NCT03263546

Internet-delivered CBT for Paediatric OCD

Implementation of Internet-delivered Cognitive-behavior Therapy for Paediatric Obsessive-compulsive Disorder in the Clinic: a Randomized Stepped Care Non-inferiority Trial

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 152 (actual)
• Sponsor: Karolinska Institutet · Academic / Other
• Sex: All
• Age: 7 Years – 17 Years
• Healthy volunteers: Not accepted

Summary

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).

Detailed 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: 1. An ICBT stepped care approach will be non-inferior to gold standard treatment (face-to-face CBT) in reducing OCD symptoms. 2. 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. 3. 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.

Conditions

• Obsessive-Compulsive Disorder

Interventions

Type	Name	Description
BEHAVIORAL	Internet-delivered cognitive behavioral therapy (ICBT)	Participants will receive internet-delivered CBT with therapist support for 16 weeks. The treatment consists of 14 online chapters with interactive features as videos and illustrations. The treatment has the main focus on exposure with ritual prevention. The children and parents have regular contact with a personal assigned therapist via written text messages in the platform. Participants that are classified as non-responders at 3 months follow-up will receive face-to-face CBT of up to 12 sessions over 12 weeks.
BEHAVIORAL	Cognitive behavioral therapy (CBT)	Participants in the gold standard group will receive 14 individual face-to-face CBT sessions over 16 weeks. The treatment is based on current evidence based recommendations for OCD, and focuses on exposure with ritual prevention. Participants that are classified as non-responders at 3 months follow-up will receive additional face-to-face CBT of up to 12 sessions over 12 weeks.

Timeline

• Start date: 2017-10-06
• Primary completion: 2020-04-28
• Completion: 2024-11-25
• First posted: 2017-08-28
• Last updated: 2025-02-14

Locations

2 sites across 1 country: Sweden