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

Obsessive-Compulsive Disorder Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01809990
• Other study ID #: BIPOCD1
• Status: Completed
• Phase: N/A
• First received: February 17, 2013
• Last updated: June 27, 2014
• Start date: January 2013
• Est. completion date: January 2014

Study information

• Verified date: June 2014
• Source: Karolinska Institutet
• Contact: n/a
• Is FDA regulated: No
• Health authority: Sweden: The National Board of Health and Welfare
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 21
• Est. completion date: January 2014
• Est. primary completion date: January 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 12 Years to 17 Years

Eligibility

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 Design

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

Related Conditions & MeSH terms

• Compulsive Behavior
• Obsessive-Compulsive Disorder

Intervention

Behavioral:
• Internet-delivered Cognitive Behavior Therapy

Locations

Country	Name	City	State
Sweden	Karolinska insititute	Stockholm

Sponsors (2)

Lead Sponsor	Collaborator
Eva Serlachius	Stockholm County Council, Sweden

Country where clinical trial is conducted

Sweden, 

References & Publications (10)

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. — View 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. — View Citation

Goodman R. The Strengths and Difficulties Questionnaire: a research note. J Child Psychol Psychiatry. 1997 Jul;38(5):581-6. — View Citation

Kovacs M. The Children's Depression, Inventory (CDI). Psychopharmacol Bull. 1985;21(4):995-8. — View 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. — View 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. — View 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. — View 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. — View Citation

Spence SH. A measure of anxiety symptoms among children. Behav Res Ther. 1998 May;36(5):545-66. — View Citation

Spitzer RL, Kroenke K, Williams JB, Löwe B. A brief measure for assessing generalized anxiety disorder: the GAD-7. Arch Intern Med. 2006 May 22;166(10):1092-7. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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	No
Other	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	No
Other	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	No
Other	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	No
Primary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No