Obsessive-Compulsive DisorderNCT03473080
An eHealth Intervention for Obsessive Compulsive Disorder in Youth With Autism Spectrum Disorder
A study testing Internet CBT in people with Obsessive-Compulsive Disorder, run by Karolinska Institutet at 1 site in Sweden.
Trial summary
This study is a feasibility study of Internet-delivered CBT for OCD in children and adolescents (7-17 years) with comorbid Autism Spectrum Disorder. 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 CBT
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 22 participants
- Where
- 1 siteSweden
- Study dates
- 9 Mar 2018to 15 Feb 2021
- 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
- a diagnosis of OCD according to DSM-5
- a diagnosis of autism according to DSM-IV or DSM-5, confirmed with the Autism Diagnostic Interview- Revised or Autism Diagnostic Observation Schedule version 1 or 2 and by medical records
- a total score of ≥ 16 on the Children's Yale-Brown Obsessive-Compulsive Scale
- age between 7 and 17 years
- ability to read and write Swedish
- 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
Who cannot join
- a diagnosis of psychosis, bipolar disorder, severe eating disorder or intellectual disabilities
- comorbid hoarding disorder or OCD with hoarding as a principal symptom.
- suicidal ideation
- 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 any anxiety disorder
- OCD treatment is not an immediate priority
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Feasibility of a Therapist and Parent Guided eHealth Intervention for Obsessive Compulsive Disorder in Youth With Autism Spectrum Disorder
This study is a feasibility study of Internet-delivered CBT for OCD in children and adolescents (7-17 years) with comorbid Autism Spectrum Disorder.
Read the detailed description
The main objectives of this study is to evaluate the feasibility, acceptability and preliminary efficacy of internet-delivered Cognitive Behavioral Therapy (ICBT) for Obsessive Compulsive Disorder (OCD) in children and adolescents (7-17 years) with Autism Spectrum Disorders (ASD). The study will an open trial with-in group mean comparison design (n=18). The treatment is delivered over 16 weeks. Study participants will be followed up at 3 (primary endpoint), 6 and 12 months after completed treatment. ICBT is expected to decrease OCD-symptoms.
- Conditions
- Obsessive-Compulsive Disorder
- Being tested
- Internet CBT
- Keywords
- OCD, ASD, Obsessive Compulsive Disorder, Autism Spectrum Disorder, ICBT, eHealth, Internet, CBT, Pediatric, Adolescents, Children, Internet-delivered
- Medical subject headings
- Obsessive-Compulsive Disorder, Autism Spectrum Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Internet CBTBehavioural
Also called ICBT, Internet-delivered Cognitive Behavior Therapy
The treatment consists of a standard cognitive behavior therapy for OCD with additional treatment components to make the treatment better suited for children and adolescents with Autism Spectrum Disorder.
| Study group | Role | What they receive |
|---|---|---|
| Internet CBT | Other | Participants and their parents receive 16 weeks of internet-delivered cognitive behavior therapy (CBT) with psychologist support. Receives: Behavioral: Internet 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
Changein obsessions and compulsions will be measured as the total score on the scale.. Total score ranges from 0 to 40 points, a higher score indicates more severe OCD. The scale is rated by a clinician.
Measured: Baseline, 16 weeks (= post treatment), 3 months after post treatment, 6 months after post treatment, 12 months after post treatment
Secondary outcomes (17)
Obsessive-compulsive inventory - child version
Child-rating of OCD symptoms. The total score range is 0-42, a higher score indicates more OCD-symptoms.
Measured: Baseline, weekly during treatment, 16 weeks (= post treatment), 3 months after post treatment, 6 months after post treatment, 12 months after post treatment
Autism spectrum quotient (AQ-10)
Parent-rated, brief screeing for symtoms relating to autism spectrum disorder. Total score ranges from 0-10, a higher score indicating more symtoms.
Measured: Baseline
Education, work and social adjustment scale - child and parent version
Self-rated and parent-rated. Ranges from 0 to 40 points, a higher score indicating more problems. Measures how much the psychiatric problems affect daily life in different areas.
Measured: Baseline, 16 weeks (= post treatment), 3 months after post treatment, 6 months after post treatment, 12 months after post treatment
Family accommodation scale for obsessive-compulsive disorder
Parent-rated scale, total score ranges from 0 to 76, a higher score indicates more family accommodation to the child's OCD.
Measured: Baseline, 16 weeks (= post treatment), 3 months after post treatment, 6 months after post treatment, 12 months after post treatment
Mood and Feeling Questionnaire - child and parent version
Self-rated and parent-rated. Measures depressive symptoms in the child. Total score ranges from 0 to 26, a higher score indicates more depressive symptoms.
