CompletedNot Applicable

A Wearable AI Feedback Tool for Pediatric OCD

Denmark36 participantsStarted 2021-09-15

Plain-language 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. 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.

Who can participate

Age range8 Years – 17 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

What they're measuring

Binary feasibility

Timeframe: Baseline to Week 8

Trial details

NCT IDNCT05064527

SponsorMental Health Centre Copenhagen, Bispebjerg and Frederiksberg Hospital

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2023-01-19