Computerized Intervention for Distress Intolerance
Studienübersicht
Status
Status
Bedingungen
Bedingungen
Intervention / Behandlung
Intervention / Behandlung
Detaillierte Beschreibung
Studientyp
Studientyp
Einschreibung (Tatsächlich)
Einschreibung
Phase
Phase
- Unzutreffend
Teilnahmekriterien
Zulassungskriterien
Zulassungskriterien
Studienberechtigtes Alter
Akzeptiert gesunde Freiwillige
Studienberechtigte Geschlechter
Beschreibung
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
Studienplan
Wie ist die Studie aufgebaut?
Designdetails
- Hauptzweck: Behandlung
- Zuteilung: Zufällig
- Interventionsmodell: Parallele Zuordnung
- Maskierung: Doppelt
Anzahl der Arme
Waffen und Interventionen
Teilnehmergruppe / ArmTeilnehmergruppe / Arm |
Intervention / BehandlungIntervention / Behandlung |
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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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Placebo-Komparator: Computerized Healthy Behaviors Intervention
Two, 1-hour computerized sessions that focus on psychoeducation about the importance of a healthy lifestyle.
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Was misst die Studie?
Primäre Ergebnismessungen
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
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Change in Distress Intolerance Index (DII) score from Baseline through 4-Month Follow-Up
Zeitfenster: 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-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
Zeitfenster: 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
Zeitfenster: 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-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
Zeitfenster: 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
Zeitfenster: Baseline, post-treatment (i.e., ~1 week following the last treatment session), 1-month follow-up, 4-month follow-up
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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
Zeitfenster: 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
Zeitfenster: 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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Sekundäre Ergebnismessungen
Sekundäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
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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
Zeitfenster: Baseline, post-treatment (i.e., ~1 week following the last treatment session)
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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
Zeitfenster: Baseline, post-treatment (i.e., ~1 week following the last treatment session)
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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
Zeitfenster: 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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Mitarbeiter und Ermittler
Sponsor
Sponsor
Mitarbeiter
Mitarbeiter
Ermittler
Ermittler
- Hauptermittler: Richard J Macatee, PhD, Auburn University
Publikationen und hilfreiche Links
Allgemeine Veröffentlichungen
- 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.
Studienaufzeichnungsdaten
Haupttermine studieren
Studienbeginn (Tatsächlich)
Studienbeginn
Primärer Abschluss (Tatsächlich)
Primärer Abschluss
Studienabschluss (Tatsächlich)
Studienabschluss
Studienanmeldedaten
Zuerst eingereicht
Zuerst eingereicht
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
Zuerst gepostet (Tatsächlich)
Zuerst gepostet
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Tatsächlich)
Letztes Update gepostet
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
Zuletzt verifiziert
Zuletzt verifiziert
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Schlüsselwörter
Andere Studien-ID-Nummern
Andere Studien-ID-Nummern
- 201720828
- F31DA039644-01A1 (US NIH Stipendium/Vertrag)
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