An interventional study of UP-CBT and Standard-CBT in Depression, Unipolar, Anxiety Disorder Social and Panic Disorder, sponsored by Psychiatric Research Unit, Region Zealand, Denmark. Completed at 4 sites in Denmark. Open to participants aged 18 Years to 64 Years. Per ClinicalTrials.gov, last updated 2020-09-16.
Sponsored by Psychiatric Research Unit, Region Zealand, Denmark · Not applicable, Interventional, and Treatment
Among 27 studies in Depressive Disorder with a site in Denmark — 3 open to participants now, 4 under way, none of them phase 3. Depressive Disorder · Denmark.
Among the 27 studies in Depressive Disorder with a site in Denmark, this one is the 4th largest by enrollment of the 23 interventional ones that give a count, is one of 2 that started in 2016, is one of 19 with no phase, and was the 10th registered.
855 studies on the registry are indexed under Depressive Disorder; 159 are open to participants now.
Browse Depressive Disorder studies →3 of the 27 studies in Depressive Disorder with a site in Denmark are open now. Recruiting first, the newest first:
Aalborg University Hospital · Sites in Denmark
Ages 18–65
Mental Health Centre Copenhagen, Bispebjerg and Frederiksberg Hospital · Sites in Denmark
Ages 18–65
Ellen Margrethe Hauge · Sites in Denmark
Ages 50–75
A study can be open while its sites in Denmark have not opened yet or have stopped. Only those recruiting at a site in Denmark →
Of the 116 Depressive Disorder studies recruiting now, 44 (38%) set no upper age limit and 66 (57%) stop at 75 or younger; 24 take children under 18; 25 take healthy volunteers.
This study: 18 Years to 64 Years · all sexes · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
27 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 2 3 · Phase 3 1 · Phase 4 1
First in 2002; this study’s year is marked. 2 started in 2016.
By drug class, each counting the studies that test any of its medicines:
This study's enrollment of 292 is above the median of 88 across 689 interventional studies indexed under Depressive Disorder.
Median enrollment 64 across the 23 interventional studies, 83 across the 4 observational. Of the 22 that completed or were terminated, 0 (0%) have results posted.
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None of the 27 has an industry lead sponsor. The 10 most frequent:
Psychiatric Research Unit, Region Zealand, Denmark is the lead sponsor of 15 studies on the registry; 3 are open to participants now.
Psychiatric Research Unit, Region Zealand, Denmark has 3 studies filed under Depressive Disorder — fewer than ten, so there is no comparison to draw.
2 of the studies in Depressive Disorder with a site in Denmark that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT07082777University of AarhusRecovery in Telling Life Stories | 2027-04-01 |
| NCT07263321Aalborg University HospitalImproving Treatment for Depression in General Practice Using a Step-by-Step Care Plan. | 2027-06 |
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Among the 27 studies in Depressive Disorder with a site in Denmark, from their registry updates:
Nothing recorded among them since 2026-09-25.
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Transdiagnostic Cognitive Behavior Therapy (CBT) delivered in the individual format, have been proven just as effective as traditional diagnosis specific CBT manuals. The investigators have translated and modified the "The Unified Protocol for Transdiagnostic Treatment of Emotional Disorders" (UP-CBT) to make it applicable as group therapy in Danish Mental Health Service and a naturalistic trial of this manual has shown promising results. As the use of one manual instead of several diagnosis specific manuals in regional clinics could simplify logistics and reduce waiting time, the investigators want to compare group UP-CBT with diagnosis specific group CBT.
Method: A partial blinded, pragmatic, non-inferiority, multicentre randomized clinical trial (RCT). UP-CBT is compared to treatment-as-usual CT. 124 patients are included in each intervention arm, recruited from three Danish regional Mental Health Service Clinics. 31st July 2018 suppl: Inclusion number expanded to 170 in each arm due to unexpected large drop-out.
Background: Transdiagnostic Cognitive Behavior Therapy (TCBT) Manuals delivered in individual format, have been reported to be just as effective as traditional diagnosis specific CBT manuals. The investigators have translated and modified the "The Unified Protocol for Transdiagnostic Treatment of Emotional Disorders" (UP-CBT) developed by Barlow and colleagues for use in Mental Health Service (MHS), and shown effects comparable to traditional CBT in a naturalistic trial. As the use of one manual instead of several diagnosis-specific manuals could simplify logistics, reduce waiting time, and increase therapist expertise compared to diagnosis specific CBT, the study aim to test the relative efficacy of group UP-CBT and diagnosis specific group CBT.
