Clinical trial NCT05291611: Smart Sensory Technology in Psychotherapy for Pediatric OCD
Official title: Smart Sensory Technology in Telepsychotherapy for the Treatment of Obsessive-compulsive Disorder in Children and Adolescents
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obsessive-Compulsive Disorder
Keywords: Obsessive-compulsive Disorder
Children and Adolescents
Cognitive-behavioral therapy
Digital sensory device
Lead sponsor: University Hospital Tuebingen
Sponsor class: OTHER
Collaborators: name: Universität Tübingen
name: University of Hohenheim
First posted: 2022-03-22
Enrollment: 20
Sex: ALL
Minimum age (years): 12
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: All participants will be treated with cognitive behavioural therapy during our feasibility study.
Primary purpose: TREATMENT

Brief summary: Telemedicine interventions enable the improvement of behavioral state-of-the-art treatment of OCD, as therapy can be delivered in the patients' immediate home environment, allowing for more valid symptom actualization. In addition, access to experts is made possible even in rural areas, and the inhibition to seek therapy can be reduced. In a preliminary study, our research group was able to demonstrate the efficiency of using telemedical access. SSTeP-KiZ aims at the further development of telemedical treatment of children with OCD by using sensor technology in the home setting, where most symptoms occur. In this context, relevant emotional states of the patients such as anxiety and stress reactions shall be quantified reliably during the therapy session with exposures by combining different sensor modalities. As a result, the therapy procedure can be immediately and individually adapted to the patient and the situation, thus optimizing the success of the treatment.

Methods: It is planned to establish the therapy system on a sample of 10 healthy children and 5-10 patients with OCD treated at University Hospital of Tübingen. Afterwards we will recruit 26 children with obsessive-compulsive disorder aged 12-18 years to conduct therapy with them. There are 14 weekly therapy sessions via teleconferencing with the children and parents. During the sessions and exposures, patients' field of view is recorded via eye trackers, measures of stress responses via heart rate and pupillometry, and movement measures for approach-avoidance behaviors. Using an AI approach, these indicators are integrated and reported back to the therapist online to optimize the therapy process. Accompanying app-based daily symptoms will also be collected by the children and parents and processed for use in the therapy process. We expect a good feasibility and significant symptom reduction by this therapeutic approach and the chance to make this system usable for broad clinical application.

Detailed description: The main goal of SSTeP-KiZ is the implementation of sensors in the existing telepsychotherapeutic treatment of children and adolescents with obsessive-compulsive disorder. SSTeP-KiZ aims to significantly improve the telepsychotherapeutic treatment options for this group of patients through the use of sensors that can be worn during symptom triggering situations at home in patients' everyday lives, and an analysis and incorporation of the multimodal sensor data into the therapeutic process.

In the medium term, SSTeP-KiZ should enable the use of real-time data on anxiety and stress levels (pupillometry, heart rate, eye tracking) obtained during therapy sessions by the therapist while the patient is still in the therapy session. Thus, even under the conditions of telepsychotherapy, despite the physical absence of the therapist, the individual intensity of the therapy sessions can be directly adjusted. In addition, the compliance and satisfaction of the patients during the accompanied therapy tasks can be directly promoted. Furthermore, the data obtained within the framework of SSTeP-KiZ should also be suitably prepared concerning the children and adolescents and their relatives and, in the sense of therapeutic feedback, suitably visualized to form an additional component of the therapy.

Goals:

A. Development of a prototype for a multisensory therapy system in healthy children and adaptation to mentally ill children with an obsessive-compulsive disorder.

B. Evaluation of the prototype in the context of an internet-based psychotherapy for mentally ill children with an obsessive-compulsive disorder C: Preparations for the introduction of the multisensory therapy system into broad clinical application in the health care system

Sample I: 10 healthy children:

Sample II: 5-10 patients of University Hospital Tübingen with OCD.

Sample III\&IV: 6 \& 20 children with OCD.

Eligibility criteria: Inclusion Criteria:

* children and adolescents with obsessive-compulsive disorders
* aged 12 to 18 years
* a primary DSM-5 obsessive-compulsive disorder
* at least one primary caretaker
* German-speaking (child \& caretakers)
* family home equipped with broadband internet connection
* written informed consent of the child and its caretakers
* psychiatric comorbidities will be allowed as long as the comorbid disorder does not have a higher treatment priority than OCD (i.e., psychosis, eating disorder and severe depression)
* Medication is allowed if treatment was stable for 6 weeks before diagnostics and will then be taken during the trial.

Exclusion Criteria:

* IQ below 70
* patients do not speak or understand German
* patients have a psychiatric comorbidity or suicidality that makes participation clinically inappropriate
* too seriously ill so that they should be treated in the hospital
* stable social environment, able to support the children adequately during therapy. - drug addiction
* if the family seems to be severely psychologically burdened so that participation in the sessions and support of the children during the trial will not be possible
* no other psychological treatment is allowed
* If reporting side effects or circumstances that make iCBT treatment clinically inappropriate, or if wished by the patients, the patients are excluded from the study and transferred to another more appropriate therapy option.

