RecruitingNot ApplicableNCT07557017

Unified Protocol for Emotional Disorders: HiTOP-PRO Trial

Investigating the Impact of the Unified Protocol on HiTOP Dimensions and Temperamental Traits in Patients With Emotional Disorders

Sponsor

National Institute of Mental Health, Czech Republic

Enrollment

90 participants

Start Date

Oct 8, 2025

Study Type

INTERVENTIONAL

Conditions

Emotional Disorder

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

Min Age: 18 Years

Inclusion Criteria6

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 Criteria6

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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Interventions

BEHAVIORALUnified Protocol

Manualised transdiagnostic cognitive-behavioural psychotherapy delivered individually according to the Unified Protocol therapist manual. Treatment consists of approximately 14-16 sessions (about 60 minutes each) delivered over \~14 weeks in routine outpatient conditions.

BEHAVIORALTreatment as usual (TAU)

Routine outpatient psychotherapy provided as part of standard clinical care at NÚDZ. The psychotherapy modality may vary according to clinical indication and usual practice (e.g., psychodynamic/psychoanalytic/integrative). Treatment is delivered over approximately the same observation window (\~14 weeks).