Actively Recruiting
Unified Protocol for Emotional Disorders: HiTOP-PRO Trial
Led by National Institute of Mental Health, Czech Republic · Updated on 2026-04-29
90
Participants Needed
1
Research Sites
146 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Unified Protocol for Emotional Disorders: HiTOP-PRO Trial
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 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: F32, F33, F34, F40, F41, F42, F43, F45, F60, F61
- Able to understand and complete study questionnaires and procedures in Czech
- Willing and able to participate in psychotherapy and complete assessments at baseline and post-treatment (14 weeks)
- If taking psychotropic medication, dose stable for at least 6 weeks prior to enrolment and expected to remain stable during the acute study period where clinically feasible
- Provides written informed consent
You will not qualify if you...
- Current or lifetime psychotic disorder or current manic/hypomanic episode
- High acute suicide risk requiring a higher level of care or current severe self-harm risk incompatible with outpatient psychotherapy study procedures
- Primary substance use disorder requiring specialised treatment or acute intoxication/withdrawal
- Severe cognitive impairment or neurodevelopmental/neurological condition preventing valid consent or completion of study procedures
- Concurrent psychological treatment conflicting with study participation unless it is the assigned treatment as usual
- Immediate need for intensive treatment such as inpatient admission at screening
- Inability to commit to the study schedule or complete required assessments
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
National Institute of Mental healh
Prague, Czechia, 170 00
Actively Recruiting
Research Team
E
Eva Dreyfus, MSc.
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
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