Cognitive therapy for generalised anxiety in youth

ISRCTN	ISRCTN50951795
DOI	https://doi.org/10.1186/ISRCTN50951795
Secondary identifying numbers	8202

Submission date: 30/06/2010
Registration date: 30/06/2010
Last edited: 04/06/2019

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Mental and Behavioural Disorders

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr Sean Perrin
Scientific

Department of Psychology
Box 213 Lund University
Lund
221 00
Sweden

Email	sean.perrin@psy.lu.se

Study information

Study design	Single centre randomised interventional treatment trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	GP practice
Study type	Treatment
Participant information sheet	Not available in web format, please use the contact details below to request a patient information sheet
Scientific title	Cognitive therapy for generalised anxiety disorder in children and young people: a pilot randomised controlled trial and qualitative investigation of their experience of treatment
Study objectives	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. On 04/02/2014 the anticipated end date was changed from 31/12/2010 to 30/11/2013. Publication of trial findings is expected in 2014.
Ethics approval(s)	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)
Health condition(s) or problem(s) studied	Topic: Mental Health Research Network; Subtopic: Anxiety; Disease: Anxiety
Intervention	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
Intervention type	Other
Primary outcome measure	GAD diagnostic status, measured with DSM-IV at entry to the trial (pre-treatment), post-treatment (10 weeks) or post-wait/self-monitoring
Secondary outcome measures	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.
Overall study start date	01/01/2009
Completion date	30/11/2013

Eligibility

Participant type(s)	Patient
Age group	Child
Lower age limit	10 Years
Upper age limit	18 Years
Sex	Both
Target number of participants	Planned sample size: 40; UK sample size: 40
Total final enrolment	40
Key inclusion criteria	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
Key exclusion criteria	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)
Date of first enrolment	01/01/2009
Date of final enrolment	30/11/2013

Locations

Countries of recruitment

Sweden
United Kingdom

Study participating centre

Lund University

Lund
221 00
Sweden

Sponsor information

King's College London (KCL) (UK)
University/education

Strand
London
WC2R 2LS
England
United Kingdom

Website	http://www.kcl.ac.uk/
"ROR"	https://ror.org/0220mzb33

Funders

Funder type

Government

Research for Patient Benefit Programme (ref: PB-PG-0808-17094)
Government organisation / National government

Alternative name(s): NIHR Research for Patient Benefit Programme, RfPB
Location: United Kingdom

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	01/12/2019	04/06/2019	Yes	No
HRA research summary			28/06/2023	No	No

Editorial Notes

04/06/2019: The following changes have been made:
1. Publication reference added.
2. The final enrolment has been added.
22/01/2019: Internal review.
28/10/2016: No publications found, verifying study status with principal investigator