Clinical trial NCT03944850: Computerized Anxiety Sensitivity Treatment for Opioid Use Disorders
Official title: Evaluating the Utility of a Brief Computerized Anxiety Sensitivity Intervention for Opioid Use Disorders: A Pilot Investigation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Opioid Use Disorder
Keywords: veterans
anxiety sensitivity
opioid use disorder
intervention
Lead sponsor: Southeast Louisiana Veterans Health Care System
Sponsor class: FED
Collaborators: name: South Central Mental Illness Research, Education & Clinical Center
First posted: 2019-05-10
Enrollment: 32
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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.

Eligibility 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)

Primary outcomes:
measure: Intervention Acceptability Questionnaire (IAQ)
timeFrame: One week post-intervention
Secondary outcomes:
measure: Alcohol Use Disorders Identification Test (AUDIT)
timeFrame: Baseline
measure: Drug Use Disorders Identification Test (DUDIT)
timeFrame: Baseline
measure: PTSD Checklist for DSM-5 (PCL-5)
timeFrame: Baseline
measure: Anxiety Sensitivity Index-3 (ASI-3)
timeFrame: Baseline, One week post-intervention, and Four weeks post-intervention
measure: Depression Anxiety Stress Scale (DASS)
timeFrame: Baseline, One week post-intervention, and Four weeks post-intervention
measure: Depression Symptom Inventory-Suicide Subscale (DSI-SS)
timeFrame: Baseline, One week post-intervention, and Four weeks post-intervention
measure: Desires for Drug Questionnaire (DDQ)
timeFrame: Baseline, One week post-intervention, and Four weeks post-intervention
measure: Obsessive Compulsive Drug Use Scale (OCDUS)
timeFrame: Baseline, One week post-intervention, and Four weeks post-intervention
measure: Short Opiate Withdrawal Scale (SOWS)
timeFrame: Baseline, One week post-intervention, and Four weeks post-intervention
measure: Work and Social Adjustment Scale (WSAS)
timeFrame: Baseline, One week post-intervention, and Four weeks post-intervention
Other outcomes:
Locations:
city: New Orleans
country: United States
facility: Southeast Louisiana Veterans Health Care System
state: Louisiana
Study officials:
affiliation: Southeast Louisiana Veterans Health Care System
name: Amanda M Raines, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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