Generalized Anxiety DisorderNCT05117255
Validating an Autonomous Interactive Internet-Based Delivery of an Empirically Supported Cognitive Behavioral Therapy for Comorbidity
A study testing Negative Emotions and Addiction Tools Program (NEAT)- Cognitive Behavioral Therapy and Progressive Muscle Relaxation Training (PMRT) in people with Generalized Anxiety Disorder and Panic Disorder, run by University of Minnesota at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Generalized Anxiety Disorder, Panic Disorder, Social Anxiety Disorder
- What is being tested?
- Negative Emotions and Addiction Tools Program (NEAT)- Cognitive Behavioral Therapy and Progressive Muscle Relaxation Training (PMRT)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 256 participants
- Where
- 1 siteUnited States
- Study dates
- 4 Jan 2022to 1 Mar 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Lodging Plus Program, Fairview Hospital
Minneapolis, Minnesota, 55454
Matt G Kushner, Ph.D.
About this study
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.
Read the 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.
- Conditions
- Generalized Anxiety Disorder, Panic Disorder, Social Anxiety Disorder, Alcohol Use Disorder, Depression
- Being tested
- Negative Emotions and Addiction Tools Program (NEAT)- Cognitive Behavioral Therapy, Progressive Muscle Relaxation Training (PMRT)
- Medical subject headings
- Generalized Anxiety Disorder, Panic Disorder, Phobia, Social, Alcoholism, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Negative Emotions and Addiction Tools Program (NEAT)- Cognitive Behavioral TherapyBehavioural
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)Behavioural
PMRT is a standard stress management coping skill that entails tensing and releasing specified muscle groups to obtain deep muscle relaxation.
| Study group | Role | What they receive |
|---|---|---|
| Experimental: Computer-delivered cognitive behavioral therapy hybrid for comorbidity | Experimental | 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. Receives: Behavioral: Negative Emotions and Addiction Tools Program (NEAT)- Cognitive Behavioral Therapy |
| Control: Progressive Muscle Relaxation Training (PMRT) | Active comparator | 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. Receives: Behavioral: Progressive Muscle Relaxation Training (PMRT) |
| Treatment as Usual (TAU) | No intervention | Participants are undergoing a standard 28 day residential alcohol treatment program. No study intervention. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: eight-months following treatment (four-month assessment is primary)
Secondary outcomes (4)
Any use of alcohol
Any use of alcohol will be binary (yes/no) indicator of whether any alcohol was consumed.
Measured: eight-months following treatment (four-month assessment is primary)
Percent days drinking
a ratio of the days that alcohol was consumed to the total number of possible drinking days.
Measured: eight-months following treatment (four-month assessment is primary)
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.
Measured: eight-months following treatment (four-month assessment is primary)
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.
Measured: eight-months following treatment (four-month assessment is primary)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Nov 2021
- Study start4 Jan 2022
- Primary completion1 Mar 2027 (estimated)
- Study completion1 Mar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Generalized Anxiety DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 256 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Minnesota
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05117255
- Sponsor's protocol ID
- STUDY00013960
- Status last verified
- Dec 2025
- First submitted
- 14 Sep 2021
- Last updated
- 17 Dec 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Validating an Autonomous Interactive Internet-Based Delivery of an Empirically Supported Cognitive Behavioral Therapy for Comorbidity
- ClinicalTrials.gov ID
- NCT05117255
- Acronym / sponsor ID
- STUDY00013960
- Conditions
- Generalized Anxiety Disorder, Panic Disorder, Social Anxiety Disorder, Alcohol Use Disorder, Depression
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 256 participants (estimated)
- Lead sponsor
- University of MinnesotaUniversity, hospital or other
- Study start
- 4 Jan 2022 (actual)
- Primary completion
- 1 Mar 2027 (estimated)
- Study completion
- 1 Mar 2027 (estimated)
- First posted
- 11 Nov 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Experimental: Computer-delivered cognitive behavioral therapy hybrid for comorbidity | Experimental | Behavioral: Negative Emotions and Addiction Tools Program (NEAT)- Cognitive Behavioral TherapyFour, 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 comparator | Behavioral: 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. |
| Treatment as Usual (TAU) | No intervention | –Participants are undergoing a standard 28 day residential alcohol treatment program. No study intervention. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Negative Emotions and Addiction Tools Program (NEAT)- Cognitive Behavioral TherapyThe 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. | Behavioural | Experimental: Computer-delivered cognitive behavioral therapy hybrid for comorbidity |
| 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. | Behavioural | Control: Progressive Muscle Relaxation Training (PMRT) |
Primary outcome
Percent heavy ("binge") days drinking
Time frame: eight-months following treatment (four-month assessment is primary)
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
Time frame: eight-months following treatment (four-month assessment is primary)
Determined for the entirety of the post treatment time for which the investigators have data up to the 8-month assessment.
4 secondary outcomes
Any use of alcohol
Time frame: eight-months following treatment (four-month assessment is primary)
Percent days drinking
Time frame: eight-months following treatment (four-month assessment is primary)
Days to first binge
Time frame: eight-months following treatment (four-month assessment is primary)
Days to first 3 consecutive days of drinking
Time frame: eight-months following treatment (four-month assessment is primary)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Dec 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Negative Emotions and Addiction Tools Program (NEAT)- Cognitive Behavioral Therapy and Progressive Muscle Relaxation Training (PMRT) in people with Generalized Anxiety Disorder and Panic Disorder, run by University of Minnesota at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 17 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Lilly Hartnett (612-625-7546, anxietystudy@umn.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percent heavy ("binge") days drinking (time frame: eight-months following treatment (four-month assessment is primary)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Dec 2025.