Emotional DisorderUP-HITOPNCT07557017
Unified Protocol for Emotional Disorders: HiTOP-PRO Trial
A study testing Unified Protocol and Treatment as usual (TAU) in people with Emotional Disorder, run by National Institute of Mental Health, Czech Republic at 1 site in Czechia.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Emotional Disorder
- What is being tested?
- Unified Protocol and Treatment as usual (TAU)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteCzechia
- Study dates
- 8 Oct 2025to 31 Jul 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- 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.
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Czechia1 site, 1 recruiting
- Recruiting
National Institute of Mental healh
Prague, 170 00
Eva Dreyfus, Master of Science, +420 283088282, eva.dreyfus@nudz.cz
Maria Dodaj, Psychology Intern, +420 283088282, maria.dodaj@nudz.cz
About this study
Official title: 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.
Read the 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.
- Conditions
- Emotional Disorder
- Being tested
- Unified Protocol, Treatment as usual (TAU)
- Keywords
- emotional disorders, unified protocol, HiTOP, Hierarchical Taxonomy Of Psychopathology, transdiagnostic therapy, personality traits, temperamental traits
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Unified ProtocolBehavioural
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.
Treatment as usual (TAU)Behavioural
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).
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: Baseline (pre-randomisation) and post-treatment (approximately 14 weeks)
Secondary outcomes (7)
HiTOP-PRO Externalising Dimension Score
HiTOP-PRO Externalising Dimension score (dimensional externalising symptom severity) assessed by self-report questionnaire.
Measured: 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).
Measured: 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
Measured: 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).
Measured: 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.
Measured: 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).
Measured: 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.
Measured: 3 months after post-treatment (UP arm only)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Apr 2026
- Study start8 Oct 2025
- Primary completion30 Apr 2028 (estimated)
- Study completion31 Jul 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Emotional DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Institute of Mental Health, Czech Republic
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07557017
- Sponsor's protocol ID
- NUDZ-UP-HITOP-01
- Other IDs
- cj 104/25
- Acronym
- UP-HITOP
- Status last verified
- Jan 2026
- First submitted
- 22 Apr 2026
- Last updated
- 29 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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 at a glance
From the registry record, last updated by the sponsor on 29 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigating the Impact of the Unified Protocol on HiTOP Dimensions and Temperamental Traits in Patients With Emotional Disorders
- ClinicalTrials.gov ID
- NCT07557017
- Acronym / sponsor ID
- UP-HITOP / NUDZ-UP-HITOP-01
- Conditions
- Emotional Disorder
- Keywords
- emotional disorders, unified protocol, HiTOP, Hierarchical Taxonomy Of Psychopathology, transdiagnostic therapy, personality traits, temperamental traits
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- National Institute of Mental Health, Czech RepublicUniversity, hospital or other
- Study start
- 8 Oct 2025 (actual)
- Primary completion
- 30 Apr 2028 (estimated)
- Study completion
- 31 Jul 2028 (estimated)
- First posted
- 29 Apr 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Unified Protocol (UP) | Experimental | Behavioral: Unified ProtocolA 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. |
| Treatment as Usual (TAU) | Active comparator | Behavioral: 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. |
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- 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.
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Unified ProtocolManualised 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. | Behavioural | Unified Protocol (UP) |
| 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). | Behavioural | Treatment as Usual (TAU) |
Primary outcome
HiTOP-PRO Internalising Dimension Score
Time frame: Baseline (pre-randomisation) and post-treatment (approximately 14 weeks)
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).
7 secondary outcomes
HiTOP-PRO Externalising Dimension Score
Time frame: Baseline (pre-randomisation) and post-treatment (approximately 14 weeks)
Depression Anxiety Stress Scales (DASS)
Time frame: Baseline (pre-randomisation) and post-treatment (approximately 14 weeks)
WHO Disability Assessment Schedule 2.0 (WHODAS 2.0) Total Score
Time frame: Baseline (pre-randomisation) and post-treatment (approximately 14 weeks)
NEO Personality Inventory-Revised (NEO PI-R) Trait Scores
Time frame: Baseline (pre-randomisation) and post-treatment (approximately 14 weeks)
Behavioural Inhibition/Behavioural Activation System Scales (BIS/BAS)
Time frame: Baseline (pre-randomisation) and post-treatment (approximately 14 weeks)
Client Satisfaction Questionnaire (CSQ-8) Total Score
Time frame: Baseline (pre-randomisation) and post-treatment (approximately 14 weeks)
HiTOP-PRO Internalising and Externalising Dimension Scores at Follow-up (UP Arm)
Time frame: 3 months after post-treatment (UP arm only)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Apr 2026.
- BackgroundBarlow DH, Farchione TJ, Sauer-Zavala S, et al. Unified Protocol for Transdiagnostic Treatment of Emotional Disorders: Therapist Guide. 2nd ed. Oxford University Press; 2017.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Unified Protocol and Treatment as usual (TAU) in people with Emotional Disorder, run by National Institute of Mental Health, Czech Republic at 1 site in Czechia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 13 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 29 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Czechia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Eva Dreyfus, MSc. (+420283088282, eva.dreyfus@nudz.cz), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
HiTOP-PRO Internalising Dimension Score (time frame: Baseline (pre-randomisation) and post-treatment (approximately 14 weeks)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07557017, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Apr 2026.