Obsessive-Compulsive DisorderNCT05064527
A Wearable AI Feedback Tool for Pediatric OCD
An observational study of Obsessive-Compulsive Disorder, run by Mental Health Centre Copenhagen, Bispebjerg and Frederiksberg Hospital at 1 site in Denmark.
Trial summary
To test the feasibility of implementing digitally enhanced psychotherapy and research in a community child and adolescent mental health center including the acceptability of the digital technology to patients, parents and therapists. Read more about this study
- Who is it for?
- Ages 8 to 17 years
- Conditions the study is for
- Obsessive-Compulsive Disorder
- What is being tested?
- wearable biosensor, Treatment as usual (TAU) and Exposure and response prevention (ERP)
- Type of treatment
- Medical device, Lifestyle or therapy programme
- How many people
- 36 participants
- Where
- 1 siteDenmark
- Study dates
- 15 Sep 2021to 19 Jan 2023
- Phase
- Observational
- 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 8 to 17 years
- All sexes
- No healthy volunteers
- Child
Study population: Patients: seeking treatment at a child and adolescent mental health center. Controls: living in the catchment area of a the same child and adolescent mental health center.
Who may be able to join
- OCD (ICD-10 F42) as the primary or secondary diagnosis, verified with a semi-structured psychopathological interview using K-SADS-PL.
- CY-BOCS > 7: mild (8-15), moderate (16-23), severe (24-31), extreme (32-40)
- A psychiatrist determined that the child is eligible for care within psychiatry for their primary diagnosis.
- Patient is age 8 through 17 years (both inclusive).
- Signed informed consent.
Who cannot join
- Participation in other OCD trials.
- Comorbid illness that contraindicates trial participation: pervasive developmental disorder not including Asperger's syndrome (ICD-10 F84.0-84.4 + F84.8-84.9)), schizophrenia/paranoid psychosis (ICD-10 F20-25 + F28-29), mania or bipolar disorder (ICD-10 F30 and F31), depressive psychotic disorders (F32.3 + F33.3), substance dependence syndrome (ICD-10 F1x.2).
- Intelligence Quotient <70.
- Any condition (e.g. allergies, eczema, hypersensitivity due to Asperger's syndrome) that would prevent the child or parent from wearing a wristband biosensor.
Trial locations and contacts
1 site in 1 country.
Denmark1 site
Child and Adolescent Mental Health Center - Capital Region of Denmark
Copenhagen, 2400
About this study
Official title: Wrist Angel: A Wearable AI Feedback Tool for OCD Treatment and Research
To test the feasibility of implementing digitally enhanced psychotherapy and research in a community child and adolescent mental health center including the acceptability of the digital technology to patients, parents and therapists.
To use passively collected physiological data and actively collected clinical and biochemical data from the patient and parents to detect and predict episodes of obsessive-compulsive disorder (OCD) -related episodes in children and accommodating behaviour in parents.
Read the detailed description
Background: Psychiatric and specifically mechanistic research have stagnated mainly due to the time, labour and bias inherent in human-based technologies that dominate the field. To advance translational and precision psychiatry, researchers within psychiatry must forge long-term collaborations with researchers and developers within technology.
Objectives: To improve assessment and psychotherapy for youth obsessive-compulsive disorder (OCD) through developing an artificial intelligence tool to support patients, parents and therapists in cognitive behavioural therapy. To give an innovative push in the public sector hospitals and research through integration of wearable sensors and machine learning techniques.
Methods: 10 patients (8-17 years) and one of their parents from a child and adolescent mental health center will be recruited as in the larger TECTO project. To examine whether the algorithms can distinguish between patients and typically developing children, 10 typically developing sex and age matched children and one of their parents or guardians will also be recruited from the catchment area. Passively sensed physiological indicators of stress are used as input to privacy preserving signal processing and machine learning algorithms, which predict OCD-episodes, clinical severity and family accommodation. Oxytocin, as a biomarker for family accommodation, is measured through saliva samples. Signal processing will be used to extract acoustic and physiological features of importance for therapeutic response.
Expected results: Results from the proposed project will be used to develop artificial intelligence (AI) tools that support clinicians, patients and parents, which will be implemented and evaluated in a public-sector hospital. Technology-enhanced therapy can be used in a stepped care model, in which subclinical symptoms are first monitored using passive sensors and then AI interventions are offered, supported by a healthcare professional, and when outpatient care is needed, the AI tool can support patient engagement. The results of this project will also advance research in computational science and psychiatry by testing biomarkers of clinical relevance.
