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Internet-delivered CBT for Paediatric OCD

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ClinicalTrials.gov Identifier: NCT03263546
Recruitment Status : Active, not recruiting
First Posted : August 28, 2017
Last Update Posted : September 5, 2021
Sponsor:
Collaborators:
Region Stockholm
Vastra Gotaland Region
Information provided by (Responsible Party):
Eva Serlachius, Karolinska Institutet

Tracking Information
First Submitted Date  ICMJE August 18, 2017
First Posted Date  ICMJE August 28, 2017
Last Update Posted Date September 5, 2021
Actual Study Start Date  ICMJE October 6, 2017
Actual Primary Completion Date April 28, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 23, 2017)
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: August 23, 2017)
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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
  • 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.
  • 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
  • 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.
  • 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
  • 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
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures
 (submitted: August 23, 2017)
  • Autism Spectrum Quotient (AQ-10) [ Time Frame: week 0 ]
    Measure of autistic symptoms at baseline
  • 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.
  • 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.
  • 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.
  • 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.
  • internet intervention Patient Adherence Scale (iiPAS) [ Time Frame: week 8 and 16 ]
    Investigate treatment adherence in the ICBT condition.
  • 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.
Original Other Pre-specified Outcome Measures Same as current
 
Descriptive Information
Brief Title  ICMJE Internet-delivered CBT for Paediatric OCD
Official Title  ICMJE Implementation of Internet-delivered Cognitive-behavior Therapy for Paediatric Obsessive-compulsive Disorder in the Clinic: a Randomized Stepped Care Non-inferiority Trial
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Obsessive-Compulsive Disorder
Intervention  ICMJE
  • 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.

Study Arms  ICMJE
  • Experimental: Stepped care
    Internet-delivered cognitive behavioral therapy (ICBT)
    Intervention: Behavioral: Internet-delivered cognitive behavioral therapy (ICBT)
  • Active Comparator: Gold standard treatment
    Cognitive behavioral therapy (CBT)
    Intervention: Behavioral: Cognitive behavioral therapy (CBT)
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Actual Enrollment  ICMJE
 (submitted: August 23, 2017)
152
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 31, 2025
Actual Primary Completion Date April 28, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 7 Years to 17 Years   (Child)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Sweden
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03263546
Other Study ID Numbers  ICMJE REPN 2017/1070-31/1
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Eva Serlachius, Karolinska Institutet
Study Sponsor  ICMJE Karolinska Institutet
Collaborators  ICMJE
  • Region Stockholm
  • Vastra Gotaland Region
Investigators  ICMJE
Principal Investigator: Eva Serlachius, MD, PhD Karolinska Institutet
PRS Account Karolinska Institutet
Verification Date September 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP