Smart Sensory Technology in Psychotherapy for Pediatric OCD

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-08-01

Study Completion Date

2023-03-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Child and Adolescent OCD Outcomes From Exposure and Response Prevention Video Teletherapy Treatment

NCT06466447

Obsessive-Compulsive Disorder

COMPLETED

Internet-based vs Face-to-face Cognitive Behavioural Therapy for Obsessive-compulsive Disorder

NCT02541968

Obsessive-compulsive Disorder

COMPLETED NA

Clinical Outcomes in Pediatric Obsessive-Compulsive Disorder

NCT01635569

Obsessive-compulsive Disorder

RECRUITING NA

Effectiveness of Trauma-Focused Cognitive-Behavioral Therapy (TF-CBT) for Children With Post-traumatic Stress Disorder (TreatChildTrauma)

NCT01516827

Post-Traumatic Stress Disorder

COMPLETED NA

ITreatOCD: Predicting the Efficacy of Internet-based Cognitive Behavioral Therapy in Obsessive-compulsive Disorder

NCT05906069

Obsessive-Compulsive Disorder

RECRUITING NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Obsessive-Compulsive Disorder

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

SINGLE_GROUP

All participants will be treated with cognitive behavioural therapy during our feasibility study.

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Treatment with cbt

Treatment for 26 patients with obsessive-compulsive disorder, 14 sessions, each about 90 minutes.

Group Type EXPERIMENTAL

Online-based Cognitive-behavioral Therapy for OCD

Intervention Type BEHAVIORAL

26 patients with obsessive-compulsive disorder (OCD) receive treatment with cognitive-behavioral therapy. 14 sessions will take place via the internet.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Online-based Cognitive-behavioral Therapy for OCD

26 patients with obsessive-compulsive disorder (OCD) receive treatment with cognitive-behavioral therapy. 14 sessions will take place via the internet.

Intervention Type BEHAVIORAL

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Online-based Psychotherapy

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.

Minimum Eligible Age

12 Years

Maximum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No