A Wearable AI Feedback Tool for Pediatric OCD

Obsessive-Compulsive Disorder Clinical Trial

Official title:

Wrist Angel: A Wearable AI Feedback Tool for OCD Treatment and Research

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05064527
• Other study ID #: H-18010607- 79689
• Status: Completed
• Start date: September 15, 2021
• Est. completion date: January 19, 2023

Study information

• Verified date: November 2022
• Source: Mental Health Services in the Capital Region, Denmark
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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.

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 36
• Est. completion date: January 19, 2023
• Est. primary completion date: January 19, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 8 Years to 17 Years

Eligibility

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.

Related Conditions & MeSH terms

• Obsessive-Compulsive Disorder

Intervention

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.
• Exposure and response prevention (ERP)
One ERP session will be offered in Week 0 and Week 8.

Locations

Country	Name	City	State
Denmark	Child and Adolescent Mental Health Center - Capital Region of Denmark	Copenhagen

Sponsors (3)

Lead Sponsor	Collaborator
Mental Health Services in the Capital Region, Denmark	Technical University of Denmark, University of Copenhagen

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Biosensor experience	Children's and parents' level of physical (dis)comfort of wearing the wristband, degree of satisfaction with the design, concerns of stigmatization and data security as well as usability. There are 13 multiple choice questions answered on a 4-point scale (0 = disagree a lot - 3 = agree a lot ) and one open-ended question.	Week 7
Other	Wristband compliance	Number of hours parents and children wear the wristband	Weeks 0 - 8
Other	Adverse reactions - wristband	Negative effects of the wristband defined as the count of events reported by the parent, child or case worker.	Weeks 0-8
Other	Subjective unit of distress	Patients rate their level of distress on an 11-point scale (0= no distress; 10 = unbearable distress) during exposure and response prevention sessions.	Week 0 and 8
Other	Symptom hierarchy	Patients rate their level of distress associated with current OCD symptoms on an 11-point scale (0= no distress; 10 = unbearable distress) on a weekly basis.	Week 0 and 8
Other	Biochemical synchrony	Correlations between child and parent oxytocin level and response child and parent.	Week 0 and 8
Other	Salivary oxytocin level-child	Concentration of oxytocin in child saliva calculated using Matlab-7 according to relevant standard curves.	Weeks 0 and 8
Other	Salivary oxytocin level-parent	Concentration of oxytocin in parent saliva calculated using Matlab-7 according to relevant standard curves.	Weeks 0 and 8
Other	Salivary oxytocin response-parent	Change in oxytocin in parent saliva.	Weeks 0 and 8
Other	Salivary oxytocin response-child	Change in oxytocin in child saliva.	Weeks 0 and 8
Other	Family Accommodation Scale - Parent Report (FAS-PR)	Self-rated degree of parental involvement in child OCD symptoms. 13-item measure with 4 subscales: Modifying routines, Participating in rituals, Parental distress caused by accommodating and Child consequences for not accommodating. Parents report the frequency of their accommodating behavior within the past week on 9 items and the severity of stress and consequences on 4 items on a five-point scale (0=never/no to 4= daily/extreme). Total and subscales scores are obtained by summing items.	Weeks 0, 4, and 8
Other	Family Environment Scale - Parent Report (FES)	Self-rated questionnaire in which parents report how they perceive their current family environment. 54 items from the following six subscales are used: 1. Cohesion, 2. Expressiveness, 3. Conflict, 4. Independence, 5. Organization, 6. Control. There are three FES forms (real, ideal, and expectations); only the FES real form will be used, which examines a family member's perception of the family as it is. The scale ranges from 10 to 40, with a score of 10 being representative of no family control and a score of 40 being representative of the greatest magnitude of family control. Therefore, a decrease in score represents a decrease in self-reported family control.	Weeks 0
Other	Parental Stress Scale (PSS)	Self-rated degree of stress related to parenting identified child. 18 items rated on 5-point scales. Positively statements are reverse scored. Scores range between 18 and 90. Higher scores reflect greater stress.	Weeks 0, 4, and 8
Other	KIDSCREEN-52	Health-related Quality of Life Screening Instrument for Children and Adolescents. Self- and parent-ratings subjective health and well-being on 52 items on 10 subscales. Rasch scores are computed for each dimension (subscale) and are transformed into T-values with a mean of 50 and a standard deviation of 10. Higher scores indicate better quality of life and well-being.	Week 0 and Week 8
Other	Depression Anxiety Stress Scales (DASS)	42-item measure of negative emotional states in adults. Self-rated on a 4-point scale. Scores for Depression, Anxiety and Stress are calculated by summing the scores for the relevant items. Higher scores indicate more depression, anxiety and stress.	Weeks 0
Other	Children's Yale-Brown Obsessive-Compulsive Scale (CY-BOCS) score	Semi-structured clinical interview that measures OCD symptom severity. 10 items, rated from 0 (no symptoms) to 4 (extreme severity), are summed to obtain a total score that can range from 0 to 40. An obsession severity score is obtained by summing the items 1-5. A compulsion severity score is obtained by summing items 6-10.	Week 0 and Week 8
Other	Clinical Global Impression Severity and Clinical Global Impressions Improvement (CGI-I)	Change in severity of psychopathology. At baseline, the one-item CGI-S is rated on a 7-point scale, with the severity of illness scale using a range of responses from 1 (normal) through to 7 (severely ill). CGI-I scores range from 1 (large improvement) through to 7 (large increase in severity).	Week 0-8
Other	OCD symptom remission	30% or more reduction in CY-BOCS score by Week 8. Dichotomous variable.	Week 0 and Week 8
Primary	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