Methods/design: It is a partially blinded, pragmatic, non-inferiority, parallel, multi-center randomized controlled trial (RCT) of UP-CBT vs diagnosis specific CBT for depression, social anxiety disorder and agoraphobia/panic disorder. In both arms, the intervention consists of weekly group session for 14 weeks. In total, 248 patients are recruited from three regional MHS centers across the country and included in two intervention arms.31st July 2018 suppl: Inclusion number expanded to 340 due to unexpected large drop-out.
Outcomes are measured at end of therapy and at 6 months follow-up. Weekly patient-rated outcomes and group evaluations are collected for every session. Outcome assessors, blind to delivered intervention, will perform the observer-based symptom ratings, and fidelity assessors will monitor manual adherence.
Discussion: The current study will be the first RCT investigating the dissemination of the UP in a MHS setting and UP delivered in groups and including patients with depression. Hence the results are expected to add substantially to the evidence base for rational group psychotherapy in MHS. The planned moderator and mediator analyses could spur new hypotheses about mechanisms of change in psychotherapy and the association between patient characteristics and treatment effect.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Referred to Danish Mental Health Service
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The American Psychiatric Association’s manual of mental health diagnoses. DSM-5 (2013, revised as DSM-5-TR in 2022) replaced DSM-IV, and some studies still name the older edition. “Meets DSM criteria for …” means diagnosed by that edition’s diagnostic criteria, usually by a clinician in an interview.
DSM diagnostic criteria
The American Psychiatric Association’s manual of mental health diagnoses. DSM-5 (2013, revised as DSM-5-TR in 2022) replaced DSM-IV, and some studies still name the older edition. “Meets DSM criteria for …” means diagnosed by that edition’s diagnostic criteria, usually by a clinician in an interview.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The "Unified Protocol for Transdiagnostic Treatment of Emotional Disorders" (UP) is one of the most widely studied transdiagnostic manuals. Here, the investigators apply a group manual that has been modified from the published UP for individual therapy based on recommendations on group delivery from the UP Institute (personal communications) and integrations modifications necessary for the delivery in the Mental Health Service. Group UP-CBT, consist of 8 treatment modules delivered in 14 group sessions given weekly in 2 hour sessions.
Behavioral: UP-CBT
Group CBT following Danish versions of diagnosis specific manuals (Social Anxiety Disorder (SAD) Group; Depression (DEP) Group; Agoraphobia/Panic Disorder (Ag/PD) (standard-CBT). The original elements of psychoeducation, cognitive restructuring, and exposure/activity scheduling are present in the applied manuals. Standard-CBT, consist of 8 treatment modules delivered in 14 group sessions given weekly in 2 hour sessions.
Behavioral: Standard-CBT
Psychotherapy in groups based on the "Unified Protocol" a third generation CBT-type psychotherapy
Psychotherapy in groups based on diagnosis specific, manualized, cognitive behavior therapy
WHO Well-Being Index (WHO-5)
Self-rating questionnaire, 5 items on positive quality of life, web-based
Time frame: Week 19 after allocation
Hopkins Symptom Check List (SCL-25)
Validated questionnaire - web-based
Time frame: Week 19 after allocation
Work and Social Adjustment Scale (WSAS)
Validated questionnaire - web-based
Time frame: Week 19 after allocation
Hamilton Depression Rating Scale (HDRS)
6-item HDRS based on telephone interview
Time frame: Week 19 after allocation
Hamilton Anxiety Rating Scale (HARS)
6-item HARS based on telephone interview
Time frame: Week 19 after allocation
Overall Anxiety Severity and Impairment Scale (OASIS)
Validated questionnaire
Time frame: Weekly, weeks 4-19 after allocation, before session
Overall Depression Severity and Impairment Scale (ODSIS)
Validated questionnaire
Time frame: Weekly, weeks 4-19 after allocation, before session
WHO Well-Being Index (WHO-5)
Validated questionnaire
