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

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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

Tracking Information
First Submitted Date  ICMJE July 3, 2014
First Posted Date  ICMJE July 16, 2014
Last Update Posted Date December 22, 2016
Study Start Date  ICMJE August 2014
Actual Primary Completion Date March 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 14, 2014)
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
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: July 14, 2014)
  • Clinical Global Impression - Severity, CGI-S [ Time Frame: Baseline, 12 weeks after treatment starts, 3 and 12 months after treatment has ended ]
  • Clinical Global Impression - Improvement, CGI-I [ Time Frame: Baseline, 12 weeks after treatment starts, 3 and 12 months after treatment has ended ]
  • Parent Adherence EX/RP Scale, PEAS [ Time Frame: Baseline, 6 and 12 weeks after treatment starts ]
  • 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 ]
  • 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 ]
  • 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 ]
  • 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 ]
  • 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 ]
  • Technology acceptance scale [ Time Frame: Baseline, 6 and 12 weeks after treatment starts, ]
  • 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 ]
  • EQ-5D - quality of life [ Time Frame: Baseline, 12 weeks after treatment starts, 3 and 12 months after treatment has ended ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures
 (submitted: July 14, 2014)
  • Measurement of homework adherence [ Time Frame: Baseline, daily measurements until 12 weeks after baseline ]
  • Number of Participants with Adverse Events [ Time Frame: 12 weeks after baseline ]
  • DNA samples (from blood and/or saliva) [ Time Frame: Baseline ]
Original Other Pre-specified Outcome Measures Same as current
 
Descriptive Information
Brief Title  ICMJE Internet-delivered CBT for Adolescents With OCD: A Randomized Controlled Study
Official Title  ICMJE Internet-delivered Cognitive Behavior Therapy for Adolescents With Obsessive-Compulsive Disorder: A Randomized Controlled Study
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.
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 Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Obsessive-Compulsive Disorder
Intervention  ICMJE 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.
Study Arms  ICMJE
  • Experimental: Internet-delivered CBT
    Participants will receive 12 weeks of internet-delivered cognitive behavior therapy with psychologist support.
    Intervention: Behavioral: Internet-delivered Cognitive Behavior Therapy
  • No Intervention: Wait list
    Participants will receive no treatment for 12 weeks. After that period participants will receive Internet-delivered Cognitive Behavior Therapy.
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: December 21, 2016)
67
Original Estimated Enrollment  ICMJE
 (submitted: July 14, 2014)
66
Actual Study Completion Date  ICMJE December 2016
Actual Primary Completion Date March 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 12 Years to 17 Years   (Child)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Sweden
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02191631
Other Study ID Numbers  ICMJE BiPOCD RCT
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Responsible Party Eva Serlachius, Karolinska Institutet
Study Sponsor  ICMJE Karolinska Institutet
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Eva Serlachius, MD, PhD Karolinska Institutet
PRS Account Karolinska Institutet
Verification Date December 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP