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NCT03807427: READY-Nepal
Regulating Emotions Through Adapted Dialectical Behavior Skills for Youth (READY-Nepal)
NA trial testing READY-Nepal in Mental Disorders in 200 participants. Completed in 30 June 2018.
30 June 2018
Quick facts
| Lead sponsor | Brandon A Kohrt, MD, PhD |
|---|---|
| Phase | NA |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | non randomized |
| Design | parallel |
| Masking | none |
| Primary purpose | other |
| Enrollment | 200 |
| Start date | 1 July 2016 |
| Primary completion | 30 June 2018 |
| Estimated completion | 30 June 2018 |
| Sites | 1 location across Nepal |
Drugs / interventions tested
- READY-Nepal
Conditions studied
- Mental Disorders — all drugs for Mental Disorders →
Sponsor
Brandon A Kohrt, MD, PhD
Who can join
Adults 13 to 17, any sex, with Mental Disorders. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
Published research on the development of mental health symptomatology among adolescents has expanded in recent years and indicates the presence of a growing public health concern. The 2015 earthquakes in Nepal are a risk factor for increased psychological distress across all age groups. Prior studies have also demonstrated high chronic risk of suicidal thoughts and behaviors (STBs) among adolescents in Nepal and throughout South Asia. Despite the need for mental health promotion interventions in Nepal, there is a lack of psychological treatments for suicide prevention that have been rigorously evaluated in Nepal. To address this gap, a trans diagnostic, emotion -focused mental health promotion intervention (Regulating Emotions through Adapted Dialectical behavior skills for Youth in Nepal; READY-Nepal) was developed for delivery in school-based settings. A pilot quasi-experimental trial utilizing a wait-list control group will be used to evaluate the feasibility and acceptability of the intervention in a cohort of school -going adolescents in the Kathmandu Valley. Qualitative methodology will be used to augment quantitative findings via exploration of gender differences in perception and uptake of the program, program feasibility and acceptability, as well as changes in coping skills and explanatory models of stress between baseline and follow- up. This pilot study will aid in modifying the intervention to inform the development of a larger, adequately powered cluster randomized trial (CRT) of READY-Nepal.
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 NCT03807427
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
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Other Brandon A Kohrt, MD, PhD trials
Trials by the same sponsor.
- NCT02793271 — Reducing Stigma Among Healthcare Providers to Improve Mental Health Services · 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 NCT03807427 (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 Brandon A Kohrt, MD, PhD
- Last refreshed: 16 January 2019
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/NCT03807427.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing