Obsessive Compulsive DisorderNCT02660099
Internet Delivered CBT for OCD in Adolescents With ASD - A Clinical Case Series
A study testing Internet-delivered Cognitive Behavior Therapy in people with Obsessive Compulsive Disorder and Autism Spectrum Disorder, run by Karolinska Institutet at 2 sites in Sweden.
Trial summary
The aim of this study is to test the feasibility and acceptability of an internet-delivered cognitive behavior therapy (ICBT) intervention originally developed for neurotypical adolescents with obsessive compulsive disorder (OCD) in adolescents with OCD and autism spectrum disorder (ASD). Read more about this study
- Who is it for?
- Ages 12 to 17 yearsHealthy volunteers can take part
- Conditions the study is for
- Obsessive Compulsive Disorder, Autism Spectrum Disorder
- What is being tested?
- Internet-delivered Cognitive Behavior Therapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 4 participants
- Where
- 2 sitesSweden
- Study dates
- Jul 2015to Jun 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 12 to 17 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- a diagnosis of OCD as defined by DSM-5 [40]
- a diagnosis of autism defined by DSM-5
- a total score of ≥ 16 on the Children's Yale-Brown Obsessive-Compulsive Scale, CY-BOCS [14]
- age between 12 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
- psychosis or bipolar disorder, severe eating disorder
- 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 another anxiety disorder
Trial locations and contacts
2 sites in 1 country.
Sweden2 sites
Karolinska Institutet
Stockholm, 171 77
Karolinska insititute
Stockholm
About this study
Official title: Internet Delivered Cognitive Behavior Therapy for Obsessive-compulsive Disorder in Adolescents With Autism Spectrum Disorder - A Clinical Case Series
The aim of this study is to test the feasibility and acceptability of an internet-delivered cognitive behavior therapy (ICBT) intervention originally developed for neurotypical adolescents with obsessive compulsive disorder (OCD) in adolescents with OCD and autism spectrum disorder (ASD). This feasibility study will inform us how to adapt the original intervention to the specific needs of patients with ASD.
Read the detailed description
To evaluate the effectiveness of ICBT for OCD in adolescents with ASD, this study will use a single case experimental design with weekly measures during two phases: A-B. The A-phase will consist of baseline measures at least three weeks prior to treatment. The B-phase will consist of the 12 weeks ICBT-program as well as one measure post-treatment. Single case descriptions of each participant will be presented. Weekly measures on the Obsessional Compulsive Inventory - Child version (OCI-CV) will be analyzed through visual inspection of each participants graph and through computation of Percentage of Non-overlapping Data (PND). PND is a frequently used effect measure in SCED and reflects how large percentage of the measurements during the treatment-phase that do not overlap with any of the measurements during the base-line phase.
To assess the feasibility and comprehension of the ICBT treatment semi-structured interviews (face-to-face or telephone) will be conducted with participants and parents weekly during the four first weeks of ICBT and semi-weekly during the rest of the treatment. Detailed notes will be taken during each interview and will serve as content material for a thematic analysis trying to determine possible accommodations to the ICBT protocol to better suit patients with ASD.
- Being tested
- Internet-delivered Cognitive Behavior Therapy
- 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-delivered Cognitive Behavior TherapyBehavioural
The treatment consists of standard cognitive behavior therapy for obsessive-compulsive disorder and is delivered via an internet platform and regular therapist contact several times per week via email and telephone. The treatment is 12 weeks. Both parents and adolescents are involved in treatment. Parents will also receive three lectures on 1, Autism spectrum disorder, 2, CBT and functional analysis and 3, Parental strategies
| Study group | Role | What they receive |
|---|---|---|
| Internet-delivered CBT | Experimental | 12 weeks of internet-delivered cognitive behavior therapy provided through a secure internet platform and online clinician contact Receives: Behavioral: Internet-delivered Cognitive Behavior Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Obsessional Compulsive Inventory - Child version, OCI-CV
Self-rated OCD symptom levels
Measured: Change from baseline to 12 weeks
Secondary outcomes (10)
Children's Yale Brown Obsessive Compulsive Scale
Clinician-rated OCD symptom levels
Measured: Change from baseline to 12 weeks
Mini International Neuropsychiatric Interview for Children and Adolescents, MINI-KID
psychiatric screening of comorbidity
Measured: Baseline
Clinical Global Impression - Severity, CGI-S
Global symptom levels
Measured: Change from baseline to 12 weeks
Clinical Global Impression - Improvement, CGI-I
Global symptom improvement
Measured: Post treatment(12 weeks)
Children's Global Assessment Scale, CGAS
Global level of functioning
Measured: Change from baseline to 12 weeks
Children´s Depression Inventory - Short version
Symptom level of depressive mood
Measured: Change from baseline to 12 weeks
Strength and difficulties, SDQ
General psychopathology
Measured: Change from baseline to 12 weeks
Family Accommodation Scale, Parent-Report, FAS-PR
Parental accommodation to OCD symptoms
Measured: Change from baseline to 12 weeks
Patient ICBT Adherence Rating, PIAR
Patient Adherence to internet delivered CBT
Measured: after 6 weeks and at post treatment(12 weeks)
Education, Work and Social Adjustment Scale - child and parent version, EWSAS
Global functioning
Measured: Change from baseline to 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jan 2016 (estimated)
- Study startJul 2015
- Primary completionApr 2016
- Study completionJun 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
- 4 participants (actual)
Sponsor and investigators
- Lead sponsor
- Karolinska Institutet
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Eva Serlachius, Karolinska Institutet
- Investigators
- David Mataix-Cols, Professor, Principal investigator, Department of Clinical Neuroscience, Karolinska Institutet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02660099
- Sponsor's protocol ID
- BiP-ASD/OCD
- Status last verified
- Sep 2016
- First submitted
- 7 Jul 2015
- Last updated
- 7 Sep 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 7 Sep 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Internet Delivered Cognitive Behavior Therapy for Obsessive-compulsive Disorder in Adolescents With Autism Spectrum Disorder - A Clinical Case Series
- ClinicalTrials.gov ID
- NCT02660099
- Acronym / sponsor ID
- BiP-ASD/OCD
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 4 participants (actual)
- Lead sponsor
- Karolinska InstitutetUniversity, hospital or other
- Study start
- Jul 2015
- Primary completion
- Apr 2016 (actual)
- Study completion
- Jun 2016 (actual)
- First posted
- 21 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 aim of this study is to test the feasibility and acceptability of an internet-delivered cognitive behavior therapy (ICBT) intervention originally developed for neurotypical adolescents with obsessive compulsive disorder (OCD) in adolescents with OCD and autism spectrum disorder (ASD). This feasibility study will inform us how to adapt the original intervention to the specific needs of patients with ASD.
