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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01809990
First Posted: March 13, 2013
Last Update Posted: June 30, 2014
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Stockholm County Council, Sweden
Information provided by (Responsible Party):
Eva Serlachius, Karolinska Institutet
  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: None (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 Eva Serlachius, 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 ]
    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 ]
    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 ]
    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 ]
    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 ]
    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 ]
    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 ]
    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 ]
    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 ]
    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 ]
    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.


Enrollment: 21
Study Start Date: January 2013
Study Completion Date: January 2014
Primary Completion Date: January 2014 (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

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   12 Years to 17 Years   (Child)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Eva Serlachius, PhD, Karolinska Institutet
ClinicalTrials.gov Identifier: NCT01809990     History of Changes
Other Study ID Numbers: BIPOCD1
First Submitted: February 17, 2013
First Posted: March 13, 2013
Last Update Posted: June 30, 2014
Last Verified: June 2014

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

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