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

Sponsor
Eva Serlachius (Other)
Overall Status
Completed
CT.gov ID
NCT01809990
Collaborator
Region Stockholm (Other)
21
1
1
12
1.8

Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Internet-delivered Cognitive Behavior Therapy
N/A

Study Design

Study Type:
Interventional
Actual Enrollment :
21 participants
Allocation:
N/A
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
Study Start Date :
Jan 1, 2013
Actual Primary Completion Date :
Jan 1, 2014
Actual Study Completion Date :
Jan 1, 2014

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

  1. Children's Yale Brown Obsessive Compulsive Scale, CY-BOCS [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

  1. Spence Child Anxiety Scale - Child and Parent version [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.

  2. Child Depression Inventory [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).

  3. Strengths Difficulties Questionnaire [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

  4. Children's Obsessional Compulsive Inventory Revised [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.

  5. Child Obsessive-Compulsive Impact Scale - Revised [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

  1. Patient Health Questionnaire PHQ-9 [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.

  2. GAD-7 [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.

  3. Obsessive Compulsive Inventory - Revised [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.

  4. Family Accommodation Scale, Parent-Report [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
12 Years to 17 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Locations

Site City State Country Postal Code
1 Karolinska insititute Stockholm Sweden

Sponsors and Collaborators

  • Eva Serlachius
  • Region Stockholm

Investigators

  • Principal Investigator: Eva Serlachius, PhD, MD, Karolinska Institutet

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Eva Serlachius, PhD, Karolinska Institutet
ClinicalTrials.gov Identifier:
NCT01809990
Other Study ID Numbers:
  • BIPOCD1
First Posted:
Mar 13, 2013
Last Update Posted:
Jun 30, 2014
Last Verified:
Jun 1, 2014

Study Results

No Results Posted as of Jun 30, 2014