A Feasibility Study of Group Metacognitive Therapy Versus Mindfulness Meditation Therapy

Not Applicable

Completed

• Conditions: Generalized Anxiety Disorder
• Interventions: Behavioral: Mindfulness Meditation Therapy; Behavioral: Group Metacognitive Therapy

• Registration Number: NCT02096484
• Lead Sponsor: University of Manchester

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2014-03-19
• Study First Submitted QC: 2014-03-21
• Study First Posted: 2014-03-26
• Study Start: 2014-08
• Primary Completion: 2015-12
• Study Completion: 2016-06
• Status Verified: 2016-10
• Last Update Submitted: 2016-10-14
• Last Update Posted: 2016-10-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Mindfulness Meditation Therapy	Mindfulness Meditation Therapy	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.
Metacognitive Therapy	Group Metacognitive Therapy	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.

Primary Outcome Measures

Name	Time	Method
Hospital Anxiety and Depression Scale (HADS)	Administered at pre treatment, mid treatment, post treatment, and 6 month follow up

Secondary Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

The Rawnsley Building, Manchester Royal Infirmary, Oxford Road; 🇬🇧 Manchester, Lancashire, United Kingdom