The Feasibility and Efficacy of a Two-week MCT Treatment of Anxiety Disorders in a Group Setting

NCT05402306 | Unknown DMC

• 1 other identifier: REK269896
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Anxiety Disorders

Keywords

Metacognitive therapy; Attention training technique

Outcome Measures

Primary Outcomes (1)

• Generalized Anxiety Disorder-7 (Change)

  The Generalized Anxiety Disorder-7 (GAD-7, Spitzer et al., 2006) will be used to measure anxiety symptoms. GAD-7 is a seven-item, self-report measure which assess the severity of anxiety symptoms within the last two weeks. The items are scored on a four-point Likert scale (0-3), with the scores ranging from minimum 0 to maximum 21. Higher scores means worse outcome.

  Change from baseline; pre-intervention; after the intervention; 3 months follow up; 6 months follow up.

Secondary Outcomes (7)

• Patient Health Questionnaire-9 (Change)

  Change from baseline; pre-intervention; after the intervention; 3 months follow up; 6 months follow up.

• Social Phobia Inventory (Change)

  Change from baseline; pre-intervention; after the intervention; 3 months follow up; 6 months follow up.

• CAS-1 (Change)

  Change from baseline; pre-intervention; after the intervention; 3 months follow up; 6 months follow up.

• Inventory of Interpersonal Problems (Change)

  Change from baseline; pre-intervention; after the intervention; 3 months follow up; 6 months follow up.

• Metacognition questionnaire 30 (Change)

  Change from baseline; pre-intervention; after the intervention; 3 months follow up; 6 months follow up.

Other Outcomes (3)

• Ecological Momentary Assessment-questions

  4 times per day before, during and after treatment. The collection will go on for a total of six weeks.

• Mini-International Neuropsychiatric Interview

  Evaluation at baseline, two weeks after the intervention and follow up at 6 months.

• ADIS Severity Scale in Anxiety Disorders Interview Schedule IV (Brown, DiNardo & Barlow, 1996)

  Evaluation at baseline, two weeks after the intervention and follow up at 6 months.

Study Arms (2)

Treatment group

EXPERIMENTAL

A two-week intensive group treatment with MCT mainly focusing on attention training. The participants will be allocated into treatment in groups of six. Group sessions will be conducted two times a day for approximately 60 minutes.

Other: Treatment group

Waitlist control group

NO INTERVENTION

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 four-week waiting period.

Interventions

Treatment group OTHER

Group metacognitive therapy, mainly with attention training technique over two weeks.

Treatment group

Eligibility Criteria

• Age: 18 Years - 30 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• University of Oslo: lead
• Modum Bad: collaborator

Study Sites (1)

Modum Bad

Vikersund, Norway

RECRUITING

MeSH Terms

Conditions

Anxiety Disorders

Condition Hierarchy (Ancestors)

Mental Disorders

Study Officials

• Sverre Urnes Johnson, PhD

  University of Oslo & Modum Bad

  PRINCIPAL INVESTIGATOR

• Henrik Nordahl, PhD

  Norwegian University of Science and Technology

  PRINCIPAL INVESTIGATOR

• KariAnne Vrabel, PhD

  Modum bad & University of Oslo

  PRINCIPAL INVESTIGATOR

• Asle Hoffart, PhD

  Modum Bad & University of Oslo

  PRINCIPAL INVESTIGATOR

• Therese R. Snuggerud, Masters

  Modum Bad

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Sverre Urnes Johnson, PhD

CONTACT

+4741633313; s.u.johnson@psykologi.uio.no

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor Sverre Urnes Johnson

Study Record Dates

• First Submitted: February 28, 2022
• First Posted: June 2, 2022
• Study Start: February 28, 2022
• Primary Completion: January 28, 2023
• Study Completion: January 28, 2023
• Last Updated: June 2, 2022

Record last verified: 2022-05

Data Sharing

• IPD Sharing: Will not share

Locations

NO (1)