Primary outcomes:
measure: System Usability Scale (SUS) - assessment of the change in the handling of the technical equipment during treatment
timeFrame: After week 1, week 7 and week 14
measure: Therapy Process Questionnaire (TPQ) - assessing the stability of the therapeutic relationship and possible changes in the treatment process
timeFrame: Weekly after each therapy session, for 14 weeks of therapy
measure: Client Satisfaction Questionnaire-8 (CSQ-8)
timeFrame: After the last session in week 14 (post treatment)
measure: Questionnaire for the evaluation of the treatment (FBB)
timeFrame: After the last session in week 14 (post treatment)
measure: Change in Health Care Utilization, measured by HCU-Q (Health Care Utilization-Questionnaire)
timeFrame: Baseline (before treatment (t0)) and after treatment (t1, after 14 weeks)
measure: Change in Quality of Life: EQ-5D-3L (European Quality of Life Five Dimensions Questionnaire)
timeFrame: Baseline (before treatment (t0)) and after treatment (t1, after 14 weeks)
measure: Change in costs spent on online interventions: CIIQ (Caregiver Indirect and Informal Care Cost Assessment Questionnaire)
timeFrame: Baseline (before treatment (t0)) and after treatment (t1, after 14 weeks)
measure: Change in affinity for technology (TA-EG)
timeFrame: Baseline (before treatment (t0)) and after treatment (t1, after 14 weeks)
measure: Change in attitudes toward and satisfaction with telemedicine psychotherapy (EZtP)
timeFrame: Baseline (before treatment (t0)) and after treatment (t1, after 14 weeks)
measure: Barriers to Treatment Participation Scale (BTPS)
timeFrame: Once after treatment (t1, after 14 weeks)
measure: Measures of feasibility: Manual Rating Form (MRF)
timeFrame: Once after treatment (t1, after 14 weeks)
measure: Measures of feasibility: Summary Therapist Feedback Form (STFF)
timeFrame: Once after treatment (t1, after 14 weeks)
measure: Implementation and satisfaction questionnaire for the children
timeFrame: Once after treatment (t1, after 14 weeks)
measure: Implementation and satisfaction questionnaire for the parents
timeFrame: Once after treatment (t1, after 14 weeks)
measure: Implementation and satisfaction questionnaire for the therapist
timeFrame: Once after treatment (t1, after 14 weeks)
Secondary outcomes:
measure: Children's Yale-Brown Obsessive Compulsive Scale (CY-BOCS)
timeFrame: Baseline (before treatment (t0)) and after treatment (t1, after 14 weeks)
measure: Children's Global Assessment Scale (CGAS)
timeFrame: Baseline (before treatment (t0)) and after treatment (t1, after 14 weeks)
measure: Clinical Global Impressions-Improvement (CGI-I)
timeFrame: Baseline (before treatment (t0)) and after treatment (t1, after 14 weeks)
measure: Clinical Global Impressions-Severity (CGI-S)
timeFrame: Baseline (before treatment (t0)) and after treatment (t1, after 14 weeks)
measure: Children's DIPS Open Access: Diagnostic Interview in Childhood and Adolescent Mental Disorders (Kinder-DIPS)
timeFrame: Baseline (before treatment (t0)) and after treatment (t1, after 14 weeks)
measure: Brief Self-Control Scale
timeFrame: After week 1, week 7 and week 14
measure: Self-efficacy
timeFrame: After week 1, week 7 and week 14
measure: Coping strategies
timeFrame: After week 1, week 7 and week 14
measure: Self-regulation
timeFrame: After week 1, week 7 and week 14
measure: Procrastination
timeFrame: After week 1, week 7 and week 14
measure: Child Behavior Checklist (CBCL)
timeFrame: Baseline (before treatment (t0)) and after treatment (t1, after 14 weeks)
measure: Youth Self-Report (YSR)
timeFrame: Baseline (before treatment (t0)) and after treatment (t1, after 14 weeks)
measure: Child Obsessive-Compulsive Impact Scale (COIS-RC)
timeFrame: Baseline (before treatment (t0)) and after treatment (t1, after 14 weeks)
measure: Fair Intelligence Test (CFT 20-R)
timeFrame: Baseline (t0) before treatment
measure: Questionnaire for self-assessment of depressive disorders (DISYPS-III SBB- DES)
timeFrame: Baseline (before treatment (t0)) and after treatment (t1, after 14 weeks)
measure: Screen for Child Anxiety Related Emotional Disorders (SCARED)
timeFrame: Baseline (before treatment (t0)) and after treatment (t1, after 14 weeks)
measure: Questionnaire for Measuring Health-Related Quality of Life in Children and Adolescents (KIDSCREEN)
timeFrame: Baseline (before treatment (t0)) and after treatment (t1, after 14 weeks)
measure: Ulm Quality of Life Inventory for Parents of Chronically Ill Children (ULQUIE)
timeFrame: Baseline (before treatment (t0)) and after treatment (t1, after 14 weeks)
measure: Affect questionnaire
timeFrame: Daily after each therapy session (approximately 5-10 minutes), for a time period of 14 weeks of therapy
Other outcomes:
Locations:
city: Tuebingen
country: Germany
facility: Department of Child and Adolescent Psychiatry, Psychosomatics and Psychotherapy
state: Baden-Württemberg
Study officials:
affiliation: University Hospital Tübingen
name: Annette Conzelmann, Prof.
role: PRINCIPAL_INVESTIGATOR
affiliation: University Hospital Tübingen
name: Tobias J Renner, Prof.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Hollmann K, Allgaier K, Hohnecker CS, Lautenbacher H, Bizu V, Nickola M, Wewetzer G, Wewetzer C, Ivarsson T, Skokauskas N, Wolters LH, Skarphedinsson G, Weidle B, de Haan E, Torp NC, Compton SN, Calvo R, Lera-Miguel S, Haigis A, Renner TJ, Conzelmann A. Internet-based cognitive behavioral therapy in children and adolescents with obsessive compulsive disorder: a feasibility study. J Neural Transm (Vienna). 2021 Sep;128(9):1445-1459. doi: 10.1007/s00702-021-02409-w. Epub 2021 Aug 25.