Clinical trial NCT05942391: Brief-intensive CBT Versus Once-weekly CBT in Anxiety-related Disorders
Official title: Fast Recovery from Anxiety-related Disorders: Brief-intensive CBT Versus Once-weekly CBT
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
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
Lead sponsor: Free University Medical Center
Sponsor class: OTHER
Collaborators: name: Netherlands Brain Foundation
First posted: 2023-07-12
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: a parallel-group randomised controlled intervention study
Primary purpose: TREATMENT

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

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Area Under the health and disability Curve at 6 months
timeFrame: baseline, 2 weeks, 4 weeks, 2 months, 3 months, 6 months
Secondary outcomes:
measure: Area Under the health and disability Curve at 12 months
timeFrame: baseline, 2 weeks, 4 weeks, 2 months, 3 months, 6 months, 12 months
measure: Change from baseline in severity of anxiety symptoms at post-treatment
timeFrame: baseline and 3 or 6 months
measure: Change from baseline in severity of anxiety symptoms at 3 months
timeFrame: baseline and 3 months
measure: Change from baseline in severity of anxiety symptoms at 12 months
timeFrame: baseline and 12 months
measure: Change from baseline in severity of depressive symptoms at post-treatment
timeFrame: baseline and 3 or 6 months
measure: Change from baseline in severity of depressive symptoms at 3 months
timeFrame: baseline and 3 months
measure: Change from baseline in severity of depressive symptoms at 12 months
timeFrame: baseline and 12 months
measure: Remission rates from anxiety-related disorder at post-treatment
timeFrame: 3 or 6 months
measure: Remission rates from anxiety-related disorder at 12 months
timeFrame: 12 months
measure: New-onset anxiety-related or depressive disorder post-treatment
timeFrame: baseline, 3 or 6 months
measure: New-onset anxiety-related or depressive disorder at 12 months
timeFrame: 12 months
measure: Productivity costs over 12 months
timeFrame: 3months, 6months, 12 months
measure: Medical costs over 12 months
timeFrame: 3months, 6months, 12 months
measure: Change from baseline in health-related quality of life over 12 months
timeFrame: baseline, 2 weeks, 4 weeks, 2 months, 3 months, 6 months, 12 months
measure: Drop-out rates at post-treatment
timeFrame: 3 or 6 months
measure: Patient satisfaction at post-treatment
timeFrame: 3 or 6 months
measure: Negative effects of psychotherapy
timeFrame: 3 or 6 months
Other outcomes:
Locations:
city: Amstelveen
country: Netherlands
facility: GGZ inGeest, polikliniek Angst & Dwang, locatie Amstelmere
city: Amsterdam
country: Netherlands
facility: GGZ inGeest, polikliniek Angst & Dwang, locatie De Nieuwe Valerius
city: Haarlem
country: Netherlands
facility: GGZ inGeest, polikliniek Angst & Dwang, locatie Zuiderpoort
city: Hilversum
country: Netherlands
facility: GGZ Centraal, Algemeen Specialistische Polikliniek
city: Hoofddorp
country: Netherlands
facility: GGZ inGeest, polikliniek Angst & Dwang, locatie Spaarnepoort
city: Utrecht
country: Netherlands
facility: Altrecht Academisch Angstcentrum
Study officials:
affiliation: Amsterdam UMC
name: Neeltje Batelaan, PhD
role: STUDY_DIRECTOR
References: