Internet-delivered CBT for Adolescents With Obsessive-Compulsive Disorder - a Pilot Study

Internet-delivered Cognitive Behavior Therapy for Adolescents With Obsessive-Compulsive Disorder - a Pilot Study

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.

Study Overview

• Status: Completed
• Conditions: Obsessive-Compulsive Disorder
• Intervention / Treatment: Behavioral: Internet-delivered Cognitive Behavior Therapy

• Study Type: Interventional
• Enrollment (Actual): 21
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Sweden
  • Stockholm, Sweden
    • Karolinska insititute

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 12 years to 17 years (CHILD)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: internet-delivered cognitive behavior therapy; Participants will be assigned to a 12 weeks internet-delivered cognitive behavior therapy program including therapist contact via an internet platform and telephone.	Behavioral: Internet-delivered Cognitive Behavior Therapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Children's Yale Brown Obsessive Compulsive Scale, CY-BOCS	Change from Baseline of obsessions and compulsions after 12 weeks and at 3- and 6 months after treatment.	Baseline, 12 weeks after treatment starts, 3 and 6 months after treatment has ended

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Spence Child Anxiety Scale - Child and Parent version	Spence Child Anxiety Scale - Child and Parent version (SCAS/P, Spence, 1998) will be used as a child and parent self-report measure of anxiety related psychopathology.	Baseline, 12 weeks after treatment starts, 3 and 6 months after treatment has ended
Child Depression Inventory	Symptom severity of depression in the adolescent will be assessed with Child Depression Inventory (CDI, Kovacs, 1985).	Baseline, 12 weeks after treatment starts, 3 and 6 months after treatment has ended
Strengths Difficulties Questionnaire	Strengths Difficulties Questionnaire (SDQ, Goodman, 1997) is a widely used self- and parent-report behavioral screening questionnaire with six subscales: emotional problems, conduct problems, hyperactivity-inattention, peer problems, prosocial behavior	Baseline, 12 weeks after treatment starts, 3 and 6 months after treatment has ended
Children's Obsessional Compulsive Inventory Revised	The Children's Obsessional Compulsive Inventory Revised, (CHOCI-R, Shafran et al., 2003) is a self- and parent-report measure of pediatric OCD symptom severity.	Baseline, 12 weeks after treatment starts, 3 and 6 months after treatment has ended
Child Obsessive-Compulsive Impact Scale - Revised	Child Obsessive-Compulsive Impact Scale - Revised (COIS-R, Piacentini, Peris, Bergman, Chang, & Jaffer, 2007) is a self- and parent-report scale of OCD symptom impact on everyday life.	Baseline, 12 weeks after treatment starts, 3 and 6 months after treatment has ended

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Patient Health Questionnaire PHQ-9	Patient Health Questionnaire PHQ-9 (Kroenke, Spitzer, & Williams, 2001) is a brief self-report measure of depressive symptoms in adults. PHQ-9 will be used to measure parental depressive symptoms.	Baseline, 12 weeks after treatment starts, 3 and 6 months after treatment has ended
GAD-7	GAD-7 (Spitzer, Kroenke, Williams, & Löwe, 2006) is a brief self-report measure of symptoms of general anxiety in adults. GAD-7 will be used to measure symptoms of anxiety in the parents.	Baseline, 12 weeks after treatment starts, 3 and 6 months after treatment has ended
Obsessive Compulsive Inventory - Revised	Obsessive Compulsive Inventory - Revised (OCI-R, Foa et al., 2002) is a reliable and valid 18-item self-report scale for screening of OCD in adults and will be used to measure parental OC symptoms of both parents.	Baseline, 12 weeks after treatment starts, 3 and 6 months after treatment has ended
Family Accommodation Scale, Parent-Report	Family Accommodation Scale, Parent-Report (FAS-PR, Flessner et al., 2009). The parent-report version of the FAS consists of 12 items focusing on accommodation behaviors of parents with a child with OCD.	Baseline, 12 weeks after treatment starts, 3 and 6 months after treatment has ended

Collaborators and Investigators

• Sponsor: Eva Serlachius
• Collaborators: Region Stockholm

Publications and helpful links

General Publications

• 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.
• 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.
• 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.
• 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.
• 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.
• Kovacs M. The Children's Depression, Inventory (CDI). Psychopharmacol Bull. 1985;21(4):995-8. No abstract available.
• 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.
• 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.
• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start: January 1, 2013
• Primary Completion (ACTUAL): January 1, 2014
• Study Completion (ACTUAL): January 1, 2014

Study Registration Dates

• First Submitted: February 17, 2013
• First Submitted That Met QC Criteria: March 11, 2013
• First Posted (ESTIMATE): March 13, 2013

Study Record Updates

• Last Update Posted (ESTIMATE): June 30, 2014
• Last Update Submitted That Met QC Criteria: June 27, 2014
• Last Verified: June 1, 2014

More Information

Terms related to this study

• Keywords: cognitive behavior therapy; pediatric obsessive-compulsive disorder; internet-delivered cognitive behavior therapy
• Additional Relevant MeSH Terms: Mental Disorders; Pathologic Processes; Personality Disorders; Anxiety Disorders; Disease; Compulsive Personality Disorder; Obsessive-Compulsive Disorder
• Other Study ID Numbers: BIPOCD1