Youth Metacognitive Therapy Feasibility Trial (YoMETA)

May 31, 2024 updated by: Adrian Wells, University of Manchester

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

95

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United Kingdom
      • Manchester, United Kingdom, M13 9WL
        • Manchester University NHS Foundation Trust

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

11 years to 16 years (Child)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Usual Treatment (Control)
Participants allocated to the control group will receive treatment as usual under the child and adolescent mental health service.
Behavioral: Treatment as usual: Control
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.
Experimental: Group MCT (Intervention)
Participants allocated to the intervention group will receive group metacognitive therapy sessions.
Behavioral: Group Metacognitive Therapy (Group-MCT): Experimental
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Baseline, 20 weeks follow up, 32 weeks follow up, 44 weeks follow up

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Strength and Difficulties Questionnaire (SDQ)
Time Frame: Baseline, 20 weeks follow up, 32 weeks follow up, 44 weeks follow up

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.
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

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.
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

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.
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

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.
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
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.
Baseline, 20 weeks follow up, 32 weeks follow up, 44 weeks follow up

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Other Feasibility Outcomes
Time Frame: Baseline, 20 weeks follow up, 32 weeks follow up, 44 weeks follow up
Feasibility will also be assessed using referral rates (Baseline), recruitment and retention rates (Baseline, 20 week, 32 weeks and 44 weeks), participant attendance at treatment sessions, and willingness to be randomized to treatment.
Baseline, 20 weeks follow up, 32 weeks follow up, 44 weeks follow up

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Manchester

Collaborators

National Institute for Health Research, United Kingdom
Greater Manchester Mental Health NHS Foundation Trust

Investigators

  • Principal Investigator: Adrian Wells, University of Manchester

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 23, 2022

Primary Completion (Actual)

October 19, 2023

Study Completion (Actual)

April 4, 2024

Study Registration Dates

First Submitted

February 7, 2022

First Submitted That Met QC Criteria

February 17, 2022

First Posted (Actual)

March 2, 2022

Study Record Updates

Last Update Posted (Actual)

June 3, 2024

Last Update Submitted That Met QC Criteria

May 31, 2024

Last Verified

May 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IRAS ID: 296079

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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