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NCT04091139
Research of Unified Protocol for the Treatment of Common Mental Disorders in Adolescents in Hong Kong
Phase 2, PHASE3 trial testing Unified protocol for adolescents (UP-A) in Depressive Disorder in 27 participants. Completed in 22 May 2020.
22 May 2020
Quick facts
| Lead sponsor | Chinese University of Hong Kong |
|---|---|
| Phase | Phase 2, PHASE3 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 27 |
| Start date | 24 September 2019 |
| Primary completion | 22 May 2020 |
| Estimated completion | 22 May 2020 |
| Sites | 1 location across Hong Kong |
Drugs / interventions tested
- Unified protocol for adolescents (UP-A)
- Treatment as usual (TAU) — full drug profile →
Conditions studied
- Depressive Disorder — all drugs for Depressive Disorder →
- Anxiety Disorders — all drugs for Anxiety Disorders →
Sponsor
Chinese University of Hong Kong
Who can join
Adults 13 to 18, any sex, with Depressive Disorder or Anxiety Disorders. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
The Unified Protocol (UP) is an emotion-focused, cognitive-behavioural intervention that is developed to target core temperamental characteristics underlying anxiety and depressive disorders. Ehrenreich and colleagues developed UP for adolescents (UP-A). The current study aims at evaluating efficacy of UP-A for the treatment of emotional disorders in Chinese adolescents in Hong Kong. The current study would recruit 27 Chinese-speaking patients, age 13 to 18, with a primary diagnosis of any Diagnostic and Statistical Manual (Fifth edition) anxiety disorders and/or depressive disorder. They would be randomized into one of the two treatment arms, namely UP-A treatment condition (UP-A), and treatment-as-usual (TAU) condition. Following randomization, participants in the UP-A condition would attend individual treatment based on UP-A, which last for 10 to 12 weeks. Participants in the TAU condition would be provided with usual clinical psychological service (i.e. treatment as usual) in the first 12 weeks before they start attending the same individual treatment program. Primary outcomes would be patient's self-rated measures on clinical symptoms, and secondary outcomes would be their clinical diagnoses, parent-rated and other self-rated measures. It is hypothesized that, comparing to those in TAU, participants in the UP-A condition would show improvements in depressive symptoms, anxiety symptoms and functional impairment at the end of treatment. When the outcomes of all participants are combined, it is hypothesized that participants will show demonstrate improvement in depressive symptoms, anxiety symptoms, and functional impairment after completing the UP-A and at the 3-month follow-up.
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
Verify or expand the search:
- PubMed search for NCT04091139
- Europe PMC full search
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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 NCT04091139 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Chinese University of Hong Kong
- Last refreshed: 27 January 2021
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/NCT04091139.
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