Youth Metacognitive Therapy Feasibility Trial

NCT05260060 | Completed DMC

• 1 other identifier: IRAS ID: 296079
• Study Type: interventional
• Target: 95
• Locations: 1 country
• Sites: 1

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.

Conditions

Child Mental Disorder; Anxiety Disorders; Depression

Keywords

Metacognitive Therapy; Feasibility; Anxiety; Depression; Mental health

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• Strength and Difficulties Questionnaire (SDQ)

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

• Metacognition Questionnaire - Adolescent Version (MCQ-A)

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

• Mood & Feelings Questionnaire (MFQ)

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

• Child Health Utility - 9D (CHU-9D)

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

• Health and Social Case Service-Use Interview (SUI)

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

Other Outcomes (1)

• Other Feasibility Outcomes

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

Study Arms (2)

Usual Treatment (Control)

ACTIVE COMPARATOR

Participants allocated to the control group will receive treatment as usual under the child and adolescent mental health service.

Behavioral: Treatment as usual: Control

Group MCT (Intervention)

EXPERIMENTAL

Participants allocated to the intervention group will receive group metacognitive therapy sessions.

Behavioral: Group Metacognitive Therapy (Group-MCT): Experimental

Interventions

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.

Usual Treatment (Control)

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.

Group MCT (Intervention)

Eligibility Criteria

• Age: 11 Years - 16 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Manchester: lead
• National Institute for Health Research, United Kingdom: collaborator
• Greater Manchester Mental Health NHS Foundation Trust: collaborator

Study Sites (1)

Manchester University NHS Foundation Trust

Manchester, M13 9WL, United Kingdom

Location

Related Publications (1)

• 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.

  PMID: 36096940 DERIVED

Related Links

• Research Project Website Page

MeSH Terms

Conditions

Neurodevelopmental Disorders; Anxiety Disorders; Depression; Psychological Well-Being

Interventions

Therapeutics

Condition Hierarchy (Ancestors)

Mental Disorders; Behavioral Symptoms; Behavior; Personal Satisfaction

Study Officials

• Adrian Wells

  University of Manchester

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Masking Details: Chief investigator, research assistants and statisticians will be blind to treatment allocation of participants.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Clinical and Experimental Psychopathology

Study Record Dates

• First Submitted: February 7, 2022
• First Posted: March 2, 2022
• Study Start: May 23, 2022
• Primary Completion: October 19, 2023
• Study Completion: April 4, 2024
• Last Updated: June 3, 2024

Record last verified: 2024-05

Locations

GB (1)