Obsessive-Compulsive DisorderNCT03263546
Internet-delivered CBT for Paediatric OCD
A study testing Internet-delivered cognitive behavioral therapy (ICBT) and Cognitive behavioral therapy (CBT) in people with Obsessive-Compulsive Disorder, run by Karolinska Institutet at 2 sites in Sweden.
Trial summary
The purpose of this study is to investigate if therapist-guided internet-delivered cognitive behavioral therapy (ICBT) in a stepped-care approach is an effective and cost-effective treatment in reducing OCD symptoms for children and adolescents compared to gold standard treatment (face-to-face CBT). Read more about this study
- Who is it for?
- Ages 7 to 17 years
- Conditions the study is for
- Obsessive-Compulsive Disorder
- What is being tested?
- Internet-delivered cognitive behavioral therapy (ICBT) and Cognitive behavioral therapy (CBT)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 152 participants
- Where
- 2 sitesSweden
- Study dates
- 6 Oct 2017to 25 Nov 2024
- 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 17 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 and 17 years
- Ability to read and write Swedish and with access to a computer and use of internet.
- Participants on psychotropic medication must had been on a stable dose for the last 6 weeks prior to baseline assessment. If the child is on medication for OCD, they will be requested to stay on stable doses for the duration of the trial.
Who cannot join
- Organic brain disorders, global learning disabilities, autism spectrum disorder, psychosis, bipolar disorder and severe eating disorder.
- Suicidal ideation
- Not able to understand the basics of the ICBT self-help material, patient being housebound or in need of intensive- or in-patient treatment.
- Having completed a course of CBT for OCD within the last 12 months (defined as at least 5 sessions CBT including exposure and response prevention).
- Children with ongoing psychological treatment for OCD or another anxiety disorder will not be included in the study.
Trial locations and contacts
2 sites in 1 country.
Sweden2 sites
BUP Specialmottagning
Gothenburg
Child and Adolescent Psychiatry (CAP) research center
Stockholm, 11330
About this study
Official title: Implementation of Internet-delivered Cognitive-behavior Therapy for Paediatric Obsessive-compulsive Disorder in the Clinic: a Randomized Stepped Care Non-inferiority Trial
The purpose of this study is to investigate if therapist-guided internet-delivered cognitive behavioral therapy (ICBT) in a stepped-care approach is an effective and cost-effective treatment in reducing OCD symptoms for children and adolescents compared to gold standard treatment (face-to-face CBT).
Read the detailed description
A randomized controlled non-inferiority trial comparing therapist-guided internet-delivered cognitive behavioral therapy (ICBT) in a stepped care model with face-to-face CBT for children and adolescents with obsessive-compulsive disorder (OCD).
Participants will be randomized to either stepped care ICBT or to gold standard face-to-face CBT. One group (stepped care) will be first offered ICBT for 16 weeks. Non-responders at the 3-month follow-up will receive additional face-to-face CBT. The other group (gold standard treatment) will be randomized directly to receive face-to-face CBT for 16 weeks. Non-responders will, as in the other group, receive additional face-to-face treatment after the 3-month follow-up. The primary endpoint will be at 6-month follow-up. Long-term effects are also investigated (1 year, 2 years and 5 years after treatment completion).
The primary objective is to evaluate whether ICBT in a stepped care approach will be non-inferior to gold standard treatment (face-to-face CBT) in reducing OCD symptoms, depression, impairment, sleep problems, health and functioning. The secondary objective is to a) carry out a full health economic evaluation and b) investigate if self-referred and referred participants differ regarding outcome in the two treatment groups.
The hypotheses are:
- An ICBT stepped care approach will be non-inferior to gold standard treatment (face-to-face CBT) in reducing OCD symptoms.
- The stepped care approach will be associated with lower costs, such as reduced therapist and administration times, service utilization, minimized work and school absence for families etc., compared to gold standard treatment.
