Ignite Creation Date:
2025-12-24 @ 9:48 PM
Ignite Modification Date:
2026-01-02 @ 3:09 AM
Study NCT ID:
NCT03300232
Status:
COMPLETED
Last Update Posted:
2022-09-13
First Post:
2017-08-03
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Adapting an Effective CBT for Comorbidity to a Computer-Delivered Format
Sponsor:
University of Minnesota
Organization:
Study Overview
Official Title:
Adapting an Effective CBT for Comorbidity to a Computer-Delivered Format
Status:
COMPLETED
Status Verified Date:
2022-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: