Overview

This trial is active, not recruiting.

Condition obsessive-compulsive disorder
Treatment internet-delivered cognitive behavior therapy
Sponsor Karolinska Institutet
Start date August 2014
End date March 2016
Trial size 66 participants
Trial identifier NCT02191631, BiPOCD RCT

Summary

The effect of Internet-delivered Cognitive Behavior Therapy (ICBT) on adolescents (12 to 17 years) with Obsessive-Compulsive Disorder is studied. Participants are randomized to either ICBT or a no-treatment condition. We expect ICBT to be superior over the no-treatment condition.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking single blind (outcomes assessor)
Primary purpose treatment
Arm
(Experimental)
Participants will receive 12 weeks of internet-delivered cognitive behavior therapy with psychologist support.
internet-delivered cognitive behavior therapy
The treatment consists of standard cognitive behavior therapy for obsessive-compulsive disorder and is delivered via an internet plattform and regular therapist contact several times per week via email and telephone. The treatment is 12 weeks.
(No Intervention)
Participants will receive no treatment for 12 weeks. After that period participants will receive Internet-delivered Cognitive Behavior Therapy.

Primary Outcomes

Measure
Children's Yale Brown Obsessive Compulsive Scale, CY-BOCS
time frame: Baseline, 12 weeks after treatment starts, 3 and 12 months after treatment has ended

Secondary Outcomes

Measure
Clinical Global Impression - Severity, CGI-S
time frame: Baseline, 12 weeks after treatment starts, 3 and 12 months after treatment has ended
Clinical Global Impression - Improvement, CGI-I
time frame: Baseline, 12 weeks after treatment starts, 3 and 12 months after treatment has ended
Parent Adherence EX/RP Scale, PEAS
time frame: Baseline, 6 and 12 weeks after treatment starts
Children's Obsessional Compulsive Inventory Revised, (CHOCI-R, Shafran et al., 2003)
time frame: Baseline, 12 weeks after treatment starts, 3 and 12 months after treatment has ended
Education, Work and Social Adjustment Scale - child and parent version (EWSAS)
time frame: Baseline, 12 weeks after treatment starts, 3 and 12 months after treatment has ended
Spence Child Anxiety Scale - Child and Parent version (SCAS-C/P, Spence, 1998
time frame: Baseline, 12 weeks after treatment starts, 3 and 12 months after treatment has ended
Child Depression Inventory - Short version (CDI-S, Kovacs, 1985)
time frame: Baseline, 12 weeks after treatment starts, 3 and 12 months after treatment has ended
Family Accommodation Scale, Parent-Report (FAS-PR, Flessner et al., 2009)
time frame: Baseline, 12 weeks after treatment starts, 3 and 12 months after treatment has ended
Technology acceptance scale
time frame: Baseline, 6 and 12 weeks after treatment starts,
Trimbos/iMTA questionnaire for Costs associated with Psychiatric Illness - Child version (TiC-P)
time frame: Baseline, 12 weeks after treatment starts, 3 and 12 months after treatment has ended
EQ-5D - quality of life
time frame: Baseline, 12 weeks after treatment starts, 3 and 12 months after treatment has ended

Eligibility Criteria

Male or female participants from 12 years up to 17 years old.

Inclusion Criteria: - a primary diagnosis of OCD as defined by DSM-5 - a total score of ≥ 16 on the Children's Yale-Brown Obsessive-Compulsive Scale, CY-BOCS - age between 12 and 17 years - ability to read and write Swedish - daily access to the internet - a parent that is able to co-participate in the treatment - Participants on psychotropic medication must have been on a stable dose for the last 6 weeks prior to baseline assessment Exclusion Criteria: - diagnosed autism spectrum disorder, psychosis or bipolar disorder, severe eating disorder - suicidal ideation - ongoing substance dependence - subject not able to read or understand the basics of the ICBT material - completed CBT for OCD within last 12 months (defined as at least 5 sessions of CBT including exposure and response prevention) - ongoing psychological treatment for OCD or another anxiety disorder

Additional Information

Official title Internet-delivered Cognitive Behavior Therapy for Adolescents With Obsessive-Compulsive Disorder: A Randomized Controlled Study
Principal investigator Eva Serlachius, MD, PhD
Description The primary objective of this study is to test the efficacy of Internet-delivered cognitive behavior therapy (ICBT) for adolescents (12 - 17 years) with OCD. We aim to conduct a randomized controlled study with N = 66 participants. Participants will be randomly assigned to ICBT or a wait list condition, either lasting 12 weeks. The primary outcome measure is the Children's Yale-Brown Obsessive Compulsive Scale (CY-BOCS). Study participants will be followed up 3 and 12 months after treatment. ICBT is expected to yield significantly better symptom reduction than the wait list condition.
Trial information was received from ClinicalTrials.gov and was last updated in September 2016.
Information provided to ClinicalTrials.gov by Karolinska Institutet.