Adapting an Effective CBT for Comorbidity to a Computer-Delivered Format
Study Details
Study Description
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
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
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N/A |
Detailed Description
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. 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 24 patients (6 to test and supply feedback on each of three 2-session therapy modules and 6 to test and supply feedback on all 3 modules given together) will be employed in this phase. The second phase (Years 2 and 3) will be devoted to conducting an RCT to test the efficacy of the refined computer-delivered VC-CBT. The investigators will randomize AUD treatment patients with co-occurring anxiety disorder to receive either the computer-delivered VC-CBT or standard AUD treatment alone (50 patients in each group) to establish significance and effect size estimates of clinical effect for the adapted e-therapy. In addition to analyzing the RCT data, the investigators will perform quasi-experimental contrasts of the process and outcome measures from the computer-delivered VC-CBT group in the RCT with parallel data from the therapist-delivered VC-CBT obtained in an earlier clinical trial. These contrasts will provide a reasonable estimate of how well the computer format compares to the therapist format of the VC-CBT. 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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Computer-based VC-CBT Computer-based VC-CBT: Six, one-hour computerized therapy sessions delivered on an interactive computerized platform with two-session 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
Computer-based VC-CBT: Six, one-hour computerized therapy sessions delivered on an interactive computerized platform with two-session therapy blocks dedicated to each of three primary modules/goals: 1) psycho-education, 2) skills learning, and 3) individualized practice
|
| No Intervention: Treatment as Usual Participants randomized to the treatment as usual control condition will not undergo the CBT therapy. |
Outcome Measures
Primary Outcome Measures
- Subject relapse [4 months]
Continuous measurement of relapse severity (i.e., percent/number days drinking) assessed using the Timeline Followback.
Eligibility Criteria
Criteria
Inclusion Criteria:
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DSM-IV diagnosis of panic disorder (with or without agoraphobia), generalized anxiety disorder, or social anxiety disorder within the past 30 days
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DSM-IV diagnosis of alcohol dependence within the last 30 days
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inpatient treatment at Lodging Plus primarily for alcohol (vs. other drug) dependence
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alcohol use in the 30 days preceding the beginning of their LP treatment
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willingness and ability to provide informed consent
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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
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familiarity with computer keyboarding as determined by history
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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:
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Active psychosis or mania in the three months preceding the study
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Physical impairment (e.g., blindness, deafness) that interferes with study participation based on self-report or as judged by PI or study physician
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current significant suicide risk (i.e., intention and plan) as deemed by the PI and study physician to be serious and ongoing
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primary PTSD as determined by the SCID interview
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suspected cognitive impairment that interferes with study participation as informed by the SCID interview or as judged by the PI or study physician
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | University of Minnesota | Minneapolis | Minnesota | United States | 55408 |
Sponsors and Collaborators
- University of Minnesota
Investigators
- Principal Investigator: Matt Kushner, PhD, University of Minnesota
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- PSYCH-2018-26640