- Conditions
- Obsessive-Compulsive Disorder
- Being tested
- wearable biosensor, Treatment as usual (TAU), Exposure and response prevention (ERP)
- Keywords
- Signal processing, Oxytocin, Family Accommodation, Biosensor, Mobile app
- 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.
wearable biosensorDevice
Also called E4 wristband
The E4 wristband will be worn by all groups for the duration of the study. It measures blood volume pulse, electrodermal activity, skin temperature, and movement. Patients will be asked to press the event tagging button when they feel stressed by OCD. Control will be asked to press the button when they feel anxious. Parents will be asked to press the button with they notice their child feels stressed by OCD or anxious.
Treatment as usual (TAU)Behavioural
Patients will receive treatment as usual at the child and adolescent mental health center. TAU can range from waitlist to one session of psychoeducation to group or individual psychotherapy to medication.
Exposure and response prevention (ERP)Behavioural
One ERP session will be offered in Week 0 and Week 8.
| Study group | Role | What they receive |
|---|---|---|
| Patients | * OCD (ICD-10 F42) as the primary or secondary diagnosis, verified with a semi-structured psychopathological interview using Kiddie Schedule for Affective Disorders and Schizophrenia (K-SADS-PL).
* CY-BOCS > 7: mild (8-15), moderate (16-23), severe (24-31), extreme (32-40)
* A psychiatrist determined that the child is eligible for care within psychiatry for their primary diagnosis.
* Patient is age 8 through 17 years (both inclusive). Receives: Device: wearable biosensor; Behavioral: Treatment as usual (TAU); Behavioral: Exposure and response prevention (ERP) | |
| Controls | * Ages 8 through 17 years (both inclusive).
* Sex and age (+/- 3months) matched to an included patient. Receives: Device: wearable biosensor | |
| Caregivers of Patients | Parent or guardian of patient with OCD Receives: Device: wearable biosensor | |
| Caregivers of Controls | Parent or guardian of control participant Receives: Device: wearable biosensor |
What is being measured
The primary outcome is the main question the study is designed to answer.
Binary feasibility
Binary feasibility outcomes in terms of recruitment, retention, biosensor functionality, acceptability of the biosensor, adherence to wearing the biosensor, adverse reactions to the biosensor, and physiological, audio, and visual signals as markers of OCD distress, severity and family dynamics. "Success" indicates that the a priori feasibility criteria have been met; "revise" indicates that the criteria have not been met.
Measured: Baseline to Week 8
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Oct 2021
- Study start15 Sep 2021
- Primary completion19 Jan 2023
- Study completion19 Jan 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Obsessive-Compulsive DisorderStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mental Health Centre Copenhagen, Bispebjerg and Frederiksberg Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Technical University of Denmark, University of Copenhagen
- Responsible party
- Sponsor
- Investigators
- Nicole N Lønfeldt, PhD, Principal investigator, Region Capital DenmarkLine Katrine H Clemmensen, PhD, Principal investigator, Technical University of DenmarkAnne K Pagsberg, MD, PhD, Principal investigator, Region Capital Denmark
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05064527
- Sponsor's protocol ID
- H-18010607- 79689
- Status last verified
- Nov 2022
- First submitted
- 7 Sep 2021
- Last updated
- 3 Feb 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Publications
Olesen KV, Lonfeldt NN, Das S, Pagsberg AK, Clemmensen LKH. Predicting Obsessive-Compulsive Disorder Events in Children and Adolescents in the Wild using a Wearable Biosensor (Wrist Angel): Protocol for the Analysis Plan of a Nonrandomized Pilot Study. JMIR Res Protoc. 2023 Nov 14;12:e48571. doi: 10.2196/48571.
PubMed 37962931Lonfeldt NN, Olesen KV, Das S, Mora-Jensen AC, Pagsberg AK, Clemmensen LKH. Predicting obsessive-compulsive disorder episodes in adolescents using a wearable biosensor-A wrist angel feasibility study. Front Psychiatry. 2023 Oct 2;14:1231024. doi: 10.3389/fpsyt.2023.1231024. eCollection 2023.
