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

NCT05942391 | Recruiting

• 1 other identifier: DR2022-00396
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 6

Brief Summary

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

Conditions

Anxiety Disorders; Obsessive-Compulsive Disorder; Posttraumatic Stress Disorder; Hypochondriasis

Keywords

agoraphobia; social anxiety disorder; generalized anxiety disorder; panic disorder; trauma; health anxiety; obsessive compulsive disorder; CBT

Outcome Measures

Primary Outcomes (1)

• Area Under the health and disability Curve at 6 months

  The 'area under the curve' for health and disability is based on the 36-item self-report World Health Organisation Disability Assessment Schedule (WHODAS 2.0). The WHODAS 2.0 captures the level of functioning in six domains of life: Cognition, Mobility, Self-care, Getting along, Life activities, Participation. Possible total scores of the items across all domains range 0 - 100. Lower scores indicate less disability.

  baseline, 2 weeks, 4 weeks, 2 months, 3 months, 6 months

Secondary Outcomes (17)

• Area Under the health and disability Curve at 12 months

  baseline, 2 weeks, 4 weeks, 2 months, 3 months, 6 months, 12 months

• Change from baseline in severity of anxiety symptoms at post-treatment

  baseline and 3 or 6 months

• Change from baseline in severity of anxiety symptoms at 3 months

  baseline and 3 months

• Change from baseline in severity of anxiety symptoms at 12 months

  baseline and 12 months

• Change from baseline in severity of depressive symptoms at post-treatment

  baseline and 3 or 6 months

Study Arms (2)

Brief-Intensive CBT

EXPERIMENTAL

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.

Behavioral: Cognitive behavioral therapy (CBT)

weekly CBT

ACTIVE COMPARATOR

20 weekly CBT sessions within 5 to 6 months. The CBT consists of exposure therapy.

Behavioral: Cognitive behavioral therapy (CBT)

Interventions

Cognitive behavioral therapy (CBT) 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.

Also known as: exposure therapy

Brief-Intensive CBT; weekly CBT

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Free University Medical Center: lead
• Netherlands Brain Foundation: collaborator

Study Sites (6)

GGZ inGeest, polikliniek Angst & Dwang, locatie Amstelmere

Amstelveen, Netherlands

RECRUITING

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

Amsterdam, Netherlands

RECRUITING

GGZ inGeest, polikliniek Angst & Dwang, locatie Zuiderpoort

Haarlem, Netherlands

RECRUITING

GGZ Centraal, Algemeen Specialistische Polikliniek

Hilversum, Netherlands

RECRUITING

GGZ inGeest, polikliniek Angst & Dwang, locatie Spaarnepoort

Hoofddorp, Netherlands

RECRUITING

Altrecht Academisch Angstcentrum

Utrecht, Netherlands

RECRUITING

MeSH Terms

Conditions

Anxiety Disorders; Obsessive-Compulsive Disorder; Stress Disorders, Post-Traumatic; Hypochondriasis; Agoraphobia; Phobia, Social; Generalized Anxiety Disorder; Panic Disorder; Wounds and Injuries

Interventions

Cognitive Behavioral Therapy; Implosive Therapy

Condition Hierarchy (Ancestors)

Mental Disorders; Stress Disorders, Traumatic; Trauma and Stressor Related Disorders; Somatoform Disorders; Phobic Disorders

Intervention Hierarchy (Ancestors)

Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities; Desensitization, Psychologic

Study Officials

• Neeltje Batelaan, PhD

  Amsterdam UMC

  STUDY DIRECTOR

Central Study Contacts

Lisa de Koning, MSc

CONTACT

+31 207884666; l.dekoning1@amsterdamumc.nl

Adrie Seldenrijk, PhD

CONTACT

+31 207884666; a.seldenrijk@ggzingeest.nl

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Model Details: a parallel-group randomised controlled intervention study

Study Record Dates

• First Submitted: June 16, 2023
• First Posted: July 12, 2023
• Study Start: April 26, 2024
• Primary Completion: March 31, 2026
• Study Completion (Estimated): September 30, 2026
• Last Updated: March 24, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

NL (6)