Actively Recruiting
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
Eligibility Criteria
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
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
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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