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

December 21, 2016 updated by: Eva Serlachius, Karolinska Institutet

Internet-delivered Cognitive Behavior Therapy for Adolescents With Obsessive-Compulsive Disorder: A Randomized Controlled Study

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Interventional

Enrollment (Actual)

67

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Sweden
      • Stockholm, Sweden, 171 77
        • Karolinska Institutet

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

12 years to 17 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Baseline, 12 weeks after treatment starts, 3 and 12 months after treatment has ended

Secondary Outcome Measures

Outcome Measure
Time Frame
Clinical Global Impression - Severity, CGI-S
Time Frame: Baseline, 12 weeks after treatment starts, 3 and 12 months after treatment has ended
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
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
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
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
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
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
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
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,
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
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
Baseline, 12 weeks after treatment starts, 3 and 12 months after treatment has ended

Other Outcome Measures

Outcome Measure
Time Frame
Measurement of homework adherence
Time Frame: Baseline, daily measurements until 12 weeks after baseline
Baseline, daily measurements until 12 weeks after baseline
Number of Participants with Adverse Events
Time Frame: 12 weeks after baseline
12 weeks after baseline
DNA samples (from blood and/or saliva)
Time Frame: Baseline
Baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Karolinska Institutet

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2014

Primary Completion (Actual)

March 1, 2016

Study Completion (Actual)

December 1, 2016

Study Registration Dates

First Submitted

July 3, 2014

First Submitted That Met QC Criteria

July 14, 2014

First Posted (Estimate)

July 16, 2014

Study Record Updates

Last Update Posted (Estimate)

December 22, 2016

Last Update Submitted That Met QC Criteria

December 21, 2016

Last Verified

December 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BiPOCD RCT

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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