Adapting an Effective CBT for Comorbidity to a Computer-Delivered Format

NCT03300232 | Completed

• 1 other identifier: PSYCH-2018-26640
• Study Type: interventional
• Target: 59
• Locations: 1 country
• Sites: 1

Brief Summary

Up to one-half of those in treatment for alcohol use disorder (AUD) has a co-occurring anxiety disorder ("comorbidity"), a condition that marks a high degree of treatment resistance, severity and relapse risk in AUD treatment patients. The investigators conceptualize comorbidity as a feed-forward system ("vicious cycle", \[VC\]) of interacting negative affect/stress, drinking motives/behavior, coping skills deficits, environmental circumstances, and neurobiological adaptations. Based on this model, the investigators developed and validated the VC cognitive-behavioral therapy (VC-CBT) to disrupt this system at several key linkage points. In a recently completed randomized controlled trial (RCT), the investigators found that adding the VC-CBT to standard AUD inpatient treatment resulted in better alcohol outcomes 4 months following treatment than did adding an anxiety treatment or standard AUD treatment alone. With a number needed to treat (NNT) index of 8 (relative to standard AUD treatment alone), the VC-CBT could, if broadly disseminated, have a large positive impact on AUD treatment. Unfortunately, several significant barriers related to the resource- and expertise-intensive delivery of the VC-CBT limit its dissemination potential and, hence, the impact of this otherwise effective treatment. Therefore, to maximize the public health and scientific potential of the investigators work, the investigators propose to adapt the therapist-delivered VC-CBT to a computer-delivered format to facilitate reliable and economical dissemination of the VC-CBT while maintaining its established efficacy.

Conditions

Generalized Anxiety Disorder; Panic Disorder; Social Anxiety; Alcohol Use Disorder

Outcome Measures

Primary Outcomes (3)

• User ratings

  Likert scale ratings of understanding, engagement, and applicability to current problems

  up to 4 days post-treatment

• Knowledge Acquisition

  Multiple choice and True/False questions to assess knowledge communicated in program

  up to 4 days post-treatment

• Skills Acquisition

  Skill demonstration rated by study staff for accuracy

  up to 4 days post-treatment

Study Arms (1)

Computer-based VC-CBT

EXPERIMENTAL

Computer-based VC-CBT: Three, one-hour computerized therapy sessions delivered on an interactive computerized platform with therapy blocks dedicated to each of three primary modules/goals: 1) psycho-education, 2) skills learning, and 3) individualized practice

Behavioral: Computer-based VC-CBT

Interventions

Computer-based VC-CBT BEHAVIORAL

Computer-based VC-CBT: Three, one-hour computerized therapy sessions delivered on an interactive computerized platform with therapy blocks dedicated to each of three primary modules/goals: 1) psycho-education, 2) skills learning, and 3) individualized practice

Computer-based VC-CBT

Eligibility Criteria

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

You may qualify if:

• Diagnostic and Statistical Manual-IV diagnosis of panic disorder (with or without agoraphobia), generalized anxiety disorder, or social anxiety disorder within the past 30 days
• Diagnostic and Statistical Manual-IV diagnosis of alcohol dependence within the last 30 days
• inpatient treatment at Lodging Plus primarily for alcohol (vs. other drug) dependence
• alcohol use in the 30 days preceding the beginning of their Lodging Plus (LP) treatment
• willingness and ability to provide informed consent
• minimum of a sixth grade English reading level (deemed necessary to complete study materials); as determined by their being able to read and understand the consent form
• familiarity with computer keyboarding as determined by history
• lives within reasonable driving distance of the Twin Cities and ability to travel to Fairview to allow for in-person follow-up interviews

You may not qualify if:

• Active psychosis or mania in the three months preceding the study
• Physical impairment (e.g., blindness, deafness) that interferes with study participation based on self-report or as judged by PI or study physician
• current significant suicide risk (i.e., intention and plan) as deemed by the PI and study physician to be serious and ongoing
• primary PTSD as determined by the Structured Clinical Interview for DSM (SCID) interview
• suspected cognitive impairment that interferes with study participation as informed by the SCID interview or as judged by the PI or study physician

Sponsors & Collaborators

• University of Minnesota: lead

Study Sites (1)

University of Minnesota

Minneapolis, Minnesota, 55408, United States

Location

MeSH Terms

Conditions

Generalized Anxiety Disorder; Panic Disorder; Alcoholism

Condition Hierarchy (Ancestors)

Anxiety Disorders; Mental Disorders; Alcohol-Related Disorders; Substance-Related Disorders; Chemically-Induced Disorders

Study Officials

• Matt Kushner, PhD

  University of Minnesota

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 3, 2017
• First Posted: October 3, 2017
• Study Start: April 16, 2018
• Primary Completion: April 26, 2021
• Study Completion: July 26, 2021
• Last Updated: September 13, 2022

Record last verified: 2022-09

Locations

US (1)