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A Feasibility Study of Group Metacognitive Therapy Versus Mindfulness Meditation Therapy (MCT)

Primary Purpose

Generalized Anxiety Disorder

Status
Completed
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
Group Metacognitive Therapy
Mindfulness Meditation Therapy
Sponsored by
University of Manchester
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Generalized Anxiety Disorder focused on measuring Metacognitive therapy, mindfulness meditation therapy, group therapy, generalized anxiety disorder, Group Based Metacognitive Therapy, Group Based Mindfulness Meditation Therapy

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • The Rawnsley Building, Manchester Royal Infirmary, Oxford Road

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Metacognitive Therapy

Mindfulness Meditation Therapy

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Hospital Anxiety and Depression Scale (HADS)

Secondary Outcome Measures

CAS-I
GAD-7
PHQ-9

Full Information

First Posted
March 19, 2014
Last Updated
October 14, 2016
Sponsor
University of Manchester
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1. Study Identification

Unique Protocol Identification Number
NCT02096484
Brief Title
A Feasibility Study of Group Metacognitive Therapy Versus Mindfulness Meditation Therapy
Acronym
MCT
Official Title
Group Metacognitive Therapy Versus Mindfulness Meditation Therapy in a Transdiagnostic Patient Sample: A Feasibility Study
Study Type
Interventional

2. Study Status

Record Verification Date
October 2016
Overall Recruitment Status
Completed
Study Start Date
August 2014 (undefined)
Primary Completion Date
December 2015 (Actual)
Study Completion Date
June 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Manchester

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Generalized Anxiety Disorder
Keywords
Metacognitive therapy, mindfulness meditation therapy, group therapy, generalized anxiety disorder, Group Based Metacognitive Therapy, Group Based Mindfulness Meditation Therapy

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
40 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Metacognitive Therapy
Arm Type
Experimental
Arm Description
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.
Arm Title
Mindfulness Meditation Therapy
Arm Type
Experimental
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Group Metacognitive Therapy
Other Intervention Name(s)
MCT
Intervention Type
Behavioral
Intervention Name(s)
Mindfulness Meditation Therapy
Other Intervention Name(s)
MMT
Primary Outcome Measure Information:
Title
Hospital Anxiety and Depression Scale (HADS)
Time Frame
Administered at pre treatment, mid treatment, post treatment, and 6 month follow up
Secondary Outcome Measure Information:
Title
CAS-I
Time Frame
Administered at pre treatment, mid treatment, post treatment, and 6 month follow up
Title
GAD-7
Time Frame
Completed prior to week 1 of treatment.This will be administered prior to treatment as a screening measure for levels of anxiety.
Title
PHQ-9
Time Frame
Completed prior to week 1 of treatment.This will be administered prior to treatment as a screening measure for levels of depression.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lora Capobianco
Organizational Affiliation
University of Manchester
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
James Thompson
Organizational Affiliation
University of Manchester
Official's Role
Principal Investigator
Facility Information:
Facility Name
The Rawnsley Building, Manchester Royal Infirmary, Oxford Road
City
Manchester
State/Province
Lancashire
ZIP/Postal Code
M23 9LT
Country
United Kingdom

12. IPD Sharing Statement

Learn more about this trial

A Feasibility Study of Group Metacognitive Therapy Versus Mindfulness Meditation Therapy

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