NCT07557017 Unified Protocol for Emotional Disorders: HiTOP-PRO Trial
| NCT ID | NCT07557017 |
| Status | Recruiting |
| Phase | — |
| Sponsor | National Institute of Mental Health, Czech Republic |
| Condition | Emotional Disorder |
| Study Type | INTERVENTIONAL |
| Enrollment | 90 participants |
| Start Date | 2025-10-08 |
| Primary Completion | 2028-04-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 90 participants in total. It began in 2025-10-08 with a primary completion date of 2028-04-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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.
Eligibility 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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07557017 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Emotional Disorder. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07557017 currently recruiting?
Yes, NCT07557017 is actively recruiting participants. Contact the research team at eva.dreyfus@nudz.cz for enrollment information.
Where is the NCT07557017 trial being conducted?
This trial is being conducted at Prague, Czechia.
Who is sponsoring the NCT07557017 clinical trial?
NCT07557017 is sponsored by National Institute of Mental Health, Czech Republic. The trial plans to enroll 90 participants.