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Completed

NCT Number: NCT02096484

A Feasibility Study of Group Metacognitive Therapy Versus Mindfulness Meditation Therapy

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.

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Key information

Conditions

Generalized Anxiety Disorder Anxiety Disorders Mental Disorders

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

The Rawnsley Building, Manchester Royal Infirmary, Oxford Road

Manchester, Lancashire, M23 9LT, United Kingdom

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Group Metacognitive Therapy

Behavioral

Other names: MCT

Mindfulness Meditation Therapy

Behavioral

Other names: MMT

Primary outcomes

  1. Hospital Anxiety and Depression Scale (HADS)

    Time frame: Administered at pre treatment, mid treatment, post treatment, and 6 month follow up

Secondary outcomes

  1. CAS-I

    Time frame: Administered at pre treatment, mid treatment, post treatment, and 6 month follow up

  2. 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.

  3. 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.

Sponsors and collaborators

Lead sponsor

University of Manchester

Other

Registry information

Official study title

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

Acronym: MCT

Important dates

Study start
2014
Primary completion
2015
Study completion
2016
First posted
Mar 26, 2014
Registry last updated
Oct 17, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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