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ISRCTN
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ISRCTN50951795
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ClinicalTrials.gov identifier
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Public title
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Cognitive therapy for generalised anxiety in youth
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Scientific title
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Cognitive therapy for generalised anxiety disorder in children and young people: a pilot randomised controlled trial and qualitative investigation of their experience of treatment
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Acronym
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N/A
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Serial number at source
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8202
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Study hypothesis
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The main aim of this project is to evaluate the effect on symptoms and quality of life of a form of cognitive therapy tageting maintaining factors specific to generalised anxiety disorder (GAD) in children and adolescents. Outcomes for this 10-week, individual, child-focused treatment will be compared to outcomes for participants offered 10 weeks of psychoeducation and self-monitoring of symptoms (delayed treatment). Participants will be randomised to the two conditions. The main hypothesis is that cognitive therapy will be superior to the control intervention in reduction of GAD diagnostic status (primary outcome variable), and self-reported worry frequency, and quality of life. The secondary aims are to evaluate the children's subjective experience of the treatment and changes in cognitions that help to maintain worry.
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Lay summary
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Ethics approval
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1. Royal Free Hospital and Medical School Research Ethics Committee approved on the 3rd December 2009 (ref: 09/H0720/127)
2. KCL/SLaM Research and Development approved on the 12th February 2010 (ref: R&D2010/015)
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Study design
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Single centre randomised interventional treatment trial
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Countries of recruitment
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United Kingdom
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Disease/condition/study domain
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Topic: Mental Health Research Network; Subtopic: Anxiety; Disease: Anxiety
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Participants - inclusion criteria
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1. Children/young people aged 10 - 18 years, either sex
2. Diagnosis of GAD according to Diagnostic and Statistical Manual of Mental Disorders, version 4 (DSM-IV) criteria
3. Consecutively referred to a National and Specialist children's anxiety clinic (if they give informed consent)
4. Participants with a comorbid Axis 1 diagnosis will be included provided GAD is the primary disorder in need of treatment
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Participants - exclusion criteria
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1. Psychosis or learning difficulties (estimated intelligence quotient [IQ] below 70) or autistic spectrum disorder
2. Another mental health problem other than GAD that is more in need of treatment at the time of referral (such as severe depression)
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Anticipated start date
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01/01/2009
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Anticipated end date
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31/12/2010
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Status of trial
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Completed |
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Patient information material
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Not available in web format, please use the contact details below to request a patient information sheet
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Target number of participants
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Planned sample size: 40; UK sample size: 40
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Interventions
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Intervention: cognitive therapy for GAD as developed by Dugas and Robichaud but adapted for use with pre-pubertal children and adolescents. Treatment will be weekly, individual and child-focused.
Control: single face-to-face session with a therapist wherein the child and the family will be provided with psychoeducation about anxiety and its treatment, symptom monitoring forms, and a date for the first treatment session in 10 weeks time.
Study entry: single randomisation only
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Primary outcome measure(s)
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GAD diagnostic status, measured with DSM-IV at entry to the trial (pre-treatment), post-treatment (10 weeks) or post-wait/self-monitoring
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Secondary outcome measure(s)
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1. Worry frequency, measured with Penn State Worry Questionnaire for Children (PSWQ-C)
2. Quality of life as measured by the Paediatric Quality of Life Enjoyment and Satisfaction Questionnaire
Measured at baseline, mid-treatment (5 weeks), end of treatment (10 weeks) and at 3-month follow up assessment.
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Sources of funding
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National Institute for Health Research (NIHR) (UK) - Research for Patient Benefit (RfPB) programme (ref: PB-PG-0808-17094)
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Trial website
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Publications
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Contact name
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Dr
Sean
Perrin
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Address
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Psychology PO77
Institute of Psychiatry
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City/town
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London
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Zip/Postcode
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SE5 8AF
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Country
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United Kingdom
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Email
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sean.perrin@slam.nhs.uk
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Sponsor
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Kings College London (KCL) (UK)
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Address
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Strand
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City/town
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London
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Zip/Postcode
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WC2R 2LS
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Country
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United Kingdom
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Sponsor website:
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http://www.kcl.ac.uk/
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Date applied
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30/06/2010
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Last edited
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02/07/2010
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Date ISRCTN assigned
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30/06/2010
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