Internet-delivered CBT for Paediatric OCD

Karolinska Institute

Status

Completed

Conditions

Obsessive-Compulsive Disorder

Treatments

Behavioral: Internet-delivered cognitive behavioral therapy (ICBT)

Behavioral: Cognitive behavioral therapy (CBT)

Study type

Interventional

Funder types

Other

Identifiers

NCT03263546

REPN 2017/1070-31/1

Details and patient eligibility

About

The purpose of this study is to investigate if therapist-guided internet-delivered cognitive behavioral therapy (ICBT) in a stepped-care approach is an effective and cost-effective treatment in reducing OCD symptoms for children and adolescents compared to gold standard treatment (face-to-face CBT).

Full description

A randomized controlled non-inferiority trial comparing therapist-guided internet-delivered cognitive behavioral therapy (ICBT) in a stepped care model with face-to-face CBT for children and adolescents with obsessive-compulsive disorder (OCD).

Participants will be randomized to either stepped care ICBT or to gold standard face-to-face CBT. One group (stepped care) will be first offered ICBT for 16 weeks. Non-responders at the 3-month follow-up will receive additional face-to-face CBT. The other group (gold standard treatment) will be randomized directly to receive face-to-face CBT for 16 weeks. Non-responders will, as in the other group, receive additional face-to-face treatment after the 3-month follow-up. The primary endpoint will be at 6-month follow-up. Long-term effects are also investigated (1 year, 2 years and 5 years after treatment completion).

The primary objective is to evaluate whether ICBT in a stepped care approach will be non-inferior to gold standard treatment (face-to-face CBT) in reducing OCD symptoms, depression, impairment, sleep problems, health and functioning. The secondary objective is to a) carry out a full health economic evaluation and b) investigate if self-referred and referred participants differ regarding outcome in the two treatment groups.

The hypotheses are:

An ICBT stepped care approach will be non-inferior to gold standard treatment (face-to-face CBT) in reducing OCD symptoms.
The stepped care approach will be associated with lower costs, such as reduced therapist and administration times, service utilization, minimized work and school absence for families etc., compared to gold standard treatment.
Self-referred patients will benefit significantly better than referred patients regarding outcome in the ICBT group, but there will not be any difference in the face-to-face CBT group.

Enrollment

152 patients

Sex

All

Ages

7 to 17 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Primary DSM-5 diagnosis of OCD
Total score of ≥16 on the Children's Yale-Brown Obsessive-Compulsive Scale (CY-BOCS)
Age between 7 and 17 years
Ability to read and write Swedish and with access to a computer and use of internet.
Participants on psychotropic medication must had been on a stable dose for the last 6 weeks prior to baseline assessment. If the child is on medication for OCD, they will be requested to stay on stable doses for the duration of the trial.

Exclusion criteria

Organic brain disorders, global learning disabilities, autism spectrum disorder, psychosis, bipolar disorder and severe eating disorder.
Suicidal ideation
Not able to understand the basics of the ICBT self-help material, patient being housebound or in need of intensive- or in-patient treatment.
Having completed a course of CBT for OCD within the last 12 months (defined as at least 5 sessions CBT including exposure and response prevention).
Children with ongoing psychological treatment for OCD or another anxiety disorder will not be included in the study.