Brief-intensive CBT Versus Once-weekly CBT in Anxiety-related Disorders

NCT ID: NCT05942391

Last Updated: 2025-03-24

Study Results

Results pending

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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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-04-26

Study Completion Date

2026-09-30

Brief Summary

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The goal of this clinical trial is to compare brief-intensive cognitive-behaviour therapy (CBT) with regular weekly CBT in people with anxiety-related disorders.

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

Detailed Description

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Rationale: Anxiety-related disorders (i.e., obsessive compulsive, health anxiety and trauma disorders) affect about 10% of the adults. Though clinically heterogeneous, transdiagnostic aspects are expected disasters, anxiety and avoidance. Profound impairments include work and family functioning. Many enter a vicious circle with comorbidity and further decline in quality of life. Hence, the impact on functioning is tremendous, with anxiety-related disorders rating highest on disability rankings in the age 15-64 years. Cognitive behavioral therapy (CBT) is the preferred and often only psychotherapy for these disorders. Because guidelines are based on weekly sessions, recovery takes half a year at least. Based on initial research findings, we expect faster recovery by providing CBT in a brief-intensive format (BI-CBT), with clear benefts for patients, families and society. Some institutions already provide BI-CBT. However, evidence to justify this or to further implement BI-CBT is insufficient.

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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Anxiety Disorders Obsessive-Compulsive Disorder Posttraumatic Stress Disorder Hypochondriasis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

a parallel-group randomised controlled intervention study
Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

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.

Group Type EXPERIMENTAL

Cognitive behavioral therapy (CBT)

Intervention Type BEHAVIORAL

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.

Group Type ACTIVE_COMPARATOR

Cognitive behavioral therapy (CBT)

Intervention Type BEHAVIORAL

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.

Intervention Type BEHAVIORAL

Other Intervention Names

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exposure therapy

Eligibility Criteria

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Inclusion Criteria

Age 18 years or older;

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

* Is in need of emergency mental health care
* Has insufficient language skills in Dutch
* Has evident cognitive limitations
* Has had changes in the use of medication during the last 3 months.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Netherlands Brain Foundation

OTHER

Sponsor Role collaborator

Free University Medical Center

OTHER

Sponsor Role lead

Responsible Party

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Dr. Adrie Seldenrijk

Principal investigator

Responsibility Role 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

Site Status RECRUITING

GGZ inGeest, polikliniek Angst & Dwang, locatie De Nieuwe Valerius

Amsterdam, , Netherlands

Site Status RECRUITING

GGZ inGeest, polikliniek Angst & Dwang, locatie Zuiderpoort

Haarlem, , Netherlands

Site Status RECRUITING

GGZ Centraal, Algemeen Specialistische Polikliniek

Hilversum, , Netherlands

Site Status RECRUITING

GGZ inGeest, polikliniek Angst & Dwang, locatie Spaarnepoort

Hoofddorp, , Netherlands

Site Status RECRUITING

Altrecht Academisch Angstcentrum

Utrecht, , Netherlands

Site Status RECRUITING

Countries

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Netherlands

Central Contacts

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Lisa de Koning, MSc

Role: CONTACT

+31 207884666

Adrie Seldenrijk, PhD

Role: CONTACT

+31 207884666

Facility Contacts

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Eline Eigenhuis, MSc

Role: primary

Willemijn Scholten, PhD

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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