Child Mental DisorderYoMETANCT05260060
Youth Metacognitive Therapy Feasibility Trial
A study testing Group Metacognitive Therapy (Group-MCT): Experimental in people with Child Mental Disorder and Anxiety Disorders, run by University of Manchester at 1 site in United Kingdom.
Trial summary
One in eight children and young people (CYP) suffer mental health problems needing support or treatment and 5% have more than one such problem. The effects can be major, affecting CYP emotionally and functionally, impacting progress at school, relationships with others and increasing long term risk of mental health… Read more about this study
- Who is it for?
- Ages 11 to 16 years
- Conditions the study is for
- Child Mental Disorder, Anxiety Disorders, Depression
- What is being tested?
- Group Metacognitive Therapy (Group-MCT): Experimental
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 95 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 23 May 2022to 4 Apr 2024
- 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 11 to 16 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Seeking treatment for emotional disorder symptoms (i.e. generalized anxiety disorder, panic disorder, agoraphobia, post-traumatic stress disorder, obsessive compulsive disorder, social anxiety and/or depression).
- Native fluency in English language
- Medication permitted but must be stabilised for 6 weeks.
Who cannot join
- Presence of significant risk or safeguarding concerns
- Head injury/organic impairment
- Formal diagnosis or under assessment for Autism Spectrum Disorder or Attention Deficit-Hyperactivity Disorder
- Eating Disorder
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Manchester University NHS Foundation Trust
Manchester, M13 9WL
About this study
Official title: Youth Metacognitive Therapy (YoMETA): A Single-Blind Parallel Randomised Feasibility Trial
One in eight children and young people (CYP) suffer mental health problems needing support or treatment and 5% have more than one such problem. The effects can be major, affecting CYP emotionally and functionally, impacting progress at school, relationships with others and increasing long term risk of mental health problems. Parents, schools, policy makers and the NHS often struggle to find the best way to help, especially within their limited budgets. The UK Government and the NHS have highlighted the need to improve mental health in CYP.
The most common treatment is cognitive behavioural therapy; however this can be time consuming, needs to be delivered over many weeks, must focus on the most upsetting problem first and is not very effective. One way to overcome this is to evaluate a group therapy that can treat multiple mental health problems at once. This new treatment is called Metacognitive Therapy (MCT).
The aim of the study is to see if participating in a randomized trial of Group MCT is a feasible and acceptable treatment for CYP suffering with anxiety, stress, depression, or a combination in comparison to usual care. This allows us to test key questions about recruitment and drop-out rates, test the protocol, and gain information about MCT including training and supervision needs of clinicians and the experience of patients receiving it.
- Conditions
- Child Mental Disorder, Anxiety Disorders, Depression
- Being tested
- Treatment as usual: Control, Group Metacognitive Therapy (Group-MCT): Experimental
- Keywords
- Metacognitive Therapy, Feasibility, Anxiety, Depression, Mental health
- Medical subject headings
- Neurodevelopmental Disorders, Anxiety Disorders, Depression, Psychological Well-Being
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Treatment as usual: ControlBehavioural
Treatment usually delivered in service that may include but is not limited to cognitive behaviour therapy, exposure, eye movement desensitisation and reprocessing , behaviour therapy, family therapy.
Group Metacognitive Therapy (Group-MCT): ExperimentalBehavioural
Group metacognitive therapy (Group-MCT) focuses on developing adaptive control of worry, repetitive negative thinking and attention and modifies beliefs that maintain unhelpful thinking patterns. Treatment is 6 to 8 weekly sessions delivered by two trained mental health professionals, guided by a treatment manual, lasting approximately 90 minutes each session.
| Study group | Role | What they receive |
|---|---|---|
| Usual Treatment (Control) | Active comparator | Participants allocated to the control group will receive treatment as usual under the child and adolescent mental health service. Receives: Behavioral: Treatment as usual: Control |
| Group MCT (Intervention) | Experimental | Participants allocated to the intervention group will receive group metacognitive therapy sessions. Receives: Behavioral: Group Metacognitive Therapy (Group-MCT): Experimental |
What is being measured
The primary outcome is the main question the study is designed to answer.
Revised Children Anxiety and Depression Scale - Short Version (RCADS)
Youth self-report questionnaire measuring total anxiety, total depression and total anxiety and depression.
This is a feasibility study and therefore it is not primarily powered to detect a difference (change in scores). The principal aim is to test the feasibility of a study using. Here we are testing the feasibility of using the measures (RCADS), therefore the measures will be assessed by monitoring descriptive data and the analysis of complete data once follow up has been completed. Specifically, range in scores, number of complete measures, proportion of missing data. Analyses of outcomes (change) will focus on descriptive statistics and confidence intervals for treatment effects.
