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| Name | Class |
|---|---|
| Brown University | OTHER |
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The investigators propose to develop and adapt Unwinding Anxiety phone app specifically for individuals with generalized anxiety disorder.
The study aims are to (1) develop and refine Unwinding Anxiety for individuals with generalized anxiety disorder, (2) determine user engagement and acceptability as well as measure effect sizes of the program vs. treatment as usual, and (3) preliminarily test mechanisms of action. The knowledge gained will set the stage for a number of future studies related to further elucidating the mechanisms of mindfulness, and the clinical efficacy and utility of this type of training delivered via digital therapeutics in general. Specifically, this study will provide necessary variances for powering larger phase 2 studies.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment as usual (TAU) | No Intervention | Individuals will receive treatment as usual | |
| TAU and Unwinding Anxiety Phone App | Active Comparator | The Unwinding Anxiety program focuses on teaching individuals 1) to understand how anxious worry is developed and perpetuated through reinforcement learning, 2) how to recognize these worry "habit loops" and 3) how to bring mindful awareness to moments of worry such that they can uncouple feelings of anxiety from reactive worry thinking and "ride out" habitual mind states that perpetuate and reinforce anxiety. Together, these help individuals "unlearn"/extinguish worry at a core mechanistic level. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Unwinding Anxiety Phone App | Behavioral | The Unwinding Anxiety program focuses on teaching individuals 1) to understand how anxious worry is developed and perpetuated through reinforcement learning, 2) how to recognize these worry "habit loops" and 3) how to bring mindful awareness to moments of worry such that they can uncouple feelings of anxiety from reactive worry thinking and "ride out" habitual mind states that perpetuate and reinforce anxiety |
| Measure | Description | Time Frame |
|---|---|---|
| UA Program engagement | Number of modules completed | Two months |
| Change in worry | Penn State Worry Questionnaire (PSWQ) | Baseline, two months |
| Measure | Description | Time Frame |
|---|---|---|
| Change in non-reactivity & awareness | Five Facet Mindfulness Questionnaire - Non-Reactivity subscale (FFMQ) | Baseline, two months |
| UA Program Acceptability | Net Promoter Score (NPS) |
| Measure | Description | Time Frame |
|---|---|---|
| Change in anxiety | Generalized Anxiety Disorder - 7 items (GAD-7) | Baseline, two months |
| Change in self-regulation | Multidimensional Assessment of Interoceptive Awareness (MAIA) |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Judson Brewer | Brown University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Brown University | Providence | Rhode Island | 02912 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36810609 | Derived | Taylor VA, Roy A, Brewer JA. Cluster-based psychological phenotyping and differences in anxiety treatment outcomes. Sci Rep. 2023 Feb 21;13(1):3055. doi: 10.1038/s41598-023-28660-7. | |
| 34860673 | Derived | Roy A, Hoge EA, Abrante P, Druker S, Liu T, Brewer JA. Clinical Efficacy and Psychological Mechanisms of an App-Based Digital Therapeutic for Generalized Anxiety Disorder: Randomized Controlled Trial. J Med Internet Res. 2021 Dec 2;23(12):e26987. doi: 10.2196/26987. |
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| Type | Date | Date Unknown |
|---|---|---|
| Release | Feb 21, 2022 | |
| Reset | Mar 18, 2022 | |
| Release | Jun 14, 2022 | |
| Reset | Jul 6, 2022 | |
| Release | Sep 20, 2022 | |
| Reset | Oct 12, 2022 | |
| Release | May 6, 2025 | |
| Reset | May 19, 2025 |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| ICF | No | No | Yes | Informed Consent Form | May 2, 2019 | Mar 16, 2020 | ICF_000.pdf |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Feb 21, 2022 | Mar 18, 2022 | |||
| Jun 14, 2022 |
| ID | Term |
|---|---|
| D001008 | Anxiety Disorders |
| ID | Term |
|---|---|
| D001523 | Mental Disorders |
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|
| Two months |
| Baseline, two months |
| Jul 6, 2022 |
| Sep 20, 2022 | Oct 12, 2022 |
| May 6, 2025 | May 19, 2025 |