Measured: Baseline, 16 weeks (= post treatment), 3 months after post treatment, 6 months after post treatment, 12 months after post treatment
Children's Obsessional Compulsive Inventory Revised - parent rated (ChOCI-R-P)
Parent-rated. Consists of 4 Subscales. Obsessive symptoms, Compulsive symtoms, Obsessive impairment and Compulsive impairment. The symptom subscales range from 10 to 30 points, a higher score indicating more symptomology. These subscales are added to get a total score for OCD-symptoms. The score of each impairment subscales ranges from 0 to 24, a higher score indicating more impairment. The score of the impairment subscales are added to get a total score of impairment. The symptom subscales will only be administered at baseline. The impairment subscales will be administered at all assessment points.
Measured: Baseline, weekly during treatment, 16 weeks (= post treatment), 3 months after post treatment, 6 months after post treatment, 12 months after post treatment
Mini International Neuropsychiatric Interview for Children and Adolescents
Clinician-rated, a semi-structured interview to asses psychiatric problems in children. Results will be presented as co-morbid psychiatric diagnoses.
Measured: Baseline
Children's global assessment scale
Clinician-rated, measures the childs global psychiatric functioning. Total score ranges from 0-100, a lower score indicates lower functioning.
Measured: Baseline, 16 weeks (= post treatment), 3 months after post treatment, 6 months after post treatment, 12 months after post treatment
Children's Assessment Scale for Developmental Disabilities
Clinician-rated. measures the childs global functioning with respect to developmental disabilities. Total score ranges from 0 to 100, a lower score indicates lower functioning.
Measured: Baseline
Clinical global impression - severity
Clinician-rated level of psychiatric severity, the score ranges from 1 to 7, a lower score indicates less severity. In this study the measure will only refer to level of OCD.
Measured: Baseline, 16 weeks (= post treatment), 3 months after post treatment, 6 months after post treatment, 12 months after post treatment
Clinical global impression - improvement
Clinician-rated level of psychiatric improvement, the score ranges from 1 to 7, a lower score indicates more improvement. In this study the measure will only refer to level of OCD.
Measured: 16 weeks (= post treatment), 3 months after post treatment, 6 months after post treatment, 12 months after post treatment
internet intervention Patient Adherence Scale
Clinician-rated, measures the patients adherence to treatment. The scale consist of 5 items measuring 1. If the patient is in phase with treatment, 2, level of engagement in treatment 3, level of communication with the clinician, 4 motivation to change 5, frequency of log-ins to the internet-treatment. Total score ranges from 0 to 20, a higher score indicates more adherence to the treatment.
Measured: 8 weeks, 16 weeks
Client Satisfaction Questionnaire (CSQ-8)
Self-rated and parent-rated. Measures level of satisfaction with the treatment. Total score ranges from 8 to 32, higher level indicates higher satisfaction.
Measured: 16 weeks
Parent strategies
A parent-rated questionnaire consisting of 4 items measuring the parents 1, participation in treatment, 2, cooperation with the child during treatment, 3, autonomus support in treatment and 4, directiveness in treatment. The questions are qualitative and results will be presented on an item level
Measured: Post-treatment
Patient EX/RP Adherence Scale
Self-rated questionnaire. Consist of 3 items: 1, percentage of attempted exposure exercises, 2, how well exposures were performed and 3, percentatge of respons-prevention during the last week. The answers will be presented on an item level.
Measured: Weekly for 16 weeks (during treatment)
Drop-out rate from treatment
Percentage of patients that drop out from ICBT
Measured: at week 16
Completed treatment modules
Number of completed treatment modules
Measured: week 16
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Mar 2018
- Study start9 Mar 2018
- Primary completion15 Feb 2021
- Study completion15 Feb 2021
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
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- Karolinska Institutet
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Fabian Lenhard, Karolinska Institutet
- Investigators
- Fabian Lenhard, PhD, Principal investigator, Karolinska Institutet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03473080
- Sponsor's protocol ID
- BIP ASD/OCD pilot
- Status last verified
- Jul 2021
- First submitted
- 16 Feb 2018
- Last updated
- 6 Jul 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility of a Therapist and Parent Guided eHealth Intervention for Obsessive Compulsive Disorder in Youth With Autism Spectrum Disorder
- ClinicalTrials.gov ID
- NCT03473080
- Acronym / sponsor ID
- BIP ASD/OCD pilot
- Conditions
- Obsessive-Compulsive Disorder
- Keywords
- OCD, ASD, Obsessive Compulsive Disorder, Autism Spectrum Disorder, ICBT, eHealth, Internet, CBT
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- Karolinska InstitutetUniversity, hospital or other
- Study start
- 9 Mar 2018 (actual)
- Primary completion
- 15 Feb 2021 (actual)
- Study completion
- 15 Feb 2021 (actual)
- First posted
- 22 Mar 2018 (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.
