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Completed

NCT Number: NCT05260060

Youth Metacognitive Therapy 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.

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Key information

Conditions

Child Mental Disorder Anxiety Disorders Behavior Behavioral Symptoms Depression Mental Disorders Neurodevelopmental Disorders Personal Satisfaction Psychological Well-Being

Age range

11 year–16 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Manchester University NHS Foundation Trust

Manchester, M13 9WL, United Kingdom

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Treatment as usual: Control

Behavioral

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): Experimental

Behavioral

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.

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

Other outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

University of Manchester

Other

Collaborators

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

Registry information

Official study title

Youth Metacognitive Therapy (YoMETA): A Single-Blind Parallel Randomised Feasibility Trial

Acronym: YoMETA

Important dates

Study start
2022
Primary completion
2023
Study completion
2024
First posted
Mar 2, 2022
Registry last updated
Jun 3, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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