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Completed

NCT Number: NCT02663167

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

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).

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Key information

Conditions

Obsessive-Compulsive Disorder Anxiety Disorders Mental Disorders

Age range

7 year–11 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

BUP CPF

Stockholm, 11330, Sweden

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Internet-delivered cognitive behavioral therapy

Behavioral

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 outcomes

  1. Children´s Yale Brown Compulsive Scale (CY-BOCS)

    Time frame: week 0, week 12, at 3 months follow up

    Change in obsessions and compulsions from baseline to week 12 and at 3 months after treatment has ended

Secondary outcomes

  1. Children's Global Assessment Scale (C-GAS)

    Time frame: week 0, week 12, at 3 months follow up

  2. Clinical Global Impression - Severity (CGI-S)

    Time frame: week 0, week 12, at 3 months follow up

  3. Clinical Global Impression - Improvement (CGI-I)

    Time frame: week 12, at 3 months follow up

  4. Obsessive-Compulsive Inventory - Child Version (OCI-CV)

    Time frame: week 0, week 12, at 3 months follow up and weekly during treatment

  5. 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

  6. Family Accommodation Scale - Self Rated (FAS-SR)

    Time frame: week 0, week 12, at 3 months follow up

  7. Euroqol - Youth (EQ-5D-Y)

    Time frame: week 0, week 12, at 3 months follow up

  8. Autism Spectrum Quotient (AQ-10)

    Time frame: week 0

  9. Education, Work and Social Adjustment Scale - child and parent version (EWSAS)

    Time frame: week 0, week 12, at 3 months follow up

  10. Child Depression Inventory - Short version (CDI-S)

    Time frame: week 0, week 12, at 3 months follow up

  11. Mood and Feeling Questionnaire - parent version (MFQ)

    Time frame: week 0, week 12, at 3 months follow up

  12. Qualitative data on treatment credibility

    Time frame: week 3

  13. Qualitative data on treatment satisfaction

    Time frame: week 12

  14. Safety Monitoring Uniform Report Form (SMURF)

    Time frame: week 6, week 12

  15. Internet Intervention Patient Adherence Scale (iiPAS)

    Time frame: week 6, week 12

  16. Patient Exposure/Response prevention Adherence Scale (PEAS)

    Time frame: week 6, week 12

Sponsors and collaborators

Lead sponsor

Karolinska Institutet

Other

Registry information

Official study title

Internet-based Cognitive-behavior Therapy for Children With Obsessive-compulsive Disorder: a Pilot Trial

Important dates

Study start
2016
Primary completion
2016
Study completion
2016
First posted
Jan 26, 2016
Registry last updated
Nov 28, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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