NCT03263546

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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
152

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Oct 2017

Longer than P75 for not_applicable

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 18, 2017

Completed
10 days until next milestone

First Posted

Study publicly available on registry

August 28, 2017

Completed
1 month until next milestone

Study Start

First participant enrolled

October 6, 2017

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 28, 2020

Completed
4.6 years until next milestone

Study Completion

Last participant's last visit for all outcomes

November 25, 2024

Completed
Last Updated

February 14, 2025

Status Verified

February 1, 2025

Enrollment Period

2.6 years

First QC Date

August 18, 2017

Last Update Submit

February 12, 2025

Conditions

Obsessive-Compulsive Disorder

Outcome Measures

Primary Outcomes (1)

  • Children's Yale Brown Obsessive-Compulsive Scale (CY-BOCS)

    Change in OCD symptom severity from baseline to week 16 and 3 and 6 months after treatment has ended, and at 1, 2 and 5 years follow-up. Primary endpoint is 6 months follow-up.

    week 0, week 16, at 3 and 6 months follow-up, at 1, 2 and 5 years follow-up.

Secondary Outcomes (11)

  • Clinical global impression severity (CGI-S)

    week 0, week 16, at 3 and 6 months follow-up, at 1, 2 and 5 years follow-up

  • Clinical global impression improvement (CGI-I)

    week 16, at 3 and 6 months follow-up, at 1, 2 and 5 years follow-up

  • Children's global assessment scale (C-GAS)

    week 0, week 16, at 3 and 6 months follow-up, at 1 year follow-up

  • Obsessive-compulsive inventory - child version (OCI-CV)

    week 0, week 16, at 3 and 6 months follow-up, at 1 year follow-up, and weekly during treatment

  • The Child Health Utility 9D (CHU9D)

    week 0, week 16, at 3 and 6 months follow-up, at 1 year follow-up

  • +6 more secondary outcomes

Other Outcomes (7)

  • Autism Spectrum Quotient (AQ-10)

    week 0

  • Treatment credibility and expectancy scale

    week 2

  • Working alliance inventory (WAI)

    week 2

  • +4 more other outcomes

Study Arms (2)

Stepped care

EXPERIMENTAL

Internet-delivered cognitive behavioral therapy (ICBT)

Behavioral: Internet-delivered cognitive behavioral therapy (ICBT)

Gold standard treatment

ACTIVE COMPARATOR

Cognitive behavioral therapy (CBT)

Behavioral: Cognitive behavioral therapy (CBT)

Interventions

Internet-delivered cognitive behavioral therapy (ICBT)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.

Stepped care
Cognitive behavioral therapy (CBT)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.

Gold standard treatment

Eligibility Criteria

Age7 Years - 17 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

BUP Specialmottagning

Gothenburg, Sweden

Location

Child and Adolescent Psychiatry (CAP) research center

Stockholm, 11330, Sweden

Location

Related Publications (2)

  • 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.

    PMID: 33974020DERIVED

  • 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.

    PMID: 31642928DERIVED

MeSH Terms

Conditions

Obsessive-Compulsive Disorder

Interventions

Cognitive Behavioral Therapy

Condition Hierarchy (Ancestors)

Anxiety DisordersMental Disorders

Intervention Hierarchy (Ancestors)

Behavior TherapyPsychotherapyBehavioral Disciplines and Activities

Study Officials

  • Eva Serlachius, MD, PhD

    Karolinska Institutet

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD, associate professor

Study Record Dates

First Submitted

August 18, 2017

First Posted

August 28, 2017

Study Start

October 6, 2017

Primary Completion

April 28, 2020

Study Completion

November 25, 2024

Last Updated

February 14, 2025

Record last verified: 2025-02

Data Sharing

IPD Sharing
Will not share

Locations

SE(2)