- Self-referred patients will benefit significantly better than referred patients regarding outcome in the ICBT group, but there will not be any difference in the face-to-face CBT group.
- Conditions
- Obsessive-Compulsive Disorder
- Being tested
- Internet-delivered cognitive behavioral therapy (ICBT), Cognitive behavioral therapy (CBT)
- 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 therapy (ICBT)Behavioural
Participants will receive internet-delivered CBT with therapist support for 16 weeks. The treatment consists of 14 online chapters with interactive features as videos and illustrations. The treatment has the main focus on exposure with ritual prevention. The children and parents have regular contact with a personal assigned therapist via written text messages in the platform.
Participants that are classified as non-responders at 3 months follow-up will receive face-to-face CBT of up to 12 sessions over 12 weeks.
Cognitive behavioral therapy (CBT)Behavioural
Participants in the gold standard group will receive 14 individual face-to-face CBT sessions over 16 weeks. The treatment is based on current evidence based recommendations for OCD, and focuses on exposure with ritual prevention.
Participants that are classified as non-responders at 3 months follow-up will receive additional face-to-face CBT of up to 12 sessions over 12 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Stepped care | Experimental | Internet-delivered cognitive behavioral therapy (ICBT) Receives: Behavioral: Internet-delivered cognitive behavioral therapy (ICBT) |
| Gold standard treatment | Active comparator | Cognitive behavioral therapy (CBT) Receives: Behavioral: Cognitive behavioral therapy (CBT) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Children's Yale Brown Obsessive-Compulsive Scale (CY-BOCS)
Change in OCD symptom severity from baseline to week 16 and 3 and 6 months after treatment has ended, and at 1, 2 and 5 years follow-up. Primary endpoint is 6 months follow-up.
Measured: week 0, week 16, at 3 and 6 months follow-up, at 1, 2 and 5 years follow-up.
Secondary outcomes (11)
Clinical global impression severity (CGI-S)
Change in global severity from baseline to week 16 and 3 and 6 months after treatment has ended, and at 1, 2 and 5 years follow-up.
Measured: week 0, week 16, at 3 and 6 months follow-up, at 1, 2 and 5 years follow-up
Clinical global impression improvement (CGI-I)
Change in global improvement from week 16 to 3 and 6 months after treatment has ended, and at 1, 2 and 5 years follow-up.
Measured: week 16, at 3 and 6 months follow-up, at 1, 2 and 5 years follow-up
Children's global assessment scale (C-GAS)
Change in global functioning from baseline to week 16 and 3 and 6 months after treatment has ended, and at 1 year follow-up.
Measured: week 0, week 16, at 3 and 6 months follow-up, at 1 year follow-up
Obsessive-compulsive inventory - child version (OCI-CV)
Change in child-rated OCD symptoms from baseline to week 16 and 3 and 6 months after treatment has ended, at 1 year follow-up, and weekly during treatment.
Measured: week 0, week 16, at 3 and 6 months follow-up, at 1 year follow-up, and weekly during treatment
The Child Health Utility 9D (CHU9D)
Change in general health from baseline to week 16 and 3 and 6 months after treatment has ended, and at 1 year follow-up.
Measured: week 0, week 16, at 3 and 6 months follow-up, at 1 year follow-up
Insomnia Severity Index (ISI)
Change in sleep problems from baseline to week 16 and 3 and 6 months after treatment has ended, and at 1 year follow-up
Measured: week 0, week 16, at 3 and 6 months follow-up, at 1 year follow-up
Children's Obsessional Compulsive Inventory Revised - parent version (ChOCI-R)
Change in parent-rated OCD symptoms from baseline to week 16 and 3 and 6 months after treatment has ended, at 1 year follow-up, and weekly during treatment.
