Group versus individual metacognitive therapy for generalized anxiety disorder

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This randomized controlled non-inferiority trial will compare individual MCT with group-based MCT in 64 adults diagnosed with GAD. Participants will be randomized 1:1, complete standardized questionnaires and clinical assessments, and permit linkage to health registries for relevant outcome data. The primary aim is to determine whether group MCT is not meaningfully less effective than individual MCT for reducing anxiety and pathological worry. Key eligibility criteria include a primary GAD diagnosis, GAD-7 ≥10, and exclusion of bipolar disorder, psychosis, active substance dependence, unstable antidepressant dosing, severe medical comorbidity, or language barriers.

Why it matters

Who can join: the full rules

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.

Where it's running

• Sørlandet Hospital HF
  Kristiansand, Agder, Norway Recruiting
• Sørlandet Hospital HF
  Kristiansand, Norway Recruiting

Study contacts

• Principal investigator: Gunvor Launes, MD, PhD — Sørlandet Hospital HF
• Study coordinator: Gunvor Launes, MD Phd
• Email: Gunvor.Launes@sshf.no
• Phone: +4747661428

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.