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Group vs. Individual Metacognitive Therapy for Generalized Anxiety Disorder

NCT07579897 · Sorlandet Hospital HF
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Official title
Generalized Anxiety Disorder: A Randomized Non-inferiority Trial Comparing Group Metacognitive Therapy With Individual Metacognitive Therapy
About this study
Generalized anxiety disorder (GAD) is a chronic and disabling condition characterized by persistent and uncontrollable worry. Individuals with GAD frequently experience reduced quality of life, impaired daily functioning, and elevated use of health care services. Although effective psychological treatments exist, including metacognitive therapy (MCT), it remains unclear which treatment delivery format provides the best balance of clinical effectiveness and efficient use of resources. MCT is an evidence-based treatment targeting the metacognitive processes that maintain excessive worry, including beliefs about the usefulness and uncontrollability of worrying and the cognitive-attentional syndrome (CAS), a pattern of worry, rumination, threat monitoring, and unhelpful coping behaviors. Individual MCT has demonstrated strong and consistent effects across several clinical trials, while group-based MCT (g-MCT) has shown promising preliminary results. However, the two formats have never been directly compared in a randomized trial conducted in routine clinical care. This represents a meaningful gap in the research literature and limits the ability of services to make informed decisions about how to organize treatment. This study addresses this gap by conducting a randomized controlled trial (RCT) comparing individual MCT with group-based MCT for adults with GAD. An RCT design is chosen because it provides the highest level of evidence for causal inference about treatment effects. A non-inferiority framework is used to test whether group MCT is not meaningfully less effective than individual MCT. This design is appropriate when an alternative treatment may offer practical advantages-such as lower cost, greater accessibility, or more efficient resource use-while aiming to demonstrate that clinical outcomes remain comparable. A total of 64 adults with a primary diagnosis of GAD will be enrolled and randomized to either individual MCT or group MCT. Both interventions follow established MCT protocols and are delivered by trained clinicians. Treatment focuses on reducing worry, modifying maladaptive metacognitive beliefs, and promoting flexible attentional control. Data collection includes validated self-report questionnaires, structured clinical assessments, and-with participant consent-information obtained from official national registers to assess work participation and sick leave pre and post treatment. Evaluating group-based MCT is particularly important in the context of mental health services, where demand often exceeds available treatment resources. If group MCT is found to be non-inferior to individual MCT, it could make it possible to offer effective therapy to more patients within the same amount of therapist time. This has the potential to reduce waiting times, improve access to evidence-based treatment, and support more sustainable use of clinical resources. The findings from this trial will contribute to the evidence base for MCT, clarify which treatment format is most appropriate for adults with GAD, and inform clinical guidelines and service organization. As the first randomized study to directly compare individual and group MCT in a real-world clinical setting, the results may have meaningful implications for both clinical practice and mental health policy.
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.
Study design
Enrollment target: 64 participants
Allocation: randomized
Masking: single
Age groups: adult, older_adult
Timeline
Starts: 2026-03-27
Estimated completion: 2028-12
Last updated: 2026-05-12
Interventions
Behavioral: Individual Metacognitive TherapyBehavioral: Group Metacognitive Therapy
Primary outcomes
  • Generalized Anxiety Disorder-7 (GAD-7) (Pre-treatment (baseline; one week before treatment start) mid-treatment A (the day after therapy session 4), mid-treatment B (The day after therapy session 7), post-treatment (one week after the last therapy session), 3-month follow-up, 12-month follow-u)
Sponsor
Sorlandet Hospital HF · other_gov
Contacts & investigators
ContactGunvor Launes, MD Phd · contact · Gunvor.Launes@sshf.no · +4747661428
ContactAnna Sorte Grindvik, MD · contact · Anna.Sorte.Grindvik@sshf.no · +4797771807
InvestigatorGunvor Launes, MD, PhD · principal_investigator, Sørlandet Hospital HF
All locations (2)
Sørlandet Hospital HFRecruiting
Kristiansand, Agder, Norway
Sørlandet Hospital HFRecruiting
Kristiansand, Norway