Measured: week 0, week 16, at 3 and 6 months follow-up, at 1 year follow-up, and weekly during treatment
Family accommodation scale for obsessive-compulsive disorder - self-rated version (FAS-SR)
Change in parent-rated family accommodation from baseline to week 16 and 3 and 6 months after treatment has ended, and at 1 year follow-up
Measured: week 0, week 16, at 3 and 6 months follow-up, at 1 year follow-up
Trimbos/iMTA questionnaire for Costs associated with Psychiatric Illness (TiC-P)
Change in economic costs from baseline to week 16 and 3 and 6 months after treatment has ended, and at 1, 2 and 5 years follow-up.
Measured: week 0, week 16, at 3 and 6 months follow-up, at 1, 2 and 5 years follow-up.
Mood and Feeling Questionnaire (MFQ)
Change in child and parent rated depressive symptoms from baseline to week 16 and 3 and 6 months after treatment has ended, and at 1 year follow-up
Measured: week 0, week 16, at 3 and 6 months follow-up, at 1 year follow-up
Education, work and social adjustment scale (EWSAS)
Change in child and parent rated impairment and functioning from baseline to week 16 and 3 and 6 months after treatment has ended, and at 1 year follow-up
Measured: week 0, week 16, at 3 and 6 months follow-up, at 1 year follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Aug 2017
- Study start6 Oct 2017
- Primary completion28 Apr 2020
- Study completion25 Nov 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 152 participants (actual)
Sponsor and investigators
- Lead sponsor
- Karolinska Institutet
- Sponsor type
- University, hospital or other
- Collaborators
- Region Stockholm, Vastra Gotaland Region
- Responsible party
- Principal investigator, Eva Serlachius, Karolinska Institutet
- Investigators
- Eva Serlachius, MD, PhD, Principal investigator, Karolinska Institutet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03263546
- Sponsor's protocol ID
- REPN 2017/1070-31/1
- Status last verified
- Feb 2025
- First submitted
- 18 Aug 2017
- Last updated
- 14 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Aspvall K, Andersson E, Melin K, Norlin L, Eriksson V, Vigerland S, Jolstedt M, Silverberg-Morse M, Wallin L, Sampaio F, Feldman I, Bottai M, Lenhard F, Mataix-Cols D, Serlachius E. Effect of an Internet-Delivered Stepped-Care Program vs In-Person Cognitive Behavioral Therapy on Obsessive-Compulsive Disorder Symptoms in Children and Adolescents: A Randomized Clinical Trial. JAMA. 2021 May 11;325(18):1863-1873. doi: 10.1001/jama.2021.3839.
PubMed 33974020Aspvall K, Andersson E, Lenhard F, Melin K, Norlin L, Wallin L, Silverberg-Morse M, Feldman I, Bottai M, Mataix-Cols D, Serlachius E. Stepped Care Internet-Delivered vs Face-to-Face Cognitive-Behavior Therapy for Pediatric Obsessive-Compulsive Disorder: A Trial Protocol for a Randomized Noninferiority Trial. JAMA Netw Open. 2019 Oct 2;2(10):e1913810. doi: 10.1001/jamanetworkopen.2019.13810.
PubMed 31642928
Study at a glance
From the registry record, last updated by the sponsor on 14 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Implementation of Internet-delivered Cognitive-behavior Therapy for Paediatric Obsessive-compulsive Disorder in the Clinic: a Randomized Stepped Care Non-inferiority Trial
- ClinicalTrials.gov ID
- NCT03263546
- Acronym / sponsor ID
- REPN 2017/1070-31/1
- Conditions
- Obsessive-Compulsive Disorder
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 152 participants (actual)
- Lead sponsor
- Karolinska InstitutetUniversity, hospital or other
- Collaborators
- Region Stockholm, Vastra Gotaland Region
- Study start
- 6 Oct 2017 (actual)
- Primary completion
- 28 Apr 2020 (actual)
- Study completion
- 25 Nov 2024 (actual)
- First posted
- 28 Aug 2017 (actual)
- 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 investigate if therapist-guided internet-delivered cognitive behavioral therapy (ICBT) in a stepped-care approach is an effective and cost-effective treatment in reducing OCD symptoms for children and adolescents compared to gold standard treatment (face-to-face CBT).
