Validating an Autonomous Interactive Internet-Based Delivery of an Empirically Supported Cognitive Behavioral Therapy for Comorbidity
1 other identifier
interventional
256
1 country
1
Brief Summary
This project is designed to determine if a computer-delivered cognitive-behavioral treatment can improve the otherwise poor alcohol use disorder treatment outcomes for individuals with a co-occurring anxiety disorder. In the past, the investigators showed that this treatment does improve outcomes for these individuals when delivered by a therapist. If the present work shows that the computer-delivered version is also effective, it would provide an inexpensive program with virtually unlimited scalability to enable access to the treatment by many more individuals than is currently the case.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Jan 2022
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 14, 2021
CompletedFirst Posted
Study publicly available on registry
November 11, 2021
CompletedStudy Start
First participant enrolled
January 4, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
March 1, 2027
December 17, 2025
December 1, 2025
5.2 years
September 14, 2021
December 9, 2025
Conditions
Outcome Measures
Primary Outcomes (2)
Percent heavy ("binge") days drinking
a ratio expressed as a percent of the days the individual drank 5 (for men) or 4 (for women) or more drinks to the total number of days over the follow-up period in which drinking was possible.
eight-months following treatment (four-month assessment is primary)
Days to first use
Determined for the entirety of the post treatment time for which the investigators have data up to the 8-month assessment.
eight-months following treatment (four-month assessment is primary)
Secondary Outcomes (4)
Any use of alcohol
eight-months following treatment (four-month assessment is primary)
Percent days drinking
eight-months following treatment (four-month assessment is primary)
Days to first binge
eight-months following treatment (four-month assessment is primary)
Days to first 3 consecutive days of drinking
eight-months following treatment (four-month assessment is primary)
Study Arms (3)
Experimental: Computer-delivered cognitive behavioral therapy hybrid for comorbidity
EXPERIMENTALFour, approximately 60 minute each, computerized therapy sessions delivered on an interactive computerized platform. All participants are undergoing a standard 28 day residential alcohol treatment program.
Control: Progressive Muscle Relaxation Training (PMRT)
ACTIVE COMPARATORFour, one-hour computerized segments delivered on an interactive computerized platform teaching Progressive Muscle Relaxation Training (PMRT). All participants are undergoing a standard 28 day residential alcohol treatment program.
Treatment as Usual (TAU)
NO INTERVENTIONParticipants are undergoing a standard 28 day residential alcohol treatment program. No study intervention.
Interventions
The program provides simplified clinical, learning and neuroscience-based education about the vicious cycle in which negative affect serves to motivate drinking, which, in turn, worsens negative affect. Participants also learn how each of three skills (breathing control, cognitive restructuring, problem solving) was designed to disrupt a specific element of the vicious cycle that includes physiological, psychological and behavioral processes.
PMRT is a standard stress management coping skill that entails tensing and releasing specified muscle groups to obtain deep muscle relaxation.
Eligibility Criteria
You may qualify if:
- current (past 30 days) Diagnostic and Statistical Manual of Mental Disorders-IV (DSM-IV) diagnosis of panic disorder with or without agoraphobia (PD/Ag), generalized anxiety disorder (GAD) or social anxiety disorder (SAD)
- receiving treatment primarily for alcohol (vs. drug) dependence
- ability to provide informed consent
- a minimum of an eighth grade English reading level
- status as a residential patient in the Lodging Plus (LP) addiction treatment program
- sufficient time left in their residential LP care to complete the study protocol through the post-treatment assessment
You may not qualify if:
- cognitive or medical impairments that prohibit study participation as determined by study PI
- serious suicide risk determined by study PI
- Self-reported past participation in a Kushner intervention study while in Lodging Plus
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Lodging Plus Program, Fairview Hospital
Minneapolis, Minnesota, 55454, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Masking Details
- Outcome assessors will not know which study group participants have been assigned to.
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 14, 2021
First Posted
November 11, 2021
Study Start
January 4, 2022
Primary Completion (Estimated)
March 1, 2027
Study Completion (Estimated)
March 1, 2027
Last Updated
December 17, 2025
Record last verified: 2025-12
Data Sharing
- IPD Sharing
- Will not share