Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
NCT07557017

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

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

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
Not Eligible

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

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Trial Site Locations

Total: 1 location

1

National Institute of Mental healh

Prague, Czechia, 170 00

Actively Recruiting

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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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