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RECRUITING
NCT07579897
NA

Group vs. Individual Metacognitive Therapy for Generalized Anxiety Disorder

Sponsor: Sorlandet Hospital HF

View on ClinicalTrials.gov

Summary

Generalized anxiety disorder (GAD) is a serious and long-lasting condition that can greatly reduce quality of life, work functioning, and use of health services. Metacognitive therapy (MCT) is an effective treatment for GAD, but it is not yet known whether individual MCT or group-based MCT provides the best results for patients. This randomized controlled trial will compare two formats of MCT: individual treatment and group-based treatment (g-MCT). A total of 64 adults with GAD (32 in each treatment arm) will participate after providing informed consent. Participants will complete questionnaires, undergo clinical assessments, and allow the study to collect relevant health information from official registries. The main aim of the study is to determine whether group-based MCT is non-inferior to individual MCT. A non-inferiority design tests whether the group format is not meaningfully less effective than the individual format. If group MCT is shown to have similar effects on anxiety symptoms and functioning, it could offer an efficient and resource-saving alternative in routine clinical care. This will be the first study to systematically compare these two treatment formats in a real-world clinical setting. If group MCT proves to be as effective as individual therapy, it may help increase access to evidence-based treatment for people with GAD, reduce strain on mental health services, and support the development of more accessible and cost-effective care.

Official title: Generalized Anxiety Disorder: A Randomized Non-inferiority Trial Comparing Group Metacognitive Therapy With Individual Metacognitive Therapy

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

64

Start Date

2026-03-27

Completion Date

2028-12

Last Updated

2026-05-12

Healthy Volunteers

No

Interventions

BEHAVIORAL

Individual Metacognitive Therapy

Individual metacognitive therapy (MCT) is delivered by a trained clinician following the established protocol for generalized anxiety disorder. The treatment focuses on modifying maladaptive metacognitive beliefs, reducing the cognitive-attentional syndrome (CAS), and promoting flexible attentional control. Participants receive 10 weekly individual sessions, each lasting approximately 45 minutes. The intervention targets excessive worry, unhelpful coping strategies, and beliefs about the uncontrollability and danger of worry.

BEHAVIORAL

Group Metacognitive Therapy

Group Metacognitive Therapy (g-MCT) is delivered by two trained clinicians following the established group MCT protocol for generalized anxiety disorder. Treatment is provided in small groups of 4-6 participants and focuses on modifying maladaptive metacognitive beliefs, reducing the cognitive-attentional syndrome (CAS), and improving attentional flexibility. Participants attend 10 weekly sessions, each lasting approximately 90 minutes.

Locations (2)

Sørlandet Hospital HF

Kristiansand, Agder, Norway

Sørlandet Hospital HF

Kristiansand, Norway