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Group vs. Individual Metacognitive Therapy for Generalized Anxiety Disorder

6 de maio de 2026 atualizado por: Sorlandet Hospital HF

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

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.

Visão geral do estudo

Descrição detalhada

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.

Tipo de estudo

Intervencional

Inscrição (Estimado)

64

Estágio

  • Não aplicável

Contactos e Locais

Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.

Contato de estudo

Estude backup de contato

Locais de estudo

Critérios de participação

Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.

Critérios de elegibilidade

Idades elegíveis para estudo

  • Adulto
  • Adulto mais velho

Aceita Voluntários Saudáveis

Não

Descrição

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.

Plano de estudo

Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.

Como o estudo é projetado?

Detalhes do projeto

  • Finalidade Principal: Tratamento
  • Alocação: Randomizado
  • Modelo Intervencional: Atribuição Paralela
  • Mascaramento: Solteiro

Armas e Intervenções

Grupo de Participantes / Braço
Intervenção / Tratamento
Comparador Ativo: Individual Metacognitive Therapy (MCT)
Participants receive individual metacognitive therapy delivered by a trained clinician according to the established MCT protocol for generalized anxiety disorder. Treatment is provided weekly for 10 weeks, each session lasting approximately 45 minutes.
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.
Experimental: Group Metacognitive Therapy (g-MCT)
Participants receive group-based metacognitive therapy delivered by two trained clinicians according to the established group MCT protocol for generalized anxiety disorder. Treatment is delivered in small groups of 4-6 participants meeting weekly for 10 weeks. Each session lasts approximately 90 minutes.
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.

O que o estudo está medindo?

Medidas de resultados primários

Medida de resultado
Descrição da medida
Prazo
Generalized Anxiety Disorder-7 (GAD-7)
Prazo: 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
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.
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

Medidas de resultados secundários

Medida de resultado
Descrição da medida
Prazo
Patient Health Questionnaire-9 (PHQ-9)
Prazo: 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
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.
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)
Prazo: 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.
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.
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)
Prazo: 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
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.
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)
Prazo: 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
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.
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)
Prazo: Post-treatment (one week after the last therapy session)
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.
Post-treatment (one week after the last therapy session)
Working Alliance Inventory - Short, Client Version (WAI-C-S)
Prazo: 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).
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.
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
Prazo: 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.
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.
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)
Prazo: 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
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.
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)
Prazo: 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
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.
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)
Prazo: Pre-treatment (baseline; one week before treatment start), post-treatment (1 week after the last therapy session), 12-month follow-up.
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.
Pre-treatment (baseline; one week before treatment start), post-treatment (1 week after the last therapy session), 12-month follow-up.

Colaboradores e Investigadores

É aqui que você encontrará pessoas e organizações envolvidas com este estudo.

Patrocinador

Investigadores

  • Investigador principal: Gunvor Launes, MD, PhD, Sørlandet Hospital HF

Publicações e links úteis

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Publicações Gerais

Datas de registro do estudo

Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados ​​pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.

Datas Principais do Estudo

Início do estudo (Real)

27 de março de 2026

Conclusão Primária (Estimado)

1 de junho de 2028

Conclusão do estudo (Estimado)

1 de dezembro de 2028

Datas de inscrição no estudo

Enviado pela primeira vez

9 de abril de 2026

Enviado pela primeira vez que atendeu aos critérios de CQ

6 de maio de 2026

Primeira postagem (Real)

12 de maio de 2026

Atualizações de registro de estudo

Última Atualização Postada (Real)

12 de maio de 2026

Última atualização enviada que atendeu aos critérios de controle de qualidade

6 de maio de 2026

Última verificação

1 de março de 2026

Mais Informações

Termos relacionados a este estudo

Plano para dados de participantes individuais (IPD)

Planeja compartilhar dados de participantes individuais (IPD)?

NÃO

Descrição do plano IPD

Our ethical approval from the Regional Committees for Medical and Health Research Ethics (REK) does not allow us to share individual participant data (IPD). In accordance with the conditions set by REK, all data are stored securely and cannot be made available to external researchers. Data sharing is further restricted by Norwegian privacy legislation (GDPR) and institutional data protection requirements.

Informações sobre medicamentos e dispositivos, documentos de estudo

Estuda um medicamento regulamentado pela FDA dos EUA

Não

Estuda um produto de dispositivo regulamentado pela FDA dos EUA

Não

Essas informações foram obtidas diretamente do site clinicaltrials.gov sem nenhuma alteração. Se você tiver alguma solicitação para alterar, remover ou atualizar os detalhes do seu estudo, entre em contato com register@clinicaltrials.gov. Assim que uma alteração for implementada em clinicaltrials.gov, ela também será atualizada automaticamente em nosso site .

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