This study is a feasibility study of Internet-delivered CBT for OCD in children and adolescents (7-17 years) with comorbid Autism Spectrum Disorder.
Detailed description
The main objectives of this study is to evaluate the feasibility, acceptability and preliminary efficacy of internet-delivered Cognitive Behavioral Therapy (ICBT) for Obsessive Compulsive Disorder (OCD) in children and adolescents (7-17 years) with Autism Spectrum Disorders (ASD). The study will an open trial with-in group mean comparison design (n=18). The treatment is delivered over 16 weeks. Study participants will be followed up at 3 (primary endpoint), 6 and 12 months after completed treatment. ICBT is expected to decrease OCD-symptoms.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Internet CBT | Other | Behavioral: Internet CBTParticipants and their parents receive 16 weeks of internet-delivered cognitive behavior therapy (CBT) with psychologist support. |
Who may qualify
- Ages
- 7 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (8 listed)
- a diagnosis of OCD according to DSM-5
- a diagnosis of autism according to DSM-IV or DSM-5, confirmed with the Autism Diagnostic Interview- Revised or Autism Diagnostic Observation Schedule version 1 or 2 and by medical records
- a total score of ≥ 16 on the Children's Yale-Brown Obsessive-Compulsive Scale
- age between 7 and 17 years
- ability to read and write Swedish
Key exclusion criteria (7 listed)
- a diagnosis of psychosis, bipolar disorder, severe eating disorder or intellectual disabilities
- comorbid hoarding disorder or OCD with hoarding as a principal symptom.
- suicidal ideation
- 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)
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 CBTAlso: ICBT, Internet-delivered Cognitive Behavior TherapyThe treatment consists of a standard cognitive behavior therapy for OCD with additional treatment components to make the treatment better suited for children and adolescents with Autism Spectrum Disorder. | Behavioural | Internet CBT |
Primary outcome
Children's Yale-Brown Obsessive Compulsive Scale
Time frame: Baseline, 16 weeks (= post treatment), 3 months after post treatment, 6 months after post treatment, 12 months after post treatment
Changein obsessions and compulsions will be measured as the total score on the scale.. Total score ranges from 0 to 40 points, a higher score indicates more severe OCD. The scale is rated by a clinician.
17 secondary outcomes
Obsessive-compulsive inventory - child version
Time frame: Baseline, weekly during treatment, 16 weeks (= post treatment), 3 months after post treatment, 6 months after post treatment, 12 months after post treatment
Autism spectrum quotient (AQ-10)
Time frame: Baseline
Education, work and social adjustment scale - child and parent version
Time frame: Baseline, 16 weeks (= post treatment), 3 months after post treatment, 6 months after post treatment, 12 months after post treatment
Family accommodation scale for obsessive-compulsive disorder
Time frame: Baseline, 16 weeks (= post treatment), 3 months after post treatment, 6 months after post treatment, 12 months after post treatment
Mood and Feeling Questionnaire - child and parent version
Time frame: Baseline, 16 weeks (= post treatment), 3 months after post treatment, 6 months after post treatment, 12 months after post treatment
Children's Obsessional Compulsive Inventory Revised - parent rated (ChOCI-R-P)
Time frame: Baseline, weekly during treatment, 16 weeks (= post treatment), 3 months after post treatment, 6 months after post treatment, 12 months after post treatment
Mini International Neuropsychiatric Interview for Children and Adolescents
Time frame: Baseline
Children's global assessment scale
Time frame: Baseline, 16 weeks (= post treatment), 3 months after post treatment, 6 months after post treatment, 12 months after post treatment
Children's Assessment Scale for Developmental Disabilities
Time frame: Baseline
Clinical global impression - severity
Time frame: Baseline, 16 weeks (= post treatment), 3 months after post treatment, 6 months after post treatment, 12 months after post treatment
Clinical global impression - improvement
Time frame: 16 weeks (= post treatment), 3 months after post treatment, 6 months after post treatment, 12 months after post treatment
internet intervention Patient Adherence Scale
Time frame: 8 weeks, 16 weeks
Client Satisfaction Questionnaire (CSQ-8)
Time frame: 16 weeks
Parent strategies
Time frame: Post-treatment
Patient EX/RP Adherence Scale
Time frame: Weekly for 16 weeks (during treatment)
Drop-out rate from treatment
Time frame: at week 16
Completed treatment modules
Time frame: week 16
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 6 Jul 2021.
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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.
Fabian Lenhard, PhD principal investigator
Karolinska Institutet
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 CBT 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 8 inclusion and 7 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 6 Jul 2021. 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 Obsessive Compulsive Scale (time frame: Baseline, 16 weeks (= post treatment), 3 months after post treatment, 6 months after post treatment, 12 months after post treatment). 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 6 Jul 2021.