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Group vs. Individual Metacognitive Therapy for Generalized Anxiety Disorder

RecruitingNAAges 18 Years - anyAllSorlandet Hospital HF
NCT07579897 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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 le

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📋 Eligibility rules (as published)
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: 1. Bipolar disorder; 2. Psychosis; 3. Ongoing substance abuse/dependence; 4. Intellectual disability based on previous medical history; 5. Eating disorder in need of medical attention; 6. Unwillingness to refrain from anxiolytic drugs during the treatment; 7. Current suicidal ideation with plan and intent; 8. Taking an unstable dose of antidepressant, with recent dose-change within the last 4 weeks; 9. Known cluster A or B personality disorder; 10. Serious medical comorbidity (e.g.: cancer, severe renal failure) 11. Language difficulties in need of an interpreter.
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What it tests

  • Individual Metacognitive Therapy
  • Group Metacognitive Therapy
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Where

2 sites
Sørlandet Hospital HF
Kristiansand, Norway
Sørlandet Hospital HF
Kristiansand, Norway
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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