Obsessive-Compulsive DisorderNCT02663167
Internet-based Cognitive-behavior Therapy for Children With Obsessive-compulsive Disorder
A study testing Internet-delivered Cognitive Behavioral Therapy in people with Obsessive-Compulsive Disorder, run by Karolinska Institutet at 1 site in Sweden.
Trial summary
The purpose of this study is to evaluate the feasibility and effectiveness of Internet-delivered Cognitive Behavior Therapy (ICBT) for children (7-11 years) with Obsessive-Compulsive Disorder (OCD). Read more about this study
- Who is it for?
- Ages 7 to 11 years
- Conditions the study is for
- Obsessive-Compulsive Disorder
- What is being tested?
- Internet-delivered Cognitive Behavioral Therapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 11 participants
- Where
- 1 siteSweden
- Study dates
- Jan 2016to Oct 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 7 to 11 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Primary DSM-5 diagnosis of OCD
- Total score of ≥16 on the Children's Yale-Brown Obsessive-Compulsive Scale (CY-BOCS)
- Age between 7-11 years
- Ability to understand Swedish
- Daily access to the Internet
- A parent that can co-participate in the treatment
- Participants on psychotropic medication must had been on a stable dose for the last 6 weeks prior to baseline assessment
Who cannot join
- Diagnosed autism spectrum disorder, psychosis, bipolar disorder, severe eating disorder, organic brain disorder, learning disability
- Suicidal ideation
- Not able to understand the basics of the ICBT self-help material
- Have completed a course of CBT for OCD within last 12 months (defined as at least 5 sessions CBT including exposure and response prevention)
- On-going psychological treatment for OCD or another anxiety disorder
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Internet-based Cognitive-behavior Therapy for Children With Obsessive-compulsive Disorder: a Pilot Trial
The purpose of this study is to evaluate the feasibility and effectiveness of Internet-delivered Cognitive Behavior Therapy (ICBT) for children (7-11 years) with Obsessive-Compulsive Disorder (OCD).
Read the detailed description
The primary objective of this study is to investigate if Internet-delivered Cognitive Behavior Therapy (ICBT) is a feasible and effective treatment for children (7-11 years) with Obsessive-Compulsive Disorder (OCD). The design of the study is a pilot study with 16 participants. The treatment duration is 12 weeks. The primary outcome measure is the Children's Yale-Brown Obsessive Compulsive Scale (CY-BOCS). Study participants will be followed up 3 months after treatment.
- Conditions
- Obsessive-Compulsive Disorder
- Being tested
- Internet-delivered Cognitive Behavioral Therapy
- Medical subject headings
- Obsessive-Compulsive Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Internet-delivered Cognitive Behavioral TherapyBehavioural
The treatment consists of a standard cognitive behavioral therapy for obsessive-compulsive disorder. The treatment is delivered through an Internet platform. The child and his/her parent(s) work through the treatment with regular therapist contact several times per week.
| Study group | Role | What they receive |
|---|---|---|
| Internet-delivered Cognitive-Behavioral Therapy | Experimental | Not described Receives: Behavioral: Internet-delivered Cognitive Behavioral Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Children´s Yale Brown Compulsive Scale (CY-BOCS)
Change in obsessions and compulsions from baseline to week 12 and at 3 months after treatment has ended
Measured: week 0, week 12, at 3 months follow up
Secondary outcomes (16)
Children's Global Assessment Scale (C-GAS)
Measured: week 0, week 12, at 3 months follow up
Clinical Global Impression - Severity (CGI-S)
Measured: week 0, week 12, at 3 months follow up
Clinical Global Impression - Improvement (CGI-I)
Measured: week 12, at 3 months follow up
Obsessive-Compulsive Inventory - Child Version (OCI-CV)
Measured: week 0, week 12, at 3 months follow up and weekly during treatment
Children's Obsessional Compulsive Inventory Revised - Parent version (ChOCI-R-P)
Measured: week 0, week 12, at 3 months follow up and weekly during treatment
Family Accommodation Scale - Self Rated (FAS-SR)
Measured: week 0, week 12, at 3 months follow up
Euroqol - Youth (EQ-5D-Y)
Measured: week 0, week 12, at 3 months follow up
Autism Spectrum Quotient (AQ-10)
Measured: week 0
Education, Work and Social Adjustment Scale - child and parent version (EWSAS)
Measured: week 0, week 12, at 3 months follow up
Child Depression Inventory - Short version (CDI-S)
Measured: week 0, week 12, at 3 months follow up
Mood and Feeling Questionnaire - parent version (MFQ)
Measured: week 0, week 12, at 3 months follow up
Qualitative data on treatment credibility
Measured: week 3
Qualitative data on treatment satisfaction
Measured: week 12
Safety Monitoring Uniform Report Form (SMURF)
Measured: week 6, week 12
Internet Intervention Patient Adherence Scale (iiPAS)
Measured: week 6, week 12
Patient Exposure/Response prevention Adherence Scale (PEAS)
Measured: week 6, week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jan 2016 (estimated)
- Study startJan 2016
- Primary completionOct 2016
- Study completionOct 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Obsessive-Compulsive DisorderStudies of the same condition, open and under way.
