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



Status:Enrolling by invitation
Conditions:Anxiety, Healthy Studies, Psychiatric
Therapuetic Areas:Psychiatry / Psychology, Other
Healthy:No
Age Range:18 - 65
Updated:10/14/2018
Start Date:June 16, 2018
End Date:May 31, 2020

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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. 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.

Inclusion Criteria:

- DSM-IV diagnosis of panic disorder (with or without agoraphobia), generalized anxiety
disorder, or social anxiety disorder within the past 30 days

- DSM-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 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 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
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