Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
NCT07579897

Group vs. Individual Metacognitive Therapy for Generalized Anxiety Disorder

Led by Sorlandet Hospital HF · Updated on 2026-05-12

64

Participants Needed

2

Research Sites

140 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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

Official Title

Group vs. Individual Metacognitive Therapy for Generalized Anxiety Disorder

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Adults with a primary diagnosis of generalized anxiety disorder (GAD)
  • GAD-7 score  10 at screening or baseline
  • Participants must report experiencing problems with excessive worry
Not Eligible

You will not qualify if you...

  • Bipolar disorder
  • Psychosis
  • Ongoing substance abuse or dependence
  • Intellectual disability based on previous medical history
  • Eating disorder requiring medical attention
  • Unwillingness to refrain from anxiolytic drugs during treatment
  • Current suicidal thoughts with plan and intent
  • Taking an unstable dose of antidepressants or recent dose change within 4 weeks
  • Known cluster A or B personality disorder
  • Serious medical conditions such as cancer or severe renal failure
  • Language difficulties requiring an interpreter

AI-Screening

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Trial Site Locations

Total: 2 locations

1

Sørlandet Hospital HF

Kristiansand, Agder, Norway

Actively Recruiting

2

Sørlandet Hospital HF

Kristiansand, Norway

Actively Recruiting

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Research Team

G

Gunvor Launes, MD Phd

CONTACT

A

Anna Sorte Grindvik, MD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

SINGLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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