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

This study has been completed.
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: June 27, 2014
Last verified: June 2014
  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.


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

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
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, see Learn About Clinical Studies.

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: June 27, 2014
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 July 29, 2014