PubMed 37850105Lonfeldt NN, Clemmensen LKH, Pagsberg AK. A Wearable Artificial Intelligence Feedback Tool (Wrist Angel) for Treatment and Research of Obsessive Compulsive Disorder: Protocol for a Nonrandomized Pilot Study. JMIR Res Protoc. 2023 Jul 24;12:e45123. doi: 10.2196/45123.
PubMed 37486738
Study at a glance
From the registry record, last updated by the sponsor on 3 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Wrist Angel: A Wearable AI Feedback Tool for OCD Treatment and Research
- ClinicalTrials.gov ID
- NCT05064527
- Acronym / sponsor ID
- H-18010607- 79689
- Conditions
- Obsessive-Compulsive Disorder
- Keywords
- Signal processing, Oxytocin, Family Accommodation, Biosensor, Mobile app
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- Mental Health Centre Copenhagen, Bispebjerg and Frederiksberg HospitalUniversity, hospital or other
- Collaborators
- Technical University of Denmark, University of Copenhagen
- Study start
- 15 Sep 2021 (actual)
- Primary completion
- 19 Jan 2023 (actual)
- Study completion
- 19 Jan 2023 (actual)
- First posted
- 1 Oct 2021 (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.
To test the feasibility of implementing digitally enhanced psychotherapy and research in a community child and adolescent mental health center including the acceptability of the digital technology to patients, parents and therapists.
To use passively collected physiological data and actively collected clinical and biochemical data from the patient and parents to detect and predict episodes of obsessive-compulsive disorder (OCD) -related episodes in children and accommodating behaviour in parents.
Detailed description
Background: Psychiatric and specifically mechanistic research have stagnated mainly due to the time, labour and bias inherent in human-based technologies that dominate the field. To advance translational and precision psychiatry, researchers within psychiatry must forge long-term collaborations with researchers and developers within technology.
Objectives: To improve assessment and psychotherapy for youth obsessive-compulsive disorder (OCD) through developing an artificial intelligence tool to support patients, parents and therapists in cognitive behavioural therapy. To give an innovative push in the public sector hospitals and research through integration of wearable sensors and machine learning techniques.
Methods: 10 patients (8-17 years) and one of their parents from a child and adolescent mental health center will be recruited as in the larger TECTO project. To examine whether the algorithms can distinguish between patients and typically developing children, 10 typically developing sex and age matched children and one of their parents or guardians will also be recruited from the catchment area. Passively sensed physiological indicators of stress are used as input to privacy preserving signal processing and machine learning algorithms, which predict OCD-episodes, clinical severity and family accommodation. Oxytocin, as a biomarker for family accommodation, is measured through saliva samples. Signal processing will be used to extract acoustic and physiological features of importance for therapeutic response.
Expected results: Results from the proposed project will be used to develop artificial intelligence (AI) tools that support clinicians, patients and parents, which will be implemented and evaluated in a public-sector hospital. Technology-enhanced therapy can be used in a stepped care model, in which subclinical symptoms are first monitored using passive sensors and then AI interventions are offered, supported by a healthcare professional, and when outpatient care is needed, the AI tool can support patient engagement. The results of this project will also advance research in computational science and psychiatry by testing biomarkers of clinical relevance.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Patients | – | Device: wearable biosensor, Behavioral: Treatment as usual (TAU), Behavioral: Exposure and response prevention (ERP)* OCD (ICD-10 F42) as the primary or secondary diagnosis, verified with a semi-structured psychopathological interview using Kiddie Schedule for Affective Disorders and Schizophrenia (K-SADS-PL). * CY-BOCS > 7: mild (8-15), moderate (16-23), severe (24-31), extreme (32-40) * A psychiatrist determined that the child is eligible for care within psychiatry for their primary diagnosis. * Patient is age 8 through 17 years (both inclusive). |
| Controls | – | Device: wearable biosensor* Ages 8 through 17 years (both inclusive). * Sex and age (+/- 3months) matched to an included patient. |
| Caregivers of Patients | – | Device: wearable biosensorParent or guardian of patient with OCD |
| Caregivers of Controls | – | Device: wearable biosensorParent or guardian of control participant |
Who may qualify
- Ages
- 8 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Patients: seeking treatment at a child and adolescent mental health center. Controls: living in the catchment area of a the same child and adolescent mental health center.
