A Feasibility Study of Group Metacognitive Therapy Versus Mindfulness Meditation Therapy

Study Overview
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Brief Summary
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The study will examine the effectiveness of group metacognitive therapy in comparison with group meditation therapy, in patients with Generalised Anxiety Disorder. Individuals will be randomly assigned to either meditation or metacognitive therapy and undergo 8 group therapy sessions of their respective treatment condition.

Official Title
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Group Metacognitive Therapy Versus Mindfulness Meditation Therapy in a Transdiagnostic Patient Sample: A Feasibility Study

Conditions
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Generalized Anxiety Disorder

Intervention / Treatment
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* Behavioral: Group Metacognitive Therapy
* Behavioral: Mindfulness Meditation Therapy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: individual's score on the GAD-7 & PHQ-9 individuals who meet the DSM-IV (Diagnostic and Statistical Manual) criteria for generalized anxiety disorder Exclusion Criteria: Individuals with major depressive disorder Individuals who report suicidality Individuals with a brain injury or neurological insult Individual who currently engage in substance abuse Individuals with bipolar disorder Individuals with psychotic symptoms Individuals who cannot converse or read English

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Metacognitive Therapy<br>Individuals randomly assigned to the metacognitive therapy group will undergo group metacognitive therapy for generalized anxiety disorder.. Individuals will undergo 8 sessions of group therapy lasting approximately 90 minutes. | Behavioral: Group Metacognitive Therapy<br> <br> * Other names: MCT;|
| Experimental: Mindfulness Meditation Therapy<br>Individuals randomly assigned to the mindfulness meditation therapy group will undergo group mindfulness meditation therapy for generalized anxiety disorder. Individuals will undergo 8 sessions of group therapy lasting approximately 90 minutes. | Behavioral: Mindfulness Meditation Therapy<br> <br> * Other names: MMT;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hospital Anxiety and Depression Scale (HADS) |  | Administered at pre treatment, mid treatment, post treatment, and 6 month follow up | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| CAS-I |  | Administered at pre treatment, mid treatment, post treatment, and 6 month follow up | 
| GAD-7 |  | Completed prior to week 1 of treatment.This will be administered prior to treatment as a screening measure for levels of anxiety. | 
| PHQ-9 |  | Completed prior to week 1 of treatment.This will be administered prior to treatment as a screening measure for levels of depression. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Metacognitive therapy, mindfulness meditation therapy, group therapy, generalized anxiety disorder, Group Based Metacognitive Therapy, Group Based Mindfulness Meditation Therapy