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

June 27, 2014 updated by: Eva Serlachius

Internet-delivered Cognitive Behavior Therapy for Adolescents With Obsessive-Compulsive Disorder - a Pilot Study

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
21

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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
        • Karolinska insititute

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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-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

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: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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 6 months after treatment has ended
Change from Baseline of obsessions and compulsions after 12 weeks and at 3- and 6 months after treatment.
Baseline, 12 weeks after treatment starts, 3 and 6 months after treatment has ended

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Spence Child Anxiety Scale - Child and Parent version
Time Frame: 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.
Baseline, 12 weeks after treatment starts, 3 and 6 months after treatment has ended
Child Depression Inventory
Time Frame: 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).
Baseline, 12 weeks after treatment starts, 3 and 6 months after treatment has ended
Strengths Difficulties Questionnaire
Time Frame: 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
Baseline, 12 weeks after treatment starts, 3 and 6 months after treatment has ended
Children's Obsessional Compulsive Inventory Revised
Time Frame: 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.
Baseline, 12 weeks after treatment starts, 3 and 6 months after treatment has ended
Child Obsessive-Compulsive Impact Scale - Revised
Time Frame: 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.
Baseline, 12 weeks after treatment starts, 3 and 6 months after treatment has ended

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Patient Health Questionnaire PHQ-9
Time Frame: 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.
Baseline, 12 weeks after treatment starts, 3 and 6 months after treatment has ended
GAD-7
Time Frame: 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.
Baseline, 12 weeks after treatment starts, 3 and 6 months after treatment has ended
Obsessive Compulsive Inventory - Revised
Time Frame: 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.
Baseline, 12 weeks after treatment starts, 3 and 6 months after treatment has ended
Family Accommodation Scale, Parent-Report
Time Frame: 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.
Baseline, 12 weeks after treatment starts, 3 and 6 months after treatment has ended

Collaborators and Investigators

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

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Eva Serlachius

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Region Stockholm

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

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 1, 2013

Primary Completion (ACTUAL)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
January 1, 2014

Study Completion (ACTUAL)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
January 1, 2014

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 17, 2013

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 11, 2013

First Posted (ESTIMATE)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 13, 2013

Study Record Updates

Last Update Posted (ESTIMATE)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 30, 2014

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 27, 2014

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • BIPOCD1

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