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Unified Protocol for Emotional Disorders: HiTOP-PRO Trial

RecruitingNAAges 18 Years - anyAllNational Institute of Mental Health, Czech Republโ€ฆ
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In plain words

What the trial is, and whether it could suit you

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.

Sign in to get the eligibility rules as simple questions to take to your doctor.

๐Ÿ“‹ Eligibility rules (as published)
Inclusion Criteria: Adults aged 18-65 years. Seeking outpatient treatment at NรšDZ 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 โ‰ฅ6 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.
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What it tests

  • Unified Protocol
  • Treatment as usual (TAU)
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Where

1 site
National Institute of Mental healh
Prague, Czechia
๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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