- More trials run by Karolinska InstitutetThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 11 participants (actual)
Sponsor and investigators
- Lead sponsor
- Karolinska Institutet
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Eva Serlachius, Karolinska Institutet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02663167
- Sponsor's protocol ID
- REPN 2015/470-31
- Status last verified
- Nov 2016
- First submitted
- 21 Jan 2016
- Last updated
- 28 Nov 2016
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Nov 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Internet-based Cognitive-behavior Therapy for Children With Obsessive-compulsive Disorder: a Pilot Trial
- ClinicalTrials.gov ID
- NCT02663167
- Acronym / sponsor ID
- REPN 2015/470-31
- Conditions
- Obsessive-Compulsive Disorder
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 11 participants (actual)
- Lead sponsor
- Karolinska InstitutetUniversity, hospital or other
- Study start
- Jan 2016
- Primary completion
- Oct 2016 (actual)
- Study completion
- Oct 2016 (actual)
- First posted
- 26 Jan 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to evaluate the feasibility and effectiveness of Internet-delivered Cognitive Behavior Therapy (ICBT) for children (7-11 years) with Obsessive-Compulsive Disorder (OCD).
Detailed description
The primary objective of this study is to investigate if Internet-delivered Cognitive Behavior Therapy (ICBT) is a feasible and effective treatment for children (7-11 years) with Obsessive-Compulsive Disorder (OCD). The design of the study is a pilot study with 16 participants. The treatment duration is 12 weeks. The primary outcome measure is the Children's Yale-Brown Obsessive Compulsive Scale (CY-BOCS). Study participants will be followed up 3 months after treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Internet-delivered Cognitive-Behavioral Therapy | Experimental | Behavioral: Internet-delivered Cognitive Behavioral Therapy |
Who may qualify
- Ages
- 7 to 11 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (7 listed)
- Primary DSM-5 diagnosis of OCD
- Total score of ≥16 on the Children's Yale-Brown Obsessive-Compulsive Scale (CY-BOCS)
- Age between 7-11 years
- Ability to understand Swedish
- Daily access to the Internet
Key exclusion criteria (5 listed)
- Diagnosed autism spectrum disorder, psychosis, bipolar disorder, severe eating disorder, organic brain disorder, learning disability
- Suicidal ideation
- Not able to understand the basics of the ICBT self-help material
- Have completed a course of CBT for OCD within last 12 months (defined as at least 5 sessions CBT including exposure and response prevention)
- On-going psychological treatment for OCD or another anxiety disorder
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Internet-delivered Cognitive Behavioral TherapyThe treatment consists of a standard cognitive behavioral therapy for obsessive-compulsive disorder. The treatment is delivered through an Internet platform. The child and his/her parent(s) work through the treatment with regular therapist contact several times per week. | Behavioural | Internet-delivered Cognitive-Behavioral Therapy |
Primary outcome
Children´s Yale Brown Compulsive Scale (CY-BOCS)
Time frame: week 0, week 12, at 3 months follow up
Change in obsessions and compulsions from baseline to week 12 and at 3 months after treatment has ended
16 secondary outcomes
Children's Global Assessment Scale (C-GAS)
Time frame: week 0, week 12, at 3 months follow up
Clinical Global Impression - Severity (CGI-S)
Time frame: week 0, week 12, at 3 months follow up
Clinical Global Impression - Improvement (CGI-I)
Time frame: week 12, at 3 months follow up
Obsessive-Compulsive Inventory - Child Version (OCI-CV)
Time frame: week 0, week 12, at 3 months follow up and weekly during treatment
Children's Obsessional Compulsive Inventory Revised - Parent version (ChOCI-R-P)
Time frame: week 0, week 12, at 3 months follow up and weekly during treatment
Family Accommodation Scale - Self Rated (FAS-SR)
Time frame: week 0, week 12, at 3 months follow up
Euroqol - Youth (EQ-5D-Y)
Time frame: week 0, week 12, at 3 months follow up
Autism Spectrum Quotient (AQ-10)
Time frame: week 0
Education, Work and Social Adjustment Scale - child and parent version (EWSAS)
Time frame: week 0, week 12, at 3 months follow up
Child Depression Inventory - Short version (CDI-S)
Time frame: week 0, week 12, at 3 months follow up
Mood and Feeling Questionnaire - parent version (MFQ)
Time frame: week 0, week 12, at 3 months follow up
Qualitative data on treatment credibility
Time frame: week 3
Qualitative data on treatment satisfaction
Time frame: week 12
Safety Monitoring Uniform Report Form (SMURF)
Time frame: week 6, week 12
Internet Intervention Patient Adherence Scale (iiPAS)
Time frame: week 6, week 12
Patient Exposure/Response prevention Adherence Scale (PEAS)
Time frame: week 6, week 12
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Nov 2016.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Internet-delivered Cognitive Behavioral Therapy in people with Obsessive-Compulsive Disorder, run by Karolinska Institutet at 1 site in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Nov 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Children´s Yale Brown Compulsive Scale (CY-BOCS) (time frame: week 0, week 12, at 3 months follow up). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Nov 2016.