Internet-delivered CBT for Adolescents With OCD: A Randomized Controlled Study

Not Applicable

Completed

• Conditions: Obsessive-Compulsive Disorder
• Interventions: Behavioral: Internet-delivered Cognitive Behavior Therapy

• Registration Number: NCT02191631
• Lead Sponsor: Karolinska Institutet

Brief 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.

Detailed 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.

Study Timeline

• Study First Submitted: 2014-07-03
• Study First Submitted QC: 2014-07-14
• Study First Posted: 2014-07-16
• Study Start: 2014-08
• Primary Completion: 2016-03
• Status Verified: 2016-12
• Study Completion: 2016-12
• Last Update Submitted: 2016-12-21
• Last Update Posted: 2016-12-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 67

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Internet-delivered CBT	Internet-delivered Cognitive Behavior Therapy	Participants will receive 12 weeks of internet-delivered cognitive behavior therapy with psychologist support.

Primary Outcome Measures

Name	Time	Method
Children's Yale Brown Obsessive Compulsive Scale, CY-BOCS	Baseline, 12 weeks after treatment starts, 3 and 12 months after treatment has ended	Change from Baseline of obsessions and compulsions after 12 weeks and at 3- and 12 months after treatment

Secondary Outcome Measures

Name	Time	Method
Clinical Global Impression - Improvement, CGI-I	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)	Baseline, 12 weeks after treatment starts, 3 and 12 months after treatment has ended
EQ-5D - quality of life	Baseline, 12 weeks after treatment starts, 3 and 12 months after treatment has ended
Parent Adherence EX/RP Scale, PEAS	Baseline, 6 and 12 weeks after treatment starts
Children's Obsessional Compulsive Inventory Revised, (CHOCI-R, Shafran et al., 2003)	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)	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	Baseline, 12 weeks after treatment starts, 3 and 12 months after treatment has ended
Child Depression Inventory - Short version (CDI-S, Kovacs, 1985)	Baseline, 12 weeks after treatment starts, 3 and 12 months after treatment has ended
Technology acceptance scale	Baseline, 6 and 12 weeks after treatment starts,
Trimbos/iMTA questionnaire for Costs associated with Psychiatric Illness - Child version (TiC-P)	Baseline, 12 weeks after treatment starts, 3 and 12 months after treatment has ended
Clinical Global Impression - Severity, CGI-S	Baseline, 12 weeks after treatment starts, 3 and 12 months after treatment has ended

Trial Locations

Locations (1)

Karolinska Institutet; 🇸🇪 Stockholm, Sweden