ClinicalTrials.gg
Active, not recruitingNCT05942391KOMMAUpdated May 29, 2026

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

An interventional study of Cognitive behavioral therapy (CBT) in Anxiety Disorders, Obsessive-Compulsive Disorder and Posttraumatic Stress Disorder, sponsored by Amsterdam UMC, location VUmc. Active, not recruiting at 6 sites in Netherlands. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-05-29.

Primary conditionObsessive-Compulsive DisorderRegistry: Anxiety DisordersReclassifiedWhy we changed it
Registry
Anxiety Disorders — the first condition term the registry derived for this study.
ClinicalTrials.gg
Obsessive-Compulsive Disorder
Why
  1. The registry often attaches Anxiety Disorders to studies about something else, and this study's title and listed conditions do not name it.
  2. The study's listed conditions name Obsessive-Compulsive Disorder, a narrower term within Anxiety Disorders.
Confidence
High: the new condition is named in the study's own listed conditions. Of 351 hand-checked studies reclassified this way, 68% were exactly right and 84% in the right disease family; the registry's first term was right for 5% (measured 2026-10-21). How we classify →
Wrong?
Tell us the study's main condition →

Sponsored by Amsterdam UMC, location VUmc · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
120
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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
Read the detailed description

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.

02

Conditions studied

  • 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
03

In context

Obsessive-Compulsive Disorder Reclassified

635 studies on the registry are indexed under Obsessive-Compulsive Disorder; 166 are open to participants now.

This study's planned enrollment of 120 is above the median of 45 across 520 interventional studies indexed under Obsessive-Compulsive Disorder.

Browse Obsessive-Compulsive Disorder studies →

Lead sponsor

Amsterdam UMC, location VUmc is the lead sponsor of 305 studies on the registry; 84 are open to participants now.

Compared within Obsessive-Compulsive Disorder, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Anxiety Disorders. The counts are of registry records indexed under each term, refreshed daily. How we classify →

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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.

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

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.
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
120 participants (estimated)

Study arms

  • Experimental
    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.

    Behavioral: Cognitive behavioral therapy (CBT)

  • Active comparator
    weekly CBT

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

    Behavioral: Cognitive behavioral therapy (CBT)

Interventions

  • BehavioralCognitive 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.

    Also known as: exposure therapy

06

What researchers measure

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.

    Time frame: baseline, 2 weeks, 4 weeks, 2 months, 3 months, 6 months

Secondary outcomes

  1. Area Under the health and disability Curve at 12 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.

    Time frame: baseline, 2 weeks, 4 weeks, 2 months, 3 months, 6 months, 12 months

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

    Severity of anxiety-related disorder, measured with the following disorder-specific severity questionnaires: the 24-item Liebowitz Social Anxiety Scale self-report version, the 7-item Panic Disorder Severity Scale self-report version, the 28-item Mobility Inventory, the 16-item Penn State Worry Questionnaire, the 10-item Yale-Brown Obsessive Compulsive Scale self-report version, the 20-item PTSD checklist for the DSM-5, or the 14-item Whitely Index. Higher scores indicate higher symptom severity. Z-scores will be calculated from individual scores for group-level analyses.

    Time frame: baseline and 3 or 6 months

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

    Severity of anxiety-related disorder, measured with the following disorder-specific severity questionnaires: the 24-item Liebowitz Social Anxiety Scale self-report version, the 7-item Panic Disorder Severity Scale self-report version, the 15-item Fear Questionnaire, the 16-item Penn State Worry Questionnaire, the 10-item Yale-Brown Obsessive Compulsive Scale self-report version, the 20-item PTSD checklist for the DSM-5, or the 14-item Whitely Index. Higher scores indicate higher symptom severity. Z-scores will be calculated from individual scores for group-level analyses.

    Time frame: baseline and 3 months

  4. Change from baseline in severity of anxiety symptoms at 12 months

    Severity of anxiety-related disorder, measured with the following disorder-specific severity questionnaires: the 24-item Liebowitz Social Anxiety Scale self-report version, the 7-item Panic Disorder Severity Scale self-report version, the 28-item Mobility Inventory, the 16-item Penn State Worry Questionnaire, the 10-item Yale-Brown Obsessive Compulsive Scale self-report version, the 20-item PTSD checklist for the DSM-5, or the 14-item Whitely Index. Higher scores indicate higher symptom severity. Z-scores will be calculated from individual scores for group-level analyses.

    Time frame: baseline and 12 months

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

    Severity of depressive symptoms are measured with the 30-item Inventory for Depressive Symptomatology self-report questionnaire. Higher scores indicate higher symptom severity.

