An interventional study of Computer-based VC-CBT in Generalized Anxiety Disorder, Panic Disorder and Social Anxiety, sponsored by University of Minnesota. Completed at 1 site in United States. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2022-09-13.
Sponsored by University of Minnesota · Not applicable, Interventional, and Treatment
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Among 265 studies in Generalized Anxiety Disorder with a site in United States — 38 open to participants now, 53 under way, 9 of them phase 3. Generalized Anxiety Disorder · United States.
Among the 265 studies in Generalized Anxiety Disorder with a site in United States, this one is the 150th largest by enrollment of the 234 interventional ones that give a count, is one of 15 that started in 2018, is one of 122 with no phase, and was the 146th registered.
518 studies on the registry are indexed under Generalized Anxiety Disorder; 125 are open to participants now.
Browse Generalized Anxiety Disorder studies →38 of the 265 studies in Generalized Anxiety Disorder with a site in United States are open now. Recruiting first, the newest first:
Virginia Polytechnic Institute and State University · Sites in United States
Ages 18–65
Otsuka Pharmaceutical Development & Commercialization, Inc. · Sites in United States
Ages 18+
Intra-Cellular Therapies, Inc. · Sites in United States
Ages 18+
BTL Industries Ltd. · Sites in United States
Ages 22+
Intra-Cellular Therapies, Inc. · Sites in United States
Ages 18+
A study can be open while its sites in United States have not opened yet or have stopped. Only those recruiting at a site in United States →
Of the 86 Generalized Anxiety Disorder studies recruiting now, 32 (37%) set no upper age limit and 52 (60%) stop at 75 or younger; 15 take children under 18; 16 take healthy volunteers.
This study: 18 Years to 65 Years · all sexes · no healthy volunteers.
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265 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 15 · Phase 2 32 · Phase 3 51 · Phase 4 28
First in 1991; this study’s year is marked. 15 started in 2018.
By drug class, each counting the studies that test any of its medicines:
This study's enrollment of 59 is below the median of 83 across 440 interventional studies indexed under Generalized Anxiety Disorder.
Median enrollment 90 across the 234 interventional studies, 220 across the 28 observational. Of the 199 that completed or were terminated, 90 (45%) have results posted.
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83 of 265 have an industry lead sponsor. The 10 most frequent:
University of Minnesota is the lead sponsor of 1,217 studies on the registry; 197 are open to participants now.
Of its 136 completed or terminated interventional studies of FDA-regulated products, 95 (70%) have results posted.
University of Minnesota has 3 studies filed under Generalized Anxiety Disorder — fewer than ten, so there is no comparison to draw.
20 of the studies in Generalized Anxiety Disorder with a site in United States that are under way reach primary completion within a year, 1 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT07123467Phase 3Wayne State UniversityCannabidiol-Assisted Learning for Managing Generalized Anxiety Disorder | 2027-08-31 |
| NCT06846320AbbVieStudy to Assess Adverse Events and Change in Disease Activity When Oral ABBV-932 is Added to Antidepressant Therapies in Adult Participants With Generalized Anxiety Disorder | 2026-11 |
| NCT06723158Boston UniversityOral Surgery Virtual Reality Glasses Study | 2026-12 |
| NCT04557891University of California, Los AngelesLow-Intensity Focused Ultrasound Pulsation (LIFUP) for the Treatment of Generalized Anxiety Disorder (GAD) | 2026-12 |
| NCT05467683Jasper A. SmitsCO2 Reactivity as a Biomarker of Non-Response to Exposure-Based Therapy | 2026-12-01 |
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Among the 265 studies in Generalized Anxiety Disorder with a site in United States, from their registry updates:
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Up to one-half of those in treatment for alcohol use disorder (AUD) has a co-occurring anxiety disorder ("comorbidity"), a condition that marks a high degree of treatment resistance, severity and relapse risk in AUD treatment patients. The investigators conceptualize comorbidity as a feed-forward system ("vicious cycle", [VC]) of interacting negative affect/stress, drinking motives/behavior, coping skills deficits, environmental circumstances, and neurobiological adaptations. Based on this model, the investigators developed and validated the VC cognitive-behavioral therapy (VC-CBT) to disrupt this system at several key linkage points. In a recently completed randomized controlled trial (RCT), the investigators found that adding the VC-CBT to standard AUD inpatient treatment resulted in better alcohol outcomes 4 months following treatment than did adding an anxiety treatment or standard AUD treatment alone. With a number needed to treat (NNT) index of 8 (relative to standard AUD treatment alone), the VC-CBT could, if broadly disseminated, have a large positive impact on AUD treatment. Unfortunately, several significant barriers related to the resource- and expertise-intensive delivery of the VC-CBT limit its dissemination potential and, hence, the impact of this otherwise effective treatment. Therefore, to maximize the public health and scientific potential of the investigators work, the investigators propose to adapt the therapist-delivered VC-CBT to a computer-delivered format to facilitate reliable and economical dissemination of the VC-CBT while maintaining its established efficacy.
The first phase of the work (Year 1) will be to adapt the 6-session therapist-delivered VC-CBT for delivery on an internet-based computer platform. This work will be done using a standard iterative process for developing e-content in partnership with local technology experts experienced in producing engaging and effective e-learning products. Approximately 5 patients will be employed in this phase. The second phase (Years 2 and 3) will be devoted to a single arm pilot trial to test the efficacy of the refined computer-delivered VC-CBT. The investigators will recruit AUD treatment patients with co-occurring anxiety disorder to receive the computer-delivered VC-CBT (50 patients). Participants will complete follow-up assessments one and four months following treatment. Participants will rate user satisfaction and will be evaluated on skill and knowledge acquisition as well as use of the tools in the follow-up period. Success in the proposed work will serve as pilot data in support of a rigorous randomized clinical trial. The proposed work aims to provide an easy and inexpensive computer-delivered version of the VC-CBT that has comparable efficacy to the validated but resource-intensive therapist-delivered version. Achieving this will enable the VC-CBT therapy to benefit more AUD treatment patients and to be more easily studied by other investigators.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Computer-based VC-CBT: Three, one-hour computerized therapy sessions delivered on an interactive computerized platform with therapy blocks dedicated to each of three primary modules/goals: 1) psycho-education, 2) skills learning, and 3) individualized practice
Behavioral: Computer-based VC-CBT
Computer-based VC-CBT: Three, one-hour computerized therapy sessions delivered on an interactive computerized platform with therapy blocks dedicated to each of three primary modules/goals: 1) psycho-education, 2) skills learning, and 3) individualized practice
User ratings
Likert scale ratings of understanding, engagement, and applicability to current problems
Time frame: up to 4 days post-treatment
Knowledge Acquisition
Multiple choice and True/False questions to assess knowledge communicated in program
Time frame: up to 4 days post-treatment
Skills Acquisition
Skill demonstration rated by study staff for accuracy
Time frame: up to 4 days post-treatment
Ran from Apr 2018 to primary completion in Apr 2021, 36 months.
Of 174 non-industry interventional studies with no phase under Generalized Anxiety Disorder, half reached primary completion within 29 months of starting (the median), counting those still running; a quarter within 16 and three quarters within 55. This study's 36 months is above that.
Counting every sponsor, half of 183 studies reached it within 28 months; a quarter within 15 and three quarters within 53.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Sep 2022. You cannot join it, but the record below documents what was studied.
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Generalized Anxiety Disorder →