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| Name | Class |
|---|---|
| Boston University | OTHER |
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This study will examine the effectiveness of digital CBT versus psychoeducation in improving anxiety for those with Generalized Anxiety Disorder.
This study aims to examine the effectiveness of app-based digital CBT for anxiety compared to psychoeducation in individuals with a diagnosis of Generalized Anxiety Disorder. The primary outcomes are anxiety symptom reduction and remission after 10 weeks.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Digital CBT | Experimental | digitally-delivered CBT for anxiety accessed via mobile app |
|
| Psychoeducation | Active Comparator | psychoeducation delivered via digital written materials |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| digital CBT | Device | An app-based intervention based on principles from cognitive behavioral therapy for anxiety. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Generalized Anxiety Disorder Questionnaire (GAD-7) | Validated questionnaire; a 7-item scale with total scores between 0 and 21 where higher scores indicate greater severity | 10 weeks post-randomization |
| Generalized Anxiety Disorder remission (score 1 or 2) on the the Clinical Global Impression Scale - Improvement (CGI-I) | A single-item measure scored between 1 and 7 where scores of 1 or 2 indicates clinically significant improvement, a score of 3 indicates mild improvement, a score of 4 indicates no change, and scores from 5 to 7 indicate deterioration | 10 weeks post-randomization |
| Measure | Description | Time Frame |
|---|---|---|
| Generalized Anxiety Disorder Questionnaire (GAD-7) | Validated questionnaire; a 7-item scale with total scores between 0 and 21 where higher scores indicate greater severity | 6 and 24 weeks post-randomization |
| Generalized Anxiety Disorder remission (score 1 or 2) on the the Clinical Global Impression Scale - Improvement (CGI-I) |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Boston University | Boston | Massachusetts | 02215 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41396602 | Derived | Parsons EM, Ball T, Carl J, Henry AL, Emsley R, Miller CB, Wong EY, Coombs E, Collins D, Long LJ, Ster AC, Smits JAJ, Otto MW. Digital Cognitive Behavioral Treatment for Generalized Anxiety Disorder: A Randomized Clinical Trial. JAMA Netw Open. 2025 Dec 1;8(12):e2548884. doi: 10.1001/jamanetworkopen.2025.48884. |
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| ID | Term |
|---|---|
| D000098647 | Generalized Anxiety Disorder |
| D001008 | Anxiety Disorders |
| ID | Term |
|---|---|
| D001523 | Mental Disorders |
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| Psychoeducation | Other | Participants will be provided with psychoeducation which will be delivered digitally upon allocation to the psychoeducation arm. |
|
A single-item measure scored between 1 and 7 where scores of 1 or 2 indicates clinically significant improvement, a score of 3 indicates mild improvement, a score of 4 indicates no change, and scores from 5 to 7 indicate deterioration |
| 24 weeks post-randomization |
| Patient Health Questionnaire (PHQ-8) | Validated questionnaire; an 8-item scale with total scores between 0 and 24 where higher scores indicate greater severity | Weeks 10 and 24 post-randomization |
| Sleep Condition Indicator (SCI-8) | Validated questionnaire; an 8-item scale with total scores between 0 and 32 where higher scores indicate better sleep | Weeks 10 and 24 post-randomization |
| Clinical Global Impression - Severity (CGI-S) | A single-item measure scored between 1 and 7 where higher scores indicate greater severity of Generalized Anxiety Disorder Symptoms | Weeks 10 and 24 post-randomization |