Première publication (Réel)

21 novembre 2019

Mises à jour des dossiers d'étude

Dernière mise à jour publiée (Réel)

21 novembre 2019

Dernière mise à jour soumise répondant aux critères de contrôle qualité

20 novembre 2019

Dernière vérification

1 novembre 2019

Plus d'information

Termes liés à cette étude

Autres numéros d'identification d'étude

  • 201720828
  • F31DA039644-01A1 (Subvention/contrat des NIH des États-Unis)

Plan pour les données individuelles des participants (IPD)

Prévoyez-vous de partager les données individuelles des participants (DPI) ?

NON

Description du régime IPD

All individual participant data will be made available upon request once primary and secondary outcome manuscripts have been published.

Informations sur les médicaments et les dispositifs, documents d'étude

Étudie un produit pharmaceutique réglementé par la FDA américaine

Non

Étudie un produit d'appareil réglementé par la FDA américaine

Non

Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .

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