Unified Protocol for Emotional Disorders: HiTOP-PRO Trial (UP-HITOP)

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

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.

Study Overview

• Status: Recruiting
• Conditions: Emotional Disorder
• Intervention / Treatment: Behavioral: Unified Protocol; Behavioral: Treatment as usual (TAU)

Detailed Description

This study is a single-site, randomised, parallel-group clinical trial conducted in routine outpatient care at the National Institute of Mental Health (NÚDZ), Czech Republic. The trial compares a manualised transdiagnostic cognitive-behavioural intervention (Unified Protocol; UP) with treatment as usual (TAU) and a waitlist (WL) condition in adults with emotional disorders. Participants are screened by telephone and diagnostic eligibility is confirmed using the ADIS-5 prior to randomisation. Randomisation is performed at the individual participant level (1:1:1) using a computer-based randomisation programme. Recruitment and enrolment occur on a rolling basis, contingent on clinical throughput and therapist availability. Assessments are completed at baseline (pre-randomisation) and at post-treatment (approximately 14 weeks) across all study arms. A planned follow-up assessment approximately 3 months after treatment completion is collected in the UP arm only; follow-up participation is voluntary and follow-up completion rates will be reported.

• Study Type: Interventional
• Enrollment (Estimated): 90
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Eva Dreyfus, MSc.; Phone Number: +420283088282; Email: eva.dreyfus@nudz.cz

Study Locations

• Czechia
  • Prague, Czechia, 170 00
    • Recruiting
    • National Institute of Mental healh
    • Contact: Eva Dreyfus, Master of Science; Phone Number: +420 283088282; Email: eva.dreyfus@nudz.cz
    • Contact: Maria Dodaj, Psychology Intern; Phone Number: +420 283088282; Email: maria.dodaj@nudz.cz
    • Sub-Investigator: Eva Dreyfus, Master of Science

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Unified Protocol (UP); 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; 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.
Active Comparator: Treatment as Usual (TAU); 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); 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).
No Intervention: Waiting List (WL); 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
HiTOP-PRO Externalising Dimension Score	HiTOP-PRO Externalising Dimension score (dimensional externalising symptom severity) assessed by self-report questionnaire.	Baseline (pre-randomisation) and post-treatment (approximately 14 weeks)
Depression Anxiety Stress Scales (DASS)	DASS self-report symptom severity (Depression, Anxiety, Stress subscales and/or total score per scoring procedures).	Baseline (pre-randomisation) and post-treatment (approximately 14 weeks)
WHO Disability Assessment Schedule 2.0 (WHODAS 2.0) Total Score	WHODAS 2.0 self-report disability/functioning total score	Baseline (pre-randomisation) and post-treatment (approximately 14 weeks)
NEO Personality Inventory-Revised (NEO PI-R) Trait Scores	NEO PI-R personality trait domain scores (including Neuroticism and Extraversion; other domains per instrument scoring).	Baseline (pre-randomisation) and post-treatment (approximately 14 weeks)
Behavioural Inhibition/Behavioural Activation System Scales (BIS/BAS)	BIS/BAS scale scores (behavioural inhibition and behavioural activation) assessed by self-report.	Baseline (pre-randomisation) and post-treatment (approximately 14 weeks)
Client Satisfaction Questionnaire (CSQ-8) Total Score	CSQ-8 total score assessing satisfaction with received psychotherapy (participants in UP or TAU arms).	Baseline (pre-randomisation) and post-treatment (approximately 14 weeks)
HiTOP-PRO Internalising and Externalising Dimension Scores at Follow-up (UP Arm)	HiTOP-PRO Internalising and Externalising Dimension scores assessed in the Unified Protocol arm to examine maintenance of change; follow-up completion is voluntary.	3 months after post-treatment (UP arm only)

Collaborators and Investigators

• Sponsor: National Institute of Mental Health, Czech Republic

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): October 8, 2025
• Primary Completion (Estimated): April 30, 2028
• Study Completion (Estimated): July 31, 2028

Study Registration Dates

• First Submitted: April 22, 2026
• First Submitted That Met QC Criteria: April 22, 2026
• First Posted (Actual): April 29, 2026

Study Record Updates

• Last Update Posted (Actual): April 29, 2026
• Last Update Submitted That Met QC Criteria: April 22, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Keywords: emotional disorders; transdiagnostic therapy; personality traits; unified protocol; HiTOP; Hierarchical Taxonomy Of Psychopathology; temperamental traits
• Additional Relevant MeSH Terms: Therapeutics
• Other Study ID Numbers: NUDZ-UP-HITOP-01; cj 104/25 (Other Identifier: NIMH Czech Republic)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No