YoMeta: A study investigating if metacognitive therapy for children and adolescents with a common mental health disorder is feasible and acceptable to deliver in child and adolescent mental health services

ISRCTN	ISRCTN18335255
DOI	https://doi.org/10.1186/ISRCTN18335255
IRAS number	296079
ClinicalTrials.gov number	NCT05260060
Secondary identifying numbers	CPMS 50997, NIHR201495, IRAS 296079

Submission date: 22/02/2022
Registration date: 24/02/2022
Last edited: 05/04/2023

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Mental and Behavioural Disorders

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English Summary

Background and study aims
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. 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.

Who can participate?
We plan to recruit participants aged 18 years or older, with anxiety, stress, depression or a combination.

What does the study involve?
Participants will be randomised to one of two groups; group MCT or treatment as usual. Group MCT will be delivered across 8 sessions lasting 90 minutes. All participants will complete questionnaires at baseline, 16 week follow up (post treatment), 28 week follow up and 40 week follow up. A qualitative study will explore participants’ experience of group MCT and
therapist views of MCT and being trained in MCT.

What are the possible benefits and risks of participating?
The information gathered as part of this study will help to inform future care within CAMHS for children and young people experiencing mental health disorders and will provide details to develop further research on MCT for children and young people.

While the risks in taking part are minimal it is possible that answering the questionnaires and/or talking about any difficulties may cause some distress. However, the group MCT is designed to aid in managing negative thoughts and feelings more effectively. The group delivery of this therapy will be facilitated by two trained CAMHS professionals, who will ensure the understanding and maintenance of confidentiality and ease any uncertainty in the situation.

Where is the study run from?
Greater Manchester Mental Health NHS Foundation Trust (UK)

When is the study starting and how long is it expected to run for?
October 2021 to October 2024

Who is funding the study?
National Institute for Health Research (NIHR) (UK).

Who is the main contact?
Dr Lora Capobianco. lora.capobianco@gmmh.nhs.uk

Study website

Contact information

Dr Lora Capobianco
Scientific

3rd Floor Rawnsley Building
Manchester Royal Infirmary
Oxford Road
Manchester
M13 9WL
United Kingdom

ORCID ID	0000-0001-6877-8650
Phone	+44 161 271 0724
Email	lora.capobianco@gmmh.nhs.uk

Prof Adrian Wells
Scientific

3rd Floor Rawnsley Building
Manchester Royal Infirmary
Oxford Road
Manchester
M13 9WL
United Kingdom

ORCID ID	0000-0001-7713-1592
Email	adrian.wells@manchester.ac.uk

Study information

Study design	Interventional randomized controlled trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Hospital
Study type	Treatment
Participant information sheet	https://adept-ru.com/research-projects/yometa/
Scientific title	Youth metacognitive therapy (YoMeta): a single blind parallel randomised feasibility trial
Study acronym	YoMeta
Study hypothesis	The aim is to conduct a two-arm single blind feasibility trial comparing group metacognitive therapy (MCT) vs. treatment as usual for children and adolescents experiencing psychological distress to investigate if a more definitive trial is an acceptable, feasible and potentially effective option
Ethics approval(s)	Approved 11/01/2022, North West - Greater Manchester East Research Ethics Committee (Barlow House, 3rd Floor, 4 Minshull Street, Manchester, M1 3DZ, UK; +44 2071048199; gmeast.rec@hra.nhs.uk), ref: 21/NW/0329
Condition	Anxiety, depression, or both
Intervention	Participants are randomised to the intervention or control condition. The intervention group will receive six weekly sessions of group-based MCT (with two additional booster session). Group-MCT will be delivered by two trained mental health professionals (i.e. clinical psychologist and high-intensity therapist). Sessions will last approximately 90 minutes. Group MCT will be guided by a treatment manual to maximise treatment adherence and fidelity. Group MCT aims to help participants develop knowledge that can facilitate control of worry, repetitive negative thinking and attention, and to modify the metacognitive beliefs that maintain unhelpful thinking patterns Control Condition: Treatment as usual (TAU) consist of cognitive behavioural therapies (CBT: behavioural activation, exposure, EMDR, cognitive therapy) and family therapy delivered on a one-to-one or group basis. Participants normally receive up to 12 sessions of TAU. QUANTITATIVE ASSESSMENTS Participants will complete quantitative assessments at four time-points: baseline, 20 weeks (end of treatment), 32 weeks (follow up) and 44 weeks (follow up). At the four time-points participants will be asked to complete the following questionnaires: •Revised Child Anxiety and Depression Scale- Short Version •Strength and Difficulties Questionnaire (SDQ) •Metacognition Questionnaire-Adolescent version (MCQ-A) •Demographic information – including child’s age, sex, school, ethnicity, medication, socioeconomic status, parental occupational status. This will be completed by parents/primary caregivers. •Child Health Utility-9D (CHU-9D) •EQ-5D-Y •Health and Social Care Service-Use Interview (SUI). The SUI will include questions about whether the child has used any primary, secondary or community-based health and social care and how often they used the service in the last 16 weeks (baseline study visit) or since the last assessment (follow-up study visits). The SUI will be developed from existing child relevant SUIs held by the co-applicants and through discussion with the PPI representative, parent advisory group and clinical members of the study team. This will be completed by parents/primary caregivers. QUALITATIVE ASSESSMENTS A nested qualitative study will be conducted to evaluate patient and clinician perspectives of MCT. We will conduct semi-structured interviews with around 10 patients and 4-6 clinicians. Qualitative interviews with patients will evaluate which aspect of the interventions they liked and disliked. Qualitative interviews with clinicians will evaluate their experience in being trained in MCT and delivering MCT.
Intervention type	Behavioural
Primary outcome measure	1. The Revised Child Anxiety and Depression Scale- Short Version is being measured at baseline, 20 weeks (end of treatment), 32 weeks (follow up) and 44 weeks (follow up). 2. Feasibility will be assessed using referral rates, recruitment and retention rates, participant attendance at sessions, their follow up and questionnaire response rates, and willingness to be randomized to treatment
Secondary outcome measures	1. Strength and Difficulties Questionnaire (SDQ) is being measured at baseline, 20 weeks (end of treatment), 32 weeks (follow up) and 44 weeks (follow up). 2. Metacognition Questionnaire-Adolescent version (MCQ-A) is being measured at baseline, 20 weeks (end of treatment), 32 weeks (follow up) and 44 weeks (follow up). 3. Child Health Utility-9D (CHU-9D) is being measured at baseline, 20 weeks (end of treatment), 32 weeks (follow up) and 44 weeks (follow up). 4. EQ-5D-Y is being measured at baseline, 20 weeks (end of treatment), 32 weeks (follow up) and 44 weeks (follow up). 5. Health Care Service Use Interview Version is being measured at baseline, 20 weeks (end of treatment), 32 weeks (follow up) and 44 weeks (follow up).
Overall study start date	01/10/2021
Overall study end date	31/10/2024

