We're building a better ClinicalTrials.gov. Check it out and tell us what you think!
Try the New Site
We're building a modernized ClinicalTrials.gov! Visit Beta.ClinicalTrials.gov to try the new functionality.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Internet-delivered CBT for Adolescents With OCD: A Randomized Controlled Study (BiPOCD)

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.
 
ClinicalTrials.gov Identifier: NCT02191631
Recruitment Status : Completed
First Posted : July 16, 2014
Last Update Posted : December 22, 2016
Sponsor:
Information provided by (Responsible Party):
Eva Serlachius, Karolinska Institutet

Study Description
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Brief Summary:
The effect of Internet-delivered Cognitive Behavior Therapy (ICBT) on adolescents (12 to 17 years) with Obsessive-Compulsive Disorder is studied. Participants are randomized to either ICBT or a no-treatment condition. We expect ICBT to be superior over the no-treatment condition.

Condition or disease Intervention/treatment Phase
Obsessive-Compulsive Disorder Behavioral: Internet-delivered Cognitive Behavior Therapy Not Applicable

Detailed Description:
The primary objective of this study is to test the efficacy of Internet-delivered cognitive behavior therapy (ICBT) for adolescents (12 - 17 years) with OCD. We aim to conduct a randomized controlled study with N = 66 participants. Participants will be randomly assigned to ICBT or a wait list condition, either lasting 12 weeks. The primary outcome measure is the Children's Yale-Brown Obsessive Compulsive Scale (CY-BOCS). Study participants will be followed up 3 and 12 months after treatment. ICBT is expected to yield significantly better symptom reduction than the wait list condition.
Study Design
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 67 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Internet-delivered Cognitive Behavior Therapy for Adolescents With Obsessive-Compulsive Disorder: A Randomized Controlled Study
Study Start Date : August 2014
Actual Primary Completion Date : March 2016
Actual Study Completion Date : December 2016

Resource links provided by the National Library of Medicine


Arms and Interventions
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm Intervention/treatment
Experimental: Internet-delivered CBT
Participants will receive 12 weeks of internet-delivered cognitive behavior therapy with psychologist support.
 Behavioral: Internet-delivered Cognitive Behavior Therapy
The treatment consists of standard cognitive behavior therapy for obsessive-compulsive disorder and is delivered via an internet plattform and regular therapist contact several times per week via email and telephone. The treatment is 12 weeks.
No Intervention: Wait list
Participants will receive no treatment for 12 weeks. After that period participants will receive Internet-delivered Cognitive Behavior Therapy.


Outcome Measures
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. Children's Yale Brown Obsessive Compulsive Scale, CY-BOCS [ Time Frame: Baseline, 12 weeks after treatment starts, 3 and 12 months after treatment has ended ]
    Change from Baseline of obsessions and compulsions after 12 weeks and at 3- and 12 months after treatment


Secondary Outcome Measures :
  1. Clinical Global Impression - Severity, CGI-S [ Time Frame: Baseline, 12 weeks after treatment starts, 3 and 12 months after treatment has ended ]
  2. Clinical Global Impression - Improvement, CGI-I [ Time Frame: Baseline, 12 weeks after treatment starts, 3 and 12 months after treatment has ended ]
  3. Parent Adherence EX/RP Scale, PEAS [ Time Frame: Baseline, 6 and 12 weeks after treatment starts ]
  4. Children's Obsessional Compulsive Inventory Revised, (CHOCI-R, Shafran et al., 2003) [ Time Frame: Baseline, 12 weeks after treatment starts, 3 and 12 months after treatment has ended ]
  5. Education, Work and Social Adjustment Scale - child and parent version (EWSAS) [ Time Frame: Baseline, 12 weeks after treatment starts, 3 and 12 months after treatment has ended ]
  6. Spence Child Anxiety Scale - Child and Parent version (SCAS-C/P, Spence, 1998 [ Time Frame: Baseline, 12 weeks after treatment starts, 3 and 12 months after treatment has ended ]
  7. Child Depression Inventory - Short version (CDI-S, Kovacs, 1985) [ Time Frame: Baseline, 12 weeks after treatment starts, 3 and 12 months after treatment has ended ]
  8. Family Accommodation Scale, Parent-Report (FAS-PR, Flessner et al., 2009) [ Time Frame: Baseline, 12 weeks after treatment starts, 3 and 12 months after treatment has ended ]
  9. Technology acceptance scale [ Time Frame: Baseline, 6 and 12 weeks after treatment starts, ]
  10. Trimbos/iMTA questionnaire for Costs associated with Psychiatric Illness - Child version (TiC-P) [ Time Frame: Baseline, 12 weeks after treatment starts, 3 and 12 months after treatment has ended ]
  11. EQ-5D - quality of life [ Time Frame: Baseline, 12 weeks after treatment starts, 3 and 12 months after treatment has ended ]

Other Outcome Measures:
  1. Measurement of homework adherence [ Time Frame: Baseline, daily measurements until 12 weeks after baseline ]
  2. Number of Participants with Adverse Events [ Time Frame: 12 weeks after baseline ]
  3. DNA samples (from blood and/or saliva) [ Time Frame: Baseline ]

Eligibility Criteria
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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.


Layout table for eligibility information
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-5
  • a total score of ≥ 16 on the Children's Yale-Brown Obsessive-Compulsive Scale, 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

Exclusion Criteria:

  • diagnosed autism spectrum disorder, psychosis or bipolar disorder, severe eating disorder
  • suicidal ideation
  • ongoing substance dependence
  • subject not able to read or understand the basics of the ICBT material
  • completed CBT for OCD within last 12 months (defined as at least 5 sessions of CBT including exposure and response prevention)
  • ongoing psychological treatment for OCD or another anxiety disorder
Contacts and Locations
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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): NCT02191631


Locations
Layout table for location information
Sweden
Karolinska Institutet
Stockholm, Sweden, 171 77
Sponsors and Collaborators
Karolinska Institutet
Investigators
Layout table for investigator information
Principal Investigator: Eva Serlachius, MD, PhD Karolinska Institutet
More Information
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Layout table for additonal information
Responsible Party: Eva Serlachius, MD, PhD, Karolinska Institutet
ClinicalTrials.gov Identifier: NCT02191631    
Other Study ID Numbers: BiPOCD RCT
First Posted: July 16, 2014    Key Record Dates
Last Update Posted: December 22, 2016
Last Verified: December 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Keywords provided by Eva Serlachius, Karolinska Institutet:
OCD
adolescents
pediatric
 internet
online
CBT
Additional relevant MeSH terms:
Layout table for MeSH terms
Compulsive Personality Disorder
Obsessive-Compulsive Disorder
Personality Disorders
Mental Disorders
Anxiety Disorders