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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
Register:
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ISRCTN |
Last refreshed on:
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5 January 2021 |
Main ID: |
ISRCTN21802136 |
Date of registration:
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12/01/2015 |
Prospective Registration:
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Yes |
Primary sponsor: |
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Public title:
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Coping with Unusual ExperienceS for 12-18 (CUES+)
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Scientific title:
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Coping with Unusual ExperienceS for 12-18 year olds (CUES+): A transdiagnostic randomised controlled trial of the effectiveness of cognitive therapy in reducing distress associated with unusual experiences in adolescent mental health services |
Date of first enrolment:
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13/01/2015 |
Target sample size:
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120 |
Recruitment status: |
Completed |
URL:
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http://isrctn.com/ISRCTN21802136 |
Study type:
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Interventional |
Study design:
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A single-centre trial of a cognitive therapy intervention compared to waitlist control (Treatment)
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Phase:
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Not Applicable
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Countries of recruitment
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United Kingdom
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Contacts
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Name:
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Address:
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Telephone:
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Email:
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Affiliation:
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Name:
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Suzanne
Jolley |
Address:
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King's College London
Institute of Psychiatry
Department of Psychology (PO77)
16 De Crespigny Park
SE5 8AF
London
United Kingdom |
Telephone:
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Email:
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Affiliation:
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Key inclusion & exclusion criteria
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Inclusion criteria: 1. Presenting to local CAMHS 2. Current UED 3. Aged 12-18 years 4. Available for the study duration 5. Sufficient English language ability to be able to complete assessment measures and therapy (with interpreter support if necessary)
Exclusion criteria: 1. Learning disability (IQ<70) 2. UED secondary to known neurological condition (e.g. epilepsy or brain injury) or limited to states of acute intoxication/withdrawal in the context of substance misuse
Age minimum:
Age maximum:
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Distressing unusual experiences (UEDs) in adolescents presenting to community Child and Adolescent Mental Health Services (CAMHS). Mental and Behavioural Disorders
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Intervention(s)
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Therapy will comprise up to 16 sessions, delivered over 16 weeks, including individual CBTp adapted for adolescents and 3-4 family support sessions. This is crucial when working with young people and has been requested by parents consulting on our studies. Family work comprises recognition and understanding of the child’s difficulties, sharing the intervention plan, and troubleshooting any key family difficulties. Individual work focuses on developing a collaborative understanding of UEDs, together with skills in affect regulation, managing negative automatic thoughts, behavioural tests, dealing with social difficulties and adverse life events, recognising and compensating for cognitive biases and a section on taking the work forward and preventing future difficulties. Therapy is tailored to take account of the developmental stage and presenting issues of the child/young person with an emphasis on identity formation, understanding self in relation to the experience of psychosis/UEDs, social inclusion and self esteem. Therapy materials have been designed to be fun, interactive and engaging.
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Primary Outcome(s)
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Distress at 16 weeks, assessed using the Emotional Problems subscale of the child reported version of the Strengths and Difficulties Questionnaire (SDQ). The SDQ is well-validated and routinely used in local services for youth up to 19 years.
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Secondary Outcome(s)
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Child-reported UED severity at 16 weeks, adverse events including A&E attendance and incidents of self harm, and economic costs, including QALYs. We will also measure the cognitive, social, emotional and behavioural therapy targets hypothesised to maintain UEDs, and sessional measures of therapy progress.
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Source(s) of Monetary Support
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National Institute for Health Research
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Ethics review
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Status:
Approval date:
Contact:
London Hampstead NRES Committee, ref: 14/LO/1970
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Results
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Results available:
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Yes |
Date Posted:
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Date Completed:
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30/09/2017 |
URL:
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