Detailed description
A randomized controlled non-inferiority trial comparing therapist-guided internet-delivered cognitive behavioral therapy (ICBT) in a stepped care model with face-to-face CBT for children and adolescents with obsessive-compulsive disorder (OCD).
Participants will be randomized to either stepped care ICBT or to gold standard face-to-face CBT. One group (stepped care) will be first offered ICBT for 16 weeks. Non-responders at the 3-month follow-up will receive additional face-to-face CBT. The other group (gold standard treatment) will be randomized directly to receive face-to-face CBT for 16 weeks. Non-responders will, as in the other group, receive additional face-to-face treatment after the 3-month follow-up. The primary endpoint will be at 6-month follow-up. Long-term effects are also investigated (1 year, 2 years and 5 years after treatment completion).
The primary objective is to evaluate whether ICBT in a stepped care approach will be non-inferior to gold standard treatment (face-to-face CBT) in reducing OCD symptoms, depression, impairment, sleep problems, health and functioning. The secondary objective is to a) carry out a full health economic evaluation and b) investigate if self-referred and referred participants differ regarding outcome in the two treatment groups.
The hypotheses are:
- An ICBT stepped care approach will be non-inferior to gold standard treatment (face-to-face CBT) in reducing OCD symptoms.
- The stepped care approach will be associated with lower costs, such as reduced therapist and administration times, service utilization, minimized work and school absence for families etc., compared to gold standard treatment.
- Self-referred patients will benefit significantly better than referred patients regarding outcome in the ICBT group, but there will not be any difference in the face-to-face CBT group.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Stepped care | Experimental | Behavioral: Internet-delivered cognitive behavioral therapy (ICBT)Internet-delivered cognitive behavioral therapy (ICBT) |
| Gold standard treatment | Active comparator | Behavioral: Cognitive behavioral therapy (CBT)Cognitive behavioral therapy (CBT) |
Who may qualify
- Ages
- 7 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 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 and 17 years
- Ability to read and write Swedish and with access to a computer and use of internet.
- Participants on psychotropic medication must had been on a stable dose for the last 6 weeks prior to baseline assessment. If the child is on medication for OCD, they will be requested to stay on stable doses for the duration of the trial.
Key exclusion criteria (5 listed)
- Organic brain disorders, global learning disabilities, autism spectrum disorder, psychosis, bipolar disorder and severe eating disorder.
- Suicidal ideation
- Not able to understand the basics of the ICBT self-help material, patient being housebound or in need of intensive- or in-patient treatment.
- Having completed a course of CBT for OCD within the last 12 months (defined as at least 5 sessions CBT including exposure and response prevention).
- Children with ongoing psychological treatment for OCD or another anxiety disorder will not be included in the study.
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 therapy (ICBT)Participants will receive internet-delivered CBT with therapist support for 16 weeks. The treatment consists of 14 online chapters with interactive features as videos and illustrations. The treatment has the main focus on exposure with ritual prevention. The children and parents have regular contact with a personal assigned therapist via written text messages in the platform. Participants that are classified as non-responders at 3 months follow-up will receive face-to-face CBT of up to 12 sessions over 12 weeks. | Behavioural | Stepped care |
| Cognitive behavioral therapy (CBT)Participants in the gold standard group will receive 14 individual face-to-face CBT sessions over 16 weeks. The treatment is based on current evidence based recommendations for OCD, and focuses on exposure with ritual prevention. Participants that are classified as non-responders at 3 months follow-up will receive additional face-to-face CBT of up to 12 sessions over 12 weeks. | Behavioural | Gold standard treatment |
Primary outcome
Children's Yale Brown Obsessive-Compulsive Scale (CY-BOCS)
Time frame: week 0, week 16, at 3 and 6 months follow-up, at 1, 2 and 5 years follow-up.
