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A Wearable AI Feedback Tool for Pediatric OCD

NCT05064527 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 36

Last updated 2023-02-03

No results posted yet for this study

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.

Conditions

  • Obsessive-Compulsive Disorder

Interventions

DEVICE

wearable biosensor

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.

BEHAVIORAL

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.

BEHAVIORAL

Exposure and response prevention (ERP)

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

Sponsors & Collaborators

  • Technical University of Denmark

    collaborator OTHER

  • University of Copenhagen

    collaborator OTHER

  • Mental Health Services in the Capital Region, Denmark

    lead OTHER

Principal Investigators

  • Nicole N Lønfeldt, PhD · Region Capital Denmark

  • Line Katrine H Clemmensen, PhD · Technical University of Denmark

  • Anne K Pagsberg, MD, PhD · Region Capital Denmark

Eligibility

Min Age
8 Years
Max Age
17 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-09-15
Primary Completion
2023-01-19
Completion
2023-01-19
FDA Device
Yes

Countries

  • Denmark

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05064527 on ClinicalTrials.gov