    Time frame: baseline and 3 or 6 months

  6. Change from baseline in severity of depressive symptoms at 3 months

    Severity of depressive symptoms are measured with the 30-item Inventory for Depressive Symptomatology self-report questionnaire. Higher scores indicate higher symptom severity.

    Time frame: baseline and 3 months

  7. Change from baseline in severity of depressive symptoms at 12 months

    Severity of depressive symptoms are measured with the 30-item Inventory for Depressive Symptomatology self-report questionnaire. Higher scores indicate higher symptom severity.

    Time frame: baseline and 12 months

  8. Remission rates from anxiety-related disorder at post-treatment

    Remission of diagnoses of anxiety-related disorders is assessed using the Mini International Neuropsychiatric Interview - Simplified for DSM-5, Dutch version 1.1 (Overbeek \& Schruers, 2019).

    Time frame: 3 or 6 months

  9. Remission rates from anxiety-related disorder at 12 months

    Remission of diagnoses of anxiety-related disorders is assessed using the Mini International Neuropsychiatric Interview - Simplified for DSM-5, Dutch version 1.1 (Overbeek \& Schruers, 2019).

    Time frame: 12 months

  10. New-onset anxiety-related or depressive disorder post-treatment

    The new onset of anxiety-related or depressive disorder between baseline and post-treatment is assessed using the Mini International Neuropsychiatric Interview - Simplified for DSM-5, Dutch version 1.1 (Overbeek \& Schruers, 2019)

    Time frame: baseline, 3 or 6 months

  11. New-onset anxiety-related or depressive disorder at 12 months

    The new onset of anxiety-related or depressive disorder between baseline and post-treatment is assessed using the Mini International Neuropsychiatric Interview - Simplified for DSM-5, Dutch version 1.1 (Overbeek \& Schruers, 2019)

    Time frame: 12 months

  12. Productivity costs over 12 months

    Productivity losses are assessed using the iMTA Productivity Cost Questionnaire (iPCQ). The iPCQ is a 12-item self-report questionnaire including three modules measuring productivity losses of paid work due to 1) absenteeism and 2) presenteeism and productivity losses related to 3) unpaid work in the past 3 months.

    Time frame: 3months, 6months, 12 months

  13. Medical costs over 12 months

    Medical costs from a mental health care perspective are assessed using the iMTA Medical Cost Questionnaire (iMCQ). The iMCQ is a 23-item self-report questionnaire, which apart from some general questions include questions on medical consumption from different healthcare providers in the past 3 months.

    Time frame: 3months, 6months, 12 months

  14. Change from baseline in health-related quality of life over 12 months

    Quality of life is measured using the EQ-5D-5L. The EQ-5D-5L scores (reflecting the level of perceived problems on the dimensions of mobility, self-care, usual activities, pain/discomfort and anxiety/depression) are used to calculate utilities using the Dutch tariff. Quality Adjusted Life Years are calculated using linear interpolation between time points. Higher QALY scores indicate more improvement in quality of life.

    Time frame: baseline, 2 weeks, 4 weeks, 2 months, 3 months, 6 months, 12 months

  15. Drop-out rates at post-treatment

    Percentage of patiënts who missed more than 25% of CBT sessions.

    Time frame: 3 or 6 months

  16. Patient satisfaction at post-treatment

    The 8-item Client Satisfaction Questionnaire (CSQ-8) measures overall satisfaction of the patient with health and human services. Each item on the CSQ-8 is scored from 1 (low satisfaction) to 4 (high satisfaction), possible total scores ranging 8-32.

    Time frame: 3 or 6 months

  17. Negative effects of psychotherapy

    The 21-item Inventory for the Assessment of Negative Effects of Psychotherapy (INEP) is a self-report instrument for assessing negative effects of psychotherapy from the patient's perspective. The negative effects cover 7 domains: Intrapersonal Change, Intimate Relationships, Stigmatization, Emotions, Workplace, Family and Friends, and Therapeutic Malpractice. The INEP items are answered using a 4-stage response format (0 = "disagree/not applicable"; 3 = "fully agree").

    Time frame: 3 or 6 months

07

Study locations

6 sites
  • 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
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 29, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05942391
Collaborators
Netherlands Brain Foundation
Responsible party
Adrie Seldenrijk (Principal investigator, Amsterdam UMC, location VUmc) — Principal investigator
First posted
Jul 12, 2023
Start date
Apr 26, 2024
Primary completion
Nov 2026 (estimated)
Completion
May 2027 (estimated)
Last update
May 29, 2026

Study contacts

Neeltje Batelaan, PhD
study director · Amsterdam UMC

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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