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CompletedNCT02096484MCTUpdated Oct 17, 2016

A Feasibility Study of Group Metacognitive Therapy Versus Mindfulness Meditation Therapy

An interventional study of Group Metacognitive Therapy and Mindfulness Meditation Therapy in Generalized Anxiety Disorder, sponsored by University of Manchester. Completed at 1 site in United Kingdom. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2016-10-17.

Sponsored by University of Manchester · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
40
Allocation
Randomized
Ages
18 Years to 65 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Generalized Anxiety Disorder

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Keywords

  • Metacognitive therapy
  • mindfulness meditation therapy
  • group therapy
  • generalized anxiety disorder
  • Group Based Metacognitive Therapy
  • Group Based Mindfulness Meditation Therapy
03

In context

Anxiety Disorders

4,868 studies on the registry are indexed under Anxiety Disorders; 1,390 are open to participants now.

This study's enrollment of 40 is below the median of 80 across 4,174 interventional studies indexed under Anxiety Disorders.

Browse Anxiety Disorders studies →

Lead sponsor

University of Manchester is the lead sponsor of 194 studies on the registry; 43 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Participant)
Enrollment
40 participants (actual)

Study arms

  • Experimental
    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.

    Behavioral: Group Metacognitive Therapy

  • Experimental
    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.

    Behavioral: Mindfulness Meditation Therapy

Interventions

  • BehavioralGroup Metacognitive Therapy

    Also known as: MCT

  • BehavioralMindfulness Meditation Therapy

    Also known as: MMT

06

What researchers measure

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.

07

Study locations

1 site
  • The Rawnsley Building, Manchester Royal Infirmary, Oxford Road
    Manchester, Lancashire M23 9LT, United Kingdom
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 17, 2016, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT02096484
Lead sponsor
University of Manchester
Responsible party
Adrian Wells (Professor of Clinical & Experimental Psychopathology, University of Manchester) — Principal investigator
First posted
Mar 26, 2014
Start date
Aug 2014
Primary completion
Dec 2015
Completion
Jun 2016
Last update
Oct 17, 2016

Study contacts

Lora Capobianco
principal investigator · University of Manchester
James Thompson
principal investigator · University of Manchester

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Oct 2016. You cannot join it, but the record below documents what was studied.

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