Clinical trial NCT01809990: Internet-delivered CBT for Adolescents With Obsessive-Compulsive Disorder - a Pilot Study
Official title: Internet-delivered Cognitive Behavior Therapy for Adolescents With Obsessive-Compulsive Disorder - a Pilot Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obsessive-Compulsive Disorder
Keywords: cognitive behavior therapy
pediatric obsessive-compulsive disorder
internet-delivered cognitive behavior therapy
Lead sponsor: Karolinska Institutet
Sponsor class: OTHER
Collaborators: name: Region Stockholm
First posted: 2013-03-13
Enrollment: 21
Sex: ALL
Minimum age (years): 12
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The main goal of this trial is to study the feasibility and effectiveness of internet-delivered cognitive behavior therapy for adolescents with obsessive-compulsive disorder.


Eligibility criteria: Inclusion Criteria:

* a primary diagnosis of OCD as defined by DSM-IV TR
* a total score of above 15 on the 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
* signed informed consent

Exclusion Criteria:

* diagnosed autism spectrum disorder, psychosis or bipolar disorder
* suicidal ideation
* ongoing substance dependence
* subject not able to read or understand the basics of the ICBT self-help material
* completed CBT for OCD within last 12 months (defined as at least 5 sessions CBT including exposure and response prevention)
* ongoing psychological treatment for OCD or another anxiety disorder

Primary outcomes:
measure: Children's Yale Brown Obsessive Compulsive Scale, CY-BOCS
timeFrame: Baseline, 12 weeks after treatment starts, 3 and 6 months after treatment has ended
Secondary outcomes:
measure: Spence Child Anxiety Scale - Child and Parent version
timeFrame: Baseline, 12 weeks after treatment starts, 3 and 6 months after treatment has ended
measure: Child Depression Inventory
timeFrame: Baseline, 12 weeks after treatment starts, 3 and 6 months after treatment has ended
measure: Strengths Difficulties Questionnaire
timeFrame: Baseline, 12 weeks after treatment starts, 3 and 6 months after treatment has ended
measure: Children's Obsessional Compulsive Inventory Revised
timeFrame: Baseline, 12 weeks after treatment starts, 3 and 6 months after treatment has ended
measure: Child Obsessive-Compulsive Impact Scale - Revised
timeFrame: Baseline, 12 weeks after treatment starts, 3 and 6 months after treatment has ended
Other outcomes:
measure: Patient Health Questionnaire PHQ-9
timeFrame: Baseline, 12 weeks after treatment starts, 3 and 6 months after treatment has ended
measure: GAD-7
timeFrame: Baseline, 12 weeks after treatment starts, 3 and 6 months after treatment has ended
measure: Obsessive Compulsive Inventory - Revised
timeFrame: Baseline, 12 weeks after treatment starts, 3 and 6 months after treatment has ended
measure: Family Accommodation Scale, Parent-Report
timeFrame: Baseline, 12 weeks after treatment starts, 3 and 6 months after treatment has ended
Locations:
city: Stockholm
country: Sweden
facility: Karolinska insititute
Study officials:
affiliation: Karolinska Institutet
name: Eva Serlachius, PhD, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Flessner CA, Sapyta J, Garcia A, Freeman JB, Franklin ME, Foa E, March J. Examining the Psychometric Properties of the Family Accommodation Scale-Parent-Report (FAS-PR). J Psychopathol Behav Assess. 2009 Mar;31(1):38-46. doi: 10.1007/s10862-010-9196-3.
citation: Foa EB, Huppert JD, Leiberg S, Langner R, Kichic R, Hajcak G, Salkovskis PM. The Obsessive-Compulsive Inventory: development and validation of a short version. Psychol Assess. 2002 Dec;14(4):485-96.
citation: Goodman R. The Strengths and Difficulties Questionnaire: a research note. J Child Psychol Psychiatry. 1997 Jul;38(5):581-6. doi: 10.1111/j.1469-7610.1997.tb01545.x.
citation: Kovacs M. The Children's Depression, Inventory (CDI). Psychopharmacol Bull. 1985;21(4):995-8. No abstract available.
citation: Kroenke K, Spitzer RL, Williams JB. The PHQ-9: validity of a brief depression severity measure. J Gen Intern Med. 2001 Sep;16(9):606-13. doi: 10.1046/j.1525-1497.2001.016009606.x.
citation: Piacentini J, Peris TS, Bergman RL, Chang S, Jaffer M. Functional impairment in childhood OCD: development and psychometrics properties of the Child Obsessive-Compulsive Impact Scale-Revised (COIS-R). J Clin Child Adolesc Psychol. 2007 Oct-Dec;36(4):645-53. doi: 10.1080/15374410701662790.
citation: Scahill L, Riddle MA, McSwiggin-Hardin M, Ort SI, King RA, Goodman WK, Cicchetti D, Leckman JF. Children's Yale-Brown Obsessive Compulsive Scale: reliability and validity. J Am Acad Child Adolesc Psychiatry. 1997 Jun;36(6):844-52. doi: 10.1097/00004583-199706000-00023.
citation: Shafran R, Frampton I, Heyman I, Reynolds M, Teachman B, Rachman S. The preliminary development of a new self-report measure for OCD in young people. J Adolesc. 2003 Feb;26(1):137-42. doi: 10.1016/s0140-1971(02)00083-0.
citation: Spence SH. A measure of anxiety symptoms among children. Behav Res Ther. 1998 May;36(5):545-66. doi: 10.1016/s0005-7967(98)00034-5.
citation: Spitzer RL, Kroenke K, Williams JB, Lowe B. A brief measure for assessing generalized anxiety disorder: the GAD-7. Arch Intern Med. 2006 May 22;166(10):1092-7. doi: 10.1001/archinte.166.10.1092.
citation: Lenhard F, Vigerland S, Andersson E, Ruck C, Mataix-Cols D, Thulin U, Ljotsson B, Serlachius E. Internet-delivered cognitive behavior therapy for adolescents with obsessive-compulsive disorder: an open trial. PLoS One. 2014 Jun 20;9(6):e100773. doi: 10.1371/journal.pone.0100773. eCollection 2014.