NCT05064527

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
36

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Sep 2021

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 7, 2021

Completed
8 days until next milestone

Study Start

First participant enrolled

September 15, 2021

Completed
16 days until next milestone

First Posted

Study publicly available on registry

October 1, 2021

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 19, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 19, 2023

Completed
Last Updated

February 3, 2023

Status Verified

November 1, 2022

Enrollment Period

1.3 years

First QC Date

September 7, 2021

Last Update Submit

February 2, 2023

Conditions

Obsessive-Compulsive Disorder

Keywords

Signal processingOxytocinFamily AccommodationBiosensorMobile app

Outcome Measures

Primary Outcomes (1)

  • 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.

    Baseline to Week 8

Other Outcomes (18)

  • Biosensor experience

    Week 7

  • Wristband compliance

    Weeks 0 - 8

  • Adverse reactions - wristband

    Weeks 0-8

  • +15 more other outcomes

Study Arms (4)

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).

Device: wearable biosensorBehavioral: 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.

Device: wearable biosensor

Caregivers of Patients

Parent or guardian of patient with OCD

Device: wearable biosensor

Caregivers of Controls

Parent or guardian of control participant

Device: wearable biosensor

Interventions

wearable biosensorDEVICE

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.

Also known as: E4 wristband
Caregivers of ControlsCaregivers of PatientsControlsPatients
Treatment as usual (TAU)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.

Patients
Exposure and response prevention (ERP)BEHAVIORAL

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

Patients

Eligibility Criteria

Age8 Years - 17 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)
Sampling MethodNon-Probability Sample
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.

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Child and Adolescent Mental Health Center - Capital Region of Denmark

Copenhagen, 2400, Denmark

Location

Related Publications (3)

  • 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.

    PMID: 37962931DERIVED

  • Lonfeldt 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.

    PMID: 37850105DERIVED

  • Lonfeldt 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.

    PMID: 37486738DERIVED

Biospecimen

Retention: SAMPLES WITHOUT DNA

Saliva samples will be collected from patients and healthy controls and one of their caregivers at baseline (Week 0) and Week 8 to measure oxytocin concentration.

MeSH Terms

Conditions

Obsessive-Compulsive Disorder

Interventions

Therapeutics

Condition Hierarchy (Ancestors)

Anxiety DisordersMental Disorders

Study Officials

  • Nicole N Lønfeldt, PhD

    Region Capital Denmark

    PRINCIPAL INVESTIGATOR

  • Line Katrine H Clemmensen, PhD

    Technical University of Denmark

    PRINCIPAL INVESTIGATOR

  • Anne K Pagsberg, MD, PhD

    Region Capital Denmark

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 7, 2021

First Posted

October 1, 2021

Study Start

September 15, 2021

Primary Completion

January 19, 2023

Study Completion

January 19, 2023

Last Updated

February 3, 2023

Record last verified: 2022-11

Locations

DK(1)