Generalized Anxiety DisorderMCTNCT02096484
A Feasibility Study of Group Metacognitive Therapy Versus Mindfulness Meditation Therapy
A study testing Group Metacognitive Therapy and Mindfulness Meditation Therapy in people with Generalized Anxiety Disorder, run by University of Manchester at 1 site in United Kingdom.
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… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Generalized Anxiety Disorder
- What is being tested?
- Group Metacognitive Therapy and Mindfulness Meditation Therapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Aug 2014to Jun 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- individual's score on the GAD-7 \& PHQ-9
- individuals who meet the DSM-IV (Diagnostic and Statistical Manual) criteria for generalized anxiety disorder
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
The Rawnsley Building, Manchester Royal Infirmary, Oxford Road
Manchester, Lancashire, M23 9LT
About this study
Official title: Group Metacognitive Therapy Versus Mindfulness Meditation Therapy in a Transdiagnostic Patient Sample: A Feasibility Study
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.
- Conditions
- Generalized Anxiety Disorder
- Being tested
- Group Metacognitive Therapy, Mindfulness Meditation Therapy
- Keywords
- Metacognitive therapy, mindfulness meditation therapy, group therapy, generalized anxiety disorder, Group Based Metacognitive Therapy, Group Based Mindfulness Meditation Therapy
- Medical subject headings
- Generalized Anxiety Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Group Metacognitive TherapyBehavioural
Also called MCT
Mindfulness Meditation TherapyBehavioural
Also called MMT
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Behavioral: Mindfulness Meditation Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hospital Anxiety and Depression Scale (HADS)
Measured: Administered at pre treatment, mid treatment, post treatment, and 6 month follow up
Secondary outcomes (3)
CAS-I
Measured: Administered at pre treatment, mid treatment, post treatment, and 6 month follow up
GAD-7
Measured: Completed prior to week 1 of treatment.This will be administered prior to treatment as a screening measure for levels of anxiety.
PHQ-9
Measured: Completed prior to week 1 of treatment.This will be administered prior to treatment as a screening measure for levels of depression.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Mar 2014 (estimated)
- Study startAug 2014
- Primary completionDec 2015
- Study completionJun 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Generalized Anxiety DisorderStudies of the same condition, open and under way.
- More trials run by University of ManchesterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Manchester
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Adrian Wells, University of Manchester
- Investigators
- Lora Capobianco, Principal investigator, University of ManchesterJames Thompson, Principal investigator, University of Manchester
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02096484
- Sponsor's protocol ID
- UM145073
- Acronym
- MCT
- Status last verified
- Oct 2016
- First submitted
- 19 Mar 2014
- Last updated
- 17 Oct 2016
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 17 Oct 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Group Metacognitive Therapy Versus Mindfulness Meditation Therapy in a Transdiagnostic Patient Sample: A Feasibility Study
- ClinicalTrials.gov ID
- NCT02096484
- Acronym / sponsor ID
- MCT / UM145073
- Conditions
- Generalized Anxiety Disorder
- Keywords
- Metacognitive therapy, mindfulness meditation therapy, group therapy, generalized anxiety disorder, Group Based Metacognitive Therapy, Group Based Mindfulness Meditation Therapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- University of ManchesterUniversity, hospital or other
- Study start
- Aug 2014
- Primary completion
- Dec 2015 (actual)
- Study completion
- Jun 2016 (actual)
- First posted
- 26 Mar 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Metacognitive Therapy | Experimental | Behavioral: Group Metacognitive TherapyIndividuals 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. |
| Mindfulness Meditation Therapy | Experimental | Behavioral: Mindfulness Meditation TherapyIndividuals 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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- individual's score on the GAD-7 \& PHQ-9
- individuals who meet the DSM-IV (Diagnostic and Statistical Manual) criteria for generalized anxiety disorder
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Group Metacognitive TherapyAlso: MCT | Behavioural | Metacognitive Therapy |
| Mindfulness Meditation TherapyAlso: MMT | Behavioural | Mindfulness Meditation Therapy |
Primary outcome
Hospital Anxiety and Depression Scale (HADS)
Time frame: Administered at pre treatment, mid treatment, post treatment, and 6 month follow up
3 secondary outcomes
CAS-I
Time frame: Administered at pre treatment, mid treatment, post treatment, and 6 month follow up
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.
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Oct 2016.
Related trials for Generalized Anxiety Disorder
Recruiting
Effect of a Brief Daily Digital Meditation on Well-Being in US Young Adults (BEGIN II)
Mental Health and General Well-being
RecruitingObservational study
Student Precarity and Psychiatry
Depressive Disorder, Major, Generalized Anxiety Disorder
Active, not recruitingObservational study
BreathinG-induced Myocardial and Cerebral Perfusion in Anxiety Disorders
Generalized Anxiety Disorder, Oxygenation Sensitive CMR
RecruitingPhase 3
A Study to Asses Safety and Tolerability of ITI-1284 Given Alone or as an Additional Treatment in Participants With Generalized Anxiety Disorder (GAD)
Generalized Anxiety Disorder
RecruitingPhase 3
A Study of JNJ-99245354 (ITI-1284) as an Adjunctive Treatment in Participants With Generalized Anxiety Disorder (GAD) Who Have an Inadequate Response to GAD Treatment
Generalized Anxiety Disorder
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lora Capobianco principal investigator
University of Manchester
James Thompson principal investigator
University of Manchester
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Group Metacognitive Therapy and Mindfulness Meditation Therapy in people with Generalized Anxiety Disorder, run by University of Manchester at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Oct 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Hospital Anxiety and Depression Scale (HADS) (time frame: Administered at pre treatment, mid treatment, post treatment, and 6 month follow up). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Oct 2016.