Adapting an Effective CBT for Comorbidity to a Computer-Delivered Format
Primary Purpose
Generalized Anxiety Disorder, Panic Disorder, Social Anxiety
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Computer-based VC-CBT
Sponsored by
About this trial
This is an interventional treatment trial for Generalized Anxiety Disorder
Eligibility Criteria
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
Sites / Locations
- University of Minnesota
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Computer-based VC-CBT
Arm Description
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
Outcomes
Primary Outcome Measures
User ratings
Likert scale ratings of understanding, engagement, and applicability to current problems
Knowledge Acquisition
Multiple choice and True/False questions to assess knowledge communicated in program
Skills Acquisition
Skill demonstration rated by study staff for accuracy
Secondary Outcome Measures
Full Information
NCT ID
NCT03300232
First Posted
August 3, 2017
Last Updated
September 8, 2022
Sponsor
University of Minnesota
1. Study Identification
Unique Protocol Identification Number
NCT03300232
Brief Title
Adapting an Effective CBT for Comorbidity to a Computer-Delivered Format
Official Title
Adapting an Effective CBT for Comorbidity to a Computer-Delivered Format
Study Type
Interventional
2. Study Status
Record Verification Date
September 2022
Overall Recruitment Status
Completed
Study Start Date
April 16, 2018 (Actual)
Primary Completion Date
April 26, 2021 (Actual)
Study Completion Date
July 26, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Minnesota
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. 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 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.
Detailed 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Generalized Anxiety Disorder, Panic Disorder, Social Anxiety, Alcohol Use Disorder
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
59 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Computer-based VC-CBT
Arm Type
Experimental
Arm Description
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
Intervention Type
Behavioral
Intervention Name(s)
Computer-based VC-CBT
Intervention Description
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
Primary Outcome Measure Information:
Title
User ratings
Description
Likert scale ratings of understanding, engagement, and applicability to current problems
Time Frame
up to 4 days post-treatment
Title
Knowledge Acquisition
Description
Multiple choice and True/False questions to assess knowledge communicated in program
Time Frame
up to 4 days post-treatment
Title
Skills Acquisition
Description
Skill demonstration rated by study staff for accuracy
Time Frame
up to 4 days post-treatment
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Matt Kushner, PhD
Organizational Affiliation
University of Minnesota
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Minnesota
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55408
Country
United States
12. IPD Sharing Statement
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Adapting an Effective CBT for Comorbidity to a Computer-Delivered Format
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