Cognitive therapy for generalised anxiety in youth
| ISRCTN | ISRCTN50951795 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN50951795 |
| Protocol serial number | 8202 |
| Sponsor | King's College London (KCL) (UK) |
| Funder | Research for Patient Benefit Programme (ref: PB-PG-0808-17094) |
- 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
Scientific
Department of Psychology
Box 213 Lund University
Lund
221 00
Sweden
| sean.perrin@psy.lu.se |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Single centre randomised interventional treatment trial |
| Secondary study design | Randomised controlled trial |
| Study type | Participant 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(s) |
GAD diagnostic status, measured with DSM-IV at entry to the trial (pre-treatment), post-treatment (10 weeks) or post-wait/self-monitoring |
| Key secondary outcome measure(s) |
1. Worry frequency, measured with Penn State Worry Questionnaire for Children (PSWQ-C) |
| Completion date | 30/11/2013 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Child |
| Lower age limit | 10 Years |
| Upper age limit | 18 Years |
| Sex | All |
| Target sample size at registration | 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
- United Kingdom
- Sweden
Study participating centre
Lund University
Lund
221 00
Sweden
221 00
Sweden
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | |
| 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 | ||
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
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
