Clinical trial NCT05402306: The Feasibility and Efficacy of a Two-week MCT Treatment of Anxiety Disorders in a Group Setting
Official title: The Feasibility and Efficacy of a Two-week MCT Treatment of Anxiety Disorders in a Group Setting
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Anxiety Disorders
Keywords: Metacognitive therapy
Attention training technique
Lead sponsor: University of Oslo
Sponsor class: OTHER
Collaborators: name: Modum Bad
First posted: 2022-06-02
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 30
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Long treatment durations may not always be feasible for patients due to pressure to get better quickly, long travel distance to treatment clinics, inflexible working hours, or childcare. To overcome these challenges intensive treatments are currently emerging and several research studies have shown significant and lasting results of diagnosis-specific intensive treatments. A transdiagnostic treatment in a group setting can contribute to a more efficient course of treatment for patients.

Research suggests that Metacognitive Therapy (MCT) is an effective treatment for anxiety disorders. However, MCT has not previously been used on inpatients over a two-week period. To make the treatment tangible for patients and easy to administer for therapists over a short time, attention training technique (ATT) will mainly be used as a changing technique.

The main aim of the study is to explore the feasibility and efficacy of intensive and short-term MCT for anxiety disorders in a group setting.

Detailed description: Design: The study will use randomized control trial with a waitlist control. Cohorts of 12 included patients will be randomly assigned to active treatment or waitlist for two weeks. The waitlist patients will receive the same treatment immediately after the two-week waiting period.

Inclusion criteria: Adults ranging from 18 to 30 years of age meeting diagnostic criteria for generalised anxiety disorder, social phobia, and/or panic disorder with or without agoraphobia will be included in the study. Further the participants must be able to communicate in Norwegian and provide written consent.

Exclusion criteria: Exclusion criteria will be ongoing drug abuse, history of psychotic episodes, current suicidality, or participants not able to adapt to an intensive group format.

Eligibility criteria: Inclusion Criteria:

* Adults between 18 and 30 years
* Meeting diagnostic criteria for generalised anxiety disorder, social phobia, and/or panic disorder with or without agoraphobia
* Provide written consent to partake in the study

Exclusion Criteria:

* Ongoing drug abuse
* History of psychotic episodes
* Current suicidality
* Participants not able to adapt to an intensive group format

Primary outcomes:
measure: Generalized Anxiety Disorder-7 (Change)
timeFrame: Change from baseline; pre-intervention; after the intervention; 3 months follow up; 6 months follow up.
Secondary outcomes:
measure: Patient Health Questionnaire-9 (Change)
timeFrame: Change from baseline; pre-intervention; after the intervention; 3 months follow up; 6 months follow up.
measure: Social Phobia Inventory (Change)
timeFrame: Change from baseline; pre-intervention; after the intervention; 3 months follow up; 6 months follow up.
measure: CAS-1 (Change)
timeFrame: Change from baseline; pre-intervention; after the intervention; 3 months follow up; 6 months follow up.
measure: Inventory of Interpersonal Problems (Change)
timeFrame: Change from baseline; pre-intervention; after the intervention; 3 months follow up; 6 months follow up.
measure: Metacognition questionnaire 30 (Change)
timeFrame: Change from baseline; pre-intervention; after the intervention; 3 months follow up; 6 months follow up.
measure: The Short Warwick-Edinburgh Mental Well-Being scale (Change)
timeFrame: Change from baseline; pre-intervention; after the intervention; 3 months follow up; 6 months follow up.
measure: Work ability score (WAS) (Change)
timeFrame: Change from baseline; pre-intervention; after the intervention; 3 months follow up; 6 months follow up.
Other outcomes:
measure: Ecological Momentary Assessment-questions
timeFrame: 4 times per day before, during and after treatment. The collection will go on for a total of six weeks.
measure: Mini-International Neuropsychiatric Interview
timeFrame: Evaluation at baseline, two weeks after the intervention and follow up at 6 months.
measure: ADIS Severity Scale in Anxiety Disorders Interview Schedule IV (Brown, DiNardo & Barlow, 1996)
timeFrame: Evaluation at baseline, two weeks after the intervention and follow up at 6 months.
Locations:
city: Vikersund
country: Norway
facility: Modum Bad
Study officials:
affiliation: University of Oslo & Modum Bad
name: Sverre Urnes Johnson, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Norwegian University of Science and Technology
name: Henrik Nordahl, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Modum bad & University of Oslo
name: KariAnne Vrabel, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Modum Bad & University of Oslo
name: Asle Hoffart, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Modum Bad
name: Therese R. Snuggerud, Masters
role: PRINCIPAL_INVESTIGATOR
References: