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Computerized Anxiety Sensitivity Treatment for Opioid Use Disorders (CAST)

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ClinicalTrials.gov Identifier: NCT03944850
Recruitment Status : Not yet recruiting
First Posted : May 10, 2019
Last Update Posted : May 10, 2019
Sponsor:
Collaborator:
South Central Mental Illness Research Education and Clinical Center
Information provided by (Responsible Party):
Amanda M. Raines, Southeast Louisiana Veterans Health Care System

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Opioid Use Disorder Behavioral: Computerized Anxiety Sensitivity Treatment Not Applicable

Detailed Description:
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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 24 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
Official Title: Evaluating the Utility of a Brief Computerized Anxiety Sensitivity Intervention for Opioid Use Disorders: A Pilot Investigation
Estimated Study Start Date : May 2019
Estimated Primary Completion Date : April 2020
Estimated Study Completion Date : April 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Allergy Anxiety

Arm Intervention/treatment
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.
Behavioral: 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. 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.




Primary Outcome Measures :
  1. Intervention Acceptability Questionnaire (IAQ) [ Time Frame: 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.


Secondary Outcome Measures :
  1. Alcohol Use Disorders Identification Test (AUDIT) [ Time Frame: 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.

  2. Drug Use Disorders Identification Test (DUDIT) [ Time Frame: 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

  3. PTSD Checklist for DSM-5 (PCL-5) [ Time Frame: 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.

  4. Anxiety Sensitivity Index-3 (ASI-3) [ Time Frame: 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.

  5. Depression Anxiety Stress Scale (DASS) [ Time Frame: 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.

  6. Depression Symptom Inventory-Suicide Subscale (DSI-SS) [ Time Frame: 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.

  7. Desires for Drug Questionnaire (DDQ) [ Time Frame: 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.

  8. Obsessive Compulsive Drug Use Scale (OCDUS) [ Time Frame: 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.

  9. Short Opiate Withdrawal Scale (SOWS) [ Time Frame: 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.

  10. Work and Social Adjustment Scale (WSAS) [ Time Frame: 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03944850


Contacts
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Contact: Amanda M Raines, PhD 504-507-2000 ext 67372 amanda.raines@va.gov
Contact: Laurel Franklin, PhD 504-507-2000 ext 67373 laurel.franklin@va.gov

Locations
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United States, Louisiana
Southeast Louisiana Veterans Health Care System Not yet recruiting
New Orleans, Louisiana, United States, 70119
Contact: Amanda M Raines, PhD    504-507-2000 ext 67372    amanda.raines@va.gov   
Contact: Laurel Franklin, PhD    504-507-2000 ext 67373    laurel.franklin@va.gov   
Sponsors and Collaborators
Southeast Louisiana Veterans Health Care System
South Central Mental Illness Research Education and Clinical Center
Investigators
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Principal Investigator: Amanda M Raines, PhD Southeast Louisiana Veterans Health Care System

Publications:
Reiss, S. and R. McNally, Expectancy model of fear, in Theoretical Issues in Behavior Therapy, S. Reiss and R. Bootzin, Editors. 1985, Academic Press: San Diego, CA. p. 107-122.
Barlow, D.H., et al., Behavioral treatment of panic disorder. Behavior Therapy, 1989. 20(2): p. 261-282.

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Responsible Party: Amanda M. Raines, Research Psychologist, Southeast Louisiana Veterans Health Care System
ClinicalTrials.gov Identifier: NCT03944850     History of Changes
Other Study ID Numbers: 365
First Posted: May 10, 2019    Key Record Dates
Last Update Posted: May 10, 2019
Last Verified: May 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: 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.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Amanda M. Raines, Southeast Louisiana Veterans Health Care System:
veterans
anxiety sensitivity
opioid use disorder
intervention

Additional relevant MeSH terms:
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Hypersensitivity
Disease
Substance-Related Disorders
Pathologic Processes
Immune System Diseases
Chemically-Induced Disorders
Mental Disorders
Analgesics, Opioid
Narcotics
Central Nervous System Depressants
Physiological Effects of Drugs
Analgesics
Sensory System Agents
Peripheral Nervous System Agents