Measured: Baseline, 20 weeks follow up, 32 weeks follow up, 44 weeks follow up
Secondary outcomes (5)
Strength and Difficulties Questionnaire (SDQ)
Measure of psychological well-being across five subscales: emotion, hyperactivity, conduct, peer relations and pro-social behaviour.
Feasibility of the measure will be assessed by monitoring descriptive data and the analysis of complete data once follow up has been completed. Analyses of outcomes (change) will focus on descriptive statistics and confidence intervals for treatment.
Measured: Baseline, 20 weeks follow up, 32 weeks follow up, 44 weeks follow up
Metacognition Questionnaire - Adolescent Version (MCQ-A)
Measure of metacognitive beliefs across five subscales: positive beliefs about worry, negative beliefs about uncontrollability and danger, cognitive confidence, cognitive self-consciousness and cognitive control.
Feasibility of the measure will be assessed by monitoring descriptive data and the analysis of complete data once follow up has been completed. Analyses of outcomes (change) will focus on descriptive statistics and confidence intervals for treatment.
Measured: Baseline, 20 weeks follow up, 32 weeks follow up, 44 weeks follow up
Mood & Feelings Questionnaire (MFQ)
Measure of depressive symptoms in 6-17 year olds.
Feasibility of the measure will be assessed by monitoring descriptive data and the analysis of complete data once follow up has been completed. Analyses of outcomes (change) will focus on descriptive statistics and confidence intervals for treatment.
Measured: Baseline, 20 weeks follow up, 32 weeks follow up, 44 weeks follow up
Child Health Utility - 9D (CHU-9D)
Measure of paediatric quality of life using dimensions: worried, sad, pain, tired, annoyed, school/homework, sleep, daily routine, ability to join in activities.
Feasibility of the measure will be assessed by monitoring descriptive data and the analysis of complete data once follow up has been completed. Analyses of outcomes (change) will focus on descriptive statistics and confidence intervals for treatment.
Measured: Baseline, 20 weeks follow up, 32 weeks follow up, 44 weeks follow up
Health and Social Case Service-Use Interview (SUI)
Assessment of the child's use of primary, secondary or community-based health and social care services and how often they have used the service in the last 16 weeks or since last study assessment.
Measured: Baseline, 20 weeks follow up, 32 weeks follow up, 44 weeks follow up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Mar 2022
- Study start23 May 2022
- Primary completion19 Oct 2023
- Study completion4 Apr 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Child Mental 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
- Investigator
- Enrolment
- 95 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Manchester
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute for Health Research, United Kingdom, Greater Manchester Mental Health NHS Foundation Trust
- Responsible party
- Principal investigator, Adrian Wells, University of Manchester
- Investigators
- Adrian Wells, Principal investigator, University of Manchester
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05260060
- Sponsor's protocol ID
- IRAS ID: 296079
- Acronym
- YoMETA
- Status last verified
- May 2024
- First submitted
- 7 Feb 2022
- Last updated
- 3 Jun 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Wells A, Carter K, Hann M, Shields G, Wallis P, Cooper B, Capobianco L. Youth Metacognitive Therapy (YoMeta): protocol for a single-blind randomised feasibility trial of a transdiagnostic intervention versus treatment as usual in 11-16-year-olds with common mental health problems. Pilot Feasibility Stud. 2022 Sep 12;8(1):207. doi: 10.1186/s40814-022-01162-5.
PubMed 36096940
Study at a glance
From the registry record, last updated by the sponsor on 3 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Youth Metacognitive Therapy (YoMETA): A Single-Blind Parallel Randomised Feasibility Trial
- ClinicalTrials.gov ID
- NCT05260060
- Acronym / sponsor ID
- YoMETA / IRAS ID: 296079
- Conditions
- Child Mental Disorder, Anxiety Disorders, Depression
- Keywords
- Metacognitive Therapy, Feasibility, Anxiety, Depression, Mental health
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 95 participants (actual)
- Lead sponsor
- University of ManchesterUniversity, hospital or other
- Collaborators
- National Institute for Health Research, United Kingdom, Greater Manchester Mental Health NHS Foundation Trust
- Study start
- 23 May 2022 (actual)
- Primary completion
- 19 Oct 2023 (actual)
- Study completion
- 4 Apr 2024 (actual)
- First posted
- 2 Mar 2022 (actual)
- 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.
One in eight children and young people (CYP) suffer mental health problems needing support or treatment and 5% have more than one such problem. The effects can be major, affecting CYP emotionally and functionally, impacting progress at school, relationships with others and increasing long term risk of mental health problems. Parents, schools, policy makers and the NHS often struggle to find the best way to help, especially within their limited budgets. The UK Government and the NHS have highlighted the need to improve mental health in CYP.
