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Internet-based Cognitive-behavior Therapy for Children With Obsessive-compulsive Disorder

Primary Purpose

Obsessive-Compulsive Disorder

Status
Completed
Phase
Not Applicable
Locations
Sweden
Study Type
Interventional
Intervention
Internet-delivered Cognitive Behavioral Therapy
Sponsored by
Karolinska Institutet
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Obsessive-Compulsive Disorder

Eligibility Criteria

7 Years - 11 Years (Child)All SexesDoes not accept healthy volunteers

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 7-11 years
  • Ability to understand Swedish
  • Daily access to the Internet
  • A parent that can co-participate in the treatment
  • Participants on psychotropic medication must had been on a stable dose for the last 6 weeks prior to baseline assessment

Exclusion Criteria:

  • Diagnosed autism spectrum disorder, psychosis, bipolar disorder, severe eating disorder, organic brain disorder, learning disability
  • Suicidal ideation
  • Not able to understand the basics of the ICBT self-help material
  • Have completed a course of CBT for OCD within last 12 months (defined as at least 5 sessions CBT including exposure and response prevention)
  • On-going psychological treatment for OCD or another anxiety disorder

Sites / Locations

  • BUP CPF

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Internet-delivered Cognitive-Behavioral Therapy

Arm Description

Outcomes

Primary Outcome Measures

Children´s Yale Brown Compulsive Scale (CY-BOCS)
Change in obsessions and compulsions from baseline to week 12 and at 3 months after treatment has ended

Secondary Outcome Measures

Children's Global Assessment Scale (C-GAS)
Clinical Global Impression - Severity (CGI-S)
Clinical Global Impression - Improvement (CGI-I)
Obsessive-Compulsive Inventory - Child Version (OCI-CV)
Children's Obsessional Compulsive Inventory Revised - Parent version (ChOCI-R-P)
Family Accommodation Scale - Self Rated (FAS-SR)
Euroqol - Youth (EQ-5D-Y)
Autism Spectrum Quotient (AQ-10)
Education, Work and Social Adjustment Scale - child and parent version (EWSAS)
Child Depression Inventory - Short version (CDI-S)
Mood and Feeling Questionnaire - parent version (MFQ)
Qualitative data on treatment credibility
Qualitative data on treatment satisfaction
Safety Monitoring Uniform Report Form (SMURF)
Internet Intervention Patient Adherence Scale (iiPAS)
Patient Exposure/Response prevention Adherence Scale (PEAS)

Full Information

First Posted
January 21, 2016
Last Updated
November 25, 2016
Sponsor
Karolinska Institutet
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1. Study Identification

Unique Protocol Identification Number
NCT02663167
Brief Title
Internet-based Cognitive-behavior Therapy for Children With Obsessive-compulsive Disorder
Official Title
Internet-based Cognitive-behavior Therapy for Children With Obsessive-compulsive Disorder: a Pilot Trial
Study Type
Interventional

2. Study Status

Record Verification Date
November 2016
Overall Recruitment Status
Completed
Study Start Date
January 2016 (undefined)
Primary Completion Date
October 2016 (Actual)
Study Completion Date
October 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Karolinska Institutet

4. Oversight

5. Study Description

Brief Summary
The purpose of this study is to evaluate the feasibility and effectiveness of Internet-delivered Cognitive Behavior Therapy (ICBT) for children (7-11 years) with Obsessive-Compulsive Disorder (OCD).
Detailed Description
The primary objective of this study is to investigate if Internet-delivered Cognitive Behavior Therapy (ICBT) is a feasible and effective treatment for children (7-11 years) with Obsessive-Compulsive Disorder (OCD). The design of the study is a pilot study with 16 participants. The treatment duration is 12 weeks. The primary outcome measure is the Children's Yale-Brown Obsessive Compulsive Scale (CY-BOCS). Study participants will be followed up 3 months after treatment.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obsessive-Compulsive Disorder

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
11 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Internet-delivered Cognitive-Behavioral Therapy
Arm Type
Experimental
Intervention Type
Behavioral
Intervention Name(s)
Internet-delivered Cognitive Behavioral Therapy
Intervention Description
The treatment consists of a standard cognitive behavioral therapy for obsessive-compulsive disorder. The treatment is delivered through an Internet platform. The child and his/her parent(s) work through the treatment with regular therapist contact several times per week.
Primary Outcome Measure Information:
Title
Children´s Yale Brown Compulsive Scale (CY-BOCS)
Description
Change in obsessions and compulsions from baseline to week 12 and at 3 months after treatment has ended
Time Frame
week 0, week 12, at 3 months follow up
Secondary Outcome Measure Information:
Title
Children's Global Assessment Scale (C-GAS)
Time Frame
week 0, week 12, at 3 months follow up
Title
Clinical Global Impression - Severity (CGI-S)
Time Frame
week 0, week 12, at 3 months follow up
Title
Clinical Global Impression - Improvement (CGI-I)
Time Frame
week 12, at 3 months follow up
Title
Obsessive-Compulsive Inventory - Child Version (OCI-CV)
Time Frame
week 0, week 12, at 3 months follow up and weekly during treatment
Title
Children's Obsessional Compulsive Inventory Revised - Parent version (ChOCI-R-P)
Time Frame
week 0, week 12, at 3 months follow up and weekly during treatment
Title
Family Accommodation Scale - Self Rated (FAS-SR)
Time Frame
week 0, week 12, at 3 months follow up
Title
Euroqol - Youth (EQ-5D-Y)
Time Frame
week 0, week 12, at 3 months follow up
Title
Autism Spectrum Quotient (AQ-10)
Time Frame
week 0
Title
Education, Work and Social Adjustment Scale - child and parent version (EWSAS)
Time Frame
week 0, week 12, at 3 months follow up
Title
Child Depression Inventory - Short version (CDI-S)
Time Frame
week 0, week 12, at 3 months follow up
Title
Mood and Feeling Questionnaire - parent version (MFQ)
Time Frame
week 0, week 12, at 3 months follow up
Title
Qualitative data on treatment credibility
Time Frame
week 3
Title
Qualitative data on treatment satisfaction
Time Frame
week 12
Title
Safety Monitoring Uniform Report Form (SMURF)
Time Frame
week 6, week 12
Title
Internet Intervention Patient Adherence Scale (iiPAS)
Time Frame
week 6, week 12
Title
Patient Exposure/Response prevention Adherence Scale (PEAS)
Time Frame
week 6, week 12

10. Eligibility

Sex
All
Minimum Age & Unit of Time
7 Years
Maximum Age & Unit of Time
11 Years
Accepts Healthy Volunteers
No
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 7-11 years Ability to understand Swedish Daily access to the Internet A parent that can co-participate in the treatment Participants on psychotropic medication must had been on a stable dose for the last 6 weeks prior to baseline assessment Exclusion Criteria: Diagnosed autism spectrum disorder, psychosis, bipolar disorder, severe eating disorder, organic brain disorder, learning disability Suicidal ideation Not able to understand the basics of the ICBT self-help material Have completed a course of CBT for OCD within last 12 months (defined as at least 5 sessions CBT including exposure and response prevention) On-going psychological treatment for OCD or another anxiety disorder
Facility Information:
Facility Name
BUP CPF
City
Stockholm
ZIP/Postal Code
11330
Country
Sweden

12. IPD Sharing Statement

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Internet-based Cognitive-behavior Therapy for Children With Obsessive-compulsive Disorder

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