Youth Metacognitive Therapy Feasibility Trial

Depression Clinical Trial

— YoMETA  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05260060
• Other study ID #: IRAS ID: 296079
• Status: Recruiting
• Phase: N/A
• Start date: May 23, 2022
• Est. completion date: February 28, 2024

Study information

• Verified date: June 2022
• Source: University of Manchester
• Contact: Adrian Wells, PhD
• Phone: 01612765399
• Email: adrian.wells[@]manchester.ac.uk
• Is FDA regulated: No
• Study type: Interventional

Clinical 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 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: February 28, 2024
• Est. primary completion date: August 31, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 11 Years to 16 Years

Eligibility

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

Related Conditions & MeSH terms

• Anxiety Disorders
• Child Mental Disorder
• Depression
• Disease
• Mental Disorders
• Neurodevelopmental Disorders

Intervention

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.
• 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.

Locations

Country	Name	City	State
United Kingdom	Manchester University NHS Foundation Trust	Manchester

Sponsors (3)

Lead Sponsor	Collaborator
University of Manchester	Greater Manchester Mental Health NHS Foundation Trust, National Institute for Health Research, United Kingdom

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Other Feasibility Outcomes	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
Primary	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.	Baseline, 20 weeks follow up, 32 weeks follow up, 44 weeks follow up
Secondary	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.	Baseline, 20 weeks follow up, 32 weeks follow up, 44 weeks follow up
Secondary	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.	Baseline, 20 weeks follow up, 32 weeks follow up, 44 weeks follow up
Secondary	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.	Baseline, 20 weeks follow up, 32 weeks follow up, 44 weeks follow up
Secondary	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.	Baseline, 20 weeks follow up, 32 weeks follow up, 44 weeks follow up
Secondary	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.	Baseline, 20 weeks follow up, 32 weeks follow up, 44 weeks follow up

External Links

•   Research Project Website Page