The most common treatment is cognitive behavioural therapy; however this can be time consuming, needs to be delivered over many weeks, must focus on the most upsetting problem first and is not very effective. One way to overcome this is to evaluate a group therapy that can treat multiple mental health problems at once. This new treatment is called Metacognitive Therapy (MCT).
The aim of the study is to see if participating in a randomized trial of Group MCT is a feasible and acceptable treatment for CYP suffering with anxiety, stress, depression, or a combination in comparison to usual care. This allows us to test key questions about recruitment and drop-out rates, test the protocol, and gain information about MCT including training and supervision needs of clinicians and the experience of patients receiving it.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Usual Treatment (Control) | Active comparator | Behavioral: Treatment as usual: ControlParticipants allocated to the control group will receive treatment as usual under the child and adolescent mental health service. |
| Group MCT (Intervention) | Experimental | Behavioral: Group Metacognitive Therapy (Group-MCT): ExperimentalParticipants allocated to the intervention group will receive group metacognitive therapy sessions. |
Who may qualify
- Ages
- 11 to 16 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Seeking treatment for emotional disorder symptoms (i.e. generalized anxiety disorder, panic disorder, agoraphobia, post-traumatic stress disorder, obsessive compulsive disorder, social anxiety and/or depression).
- Native fluency in English language
- Medication permitted but must be stabilised for 6 weeks.
Key exclusion criteria (4 listed)
- Presence of significant risk or safeguarding concerns
- Head injury/organic impairment
- Formal diagnosis or under assessment for Autism Spectrum Disorder or Attention Deficit-Hyperactivity Disorder
- Eating 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 |
|---|---|---|
| Treatment as usual: ControlTreatment usually delivered in service that may include but is not limited to cognitive behaviour therapy, exposure, eye movement desensitisation and reprocessing , behaviour therapy, family therapy. | Behavioural | Usual Treatment (Control) |
| Group Metacognitive Therapy (Group-MCT): ExperimentalGroup metacognitive therapy (Group-MCT) focuses on developing adaptive control of worry, repetitive negative thinking and attention and modifies beliefs that maintain unhelpful thinking patterns. Treatment is 6 to 8 weekly sessions delivered by two trained mental health professionals, guided by a treatment manual, lasting approximately 90 minutes each session. | Behavioural | Group MCT (Intervention) |
Primary outcome
Revised Children Anxiety and Depression Scale - Short Version (RCADS)
Time frame: Baseline, 20 weeks follow up, 32 weeks follow up, 44 weeks follow up
Youth self-report questionnaire measuring total anxiety, total depression and total anxiety and depression. This is a feasibility study and therefore it is not primarily powered to detect a difference (change in scores). The principal aim is to test the feasibility of a study using. Here we are testing the feasibility of using the measures (RCADS), therefore the measures will be assessed by monitoring descriptive data and the analysis of complete data once follow up has been completed. Specifically, range in scores, number of complete measures, proportion of missing data. Analyses of outcomes (change) will focus on descriptive statistics and confidence intervals for treatment effects.
5 secondary outcomes
Strength and Difficulties Questionnaire (SDQ)
Time frame: Baseline, 20 weeks follow up, 32 weeks follow up, 44 weeks follow up
Metacognition Questionnaire - Adolescent Version (MCQ-A)
Time frame: Baseline, 20 weeks follow up, 32 weeks follow up, 44 weeks follow up
Mood & Feelings Questionnaire (MFQ)
Time frame: Baseline, 20 weeks follow up, 32 weeks follow up, 44 weeks follow up
Child Health Utility - 9D (CHU-9D)
Time frame: Baseline, 20 weeks follow up, 32 weeks follow up, 44 weeks follow up
Health and Social Case Service-Use Interview (SUI)
Time frame: Baseline, 20 weeks follow up, 32 weeks follow up, 44 weeks follow up
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 3 Jun 2024.
- Derived from this study: PubMed 36096940Wells A, Carter K, Hann M, Shields G, Wallis P, Cooper B, Capobianco L. Youth Metacognitive Therapy (YoMeta): protocol for a single-blind randomised feasibility trial of a transdiagnostic intervention versus treatment as usual in 11-16-year-olds with common mental health problems. Pilot Feasibility Stud. 2022 Sep 12;8(1):207. doi: 10.1186/s40814-022-01162-5.
- Research Project Website PageLink provided by the sponsor.
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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.
Adrian Wells 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 (Group-MCT): Experimental in people with Child Mental Disorder and Anxiety Disorders, 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 3 inclusion and 4 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 3 Jun 2024. 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?
Revised Children Anxiety and Depression Scale - Short Version (RCADS) (time frame: Baseline, 20 weeks follow up, 32 weeks follow up, 44 weeks follow up). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05260060, which also lists 1 linked publication.
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 3 Jun 2024.