Smart Sensory Technology in Psychotherapy for Pediatric OCD (SSTeP-KiZ)

University Hospital Tuebingen

Status

Completed

Conditions

Obsessive-Compulsive Disorder

Treatments

Behavioral: Online-based Cognitive-behavioral Therapy for OCD

Study type

Interventional

Funder types

Other

Identifiers

NCT05291611

877/2020BO1

Details and patient eligibility

About

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.

Full 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.

Enrollment

20 patients

Sex

All

Ages

12 to 18 years old

Volunteers

No Healthy Volunteers

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.