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Computerized Anxiety Sensitivity Treatment for Opioid Use Disorders (CAST-O)

3. November 2020 aktualisiert von: Amanda M. Raines, Southeast Louisiana Veterans Health Care System

Evaluating the Utility of a Brief Computerized Anxiety Sensitivity Intervention for Opioid Use Disorders: A Pilot Investigation

The primary aim of the current project is to test the acceptability and feasibility of a computerized intervention, titled Computerized Anxiety Sensitivity Treatment (CAST), delivered to Veterans seeking treatment for an opioid use disorder. The second aim of the study is to examine the utility of CAST by gathering data on symptom change. The final aim of the current study is to test the effects of CAST on rates of attendance and retention in a substance use disorder treatment (SUDT) program.

Studienübersicht

Status

Abgeschlossen

Bedingungen

Detaillierte Beschreibung

The pilot project will examine the effects of a brief, one-session computerized intervention delivered to Veterans seeking treatment for an opioid use disorder. The opioid epidemic in the United States (US) is having a disproportionate impact on Veterans. Indeed, Veterans are twice as likely to die from an accidental opioid overdose than members of the general population, even after accounting for gender and age distribution. Although many individuals with an opioid addiction seek treatment, a large proportion drop out prematurely and/or relapse, highlighting the need to identify modifiable factors that may contribute to this process. One variable that may be useful in understanding attrition in addiction treatment is anxiety sensitivity (AS). AS is a well-established psychological risk factor reflecting the tendency to fear anxious arousal due to the belief that this arousal will have harmful physical, mental, and/or social consequences. AS is elevated in opioid use populations and predicts treatment dropout among opioid users. Importantly, research suggests that AS is highly malleable. Despite this, to our knowledge no published research to date has systematically explored the utility of AS reduction protocols among opioid users. The first aim of the current project is to test the acceptability and feasibility of a brief, one-session Computerized AS Treatment (CAST) delivered to Veterans seeking treatment for an opioid use disorder. Because this is a pilot project and the study will likely be underpowered to detect treatment effects, we will not emphasize symptom reduction. Nevertheless, a second aim of the current project is to examine the utility of CAST by gathering data on symptom change. Finally, a third aim of the current project is to examine the effects of CAST on rates of attendance and retention in a substance use disorder treatment (SUDT) program.

Studientyp

Interventionell

Einschreibung (Tatsächlich)

32

Phase

  • Unzutreffend

Kontakte und Standorte

Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.

Studienorte

    • Louisiana
      • New Orleans, Louisiana, Vereinigte Staaten, 70119
        • Southeast Louisiana Veterans Health Care System

Teilnahmekriterien

Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.

Zulassungskriterien

Studienberechtigtes Alter

18 Jahre und älter (Erwachsene, Älterer Erwachsener)

Akzeptiert gesunde Freiwillige

Nein

Studienberechtigte Geschlechter

Alle

Beschreibung

Inclusion Criteria:

  • Veterans must be diagnosed with an opioid use disorder

Exclusion Criteria:

  • Less than 18 years of age
  • Actively suicidal
  • Actively psychotic
  • Uncontrolled bipolar disorder (i.e., not stable on medications for at least one month)

Studienplan

Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.

Wie ist die Studie aufgebaut?

Designdetails

  • Hauptzweck: Behandlung
  • Zuteilung: N / A
  • Interventionsmodell: Einzelgruppenzuweisung
  • Maskierung: Keine (Offenes Etikett)

Waffen und Interventionen

Teilnehmergruppe / Arm
Intervention / Behandlung
Experimental: Computerized Anxiety Sensitivity Treatment
CAST is a newly developed computerized intervention designed to closely model the educational and behavioral techniques that are commonly used in the treatment of anxiety and related conditions.The one time intervention takes approximately 45 minutes to complete.
CAST is a newly developed computerized intervention designed to closely model the educational and behavioral techniques that are commonly used in the treatment of anxiety and related conditions. A psychoeducation component focuses on the nature of anxiety and its effects on the mind and body. Veterans will be taught that physiological and psychological arousal is not dangerous, although they may have developed a conditioned fear of this arousal. Interoceptive exposure (IE) exercises will also be introduced to as a way to reduce or eliminate the conditioned fear response.

Was misst die Studie?

Primäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Intervention Acceptability Questionnaire (IAQ)
Zeitfenster: One week post-intervention
The IAQ is an 11-item self-report questionnaire designed to measure treatment satisfaction. The IAQ includes nine items assessing acceptability (e.g., Do you think the information provided during the computerized intervention was helpful? How likely are you to use the information and techniques you learned during the computerized intervention?), which are rated on a 4-point Likert-type scale (0 = no; 1 = somewhat; 2 = moderately; 3 = yes) and two free response items requesting suggestions for improving the treatment. The IAQ will be administered at post-intervention to allow us to assess treatment acceptability.
One week post-intervention

Sekundäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Alcohol Use Disorders Identification Test (AUDIT)
Zeitfenster: Baseline
The AUDIT is a 10-item self-report questionnaire designed by the World Health Organization to classify individuals with alcohol-related problems. The AUDIT will be administered at baseline for descriptive purposes.
Baseline
Drug Use Disorders Identification Test (DUDIT)
Zeitfenster: Baseline
The DUDIT is an 11-item self-report questionnaire intended for use with the AUDIT as a way to classify individuals with drug-related problems. The DUDIT will be administered at baseline for descriptive purposes
Baseline
PTSD Checklist for DSM-5 (PCL-5)
Zeitfenster: Baseline
The PCL-5 is a 20-item self-report questionnaire designed to assess DSM-5 symptoms of PTSD. The PCL-5 will be administered at baseline for descriptive purposes.
Baseline
Anxiety Sensitivity Index-3 (ASI-3)
Zeitfenster: Baseline, One week post-intervention, and Four weeks post-intervention
The ASI-3 is an 18-item self-report questionnaire designed to measure fear of and concern about the negative effects of anxious arousal. The ASI-3 will be administered at all timepoints to allow us to assess treatment-related changes in AS.
Baseline, One week post-intervention, and Four weeks post-intervention
Depression Anxiety Stress Scale (DASS)
Zeitfenster: Baseline, One week post-intervention, and Four weeks post-intervention
The DASS is a 21-item self-report questionnaire assessing depression, anxiety, and stress symptoms. The DASS will be administered at all timepoints to allow us to assess treatment-related changes in depression, anxiety, and stress symptoms.
Baseline, One week post-intervention, and Four weeks post-intervention
Depression Symptom Inventory-Suicide Subscale (DSI-SS)
Zeitfenster: Baseline, One week post-intervention, and Four weeks post-intervention
The DSI-SS is a four-item self-report questionnaire designed to assess suicidal ideation, suicidal plans, control of suicidal thoughts, and suicidal impulses. The DSI-SS will be administered at all timepoints to allow us to assess treatment-related changes in suicidality.
Baseline, One week post-intervention, and Four weeks post-intervention
Desires for Drug Questionnaire (DDQ)
Zeitfenster: Baseline, One week post-intervention, and Four weeks post-intervention
The DDQ is a 13-item self-report questionnaire designed to measure instant (i.e., present moment) cravings associated with opioid use. The DDQ will be administered at all timepoints to allow us to assess treatment-related changes in cravings.
Baseline, One week post-intervention, and Four weeks post-intervention
Obsessive Compulsive Drug Use Scale (OCDUS)
Zeitfenster: Baseline, One week post-intervention, and Four weeks post-intervention
The OCDUS is a 12-item self-report questionnaire designed to assess heroin thoughts and interference, intention to use heroin and control of its consumption, and resistance against thoughts and decisions to use heroin. The OCDUS will be administered at all timepoints to allow us to assess treatment related changes in thoughts and control over thoughts.
Baseline, One week post-intervention, and Four weeks post-intervention
Short Opiate Withdrawal Scale (SOWS)
Zeitfenster: Baseline, One week post-intervention, and Four weeks post-intervention
The SOWS is a 10-item self-report questionnaire designed to assess various symptoms of opiate withdrawal. The SOWS will be administered at all timepoints to allow us to assess treatment-related changes in withdrawal symptoms.
Baseline, One week post-intervention, and Four weeks post-intervention
Work and Social Adjustment Scale (WSAS)
Zeitfenster: Baseline, One week post-intervention, and Four weeks post-intervention
The WSAS is a 5-item descriptive measure of subjective interference of psychiatric symptoms in various life domains (e.g., work, leisure, and family). The WSAS will be administered at all timepoints to allow us to assess treatment-related changes in global life domains.
Baseline, One week post-intervention, and Four weeks post-intervention

Mitarbeiter und Ermittler

Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.

Ermittler

  • Hauptermittler: Amanda M Raines, PhD, Southeast Louisiana Veterans Health Care System

Publikationen und hilfreiche Links

Die Bereitstellung dieser Publikationen erfolgt freiwillig durch die für die Eingabe von Informationen über die Studie verantwortliche Person. Diese können sich auf alles beziehen, was mit dem Studium zu tun hat.

Allgemeine Veröffentlichungen

Studienaufzeichnungsdaten

Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.

Haupttermine studieren

Studienbeginn (Tatsächlich)

28. Mai 2019

Primärer Abschluss (Tatsächlich)

10. Januar 2020

Studienabschluss (Tatsächlich)

31. Januar 2020

Studienanmeldedaten

Zuerst eingereicht

6. Mai 2019

Zuerst eingereicht, das die QC-Kriterien erfüllt hat

7. Mai 2019

Zuerst gepostet (Tatsächlich)

10. Mai 2019

Studienaufzeichnungsaktualisierungen

Letztes Update gepostet (Tatsächlich)

5. November 2020

Letztes eingereichtes Update, das die QC-Kriterien erfüllt

3. November 2020

Zuletzt verifiziert

1. November 2020

Mehr Informationen

Begriffe im Zusammenhang mit dieser Studie

Plan für individuelle Teilnehmerdaten (IPD)

Planen Sie, individuelle Teilnehmerdaten (IPD) zu teilen?

NEIN

Beschreibung des IPD-Plans

Data sets underlying this project will not be shared outside the VA, except as required under the Freedom of Information Act (FOIA), for a number of reasons. First, data will be used by the research team to answer additional research questions. Further, veterans may be hesitant to participate in research in which the data will be shared outside the VA and this may act as a barrier to participation and/or benefit from treatment.

Arzneimittel- und Geräteinformationen, Studienunterlagen

Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt

Nein

Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt

Nein

Diese Informationen wurden ohne Änderungen direkt von der Website clinicaltrials.gov abgerufen. Wenn Sie Ihre Studiendaten ändern, entfernen oder aktualisieren möchten, wenden Sie sich bitte an register@clinicaltrials.gov. Sobald eine Änderung auf clinicaltrials.gov implementiert wird, wird diese automatisch auch auf unserer Website aktualisiert .

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