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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
64
Individual metacognitive therapy (MCT) is delivered by a trained clinician following the established protocol for generalized anxiety disorder. The treatment focuses on modifying maladaptive metacognitive beliefs, reducing the cognitive-attentional syndrome (CAS), and promoting flexible attentional control. Participants receive 10 weekly individual sessions, each lasting approximately 45 minutes. The intervention targets excessive worry, unhelpful coping strategies, and beliefs about the uncontrollability and danger of worry.
Group Metacognitive Therapy (g-MCT) is delivered by two trained clinicians following the established group MCT protocol for generalized anxiety disorder. Treatment is provided in small groups of 4-6 participants and focuses on modifying maladaptive metacognitive beliefs, reducing the cognitive-attentional syndrome (CAS), and improving attentional flexibility. Participants attend 10 weekly sessions, each lasting approximately 90 minutes.
Sørlandet Hospital HF
Kristiansand, Agder, Norway
RECRUITINGSørlandet Hospital HF
Kristiansand, Norway
RECRUITINGGeneralized Anxiety Disorder-7 (GAD-7)
The Generalized Anxiety Disorder-7 (GAD-7) is a validated 7-item self-report measure assessing the severity of generalized anxiety symptoms over the past two weeks. Total scores range from 0 to 21, with higher scores indicating greater symptom severity. The primary outcome is change in GAD-7 score from pre-treatment (baseline, one week before treatment start) to post-treatment (one week after the last therapy session) and 3- month and 12- month follow up. The measure is widely used in clinical research and has demonstrated strong reliability, sensitivity to change, and clinical validity in GAD populations.
Time frame: 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
Patient Health Questionnaire-9 (PHQ-9)
The Patient Health Questionnaire-9 (PHQ-9) is a 9-item validated self-report measure of depressive symptom severity over the past two weeks. Scores range from 0-27, with higher scores indicating more severe depressive symptoms.
Time frame: 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 sessio), 3-month follow-up, 12-month follow-up
Generalized Anxiety Disorder Scale-Revised (GADS-R)
The Generalized Anxiety Disorder Scale-Revised (GADS-R) is a self report questionaire assessing cognitive and behavioral symptoms of generalized anxiety disorder. The scale measures worry severety and maladaptive coping strategies on a 9-point Likert scale (0-8), while metacognitive beliefs about worry are rated on a 0-100 scale. Higher scores indicate greater symptom severity. Secondary outcomes include change in GADS-R score from pre-treatment (baseline) to post-treatment, as well as repeated GADS-R assessments administered during treatment (prior to each therapy session) and at 3-month and 12-month follow-up, to monitor clinical change over time.
Time frame: Pre-treatment (baseline; one week before treatment start) , one day before each therapy session session, post-treatment (one week after last therapy session), 3-month follow-up, 12-month follow-up.
Work and Social Adjustment Scale (WSAS)
The Work and Social Adjustment Scale (WSAS) is a 5-item self-report questionnaire assessing functional impairment in work, home management, social leisure, private leisure, and close relationships. Scores range from 0-40, with higher scores indicating greater impairment. Secondary outcomes include change in WSAS score from pre-treatment (baseline) to post-treatment (one week after the last therapy session), as well as WSAS scores at 3-month and 12-month follow-up.
Time frame: Pre-treatment (baseline; one week before treatment start) post-treatment (one week after the last therapy session), 3-month follow-up, and 12-month follow-up
Metacognitions Questionnaire- 30 (MCQ-30)
The Metacognitions Questionnaire- 30 (MCQ-30) is a 30-item self-report measure assessing maladaptive metacognitive beliefs across five domains.Total scores range from 30 to 120, with higher scores indicating stronger dysfunctional metacognitive beliefs.
Time frame: Pre-treatment (baseline; one week before treatment start), post-treatment (one week after the last therapy session), 3-month follow-up, and 12-month follow-up
Client Satisfaction Questionnaire (CSQ-8)
The Client Satisfaction Questionnaire (CSQ-8) is an 8-item self-report measure assessing satisfaction with treatment. Total scores range from 8 to 32, with higher scores indicating greater satisfaction.
Time frame: Post-treatment (one week after the last therapy session)
Working Alliance Inventory - Short, Client Version (WAI-C-S)
The Working Alliance Inventory - Short, Client Version (WAI-C-S) is a 12-item validated measure assessing the therapeutic alliance across goals, tasks, and bond. Total scores range from 12 to 84, with higher scores indicating a stronger therapeutic alliance.
Time frame: Mid-treatment A (the day after therapy session 4), mid-treatment B (the day after therapy session 7), and post-treatment (one week after the last therapy session).
EQ-5D-5L
The EQ-5D-5L is a standardized self-report measure assessing health-related quality of life across five domains and includes a visual analogue scale (VAS). Higher scores indicate better perceived health.
Time frame: Pre-treatment (baseline; one week before treatment start), post-treatment (one week after the last therapy session), 3-month follow-up, and 12-month follow-up.
Social Phobia Inventory (SPIN)
The Social Phobia Inventory (SPIN) is a 17-item measure evaluating fear, avoidance, and physiological symptoms of social anxiety. Scores range from 0-68, with higher scores indicating greater social anxiety.
Time frame: Pre-treatment (baseline; one week before treatment start), post-treatment (one week after the last therapy session), 3-month follow-up, and 12-month follow-up
Work Ability Score (WAS)
The Work Ability Score (WAS) is a single-item measure rating current work ability compared to lifetime best on a scale of 0-10. Higher scores reflect better work ability.
Time frame: Pre-treatment (baseline; one week before treatment start), post-treatment (one week after the last therapy session), 3-month follow-up, and 12-month follow-up
Clinical Severity Rating (CSR)
The Clinical Severity Rating (CSR) is a clinician-rated measure of overall diagnostic severity on a 0-8 scale, where higher scores indicate greater symptom severity and functional impairment. An external, independent clinician (physician or psychologist not involved in treatment or study procedures) conducts a brief structured assessment with each participant. The CSR evaluates both the primary diagnosis of generalized anxiety disorder (GAD) and any comorbid conditions, providing a standardized, observer-based measure of clinical severity and change over time.
Time frame: Pre-treatment (baseline; one week before treatment start), post-treatment (1 week after the last therapy session), 12-month follow-up.
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