Recruiting

Cognitive Behavioral Therapy

Sponsor:

University of Minnesota

Code:

NCT05117255

Conditions

Generalized Anxiety Disorder

Panic Disorder

Social Anxiety Disorder

Alcohol Use Disorder

Depression

Eligibility Criteria

Sex: All

Age: 18 - 65

Healthy Volunteers: Not accepted

Interventions

Negative Emotions and Addiction Tools Program (NEAT)- Cognitive Behavioral Therapy

Progressive Muscle Relaxation Training (PMRT)

Study Details

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.

Conditions

Generalized Anxiety Disorder

Panic Disorder

Social Anxiety Disorder

Alcohol Use Disorder

Depression

Study ID

NCT05117255

Start date

Jan 4, 2022

Status verified date

Dec, 2025

Completion date

Mar 1, 2027

Anticipated

Primary completion date

Mar 1, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 65

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • cognitive or medical impairments that prohibit study participation as determined by study PI
  • serious suicide risk determined by study PI
  • court-ordered treatment. (The exclusion is based on its classification as a "vulnerable" population.)
  • Self-reported past participation in a Kushner intervention study while in Lodging Plus

Study Design

Enrollment

256 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

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.

Interventions

Negative Emotions and Addiction Tools Program (NEAT)- Cognitive Behavioral Therapy

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)

PMRT is a standard stress management coping skill that entails tensing and releasing specified muscle groups to obtain deep muscle relaxation.

Primary outcome measure

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

Central Contacts and Locations

Central contacts

Lilly Hartnett

612-625-7546anxietystudy@umn.edu

Locations

Lodging Plus Program, Fairview Hospital

Recruiting

Minneapolis, Minnesota, United States, 55454

Principal Investigator:

Matt G Kushner, Ph.D.

More Information

Sponsor

University of Minnesota

Last update posted

Dec 17, 2025

Last verified

Dec, 2025

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Minnesota on 2025-12-17.