Unified Protocol for Emotional Disorders: HiTOP-PRO Trial
ConditionEmotional Disorder
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorNational Institute of Mental Health, Czech Republic
About this trial
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 criteria
This trial does not accept healthy volunteersQualifiers
None
Disqualifiers
None
Trial design
Design model
Parallel
Treatments tested in this trial
Unified Protocol
BehavioralManualised 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)
BehavioralRoutine 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 groups
90 Participants
are divided into 3 treatment groupsGroup A: Unified Protocol (UP)Experimental treatment 1 intervention
Group B: Treatment as Usual (TAU)Active comparator 1 intervention
Group C: Waiting List (WL)No intervention 0 interventions
Trial outcomes
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).
Time frame
Baseline (pre-randomisation) and post-treatment (approximately 14 weeks)Secondary outcomes
1
HiTOP-PRO Externalising Dimension Score
HiTOP-PRO Externalising Dimension score (dimensional externalising symptom severity) assessed by self-report questionnaire.
Time frame
Baseline (pre-randomisation) and post-treatment (approximately 14 weeks)2
Depression Anxiety Stress Scales (DASS)
DASS self-report symptom severity (Depression, Anxiety, Stress subscales and/or total score per scoring procedures).
Time frame
Baseline (pre-randomisation) and post-treatment (approximately 14 weeks)3
WHO Disability Assessment Schedule 2.0 (WHODAS 2.0) Total Score
WHODAS 2.0 self-report disability/functioning total score
Time frame
Baseline (pre-randomisation) and post-treatment (approximately 14 weeks)4
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).
Time frame
Baseline (pre-randomisation) and post-treatment (approximately 14 weeks)Sponsors and contacts
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Source ClinicalTrials.gov