An observational study in Obsessive-Compulsive Disorder, sponsored by Mental Health Services in the Capital Region, Denmark. Completed at 1 site in Denmark. Open to participants aged 8 Years to 17 Years. Per ClinicalTrials.gov, last updated 2023-02-03.
Sponsored by Mental Health Services in the Capital Region, Denmark · Observational
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.
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.
606 studies on the registry are indexed under Obsessive-Compulsive Disorder; 160 are open to participants now.
This study's enrollment of 36 is below the median of 143 across 84 observational studies indexed under Obsessive-Compulsive Disorder.
Browse Obsessive-Compulsive Disorder studies →Mental Health Services in the Capital Region, Denmark is the lead sponsor of 51 studies on the registry; 9 are open to participants now.
Counted across the registry records on this site, refreshed daily.
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.
Exclusion Criteria:
* 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 biosensor · Behavioral: Treatment as usual (TAU) · Behavioral: Exposure and response prevention (ERP)
* Ages 8 through 17 years (both inclusive). * Sex and age (+/- 3months) matched to an included patient.
Device: wearable biosensor
Parent or guardian of patient with OCD
Device: wearable biosensor
Parent or guardian of control participant
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.
Also known as: E4 wristband
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.
One ERP session will be offered in Week 0 and Week 8.
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.
Time frame: Baseline to Week 8
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.
Time frame: Week 7
Wristband compliance
Number of hours parents and children wear the wristband
Time frame: Weeks 0 - 8
Adverse reactions - wristband
Negative effects of the wristband defined as the count of events reported by the parent, child or case worker.
Time frame: Weeks 0-8
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.
Time frame: Week 0 and 8
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.
Time frame: Week 0 and 8
Biochemical synchrony
Correlations between child and parent oxytocin level and response child and parent.
Time frame: Week 0 and 8
Salivary oxytocin level-child
Concentration of oxytocin in child saliva calculated using Matlab-7 according to relevant standard curves.
Time frame: Weeks 0 and 8
Salivary oxytocin level-parent
Concentration of oxytocin in parent saliva calculated using Matlab-7 according to relevant standard curves.
Time frame: Weeks 0 and 8
Salivary oxytocin response-parent
Change in oxytocin in parent saliva.
Time frame: Weeks 0 and 8
Salivary oxytocin response-child
Change in oxytocin in child saliva.
Time frame: Weeks 0 and 8
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.
Time frame: Weeks 0, 4, and 8
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.
Time frame: Weeks 0
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.
Time frame: Weeks 0, 4, and 8
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.
Time frame: Week 0 and Week 8
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.
Time frame: Weeks 0
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.
Time frame: Week 0 and Week 8
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).
Time frame: Week 0-8
OCD symptom remission
30% or more reduction in CY-BOCS score by Week 8. Dichotomous variable.
Time frame: Week 0 and Week 8
This study is completed, as verified in Nov 2022. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Obsessive-Compulsive Disorder→
Mental Health Services in the Capital Region, Denmark