Time frame: Weekly, weeks 4-19 after allocation, before session
Positive Affect and Negative Affect Schedule (PANAS)
Validated questionnaire - web-based
Time frame: Week 19 after allocation
Positive Affect and Negative Affect Schedule (PANAS)
Validated questionnaire - web-based
Time frame: Week 42-43 after allocation
Hopkins Symptom Check List (SCL-25)
Validated questionnaire - web-based
Time frame: Week 42-43 after allocation
Emotion Regulation Questionnaire (ERQ)
Validated questionnaire - web-based
Time frame: Week 19 after allocation
Emotion Regulation Questionnaire (ERQ)
Validated questionnaire - web-based
Time frame: Week 42-43 after allocation
WHO Well-Being Index (WHO-5)
Self-rating questionnaire, 5 items on positive quality of life, web-based
Time frame: Week 42-43 after allocation
Emotion Regulation Strategies Questionnaire (ERSQ)
Validated questionnaire - web-based
Time frame: Week 19 after allocation
Emotion Regulation Strategies Questionnaire (ERSQ)
Validated questionnaire - web-based
Time frame: Week 42-43 after allocation
Perseverative Thinking Questionnaire (PTQ)
Validated questionnaire - web-based
Time frame: Week 19 after allocation
Perseverative Thinking Questionnaire (PTQ)
Validated questionnaires - web-based
Time frame: Week 42-43 after allocation
Becks Depression inventory (BDI-II)
Validated questionnaire - web-based
Time frame: Week 19 after allocation
Becks Depression inventory (BDI-II)
Validated questionnaire - web-based
Time frame: Week 42-43 after allocation
Work and Social Adjustment Scale (WSAS)
Validated questionnaire - web-based
Time frame: Week 42-43 after allocation
Personality Inventory for DSM-5 - Short Form (PID-5 SF) Negative Affectivity and Detachment domain scores
Validated questionnaire - web-based
Time frame: Week 19 after allocation
Personality Inventory for DSM-5 - Short Form (PID-5 SF) Negative Affectivity and Detachment domain scores
Validated questionnaire - web-based
Time frame: Week 42-43 after allocation
Liebowitch Social Anxiety Scale (LSAS)
Validated questionnaire - web-based
Time frame: Week 19 after allocation
Liebowitch Social Anxiety Scale (LSAS)
Validated questionnaire - web-based
Time frame: Week 42-43 after allocation
Panic Disorder Severity Scale (PDSS)
Validated questionnaire - web-based
Time frame: Week19 after allocation
Panic Disorder Severity Scale (PDSS)
Validated questionnaire - web-based
Time frame: Week 42-43 after allocation
Mobility Inventory for Agoraphobia (MIA)
Validated questionnaire - web-based
Time frame: Week 19 after allocation
Mobility Inventory for Agoraphobia (MIA)
Validated questionnaire - web-based
Time frame: Week 42-43 after allocation
Hamilton Depression Rating Scale
6-item HDRS based on telephone interview
Time frame: Week 42-43 after allocation
Hamilton Anxiety Rating Scale
6-item HARS based on telephone interview
Time frame: Week 42-43 after allocation
Client Satisfaction Questionnaire
8-item validated questionnaire, web-based
Time frame: Week 43
Patient Evaluation of Group Therapy
Purpose-made questionnaire
Time frame: Week 19
Group Questionnaire - brief
8 items from validated questionnaire about group atmosphere
Time frame: Weekly, weeks 4-19 after allocation, after session
Therapist Ratings of session methods and atmosphere
Purpose-made questionnaire
Time frame: Weekly, weeks 4-19 after allocation, after session
Homework and Event Tracker
Purpose-made question for patients about homework and events previous week
Time frame: Weekly, weeks 4-19 after allocation, before session
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: No — The datasets generated by the planned study will not be publicly available due to the rules of the Danish Data Protection Agency, but will be available from the corresponding author, after publication, on reasonable request and following signed confidentiality agreement with PI and the Danish Data Protection Agency Region Zealand.
The record gives a start of Dec 2016, a primary completion of Apr 2019 and a completion of Dec 2019. It does not say whether these dates are actual or estimated.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Sep 2020. You cannot join it, but the record below documents what was studied.
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Psychiatric Research Unit, Region Zealand, Denmark