Change in OCD symptom severity from baseline to week 16 and 3 and 6 months after treatment has ended, and at 1, 2 and 5 years follow-up. Primary endpoint is 6 months follow-up.
11 secondary outcomes
Clinical global impression severity (CGI-S)
Time frame: week 0, week 16, at 3 and 6 months follow-up, at 1, 2 and 5 years follow-up
Clinical global impression improvement (CGI-I)
Time frame: week 16, at 3 and 6 months follow-up, at 1, 2 and 5 years follow-up
Children's global assessment scale (C-GAS)
Time frame: week 0, week 16, at 3 and 6 months follow-up, at 1 year follow-up
Obsessive-compulsive inventory - child version (OCI-CV)
Time frame: week 0, week 16, at 3 and 6 months follow-up, at 1 year follow-up, and weekly during treatment
The Child Health Utility 9D (CHU9D)
Time frame: week 0, week 16, at 3 and 6 months follow-up, at 1 year follow-up
Insomnia Severity Index (ISI)
Time frame: week 0, week 16, at 3 and 6 months follow-up, at 1 year follow-up
Children's Obsessional Compulsive Inventory Revised - parent version (ChOCI-R)
Time frame: week 0, week 16, at 3 and 6 months follow-up, at 1 year follow-up, and weekly during treatment
Family accommodation scale for obsessive-compulsive disorder - self-rated version (FAS-SR)
Time frame: week 0, week 16, at 3 and 6 months follow-up, at 1 year follow-up
Trimbos/iMTA questionnaire for Costs associated with Psychiatric Illness (TiC-P)
Time frame: week 0, week 16, at 3 and 6 months follow-up, at 1, 2 and 5 years follow-up.
Mood and Feeling Questionnaire (MFQ)
Time frame: week 0, week 16, at 3 and 6 months follow-up, at 1 year follow-up
Education, work and social adjustment scale (EWSAS)
Time frame: week 0, week 16, at 3 and 6 months follow-up, at 1 year follow-up
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 14 Feb 2025.
- Derived from this study: PubMed 33974020Aspvall K, Andersson E, Melin K, Norlin L, Eriksson V, Vigerland S, Jolstedt M, Silverberg-Morse M, Wallin L, Sampaio F, Feldman I, Bottai M, Lenhard F, Mataix-Cols D, Serlachius E. Effect of an Internet-Delivered Stepped-Care Program vs In-Person Cognitive Behavioral Therapy on Obsessive-Compulsive Disorder Symptoms in Children and Adolescents: A Randomized Clinical Trial. JAMA. 2021 May 11;325(18):1863-1873. doi: 10.1001/jama.2021.3839.
- Derived from this study: PubMed 31642928Aspvall K, Andersson E, Lenhard F, Melin K, Norlin L, Wallin L, Silverberg-Morse M, Feldman I, Bottai M, Mataix-Cols D, Serlachius E. Stepped Care Internet-Delivered vs Face-to-Face Cognitive-Behavior Therapy for Pediatric Obsessive-Compulsive Disorder: A Trial Protocol for a Randomized Noninferiority Trial. JAMA Netw Open. 2019 Oct 2;2(10):e1913810. doi: 10.1001/jamanetworkopen.2019.13810.
- Individual participant dataSharing planned: No
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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.
Eva Serlachius, MD, PhD principal investigator
Karolinska Institutet
2 sites 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 (ICBT) and Cognitive behavioral therapy (CBT) in people with Obsessive-Compulsive Disorder, run by Karolinska Institutet at 2 sites 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 5 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 14 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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 Obsessive-Compulsive Scale (CY-BOCS) (time frame: week 0, week 16, at 3 and 6 months follow-up, at 1, 2 and 5 years follow-up.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03263546, which also lists 2 linked publications.
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 14 Feb 2025.