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- Ensaio Clínico NCT04173078
Computerized Intervention for Distress Intolerance
20 de novembro de 2019 atualizado por: 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.
Visão geral do estudo
Status
Concluído
Condições
Descrição detalhada
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 de estudo
Intervencional
Inscrição (Real)
60
Estágio
- Não aplicável
Critérios de participação
Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.
Critérios de elegibilidade
Idades elegíveis para estudo
18 anos a 30 anos (Adulto)
Aceita Voluntários Saudáveis
Não
Gêneros Elegíveis para o Estudo
Tudo
Descrição
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
Plano de estudo
Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Tratamento
- Alocação: Randomizado
- Modelo Intervencional: Atribuição Paralela
- Mascaramento: Dobro
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
---|---|
Experimental: 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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Comparador de 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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O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
---|---|---|
Change in Distress Intolerance Index (DII) score from Baseline through 4-Month Follow-Up
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: Baseline, 4-month follow-up
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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
Prazo: 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
Prazo: 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
Prazo: Baseline, post-treatment (i.e., ~1 week following the last treatment session)
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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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Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
---|---|---|
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
Prazo: 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).
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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 threat reactivity (assessed by the Late Positive Potential [LPP]) from Baseline to Post-Treatment
Prazo: 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
Prazo: Baseline, post-treatment (i.e., ~1 week following the last treatment session)
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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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Colaboradores e Investigadores
É aqui que você encontrará pessoas e organizações envolvidas com este estudo.
Patrocinador
Investigadores
- Investigador principal: Richard J Macatee, PhD, Auburn University
Publicações e links úteis
A pessoa responsável por inserir informações sobre o estudo fornece voluntariamente essas publicações. Estes podem ser sobre qualquer coisa relacionada ao estudo.
Publicações Gerais
- 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.
Datas de registro do estudo
Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.
Datas Principais do Estudo
Início do estudo (Real)
1 de junho de 2016
Conclusão Primária (Real)
30 de outubro de 2017
Conclusão do estudo (Real)
30 de outubro de 2017
Datas de inscrição no estudo
Enviado pela primeira vez
13 de novembro de 2019
Enviado pela primeira vez que atendeu aos critérios de CQ
20 de novembro de 2019
Primeira postagem (Real)
21 de novembro de 2019
Atualizações de registro de estudo
Última Atualização Postada (Real)
21 de novembro de 2019
Última atualização enviada que atendeu aos critérios de controle de qualidade
20 de novembro de 2019
Última verificação
1 de novembro de 2019
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Outros números de identificação do estudo
- 201720828
- F31DA039644-01A1 (Concessão/Contrato do NIH dos EUA)
Plano para dados de participantes individuais (IPD)
Planeja compartilhar dados de participantes individuais (IPD)?
NÃO
Descrição do plano IPD
All individual participant data will be made available upon request once primary and secondary outcome manuscripts have been published.
Informações sobre medicamentos e dispositivos, documentos de estudo
Estuda um medicamento regulamentado pela FDA dos EUA
Não
Estuda um produto de dispositivo regulamentado pela FDA dos EUA
Não
Essas informações foram obtidas diretamente do site clinicaltrials.gov sem nenhuma alteração. Se você tiver alguma solicitação para alterar, remover ou atualizar os detalhes do seu estudo, entre em contato com register@clinicaltrials.gov. Assim que uma alteração for implementada em clinicaltrials.gov, ela também será atualizada automaticamente em nosso site .