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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Stockholm County Council, Sweden
Information provided by (Responsible Party):
Eva Serlachius, Karolinska Institutet
ClinicalTrials.gov Identifier:
NCT01809990
First received: February 17, 2013
Last updated: November 18, 2013
Last verified: March 2013
  Purpose

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.


Condition Intervention
Obsessive-Compulsive Disorder
Behavioral: Internet-delivered Cognitive Behavior Therapy

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Internet-delivered Cognitive Behavior Therapy for Adolescents With Obsessive-Compulsive Disorder - a Pilot Study

Resource links provided by NLM:


Further study details as provided by Karolinska Institutet:

Primary Outcome Measures:
  • Children's Yale Brown Obsessive Compulsive Scale, CY-BOCS [ Time Frame: Baseline, 12 weeks after treatment starts, 3 and 6 months after treatment has ended ] [ Designated as safety issue: No ]
    Change from Baseline of obsessions and compulsions after 12 weeks and at 3- and 6 months after treatment.


Secondary Outcome Measures:
  • Spence Child Anxiety Scale - Child and Parent version [ Time Frame: Baseline, 12 weeks after treatment starts, 3 and 6 months after treatment has ended ] [ Designated as safety issue: No ]
    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.

  • Child Depression Inventory [ Time Frame: Baseline, 12 weeks after treatment starts, 3 and 6 months after treatment has ended ] [ Designated as safety issue: No ]
    Symptom severity of depression in the adolescent will be assessed with Child Depression Inventory (CDI, Kovacs, 1985).

  • Strengths Difficulties Questionnaire [ Time Frame: Baseline, 12 weeks after treatment starts, 3 and 6 months after treatment has ended ] [ Designated as safety issue: No ]
    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

  • Children's Obsessional Compulsive Inventory Revised [ Time Frame: Baseline, 12 weeks after treatment starts, 3 and 6 months after treatment has ended ] [ Designated as safety issue: No ]
    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.

  • Child Obsessive-Compulsive Impact Scale - Revised [ Time Frame: Baseline, 12 weeks after treatment starts, 3 and 6 months after treatment has ended ] [ Designated as safety issue: No ]
    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.


Other Outcome Measures:
  • Patient Health Questionnaire PHQ-9 [ Time Frame: Baseline, 12 weeks after treatment starts, 3 and 6 months after treatment has ended ] [ Designated as safety issue: No ]
    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.

  • GAD-7 [ Time Frame: Baseline, 12 weeks after treatment starts, 3 and 6 months after treatment has ended ] [ Designated as safety issue: No ]
    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.

  • Obsessive Compulsive Inventory - Revised [ Time Frame: Baseline, 12 weeks after treatment starts, 3 and 6 months after treatment has ended ] [ Designated as safety issue: No ]
    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.

  • Family Accommodation Scale, Parent-Report [ Time Frame: Baseline, 12 weeks after treatment starts, 3 and 6 months after treatment has ended ] [ Designated as safety issue: No ]
    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.


Estimated Enrollment: 30
Study Start Date: January 2013
Estimated Study Completion Date: January 2014
Estimated Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   12 Years to 17 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01809990

Locations
Sweden
Karolinska insititute
Stockholm, Sweden
Sponsors and Collaborators
Eva Serlachius
Stockholm County Council, Sweden
Investigators
Principal Investigator: Eva Serlachius, PhD, MD Karolinska Institutet
  More Information

Publications:
Responsible Party: Eva Serlachius, PhD, Karolinska Institutet
ClinicalTrials.gov Identifier: NCT01809990     History of Changes
Other Study ID Numbers: BIPOCD1
Study First Received: February 17, 2013
Last Updated: November 18, 2013
Health Authority: Sweden: The National Board of Health and Welfare

Keywords provided by Karolinska Institutet:
cognitive behavior therapy
pediatric obsessive-compulsive disorder
internet-delivered cognitive behavior therapy

Additional relevant MeSH terms:
Obsessive-Compulsive Disorder
Compulsive Personality Disorder
Anxiety Disorders
Mental Disorders
Personality Disorders

ClinicalTrials.gov processed this record on April 17, 2014