Unified Protocol for Emotional Disorders: HiTOP-PRO Trial
This randomised, parallel-group clinical trial evaluates the effects of the Unified Protocol (UP), a transdiagnostic cognitive-behavioural psychotherapy, on dimensional symptom outcomes aligned with the Hierarchical Taxonomy of Psychopathology (HiTOP) and on related temperamental/personality traits in adults with emoti
| Condition(s) | Emotional Disorder |
|---|---|
| Status | Recruiting |
| Phase | NA |
| Study type | Interventional |
| Summary | This randomised, parallel-group clinical trial evaluates the effects of the Unified Protocol (UP), a transdiagnostic cognitive-behavioural psychotherapy, on dimensional symptom outcomes aligned with the Hierarchical Taxonomy of Psychopathology (HiTOP) and on related temperamental/personality traits in adults with emotional disorders. Participants are randomly assigned (1:1:1) to UP, treatment as usual (TAU), or a waitlist (WL). Outcomes are assessed at baseline and after approximately 14 weeks. A planned follow-up assessment approximately 3 months after treatment completion is collected in the UP arm only. |
| Who can participate | Inclusion Criteria: Adults aged 18-65 years. Seeking outpatient treatment at NÚDZ for emotional disorder symptoms. Meets diagnostic eligibility on ADIS-5 for at least one of the following (ICD-10 categories consistent with the protocol): F32, F33, F34, F40, F41, F42, F43, F45, F60, F61. Able to understand and complete study questionnaires and procedures (Czech language). Willing and able to participate in psychotherapy and complete assessments at baseline and post-treatment (14 weeks). If taking psychotropic medication: dose stable for ≥6 weeks prior to enrolment and expected to remain stable during the acute study period where clinically feasible. Provides written informed consent. Exclusion Criteria: Current or lifetime psychotic disorder or current manic/hypomanic episode. High acute su |
| Ages | 18 Years |
| Sex | All |
| Lead sponsor | National Institute of Mental Health, Czech Republic |
| Locations | Prague, Czechia |
| Start date | 2025-10-08 |
| NCT ID | NCT07557017 |
| Official listing | https://clinicaltrials.gov/study/NCT07557017 |