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

November 3, 2020 updated by: 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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

32

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Louisiana
      • New Orleans, Louisiana, United States, 70119
        • Southeast Louisiana Veterans Health Care System

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
One week post-intervention

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Baseline
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
Baseline
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.
Baseline
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.
Baseline, One week post-intervention, and Four weeks post-intervention
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.
Baseline, One week post-intervention, and Four weeks post-intervention
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.
Baseline, One week post-intervention, and Four weeks post-intervention
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.
Baseline, One week post-intervention, and Four weeks post-intervention
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.
Baseline, One week post-intervention, and Four weeks post-intervention
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.
Baseline, One week post-intervention, and Four weeks post-intervention
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.
Baseline, One week post-intervention, and Four weeks post-intervention

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Southeast Louisiana Veterans Health Care System

Collaborators

South Central Mental Illness Research, Education & Clinical Center

Investigators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 28, 2019

Primary Completion (Actual)

January 10, 2020

Study Completion (Actual)

January 31, 2020

Study Registration Dates

First Submitted

May 6, 2019

First Submitted That Met QC Criteria

May 7, 2019

First Posted (Actual)

May 10, 2019

Study Record Updates

Last Update Posted (Actual)

November 5, 2020

Last Update Submitted That Met QC Criteria

November 3, 2020

Last Verified

November 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 365

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD 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.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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