Group versus individual metacognitive therapy for generalized anxiety disorder

Generalized Anxiety Disorder: A Randomized Non-inferiority Trial Comparing Group Metacognitive Therapy With Individual Metacognitive Therapy

This study will see if group-based metacognitive therapy works as well as individual metacognitive therapy for adults with generalized anxiety disorder who score 10 or higher on the GAD-7.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 64 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Sorlandet Hospital HF (other gov)
• Locations: 2 sites (Kristiansand, Agder and 1 other locations)
• Trial ID: NCT07579897 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Adults with a primary diagnosis of GAD, significant worry (GAD-7 ≥10), and the ability to attend in-person sessions and follow study medication guidance are ideal candidates.

Not a fit: Patients with bipolar disorder, psychosis, active substance dependence, unstable antidepressant dosing, severe medical illnesses, current suicidal intent, cluster A or B personality disorders, intellectual disability, or who need an interpreter are unlikely to be eligible or to benefit from this comparison.

Why it matters

Potential benefit: If group MCT is shown to be similarly effective, more patients could access effective therapy with lower resource use and shorter wait times.

How similar studies have performed: Individual MCT has demonstrated strong effects in multiple trials while group MCT has shown promising but less extensive preliminary results and has not been directly compared head-to-head in routine care.

Eligibility criteria

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 this trial is running

Kristiansand, Agder and 1 other locations

• 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

Conditions: Generalized Anxiety Disorder, GAD, Anxiety, Metacognitive Therapy, MCT, Group Metacognitive Therapy, Individual Metacognitive Therapy, Worry