Unified Protocol for Emotional Disorders: HiTOP-PRO Trial

NCT07557017 | Recruiting

• 2 other identifiers: NUDZ-UP-HITOP-01cj 104/25
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

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.

Conditions

Emotional Disorder

Keywords

emotional disorders; unified protocol; HiTOP; Hierarchical Taxonomy Of Psychopathology; transdiagnostic therapy; personality traits; temperamental traits

Outcome Measures

Primary Outcomes (1)

• HiTOP-PRO Internalising Dimension Score

  Self-reported internalising symptom severity measured with the HiTOP-PRO Internalising Dimension score. Primary analysis compares treatment groups on post-treatment Internalising score with baseline Internalising score as a covariate (ANCOVA).

  Baseline (pre-randomisation) and post-treatment (approximately 14 weeks)

Secondary Outcomes (7)

• HiTOP-PRO Externalising Dimension Score

  Baseline (pre-randomisation) and post-treatment (approximately 14 weeks)

• Depression Anxiety Stress Scales (DASS)

  Baseline (pre-randomisation) and post-treatment (approximately 14 weeks)

• WHO Disability Assessment Schedule 2.0 (WHODAS 2.0) Total Score

  Baseline (pre-randomisation) and post-treatment (approximately 14 weeks)

• NEO Personality Inventory-Revised (NEO PI-R) Trait Scores

  Baseline (pre-randomisation) and post-treatment (approximately 14 weeks)

• Behavioural Inhibition/Behavioural Activation System Scales (BIS/BAS)

  Baseline (pre-randomisation) and post-treatment (approximately 14 weeks)

Study Arms (3)

Unified Protocol (UP)

EXPERIMENTAL

A manualised transdiagnostic cognitive-behavioural therapy for emotional disorders, delivered individually in 14-16 sessions (approximately 60 minutes each) over approximately 14 weeks, following the UP therapist guide/manual.

Behavioral: Unified Protocol

Treatment as Usual (TAU)

ACTIVE COMPARATOR

Participants receive treatment as usual (TAU) in routine outpatient care at NÚDZ. TAU consists of standard psychotherapy delivered according to clinical indication and service availability; the modality may vary (e.g., psychodynamic/psychoanalytic/integrative). Treatment is provided during the approximately 14-week study observation period.

Behavioral: Treatment as usual (TAU)

Waiting List (WL)

NO INTERVENTION

Participants are assigned to a waitlist condition and receive no active study psychotherapy during the approximately 14-week observation period. They complete the same assessment schedule as other arms (baseline and post-assessment). After completion of study assessments, participants are offered treatment.

Interventions

Unified Protocol BEHAVIORAL

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.

Unified Protocol (UP)

Treatment as usual (TAU) BEHAVIORAL

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).

Treatment as Usual (TAU)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• National Institute of Mental Health, Czech Republic: lead

Study Sites (1)

National Institute of Mental healh

Prague, 170 00, Czechia

RECRUITING

Related Publications (1)

• Barlow DH, Farchione TJ, Sauer-Zavala S, et al. Unified Protocol for Transdiagnostic Treatment of Emotional Disorders: Therapist Guide. 2nd ed. Oxford University Press; 2017.

  BACKGROUND

MeSH Terms

Interventions

Therapeutics

Central Study Contacts

Eva Dreyfus, MSc.

CONTACT

+420283088282; eva.dreyfus@nudz.cz

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: This is an open-label behavioural psychotherapy trial. Treatment assignment is not masked to participants or therapists. Questionnaire outcomes are self-reported and collected under pseudonymised study IDs; therapists do not have access to outcome datasets. The data analyst receives a de-identified dataset without direct identifiers.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 22, 2026
• First Posted: April 29, 2026
• Study Start: October 8, 2025
• Primary Completion (Estimated): April 30, 2028
• Study Completion (Estimated): July 31, 2028
• Last Updated: April 29, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

CZ (1)