Internet-delivered CBT for Paediatric OCD

NCT ID: NCT03263546

Last Updated: 2025-02-14

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 152 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-10-06
• Study Completion Date: 2024-11-25

Brief 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Stepped care

Internet-delivered cognitive behavioral therapy (ICBT)

Group Type: EXPERIMENTAL

Internet-delivered cognitive behavioral therapy (ICBT)

Intervention Type: BEHAVIORAL

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.

Gold standard treatment

Cognitive behavioral therapy (CBT)

Group Type: ACTIVE_COMPARATOR

Cognitive behavioral therapy (CBT)

Intervention Type: BEHAVIORAL

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.

Interventions

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.

Intervention Type: 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.

Intervention Type: BEHAVIORAL

Eligibility Criteria

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.

• Minimum Eligible Age: 7 Years
• Maximum Eligible Age: 17 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Region Stockholm

OTHER_GOV

Sponsor Role: collaborator

Vastra Gotaland Region

OTHER_GOV

Sponsor Role: collaborator

Karolinska Institutet

OTHER

Sponsor Role: lead

Responsible Party

Eva Serlachius

MD, associate professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Eva Serlachius, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Karolinska Institutet

Locations

BUP Specialmottagning

Gothenburg, , Sweden

Child and Adolescent Psychiatry (CAP) research center

Stockholm, , Sweden

Countries

Sweden

References

Aspvall K, Andersson E, Melin K, Norlin L, Eriksson V, Vigerland S, Jolstedt M, Silverberg-Morse M, Wallin L, Sampaio F, Feldman I, Bottai M, Lenhard F, Mataix-Cols D, Serlachius E. Effect of an Internet-Delivered Stepped-Care Program vs In-Person Cognitive Behavioral Therapy on Obsessive-Compulsive Disorder Symptoms in Children and Adolescents: A Randomized Clinical Trial. JAMA. 2021 May 11;325(18):1863-1873. doi: 10.1001/jama.2021.3839.

Reference Type: DERIVED

PMID: 33974020 (View on PubMed)

Aspvall K, Andersson E, Lenhard F, Melin K, Norlin L, Wallin L, Silverberg-Morse M, Feldman I, Bottai M, Mataix-Cols D, Serlachius E. Stepped Care Internet-Delivered vs Face-to-Face Cognitive-Behavior Therapy for Pediatric Obsessive-Compulsive Disorder: A Trial Protocol for a Randomized Noninferiority Trial. JAMA Netw Open. 2019 Oct 2;2(10):e1913810. doi: 10.1001/jamanetworkopen.2019.13810.

Reference Type: DERIVED

PMID: 31642928 (View on PubMed)

Other Identifiers

REPN 2017/1070-31/1

Identifier Type: -

Identifier Source: org_study_id