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NCT02096484 Clinical Trial

A Feasibility Study of Group Metacognitive Therapy Versus Mindfulness Meditation Therapy

Generalized Anxiety Disorder Clinical Trial

— MCT  

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT02096484
Other study ID # UM145073
Secondary ID
Status Completed
Phase N/A
First received March 19, 2014
Last updated October 14, 2016
Start date August 2014
Est. completion date June 2016

Study information
Verified date October 2016
Source University of Manchester
Contact n/a
Is FDA regulated No
Health authority United Kingdom: University of Manchester Research Ethics CommitteeUnited Kingdom: Manchester Mental Health and Social Care Trust
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 40
Est. completion date June 2016
Est. primary completion date December 2015
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 65 Years
Eligibility 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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Behavioral:
• Group Metacognitive Therapy

• Mindfulness Meditation Therapy

Locations
Country Name City State
United Kingdom The Rawnsley Building, Manchester Royal Infirmary, Oxford Road Manchester Lancashire

Sponsors (1)
Lead Sponsor Collaborator
University of Manchester

Country where clinical trial is conducted

United Kingdom, 

Outcome
Type Measure Description Time frame Safety issue
Primary Hospital Anxiety and Depression Scale (HADS) Administered at pre treatment, mid treatment, post treatment, and 6 month follow up No
Secondary CAS-I Administered at pre treatment, mid treatment, post treatment, and 6 month follow up No
Secondary GAD-7 Completed prior to week 1 of treatment.This will be administered prior to treatment as a screening measure for levels of anxiety. No
Secondary PHQ-9 Completed prior to week 1 of treatment.This will be administered prior to treatment as a screening measure for levels of depression. No
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