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Group vs. Individual Metacognitive Therapy for Generalized Anxiety Disorder

NCT07579897 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 64

Last updated 2026-05-12

No results posted yet for this study

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.

Conditions

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.

Sponsors & Collaborators

  • Sorlandet Hospital HF

    lead OTHER_GOV

Principal Investigators

  • Gunvor Launes, MD, PhD · Sørlandet Hospital HF

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-03-27
Primary Completion
2028-06-30
Completion
2028-12-31

Countries

  • Norway

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07579897 on ClinicalTrials.gov