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NCT05748652: GATE
Generalized Anxiety Therapy Effectiveness
NA trial testing digital CBT in Generalized Anxiety Disorder in 351 participants. Completed in 28 February 2024.
15 November 2023
Quick facts
| Lead sponsor | Big Health Inc. |
|---|---|
| Phase | NA |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | double |
| Primary purpose | treatment |
| Enrollment | 351 |
| Start date | 6 March 2023 |
| Primary completion | 15 November 2023 |
| Estimated completion | 28 February 2024 |
| Sites | 1 location across United States |
Drugs / interventions tested
- digital CBT
- Psychoeducation
Conditions studied
- Generalized Anxiety Disorder — all drugs for Generalized Anxiety Disorder →
Sponsor
Big Health Inc.
Who can join
22 and older, any sex, with Generalized Anxiety Disorder. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
This study will examine the effectiveness of digital CBT versus psychoeducation in improving anxiety for those with Generalized Anxiety Disorder.
Publications & conference data
2 peer-reviewed publications reference this trial (live from Europe PMC):
-
Cost-effectiveness of automated digital CBT (Daylight) for generalized anxiety disorder: A Markov simulation model in the United States.
Darden M, Carl JR, Smits JAJ, Otto MW, et al · · 2024 · cited 1× · PMID 41661766 · DOI 10.1371/journal.pmen.0000116 -
Digital Cognitive Behavioral Treatment for Generalized Anxiety Disorder: A Randomized Clinical Trial.
Parsons EM, Ball T, Carl J, Henry AL, et al · · 2025 · PMID 41396602 · DOI 10.1001/jamanetworkopen.2025.48884
Verify or expand the search:
- PubMed search for NCT05748652
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other recruiting trials for Generalized Anxiety Disorder
Currently open trials in the same condition.
- NCT06661460 — Internet-Delivered Cognitive Behavioral Intervention for Youths With Anxiety Disorders · NA · recruiting
- NCT06934525 — Implementing Team-Based Treatment for Pediatric Anxiety in Community Mental Health Settings · NA · recruiting
- NCT07305701 — Cohort Study on Medical Students' Mental Health · recruiting
- NCT07330648 — Prospective Clinical Trial of Crisugabalin Capsules in the Treatment of Generalized Anxiety Disorder · Phase 2 · recruiting
- NCT07121712 — Navigated cTBS for the Treatment of Generalized Anxiety Disorder · NA · recruiting
Other Big Health Inc. trials
Trials by the same sponsor.
- NCT06003361 — Rise Study for Depression · NA · completed
- NCT05541055 — Digital CBT-I for Insomnia Disorder · NA · completed
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT05748652 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Big Health Inc.
- Last refreshed: 5 April 2024
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05748652.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing