search
Back to results

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

Primary Purpose

Generalized Anxiety Disorder, Panic Disorder, Social Anxiety Disorder

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Negative Emotions and Addiction Tools Program (NEAT)- Cognitive Behavioral Therapy
Progressive Muscle Relaxation Training (PMRT)
Sponsored by
University of Minnesota
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Generalized Anxiety Disorder

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Lodging Plus Program, Fairview HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

No Intervention

Arm Label

Experimental: Computer-delivered cognitive behavioral therapy hybrid for comorbidity

Control: Progressive Muscle Relaxation Training (PMRT)

Treatment as Usual (TAU)

Arm Description

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.

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.

Participants are undergoing a standard 28 day residential alcohol treatment program. No study intervention.

Outcomes

Primary Outcome Measures

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.
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.

Secondary Outcome Measures

Any use of alcohol
Any use of alcohol will be binary (yes/no) indicator of whether any alcohol was consumed.
Percent days drinking
a ratio of the days that alcohol was consumed to the total number of possible drinking days.
Days to first binge
Determined for the entirety of the post treatment time for which the investigators have data up to the 8-month assessment.
Days to first 3 consecutive days of drinking
Determined for the entirety of the post treatment time for which the investigators have data up to the 8-month assessment.

Full Information

First Posted
September 14, 2021
Last Updated
January 20, 2023
Sponsor
University of Minnesota
search

1. Study Identification

Unique Protocol Identification Number
NCT05117255
Brief Title
Validating an Autonomous Interactive Internet-Based Delivery of an Empirically Supported Cognitive Behavioral Therapy for Comorbidity
Official Title
Validating an Autonomous Interactive Internet-Based Delivery of an Empirically Supported Cognitive Behavioral Therapy for Comorbidity
Study Type
Interventional

2. Study Status

Record Verification Date
January 2023
Overall Recruitment Status
Recruiting
Study Start Date
January 4, 2022 (Actual)
Primary Completion Date
December 31, 2025 (Anticipated)
Study Completion Date
March 1, 2026 (Anticipated)

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
Data Monitoring Committee
Yes

5. Study Description

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.
Detailed Description
The broad goal of the proposed work is to conduct a randomized controlled trial of a specialized computer-delivered cognitive-behavioral therapy (CBT) to supplement standard alcohol use disorder (AUD) treatment in patients with a co-occurring anxiety disorder ("comorbidity"). Comorbidity is both common in AUD treatment patients (up to 50%) and confers a substantial increase in the risk of a return to drinking in the months following treatment. Because research shows that simply adding a standard psychiatric treatment does not substantially improve the AUD outcomes of comorbid individuals, the investigators developed a CBT-based intervention aimed at disrupting the positive-feedback loop ("vicious cycle"; VC) of mutually aggravating negative affect and drinking behavior/urges (the "VC-CBT"). In an Randomized Controlled Trial (RCT), AUD treatment patients who received the therapist-delivered VC-CBT demonstrated significantly improved alcohol use outcomes as compared to those who received a standard anxiety treatment. Unfortunately, most community-based AUD treatment programs do not have clinical staff with the specialized training and technical expertise needed to deliver the VC-CBT. To help bridge this "research-to-practice" gap, the investigators went on to develop a fully autonomous and interactive computer-delivered version of the VC-CBT and have demonstrated its functionality in AUD patients. Now, the investigators propose to test the clinical efficacy of the computer-delivered VC-CBT, as well as the mechanisms and processes by which it is hypothesized to work. Aim I is a randomized controlled trial comparing the computer-delivered VC-CBT to an intensity-matched computer-delivered active control intervention that focuses on healthy lifestyles. 256 individuals in residential AUD treatment who have a comorbid anxiety disorder will receive either the VC-CBT or the active control intervention to obtain 200 cases that complete a 1-, 4- and 8-month follow-up. The investigators predict the VC-CBT group will demonstrate superior alcohol-related outcomes at follow-up relative to the control group. Aim II evaluates the extent to which the computer-delivered VC-CBT selectively imparts the skills targeted and whether they convey (mediate) the interventions therapeutic effect. This entails a formal series of "causal steps" analyses of the associations of: treatment->skills; skills->outcomes; and, treatment -> outcomes, with vs. without the effect of skills->outcomes statistically controlled. Aim III will test the theoretically-derived prediction that the computer-delivered VC-CBT moderates (i.e., weakens) the association of near real-time negative affect and negative situations with drinking behavior and drinking urges. This will be accomplished by analyzing a series of electronic Ecological Momentary Assessment (EMA) recordings completed in participants' natural environment in each of the 30 days following the conclusion of treatment. The impact of this work would be to provide a scalable and inexpensive means of improving the otherwise poor AUD treatment outcomes of comorbid AUD treatment patients. The work will also provide new scientific knowledge about the mechanisms and processes of change stemming from comorbidity treatment.

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 Disorder, Alcohol Use Disorder, Depression

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Masking Description
Outcome assessors will not know which study group participants have been assigned to.
Allocation
Randomized
Enrollment
256 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Experimental: Computer-delivered cognitive behavioral therapy hybrid for comorbidity
Arm Type
Experimental
Arm Description
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.
Arm Title
Control: Progressive Muscle Relaxation Training (PMRT)
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Treatment as Usual (TAU)
Arm Type
No Intervention
Arm Description
Participants are undergoing a standard 28 day residential alcohol treatment program. No study intervention.
Intervention Type
Behavioral
Intervention Name(s)
Negative Emotions and Addiction Tools Program (NEAT)- Cognitive Behavioral Therapy
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Progressive Muscle Relaxation Training (PMRT)
Intervention Description
PMRT is a standard stress management coping skill that entails tensing and releasing specified muscle groups to obtain deep muscle relaxation.
Primary Outcome Measure Information:
Title
Percent heavy ("binge") days drinking
Description
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.
Time Frame
eight-months following treatment (four-month assessment is primary)
Title
Days to first use
Description
Determined for the entirety of the post treatment time for which the investigators have data up to the 8-month assessment.
Time Frame
eight-months following treatment (four-month assessment is primary)
Secondary Outcome Measure Information:
Title
Any use of alcohol
Description
Any use of alcohol will be binary (yes/no) indicator of whether any alcohol was consumed.
Time Frame
eight-months following treatment (four-month assessment is primary)
Title
Percent days drinking
Description
a ratio of the days that alcohol was consumed to the total number of possible drinking days.
Time Frame
eight-months following treatment (four-month assessment is primary)
Title
Days to first binge
Description
Determined for the entirety of the post treatment time for which the investigators have data up to the 8-month assessment.
Time Frame
eight-months following treatment (four-month assessment is primary)
Title
Days to first 3 consecutive days of drinking
Description
Determined for the entirety of the post treatment time for which the investigators have data up to the 8-month assessment.
Time Frame
eight-months following treatment (four-month assessment is primary)

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: 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Nikki Degeneffe
Phone
612-625-7546
Email
anxietystudy@umn.edu
Facility Information:
Facility Name
Lodging Plus Program, Fairview Hospital
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55454
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Matt G Kushner, Ph.D.

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

We'll reach out to this number within 24 hrs