About Bolder Science

Our mission is to provide healthcare professionals with unbiased clinical research information, easily.

Currently, you can access the following clinical trials being conducted worldwide:

359,057 studies
in
219 countries
Clinical trial information and results are updated daily from ClinicalTrials.gov. The latest data update was conducted on 01/22/2021.
This website is for US healthcare professionals

Log In to Bolder Science

or

Don't have an account? Sign Up

Please enter your email address.

You will receive a link to create a new password via email.

Log In

Create an Account

or
(optional) ?

Welcome, !

Please complete the following 4 questions to ensure you receive the information that best suits your needs.

Clinical Trials of Interest

When I’m looking for information on clinical trials, I usually am interested in...

finding clinical trials in which to enroll my patients

Rarely Often

finding newly launched clinical trials (for all phases)

Rarely Often

updates on status changes for clinical trials

Rarely Often

pipeline molecules

Rarely Often

Drug Interventions

Enter up to 3 drug interventions you are currently interested in:

Clinical trial information and results are updated daily from ClinicalTrials.gov. The latest data update was conducted on 01/22/2021.

Computerized Anxiety Sensitivity Treatment for Opioid Use Disorders

Clinicaltrials.gov identifier NCT03944850

Recruitment Status Completed

First Posted May 10, 2019

Last update posted March 2, 2020

Study Description

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:Opioid Use Disorder
  • Intervention/Treatment: Behavioral: Computerized Anxiety Sensitivity Treatment
  • Phase: N/A
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 Design
  • Study Type: Interventional
  • Actual Enrollment: 32 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
  • Actual Study Start Date: May 2019
  • Actual Primary Completion Date: January 2020
  • Actual Study Completion Date: January 2020
Arms and interventions
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.
Outcome Measures
  • 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.
Eligibility Criteria
  • 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)

Contacts and Locations
Contacts
Locations

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

Sponsors and Collaborators

Southeast Louisiana Veterans Health Care System

South Central Mental Illness Research, Education & Clinical Center

Investigators

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

More Information