Unified Protocol treatment for emotional disorders (HiTOP-PRO)
Investigating the Impact of the Unified Protocol on HiTOP Dimensions and Temperamental Traits in Patients With Emotional Disorders
NA · National Institute of Mental Health, Czech Republic · NCT07557017
This project will test whether the Unified Protocol—a transdiagnostic cognitive-behavioral therapy—helps adults with emotional disorders feel better than usual care or being on a waitlist.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 90 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | National Institute of Mental Health, Czech Republic (other) |
| Locations | 1 site (Prague) |
| Trial ID | NCT07557017 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Adults aged 18–65 seeking outpatient treatment at NÚDZ who meet ADIS-5 diagnostic criteria for specified emotional disorder categories, can complete Czech-language assessments, and have stable psychotropic medication doses when applicable are ideal candidates.
Not a fit: People with a current or lifetime psychotic disorder, a current manic/hypomanic episode, or high acute suicide/self-harm risk requiring higher-level care are excluded and unlikely to benefit from this outpatient psychotherapy protocol.
Why it matters
Potential benefit: If successful, UP could reduce broad dimensional symptoms across emotional disorders and improve related temperamental or personality traits, making one structured treatment useful for multiple diagnoses.
How similar studies have performed: The Unified Protocol has prior randomized-trial evidence showing efficacy across anxiety and depressive disorders, but applying HiTOP-aligned dimensional outcomes and conducting this comparison in routine Czech outpatient care is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Prague
- National Institute of Mental healh — Prague, Czechia (RECRUITING)
Study contacts
- Study coordinator: Eva Dreyfus, MSc.
- Email: eva.dreyfus@nudz.cz
- Phone: +420283088282
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Emotional Disorder, emotional disorders, unified protocol, HiTOP, Hierarchical Taxonomy Of Psychopathology, transdiagnostic therapy, personality traits, temperamental traits