Unified Protocol treatment for emotional disorders (HiTOP-PRO)

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a single-site, randomized, parallel-group trial at the National Institute of Mental Health (NÚDZ) in Prague comparing the manualised Unified Protocol (UP) to treatment as usual (TAU) and a waitlist (WL). Adults seeking outpatient care are screened by telephone and diagnostic eligibility is confirmed with the ADIS-5, then randomized 1:1:1 to UP, TAU, or WL. Outcomes focused on HiTOP-aligned dimensional symptom measures and temperamental/personality traits are collected at baseline and approximately 14 weeks post-randomization, with an optional ~3-month follow-up only in the UP arm. Recruitment is rolling and dependent on clinic throughput and therapist availability.

Why it matters

Who can join: the full rules

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 suicide risk requiring a higher level of care (e.g., imminent risk, recent serious attempt) 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 that prevents valid consent or completion of study procedures.

Concurrent psychological treatment that would conflict with study participation (e.g., starting a new structured psychotherapy during the 14-week study period), unless it constitutes the assigned TAU.

Immediate need for intensive treatment (e.g., inpatient admission) at the time of screening.

Inability to commit to the study schedule or complete required assessments.

Where it's running

• National Institute of Mental healh
  Prague, Czechia Recruiting

Study contacts

• Study coordinator: Eva Dreyfus, MSc.
• Email: eva.dreyfus@nudz.cz
• Phone: +420283088282

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.