Internet-delivered CBT for Paediatric OCD

February 12, 2025 updated by: Eva Serlachius, Karolinska Institutet

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

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).

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
152

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Sweden
      • Göteborg, Sweden
        • BUP Specialmottagning
      • Stockholm, Sweden, 11330
        • Child and Adolescent Psychiatry (CAP) research center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

7 years to 17 years (Child)

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Stepped care
Internet-delivered cognitive behavioral therapy (ICBT)
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.
Active Comparator: Gold standard treatment
Cognitive behavioral therapy (CBT)
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Children's Yale Brown Obsessive-Compulsive Scale (CY-BOCS)
Time Frame: week 0, week 16, at 3 and 6 months follow-up, at 1, 2 and 5 years follow-up.
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 Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Clinical global impression severity (CGI-S)
Time Frame: week 0, week 16, at 3 and 6 months follow-up, at 1, 2 and 5 years follow-up
Change in global severity from baseline to week 16 and 3 and 6 months after treatment has ended, and at 1, 2 and 5 years follow-up.
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)
Time Frame: week 16, at 3 and 6 months follow-up, at 1, 2 and 5 years follow-up
Change in global improvement from week 16 to 3 and 6 months after treatment has ended, and at 1, 2 and 5 years follow-up.
week 16, at 3 and 6 months follow-up, at 1, 2 and 5 years follow-up
Children's global assessment scale (C-GAS)
Time Frame: week 0, week 16, at 3 and 6 months follow-up, at 1 year follow-up
Change in global functioning from baseline to week 16 and 3 and 6 months after treatment has ended, and at 1 year follow-up.
week 0, week 16, at 3 and 6 months follow-up, at 1 year follow-up
Obsessive-compulsive inventory - child version (OCI-CV)
Time Frame: week 0, week 16, at 3 and 6 months follow-up, at 1 year follow-up, and weekly during treatment
Change in child-rated OCD symptoms from baseline to week 16 and 3 and 6 months after treatment has ended, at 1 year follow-up, and weekly during treatment.
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)
Time Frame: week 0, week 16, at 3 and 6 months follow-up, at 1 year follow-up
Change in general health from baseline to week 16 and 3 and 6 months after treatment has ended, and at 1 year follow-up.
week 0, week 16, at 3 and 6 months follow-up, at 1 year follow-up
Insomnia Severity Index (ISI)
Time Frame: week 0, week 16, at 3 and 6 months follow-up, at 1 year follow-up
Change in sleep problems from baseline to week 16 and 3 and 6 months after treatment has ended, and at 1 year follow-up
week 0, week 16, at 3 and 6 months follow-up, at 1 year follow-up
Children's Obsessional Compulsive Inventory Revised - parent version (ChOCI-R)
Time Frame: week 0, week 16, at 3 and 6 months follow-up, at 1 year follow-up, and weekly during treatment
Change in parent-rated OCD symptoms from baseline to week 16 and 3 and 6 months after treatment has ended, at 1 year follow-up, and weekly during treatment.
week 0, week 16, at 3 and 6 months follow-up, at 1 year follow-up, and weekly during treatment
Family accommodation scale for obsessive-compulsive disorder - self-rated version (FAS-SR)
Time Frame: week 0, week 16, at 3 and 6 months follow-up, at 1 year follow-up
Change in parent-rated family accommodation from baseline to week 16 and 3 and 6 months after treatment has ended, and at 1 year follow-up
week 0, week 16, at 3 and 6 months follow-up, at 1 year follow-up
Trimbos/iMTA questionnaire for Costs associated with Psychiatric Illness (TiC-P)
Time Frame: week 0, week 16, at 3 and 6 months follow-up, at 1, 2 and 5 years follow-up.
Change in economic costs from baseline to week 16 and 3 and 6 months after treatment has ended, and at 1, 2 and 5 years follow-up.
week 0, week 16, at 3 and 6 months follow-up, at 1, 2 and 5 years follow-up.
Mood and Feeling Questionnaire (MFQ)
Time Frame: week 0, week 16, at 3 and 6 months follow-up, at 1 year follow-up
Change in child and parent rated depressive symptoms from baseline to week 16 and 3 and 6 months after treatment has ended, and at 1 year follow-up
week 0, week 16, at 3 and 6 months follow-up, at 1 year follow-up
Education, work and social adjustment scale (EWSAS)
Time Frame: week 0, week 16, at 3 and 6 months follow-up, at 1 year follow-up
Change in child and parent rated impairment and functioning from baseline to week 16 and 3 and 6 months after treatment has ended, and at 1 year follow-up
week 0, week 16, at 3 and 6 months follow-up, at 1 year follow-up

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Autism Spectrum Quotient (AQ-10)
Time Frame: week 0
Measure of autistic symptoms at baseline
week 0
Treatment credibility and expectancy scale
Time Frame: week 2
Child and parent version. Investigate if both conditions have equal credibility in order to rule out placebo.
week 2
Working alliance inventory (WAI)
Time Frame: week 2
Child and parent version. Investigate if both conditions have equal working alliance in order to rule out non-specific factors.
week 2
Client Satisfaction Questionnaire (CSQ-8)
Time Frame: week 16 and at 6 months follow-up
Child and parent version. Investigate if both conditions have equal satisfaction.
week 16 and at 6 months follow-up
Patient EX/RP Adherence Scale (PEAS)
Time Frame: week 1, week 2, week 3, week 4, week 5, week 6, week 7, week 8, week 9, week 10, week 11, week 12, week 13, week 14, week 15, week 16
Clinician-rated version during face-to-face CBT. Self-rated version during both ICBT and face-to-face CBT. Investigate treatment adherence in both conditions.
week 1, week 2, week 3, week 4, week 5, week 6, week 7, week 8, week 9, week 10, week 11, week 12, week 13, week 14, week 15, week 16
internet intervention Patient Adherence Scale (iiPAS)
Time Frame: week 8 and 16
Investigate treatment adherence in the ICBT condition.
week 8 and 16
Parental strategy scale
Time Frame: week 1, week 2, week 3, week 4, week 5, week 6, week 7, week 8, week 9, week 10, week 11, week 12, week 13, week 14, week 15, week 16
Investigate the use of parental strategies weekly during treatment.
week 1, week 2, week 3, week 4, week 5, week 6, week 7, week 8, week 9, week 10, week 11, week 12, week 13, week 14, week 15, week 16

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Karolinska Institutet

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Vastra Gotaland Region
Region Stockholm

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Eva Serlachius, MD, PhD, Karolinska Institutet

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 6, 2017

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
April 28, 2020

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
November 25, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 18, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 23, 2017

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 28, 2017

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 25, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 12, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • REPN 2017/1070-31/1

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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