A Wearable AI Feedback Tool for Pediatric OCD

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

36 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-09-15

Study Completion Date

2023-01-19

Brief Summary

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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.

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Detailed Description

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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

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Obsessive-Compulsive Disorder

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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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).

wearable biosensor

Intervention Type DEVICE

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)

Intervention Type BEHAVIORAL

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.

Intervention Type BEHAVIORAL

Exposure and response prevention (ERP)

One ERP session will be offered in Week 0 and Week 8.

Intervention Type BEHAVIORAL

Other Intervention Names

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E4 wristband

Eligibility Criteria

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Inclusion Criteria

* 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.

Exclusion Criteria

* 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.

Minimum Eligible Age

8 Years

Maximum Eligible Age

17 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No