Eligibility

Participant type(s)	Patient
Age group	Adult
Sex	Both
Target number of participants	Planned Sample Size: 100; UK Sample Size: 100
Participant inclusion criteria	1. Aged between 11-16 years 2. Consent given 3. Native fluency in English language 4. 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) 5. Medication for mental health problems permitted but participants must be stabilised for 6 weeks
Participant exclusion criteria	1. Presence of significant risk or safeguarding concerns 2. Head injury/organic impairment 3. Autism Spectrum Disorder, Attention Deficit-Hyperactivity Disorder 4. Eating Disorder 5. Non-English speaking children Note: Only patients with a formal diagnosis or under assessment for one of the exclusion criteria will be excluded from the study.
Recruitment start date	23/05/2022
Recruitment end date	31/05/2023

Locations

Countries of recruitment

England
United Kingdom

Study participating centre

Manchester Children and Adolescent Mental Health Services

Winnicot Centre
Hathersage Road
Manchester
M13 0JE
United Kingdom

Sponsor information

Greater Manchester Mental Health NHS Foundation Trust
Hospital/treatment centre

Prestwich Hospital
Bury New Road
Prestwich
Manchester
M25 3BL
England
United Kingdom

Phone	+44 1612710084
Email	researchoffice@gmmh.nhs.uk
Website	https://www.gmmh.nhs.uk//
"ROR"	https://ror.org/05sb89p83

Funders

Funder type

Government

NIHR Central Commissioning Facility (CCF)

No information available

National Institute for Health Research
Government organisation / National government

Alternative name(s): National Institute for Health Research, NIHR Research, NIHRresearch, NIHR - National Institute for Health Research, NIHR (The National Institute for Health and Care Research), NIHR
Location: United Kingdom

Results and Publications

Intention to publish date	30/09/2025
Individual participant data (IPD) Intention to share	Yes
IPD sharing plan summary	Available on request
Publication and dissemination plan	Planned publication in a high-impact peer-reviewed journal
IPD sharing plan	The datasets generated during and/or analysed during the current study are/will be available upon request from Professor Adrian Wells (adrian.wells@manchester.ac.uk)

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Protocol article		12/09/2022	15/03/2023	Yes	No
HRA research summary			28/06/2023	No	No

Editorial Notes

05/04/2023: The recruitment end date was changed from 30/04/2023 to 31/05/2023.
15/03/2023: The following changes were made to the trial record:
1. Publication reference and ClinicalTrials.gov number added.
2. The recruitment end date was changed from 31/03/2023 to 30/04/2023.
3. The overall trial end date was changed from 30/09/2024 to 31/10/2024.
30/06/2022: The recruitment start date was changed from 03/05/2022 to 23/05/2022.
06/05/2022: The recruitment start date has been changed from 01/04/2022 to 03/05/2022.
22/02/2022: Trial's existence confirmed by the National Institute for Health Research (NIHR) (UK).