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

Obsessive-Compulsive Disorder Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02663167
• Other study ID #: REPN 2015/470-31
• Status: Completed
• Phase: N/A
• First received: January 21, 2016
• Last updated: November 25, 2016
• Start date: January 2016
• Est. completion date: October 2016

Study information

• Verified date: November 2016
• Source: Karolinska Institutet
• Contact: n/a
• Is FDA regulated: No
• Health authority: Sweden: Ethical eview board Stockholm
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 11
• Est. completion date: October 2016
• Est. primary completion date: October 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 7 Years to 11 Years

Eligibility

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

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Compulsive Behavior
• Disease
• Obsessive-Compulsive Disorder

Intervention

Behavioral:
• Internet-delivered Cognitive Behavioral Therapy
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.

Locations

Country	Name	City	State
Sweden	BUP CPF	Stockholm

Sponsors (1)

Lead Sponsor	Collaborator
Karolinska Institutet

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	week 0, week 12, at 3 months follow up	No
Secondary	Children's Global Assessment Scale (C-GAS)		week 0, week 12, at 3 months follow up	No
Secondary	Clinical Global Impression - Severity (CGI-S)		week 0, week 12, at 3 months follow up	No
Secondary	Clinical Global Impression - Improvement (CGI-I)		week 12, at 3 months follow up	No
Secondary	Obsessive-Compulsive Inventory - Child Version (OCI-CV)		week 0, week 12, at 3 months follow up and weekly during treatment	No
Secondary	Children's Obsessional Compulsive Inventory Revised - Parent version (ChOCI-R-P)		week 0, week 12, at 3 months follow up and weekly during treatment	No
Secondary	Family Accommodation Scale - Self Rated (FAS-SR)		week 0, week 12, at 3 months follow up	No
Secondary	Euroqol - Youth (EQ-5D-Y)		week 0, week 12, at 3 months follow up	No
Secondary	Autism Spectrum Quotient (AQ-10)		week 0	No
Secondary	Education, Work and Social Adjustment Scale - child and parent version (EWSAS)		week 0, week 12, at 3 months follow up	No
Secondary	Child Depression Inventory - Short version (CDI-S)		week 0, week 12, at 3 months follow up	No
Secondary	Mood and Feeling Questionnaire - parent version (MFQ)		week 0, week 12, at 3 months follow up	No
Secondary	Qualitative data on treatment credibility		week 3	No
Secondary	Qualitative data on treatment satisfaction		week 12	No
Secondary	Safety Monitoring Uniform Report Form (SMURF)		week 6, week 12	No
Secondary	Internet Intervention Patient Adherence Scale (iiPAS)		week 6, week 12	No
Secondary	Patient Exposure/Response prevention Adherence Scale (PEAS)		week 6, week 12	No