Validating an Autonomous Interactive Internet-Based Delivery of an Empirically Supported Cognitive Behavioral Therapy for Comorbidity

Part of paid clinical trials in Minneapolis, Minnesota.

Sponsor
University of Minnesota
Study ID
NCT05117255
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 65 Years
Healthy Volunteers
Not accepted

Interventions

  • Negative Emotions and Addiction Tools Program (NEAT)- Cognitive Behavioral Therapy — BEHAVIORAL
    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.
  • Progressive Muscle Relaxation Training (PMRT) — BEHAVIORAL
    PMRT is a standard stress management coping skill that entails tensing and releasing specified muscle groups to obtain deep muscle relaxation.

Study Details

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.

Key Dates

Start date
Jan 4, 2022
Status verified
Dec 2025
Primary completion
Mar 1, 2027
Completion
Mar 1, 2027

Study Design

Enrollment
256 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Experimental: Computer-delivered cognitive behavioral therapy hybrid for comorbidity
    Four, 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.
  • Active Comparator: Control: Progressive Muscle Relaxation Training (PMRT)
    Four, 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.
  • No Intervention: Treatment as Usual (TAU)
    Participants are undergoing a standard 28 day residential alcohol treatment program. No study intervention.

Primary Outcome Measure

Percent heavy ("binge") days drinking [ Time Frame: eight-months following treatment (four-month assessment is primary) ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Lodging Plus Program, Fairview HospitalMinneapolisMinnesota55454
Matt G Kushner, Ph.D. (PRINCIPAL_INVESTIGATOR)

Find similar trials in Minneapolis, MN

By condition
Substance use disorderDepression
By specialty
Behavioral healthAddiction medicinePsychiatryMental health
By research site
Lodging Plus Program, Fairview Hospital· Minneapolis, MN

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