Youth Metacognitive Therapy Feasibility Trial

NCT ID: NCT05260060

Last Updated: 2024-06-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

95 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-05-23

Study Completion Date

2024-04-04

Brief Summary

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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.

Detailed Description

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Conditions

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Child Mental Disorder Anxiety Disorders Depression

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Investigators
Chief investigator, research assistants and statisticians will be blind to treatment allocation of participants.

Study Groups

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Usual Treatment (Control)

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

Group Type ACTIVE_COMPARATOR

Treatment as usual: Control

Intervention Type 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 MCT (Intervention)

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

Group Type EXPERIMENTAL

Group Metacognitive Therapy (Group-MCT): Experimental

Intervention Type 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.

Interventions

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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.

Intervention Type 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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

11 Years

Maximum Eligible Age

16 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Institute for Health Research, United Kingdom

OTHER_GOV

Sponsor Role collaborator

Greater Manchester Mental Health NHS Foundation Trust

OTHER

Sponsor Role collaborator

University of Manchester

OTHER

Sponsor Role lead

Responsible Party

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Adrian Wells

Professor of Clinical and Experimental Psychopathology

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Adrian Wells

Role: PRINCIPAL_INVESTIGATOR

University of Manchester

Locations

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Manchester University NHS Foundation Trust

Manchester, , United Kingdom

Site Status

Countries

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United Kingdom

References

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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.

Reference Type DERIVED
PMID: 36096940 (View on PubMed)

Related Links

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Other Identifiers

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IRAS ID: 296079

Identifier Type: -

Identifier Source: org_study_id

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