Brief-intensive CBT Versus Once-weekly CBT in Anxiety-related Disorders
NCT ID: NCT05942391
Last Updated: 2025-03-24
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
120 participants
INTERVENTIONAL
2024-04-26
2026-09-30
Brief Summary
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The main question to answer is: will brief-intensive CBT improve functioning (work, family, social) more and faster than does regular weekly CBT?
Participants will be asked to follow CBT treatment (20 sessions of 45 minutes in both conditions), and participate in 7 measurements with a total duration of 5 hours over 1 year.
Researchers will compare:
* Brief-intensive CBT: 16 sessions in 2 weeks + 4 follow-up sessions within 3 months
* Regular CBT with 20 weekly sessions in 6 months
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Detailed Description
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Study design: a parallel-group randomised controlled multicenter intervention study.
Study population: Adults aged 18-65 yr old with an anxiety-related disorder (panic, agrophobia, social anxiety, generalised anxiety obsessions/compulsions, health anxiety and post-traumatic stress)
Intervention (if applicable): One group receives BI-CBT (16 sessions in 2 weeks + 4 follow up sessions) and the other group receives 20 weekly CBT sessions. Treatment in both conditions can be personalised by a focus on work or family functioning.
Main study parameters/endpoints: The main study parameter is the 'area under the curve' for 6-month health and disability. Also, 1 year efficacy (both on functioning and symptom-level), cost-effectiveness, and feasibility will be assessed. Potential predictors of treatment preference, efficacy and drop-out will be explored.
All patients are expected to follow CBT (20 sessions of 45min) and participate in 7 measurements over 1 year.
The general measurements are online questionnaires and interviews by telephone, asking about someones functioning, quality of life and symptoms of anxiety or depression, how one copes with these and what one expects of the therapy.
The acronym KOMMA is based on the Dutch translation of 'to put a quick end to anxiety': Korte Metten Met Angst.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Brief-Intensive CBT
16 sessions in 2 weeks + 4 follow up sessions. The CBT consists of 16 sessions exposure therapy, spread over 4 half-days in 2 weeks, + 4 sessions within 3 months.
Cognitive behavioral therapy (CBT)
The intervention is brief-intensive, guided exposure therapy and consists of 16 sessions exposure therapy, spread over 4 half-days in 2 weeks plus 4 follow-up sessions within 3 months.
weekly CBT
20 weekly CBT sessions within 5 to 6 months. The CBT consists of exposure therapy.
Cognitive behavioral therapy (CBT)
The intervention is brief-intensive, guided exposure therapy and consists of 16 sessions exposure therapy, spread over 4 half-days in 2 weeks plus 4 follow-up sessions within 3 months.
Interventions
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Cognitive behavioral therapy (CBT)
The intervention is brief-intensive, guided exposure therapy and consists of 16 sessions exposure therapy, spread over 4 half-days in 2 weeks plus 4 follow-up sessions within 3 months.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
Reaching out for mental health care for one of the following disorders:
panic disorder, agoraphobia, generalised anxiety disorder, social anxiety disorder, posttraumatic stress disorder, obsessive-compulsive disorder, health anxiety disorder.
Exclusion Criteria
* Has insufficient language skills in Dutch
* Has evident cognitive limitations
* Has had changes in the use of medication during the last 3 months.
18 Years
ALL
No
Sponsors
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Netherlands Brain Foundation
OTHER
Free University Medical Center
OTHER
Responsible Party
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Dr. Adrie Seldenrijk
Principal investigator
Principal Investigators
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Neeltje Batelaan, PhD
Role: STUDY_DIRECTOR
Amsterdam UMC
Locations
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GGZ inGeest, polikliniek Angst & Dwang, locatie Amstelmere
Amstelveen, , Netherlands
GGZ inGeest, polikliniek Angst & Dwang, locatie De Nieuwe Valerius
Amsterdam, , Netherlands
GGZ inGeest, polikliniek Angst & Dwang, locatie Zuiderpoort
Haarlem, , Netherlands
GGZ Centraal, Algemeen Specialistische Polikliniek
Hilversum, , Netherlands
GGZ inGeest, polikliniek Angst & Dwang, locatie Spaarnepoort
Hoofddorp, , Netherlands
Altrecht Academisch Angstcentrum
Utrecht, , Netherlands
Countries
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Central Contacts
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Facility Contacts
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Eline Eigenhuis, MSc
Role: primary
Anna Muntingh, PhD
Role: primary
Malinda Geitenbeek de Vos - van Steenwijk, MSc
Role: primary
Romy Poll, MSc
Role: primary
Aart de Leeuw, PhD
Role: primary
Other Identifiers
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DR2022-00396
Identifier Type: -
Identifier Source: org_study_id
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