Detailed description
To evaluate the effectiveness of ICBT for OCD in adolescents with ASD, this study will use a single case experimental design with weekly measures during two phases: A-B. The A-phase will consist of baseline measures at least three weeks prior to treatment. The B-phase will consist of the 12 weeks ICBT-program as well as one measure post-treatment. Single case descriptions of each participant will be presented. Weekly measures on the Obsessional Compulsive Inventory - Child version (OCI-CV) will be analyzed through visual inspection of each participants graph and through computation of Percentage of Non-overlapping Data (PND). PND is a frequently used effect measure in SCED and reflects how large percentage of the measurements during the treatment-phase that do not overlap with any of the measurements during the base-line phase.
To assess the feasibility and comprehension of the ICBT treatment semi-structured interviews (face-to-face or telephone) will be conducted with participants and parents weekly during the four first weeks of ICBT and semi-weekly during the rest of the treatment. Detailed notes will be taken during each interview and will serve as content material for a thematic analysis trying to determine possible accommodations to the ICBT protocol to better suit patients with ASD.
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 CBT | Experimental | Behavioral: Internet-delivered Cognitive Behavior Therapy12 weeks of internet-delivered cognitive behavior therapy provided through a secure internet platform and online clinician contact |
Who may qualify
- Ages
- 12 to 17 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (8 listed)
- a diagnosis of OCD as defined by DSM-5 [40]
- a diagnosis of autism defined by DSM-5
- a total score of ≥ 16 on the Children's Yale-Brown Obsessive-Compulsive Scale, CY-BOCS [14]
- age between 12 and 17 years
- ability to read and write Swedish
Key exclusion criteria (5 listed)
- psychosis or bipolar disorder, severe eating disorder
- 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 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 Behavior TherapyThe treatment consists of standard cognitive behavior therapy for obsessive-compulsive disorder and is delivered via an internet platform and regular therapist contact several times per week via email and telephone. The treatment is 12 weeks. Both parents and adolescents are involved in treatment. Parents will also receive three lectures on 1, Autism spectrum disorder, 2, CBT and functional analysis and 3, Parental strategies | Behavioural | Internet-delivered CBT |
Primary outcome
Obsessional Compulsive Inventory - Child version, OCI-CV
Time frame: Change from baseline to 12 weeks
Self-rated OCD symptom levels
10 secondary outcomes
Children's Yale Brown Obsessive Compulsive Scale
Time frame: Change from baseline to 12 weeks
Mini International Neuropsychiatric Interview for Children and Adolescents, MINI-KID
Time frame: Baseline
Clinical Global Impression - Severity, CGI-S
Time frame: Change from baseline to 12 weeks
Clinical Global Impression - Improvement, CGI-I
Time frame: Post treatment(12 weeks)
Children's Global Assessment Scale, CGAS
Time frame: Change from baseline to 12 weeks
Children´s Depression Inventory - Short version
Time frame: Change from baseline to 12 weeks
Strength and difficulties, SDQ
Time frame: Change from baseline to 12 weeks
Family Accommodation Scale, Parent-Report, FAS-PR
Time frame: Change from baseline to 12 weeks
Patient ICBT Adherence Rating, PIAR
Time frame: after 6 weeks and at post treatment(12 weeks)
Education, Work and Social Adjustment Scale - child and parent version, EWSAS
Time frame: Change from baseline to 12 weeks
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 7 Sep 2016.
- Individual participant dataSharing planned: Undecided
Related trials for Obsessive Compulsive Disorder
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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.
David Mataix-Cols, Professor principal investigator
Department of Clinical Neuroscience, 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 Behavior Therapy in people with Obsessive Compulsive Disorder and Autism Spectrum 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 8 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 7 Sep 2016. 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?
Obsessional Compulsive Inventory - Child version, OCI-CV (time frame: Change from baseline to 12 weeks). 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 7 Sep 2016.