Group vs. Individual Metacognitive Therapy for Generalized Anxiety Disorder
Recruiting · NCT07579897 · Interventional (participants receive a specific treatment) · Lead sponsor: Sorlandet Hospital HF
View the official record on ClinicalTrials.gov →Interventions studied
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.
Who can take part
Inclusion criteria
- Adults with a primary diagnosis of generalized anxiety disorder (GAD). GAD-7 score ≥ 10 at screening/baseline. Participants must endorse that they experience problems with excessive worry
Exclusion criteria
- Bipolar disorder;
- Psychosis;
- Ongoing substance abuse/dependence;
- Intellectual disability based on previous medical history;
- Eating disorder in need of medical attention;
- Unwillingness to refrain from anxiolytic drugs during the treatment;
- Current suicidal ideation with plan and intent;
- Taking an unstable dose of antidepressant, with recent dose-change within the last 4 weeks;
- Known cluster A or B personality disorder;
- Serious medical comorbidity (e.g.: cancer, severe renal failure)
- Language difficulties in need of an interpreter.
Where it is running
2 locations listed.
- Sørlandet Hospital HF - Kristiansand, Norway
- Sørlandet Hospital HF - Kristiansand, Agder, Norway