A pilot randomised controlled trial of an internet-based cognitive behavioral therapy (CBT) treatment for adolescent anxiety

ISRCTN	ISRCTN79652741
DOI	https://doi.org/10.1186/ISRCTN79652741
Secondary identifying numbers	12109

Submission date: 11/06/2012
Registration date: 11/06/2012
Last edited: 04/07/2018

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

Record updated in last year

Plain English summary of protocol

Background and study aims
The aim of this study is to evaluate the effectiveness of an internet-based cognitive behavioral therapy (CBT) treatment for adolescents with an anxiety disorder. We want to find out whether anxious adolescents who receive the internet-based CBT treatment experience an improvement in their symptoms of anxiety immediately following treatment and whether these treatment gains are maintained 6 months and 1 year later. We also want to find out whether parental over-protection and over-control reduces the impact of treatment.

Who can participate?
Adolescents (aged 13 to 18) who meet the diagnostic criteria for a primary anxiety disorder, and the parent who is their primary caregiver.

What does the study involve?
Participants are randomly allocated to receive either internet-based CBT, the same internet-based CBT with additional sessions for their parent, or to be put on a waiting list to be randomly allocated to receive one of the treatments at a later date. Assessments are conducted before and after treatment and at 6-month and one-year follow-up.

What are the possible benefits and risks of participating?
The benefit of taking part is receiving treatment for an anxiety disorder. There are no anticipated adverse effects of the treatment. Thirty participants will wait 10 weeks for treatment to begin. However, local clinical services typically have a wait of 10 weeks or more for treatment and participants are given contact details for the clinic and asked to get in contact if they have any concerns or if there is a deterioration in the adolescent's symptoms in that time. Successful treatment of anxiety may involve some distress. However, this will be managed and contained by the therapists, who will receive regular supervision from an experienced Clinical Psychologist.

Where is the study run from?
University of Reading (UK)

When is the study starting and how long is it expected to run for?
June 2012 to May 2013

Who is funding the study?
Medical Research Council (MRC) (UK)

Who is the main contact?
Dr Polly Waite
p.l.waite@reading.ac.uk

Contact information

Dr Polly Waite
Scientific

Department of Psychology
PO Box 238
Reading
RG6 6AL
United Kingdom

ORCID ID	0000-0002-1967-8028
Email	p.l.waite@reading.ac.uk

Study information

Study design	Randomised; Interventional; Design type: Treatment
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Hospital
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	A pilot randomised controlled trial of an internet-based cognitive behavioral therapy (CBT) treatment for adolescent anxiety
Study objectives	The study is a randomised controlled trial to evaluate the efficacy of an internet-based cognitive behavioral therapy (CBT) treatment for adolescents with an anxiety disorder. The purpose of this research is to evaluate the treatment and conduct a preliminary investigation of whether any family processes associated with adolescent anxiety are associated with treatment outcome. The study hypotheses are: 1. Anxious adolescents who receive an internet-based cognitive-behavioural treatment will be less likely to meet criteria for their primary anxiety diagnosis and be more likely to experience improvement in their symptoms of anxiety immediately post-treatment than a waitlist control group; and these treatment gains will be maintained at 6-month and one-year follow-up assessment. 2. Parental over-protection and over-control will moderate the impact of treatment that is, the more these parental characteristics are present, the less well the adolescents will fare in treatment.
Ethics approval(s)	NRES London - Brent, 30/01/2012, ref: 12/LO/0119MHRNB
Health condition(s) or problem(s) studied	Topic: Mental Health Research Network; Subtopic: Anxiety; Disease: Anxiety
Intervention	Adolescents will be randomised to receive either internet-based CBT (n=20), the same internet-based CBT with additional parental sessions (n=20), or waitlist control (n=20) 1. CBT for adolescent anxiety: 10 sessions of internet-based CBT for adolescent anxiety. 2. CBT adolescent anxiety + parents: 10 sessions of internet-based CBT for adolescent anxiety and 5 sessions of internet-based sessions for parents. 3. Once the waitlist period is completed, the waitlist group will be randomly allocated to receive one of the two treatments. Systematic assessments will also be conducted for the waitlist group once they have received treatment (to give total treated sample of n=60). Assessments will be conducted pre- and post-treatment and at 6-month and one-year follow-up.
Intervention type	Behavioural
Primary outcome measure	Clinical diagnoses; Timepoint(s): post-treatment and at 6-month and one-year follow-up
Secondary outcome measures	Added 12/04/2016: 1. Anxiety severity, measured by the ADIS-C/P 2. Self-report measure of anxiety symptoms (SCAS-C/P) 3. Impact of anxiety on the adolescent's life (CAIS-C/P) Timepoint(s): post-treatment and at 6-month and one-year follow-up
Overall study start date	01/06/2012
Completion date	01/05/2013

Eligibility

Participant type(s)	Patient
Age group	Child
Lower age limit	13 Years
Upper age limit	18 Years
Sex	Both
Target number of participants	Planned Sample Size: 60; UK Sample Size: 60
Key inclusion criteria	1. Current primary anxiety disorder identified as primary problem 2. Any psychoactive medication at a stable dose for at least two months before the initial assessment, with agreement to maintain that dose until after the laboratory assessment 3. Able to understand and speak English at an age-appropriate level 4. Parent who is primary caregiver and the person that the adolescent lives with (for the majority of the time) agrees to participate in the study 5. Target Gender: Male & Female; Upper Age Limit 18 years; Lower Age Limit 13 years
Key exclusion criteria	1. Presence of psychotic symptoms, substance dependence, a risk of deliberate self-harm, attention deficit hyperactivity disorder (ADHD), conduct disorder, an autistic spectrum disorder or learning problems that would interfere with their understanding and participation in the trial (based on school/clinic/parent information) 2. Currently receiving therapy for their anxiety disorder 3. Parent has a significant intellectual impairment (as evidenced by them receiving a service from the local learning disabilities service) Non-anxious adolescents: Parent has a significant intellectual impairment (as evidenced by them receiving a service from the local learning disabilities service)
Date of first enrolment	01/06/2012
Date of final enrolment	01/05/2013

Locations

Countries of recruitment

England
United Kingdom

Study participating centre

University of Reading

Reading
RG6 6AL
United Kingdom

Sponsor information

University of Reading (UK)
University/education

PO Box 238
Reading
RG6 6AL
England
United Kingdom

"ROR"	https://ror.org/05v62cm79

Funders

Funder type

Research council

Medical Research Council (MRC) (UK) Grant Codes: G1002011
Government organisation / National government

Alternative name(s): Medical Research Council (United Kingdom), UK Medical Research Council, MRC
Location: United Kingdom

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Stored in repository
Publication and dissemination plan	The trialists aim to publish the results in 2016
IPD sharing plan

Editorial Notes

04/07/2018: No publications found, verifying study status with principal investigator