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

Alcohol Use Disorder Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03300232
• Other study ID #: PSYCH-2018-26640
• Status: Completed
• Phase: N/A
• Start date: April 16, 2018
• Est. completion date: July 26, 2021

Study information

• Verified date: September 2022
• Source: University of Minnesota
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

The first phase of the work (Year 1) will be to adapt the 6-session therapist-delivered VC-CBT for delivery on an internet-based computer platform. This work will be done using a standard iterative process for developing e-content in partnership with local technology experts experienced in producing engaging and effective e-learning products. Approximately 5 patients will be employed in this phase. The second phase (Years 2 and 3) will be devoted to a single arm pilot trial to test the efficacy of the refined computer-delivered VC-CBT. The investigators will recruit AUD treatment patients with co-occurring anxiety disorder to receive the computer-delivered VC-CBT (50 patients). Participants will complete follow-up assessments one and four months following treatment. Participants will rate user satisfaction and will be evaluated on skill and knowledge acquisition as well as use of the tools in the follow-up period. Success in the proposed work will serve as pilot data in support of a rigorous randomized clinical trial. The proposed work aims to provide an easy and inexpensive computer-delivered version of the VC-CBT that has comparable efficacy to the validated but resource-intensive therapist-delivered version. Achieving this will enable the VC-CBT therapy to benefit more AUD treatment patients and to be more easily studied by other investigators.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 59
• Est. completion date: July 26, 2021
• Est. primary completion date: April 26, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

Related Conditions & MeSH terms

• Alcohol Use Disorder
• Alcoholism
• Anxiety Disorders
• Disease
• Generalized Anxiety Disorder
• Panic Disorder
• Social Anxiety

Intervention

Behavioral:
• Computer-based VC-CBT
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

Locations

Country	Name	City	State
United States	University of Minnesota	Minneapolis	Minnesota

Sponsors (1)

Lead Sponsor	Collaborator
University of Minnesota

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	User ratings	Likert scale ratings of understanding, engagement, and applicability to current problems	up to 4 days post-treatment
Primary	Knowledge Acquisition	Multiple choice and True/False questions to assess knowledge communicated in program	up to 4 days post-treatment
Primary	Skills Acquisition	Skill demonstration rated by study staff for accuracy	up to 4 days post-treatment