Key inclusion criteria (5 listed)
- OCD (ICD-10 F42) as the primary or secondary diagnosis, verified with a semi-structured psychopathological interview using K-SADS-PL.
- CY-BOCS > 7: mild (8-15), moderate (16-23), severe (24-31), extreme (32-40)
- A psychiatrist determined that the child is eligible for care within psychiatry for their primary diagnosis.
- Patient is age 8 through 17 years (both inclusive).
- Signed informed consent.
Key exclusion criteria (4 listed)
- Participation in other OCD trials.
- Comorbid illness that contraindicates trial participation: pervasive developmental disorder not including Asperger's syndrome (ICD-10 F84.0-84.4 + F84.8-84.9)), schizophrenia/paranoid psychosis (ICD-10 F20-25 + F28-29), mania or bipolar disorder (ICD-10 F30 and F31), depressive psychotic disorders (F32.3 + F33.3), substance dependence syndrome (ICD-10 F1x.2).
- Intelligence Quotient <70.
- Any condition (e.g. allergies, eczema, hypersensitivity due to Asperger's syndrome) that would prevent the child or parent from wearing a wristband biosensor.
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 |
|---|---|---|
| wearable biosensorAlso: E4 wristbandThe E4 wristband will be worn by all groups for the duration of the study. It measures blood volume pulse, electrodermal activity, skin temperature, and movement. Patients will be asked to press the event tagging button when they feel stressed by OCD. Control will be asked to press the button when they feel anxious. Parents will be asked to press the button with they notice their child feels stressed by OCD or anxious. | Device | Caregivers of Controls, Caregivers of Patients, Controls, Patients |
| Treatment as usual (TAU)Patients will receive treatment as usual at the child and adolescent mental health center. TAU can range from waitlist to one session of psychoeducation to group or individual psychotherapy to medication. | Behavioural | Patients |
| Exposure and response prevention (ERP)One ERP session will be offered in Week 0 and Week 8. | Behavioural | Patients |
Primary outcome
Binary feasibility
Time frame: Baseline to Week 8
Binary feasibility outcomes in terms of recruitment, retention, biosensor functionality, acceptability of the biosensor, adherence to wearing the biosensor, adverse reactions to the biosensor, and physiological, audio, and visual signals as markers of OCD distress, severity and family dynamics. "Success" indicates that the a priori feasibility criteria have been met; "revise" indicates that the criteria have not been met.
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 3 Feb 2023.
- Derived from this study: PubMed 37962931Olesen KV, Lonfeldt NN, Das S, Pagsberg AK, Clemmensen LKH. Predicting Obsessive-Compulsive Disorder Events in Children and Adolescents in the Wild using a Wearable Biosensor (Wrist Angel): Protocol for the Analysis Plan of a Nonrandomized Pilot Study. JMIR Res Protoc. 2023 Nov 14;12:e48571. doi: 10.2196/48571.
- Derived from this study: PubMed 37850105Lonfeldt NN, Olesen KV, Das S, Mora-Jensen AC, Pagsberg AK, Clemmensen LKH. Predicting obsessive-compulsive disorder episodes in adolescents using a wearable biosensor-A wrist angel feasibility study. Front Psychiatry. 2023 Oct 2;14:1231024. doi: 10.3389/fpsyt.2023.1231024. eCollection 2023.
- Derived from this study: PubMed 37486738Lonfeldt NN, Clemmensen LKH, Pagsberg AK. A Wearable Artificial Intelligence Feedback Tool (Wrist Angel) for Treatment and Research of Obsessive Compulsive Disorder: Protocol for a Nonrandomized Pilot Study. JMIR Res Protoc. 2023 Jul 24;12:e45123. doi: 10.2196/45123.
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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.
Nicole N Lønfeldt, PhD principal investigator
Region Capital Denmark
Line Katrine H Clemmensen, PhD principal investigator
Technical University of Denmark
Anne K Pagsberg, MD, PhD principal investigator
Region Capital Denmark
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Obsessive-Compulsive Disorder, run by Mental Health Centre Copenhagen, Bispebjerg and Frederiksberg Hospital at 1 site in Denmark.
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 4 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 3 Feb 2023. 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 Denmark. 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?
Binary feasibility (time frame: Baseline to Week 8). 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 NCT05064527, which also lists 3 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 3 Feb 2023.