Clinical trial NCT05260060: Youth Metacognitive Therapy Feasibility Trial
Official title: Youth Metacognitive Therapy (YoMETA): A Single-Blind Parallel Randomised Feasibility Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Child Mental Disorder
Anxiety Disorders
Depression
Keywords: Metacognitive Therapy
Feasibility
Anxiety
Depression
Mental health
Lead sponsor: University of Manchester
Sponsor class: OTHER
Collaborators: name: National Institute for Health Research, United Kingdom
name: Greater Manchester Mental Health NHS Foundation Trust
First posted: 2022-03-02
Enrollment: 95
Sex: ALL
Minimum age (years): 11
Maximum age (years): 16
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.


Eligibility criteria: 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

Primary outcomes:
measure: Revised Children Anxiety and Depression Scale - Short Version (RCADS)
timeFrame: Baseline, 20 weeks follow up, 32 weeks follow up, 44 weeks follow up
Secondary outcomes:
measure: Strength and Difficulties Questionnaire (SDQ)
timeFrame: Baseline, 20 weeks follow up, 32 weeks follow up, 44 weeks follow up
measure: Metacognition Questionnaire - Adolescent Version (MCQ-A)
timeFrame: Baseline, 20 weeks follow up, 32 weeks follow up, 44 weeks follow up
measure: Mood & Feelings Questionnaire (MFQ)
timeFrame: Baseline, 20 weeks follow up, 32 weeks follow up, 44 weeks follow up
measure: Child Health Utility - 9D (CHU-9D)
timeFrame: Baseline, 20 weeks follow up, 32 weeks follow up, 44 weeks follow up
measure: Health and Social Case Service-Use Interview (SUI)
timeFrame: Baseline, 20 weeks follow up, 32 weeks follow up, 44 weeks follow up
Other outcomes:
measure: Other Feasibility Outcomes
timeFrame: Baseline, 20 weeks follow up, 32 weeks follow up, 44 weeks follow up
Locations:
city: Manchester
country: United Kingdom
facility: Manchester University NHS Foundation Trust
Study officials:
affiliation: University of Manchester
name: Adrian Wells
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.