NCT02096484

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Aug 2014

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 19, 2014

Completed
7 days until next milestone

First Posted

Study publicly available on registry

March 26, 2014

Completed
4 months until next milestone

Study Start

First participant enrolled

August 1, 2014

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2015

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2016

Completed
Last Updated

October 17, 2016

Status Verified

October 1, 2016

Enrollment Period

1.3 years

First QC Date

March 19, 2014

Last Update Submit

October 14, 2016

Conditions

Generalized Anxiety Disorder

Keywords

Metacognitive therapymindfulness meditation therapygroup therapygeneralized anxiety disorderGroup Based Metacognitive TherapyGroup Based Mindfulness Meditation Therapy

Outcome Measures

Primary Outcomes (1)

  • Hospital Anxiety and Depression Scale (HADS)

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

Secondary Outcomes (3)

  • 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.

Study Arms (2)

Metacognitive Therapy

EXPERIMENTAL

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

Mindfulness Meditation Therapy

EXPERIMENTAL

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

Group Metacognitive TherapyBEHAVIORAL
Also known as: MCT
Metacognitive Therapy
Mindfulness Meditation TherapyBEHAVIORAL
Also known as: MMT
Mindfulness Meditation Therapy

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • individual's score on the GAD-7 \& PHQ-9
  • individuals who meet the DSM-IV (Diagnostic and Statistical Manual) criteria for generalized anxiety disorder

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The Rawnsley Building, Manchester Royal Infirmary, Oxford Road

Manchester, Lancashire, M23 9LT, United Kingdom

Location

MeSH Terms

Conditions

Generalized Anxiety Disorder

Interventions

2-methylcyclopentadienyl manganese tricarbonyl

Condition Hierarchy (Ancestors)

Anxiety DisordersMental Disorders

Study Officials

  • Lora Capobianco

    University of Manchester

    PRINCIPAL INVESTIGATOR

  • James Thompson

    University of Manchester

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor of Clinical & Experimental Psychopathology

Study Record Dates

First Submitted

March 19, 2014

First Posted

March 26, 2014

Study Start

August 1, 2014

Primary Completion

December 1, 2015

Study Completion

June 1, 2016

Last Updated

October 17, 2016

Record last verified: 2016-10

Locations

GB(1)