Computerized Anxiety Sensitivity Treatment for Opioid Use Disorders

NCT03944850 | Completed

• 1 other identifier: 365
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

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.

Conditions

Opioid Use Disorder

Keywords

veterans; anxiety sensitivity; opioid use disorder; intervention

Outcome Measures

Primary Outcomes (1)

• Intervention Acceptability Questionnaire (IAQ)

  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 Outcomes (10)

• Alcohol Use Disorders Identification Test (AUDIT)

  Baseline

• Drug Use Disorders Identification Test (DUDIT)

  Baseline

• PTSD Checklist for DSM-5 (PCL-5)

  Baseline

• Anxiety Sensitivity Index-3 (ASI-3)

  Baseline, One week post-intervention, and Four weeks post-intervention

• Depression Anxiety Stress Scale (DASS)

  Baseline, One week post-intervention, and Four weeks post-intervention

Study Arms (1)

Computerized Anxiety Sensitivity Treatment

EXPERIMENTAL

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

Interventions

Computerized Anxiety Sensitivity Treatment BEHAVIORAL

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.

Computerized Anxiety Sensitivity Treatment

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Veterans must be diagnosed with an opioid use disorder

You may not qualify if:

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

Sponsors & Collaborators

• Southeast Louisiana Veterans Health Care System: lead
• South Central Mental Illness Research, Education & Clinical Center: collaborator

Study Sites (1)

Southeast Louisiana Veterans Health Care System

New Orleans, Louisiana, 70119, United States

Location

Related Publications (12)

• Bohnert AS, Valenstein M, Bair MJ, Ganoczy D, McCarthy JF, Ilgen MA, Blow FC. Association between opioid prescribing patterns and opioid overdose-related deaths. JAMA. 2011 Apr 6;305(13):1315-21. doi: 10.1001/jama.2011.370.

  PMID: 21467284 BACKGROUND

• Bohnert AS, Ilgen MA, Galea S, McCarthy JF, Blow FC. Accidental poisoning mortality among patients in the Department of Veterans Affairs Health System. Med Care. 2011 Apr;49(4):393-6. doi: 10.1097/MLR.0b013e318202aa27.

  PMID: 21407033 BACKGROUND

• Veilleux JC, Colvin PJ, Anderson J, York C, Heinz AJ. A review of opioid dependence treatment: pharmacological and psychosocial interventions to treat opioid addiction. Clin Psychol Rev. 2010 Mar;30(2):155-66. doi: 10.1016/j.cpr.2009.10.006. Epub 2009 Oct 30.

  PMID: 19926374 BACKGROUND

• 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.

  BACKGROUND

• Lejuez CW, Paulson A, Daughters SB, Bornovalova MA, Zvolensky MJ. The association between heroin use and anxiety sensitivity among inner-city individuals in residential drug use treatment. Behav Res Ther. 2006 May;44(5):667-77. doi: 10.1016/j.brat.2005.04.006. Epub 2005 Jul 5.

  PMID: 16002042 BACKGROUND

• Hearon BA, Calkins AW, Halperin DM, McHugh RK, Murray HW, Otto MW. Anxiety sensitivity and illicit sedative use among opiate-dependent women and men. Am J Drug Alcohol Abuse. 2011 Jan;37(1):43-7. doi: 10.3109/00952990.2010.535581. Epub 2010 Nov 19.

  PMID: 21090958 BACKGROUND

• Lejuez CW, Zvolensky MJ, Daughters SB, Bornovalova MA, Paulson A, Tull MT, Ettinger K, Otto MW. Anxiety sensitivity: a unique predictor of dropout among inner-city heroin and crack/cocaine users in residential substance use treatment. Behav Res Ther. 2008 Jul;46(7):811-8. doi: 10.1016/j.brat.2008.03.010. Epub 2008 Mar 28.

  PMID: 18466878 BACKGROUND

• Schmidt NB, Capron DW, Raines AM, Allan NP. Randomized clinical trial evaluating the efficacy of a brief intervention targeting anxiety sensitivity cognitive concerns. J Consult Clin Psychol. 2014 Dec;82(6):1023-33. doi: 10.1037/a0036651. Epub 2014 May 12.

  PMID: 24821096 BACKGROUND

• Schmidt NB, Norr AM, Allan NP, Raines AM, Capron DW. A randomized clinical trial targeting anxiety sensitivity for patients with suicidal ideation. J Consult Clin Psychol. 2017 Jun;85(6):596-610. doi: 10.1037/ccp0000195. Epub 2017 Mar 13.

  PMID: 28287798 BACKGROUND

• Barlow, D.H., et al., Behavioral treatment of panic disorder. Behavior Therapy, 1989. 20(2): p. 261-282.

  BACKGROUND

• Keough ME, Schmidt NB. Refinement of a brief anxiety sensitivity reduction intervention. J Consult Clin Psychol. 2012 Oct;80(5):766-72. doi: 10.1037/a0027961. Epub 2012 Apr 2.

  PMID: 22468909 BACKGROUND

• Schmidt NB, Eggleston AM, Woolaway-Bickel K, Fitzpatrick KK, Vasey MW, Richey JA. Anxiety Sensitivity Amelioration Training (ASAT): a longitudinal primary prevention program targeting cognitive vulnerability. J Anxiety Disord. 2007;21(3):302-19. doi: 10.1016/j.janxdis.2006.06.002. Epub 2006 Aug 4.

  PMID: 16889931 BACKGROUND

MeSH Terms

Conditions

Opioid-Related Disorders

Condition Hierarchy (Ancestors)

Narcotic-Related Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders

Study Officials

• Amanda M Raines, PhD

  Southeast Louisiana Veterans Health Care System

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: FED
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research Psychologist

Study Record Dates

• First Submitted: May 6, 2019
• First Posted: May 10, 2019
• Study Start: May 28, 2019
• Primary Completion: January 10, 2020
• Study Completion: January 31, 2020
• Last Updated: November 5, 2020

Record last verified: 2020-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)