Smart Sensory Technology in Psychotherapy for Pediatric OCD

Obsessive-Compulsive Disorder Clinical Trial

— SSTeP-KiZ  

Official title:

Smart Sensory Technology in Telepsychotherapy for the Treatment of Obsessive-compulsive Disorder in Children and Adolescents

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05291611
• Other study ID #: 877/2020BO1
• Status: Completed
• Phase: N/A
• Start date: August 1, 2021
• Est. completion date: March 31, 2023

Study information

• Verified date: September 2023
• Source: University Hospital Tuebingen
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: March 31, 2023
• Est. primary completion date: March 31, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 12 Years to 18 Years

Eligibility

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.

Related Conditions & MeSH terms

• Obsessive-Compulsive Disorder

Intervention

Behavioral:
• 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.

Locations

Country	Name	City	State
Germany	Department of Child and Adolescent Psychiatry, Psychosomatics and Psychotherapy	Tuebingen	Baden-Württemberg

Sponsors (3)

Lead Sponsor	Collaborator
University Hospital Tuebingen	Universität Tübingen, University of Hohenheim

Country where clinical trial is conducted

Germany, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	System Usability Scale (SUS) - assessment of the change in the handling of the technical equipment during treatment	Patients are to answer a total of 60 questions with 10 questions for each technical device from the system usability scale (SUS), regarding the handling of the technical equipment and to capture the change in it.	After week 1, week 7 and week 14
Primary	Therapy Process Questionnaire (TPQ) - assessing the stability of the therapeutic relationship and possible changes in the treatment process	Patients are to rate how they perceive the therapeutic process.	Weekly after each therapy session, for 14 weeks of therapy
Primary	Client Satisfaction Questionnaire-8 (CSQ-8)	We assess participant's perceptions of the value of the treatment they received	After the last session in week 14 (post treatment)
Primary	Questionnaire for the evaluation of the treatment (FBB)	It records how satisfied the participants were with the treatment. We reduced the total number of questions from 20 to 17, as 3 items covered circumstances that did not occur in the context of internet-based therapy.	After the last session in week 14 (post treatment)
Primary	Change in Health Care Utilization, measured by HCU-Q (Health Care Utilization-Questionnaire)	Questionnaire to capture costs and time spent on online-based treatments; Health Care Utilization-Questionnaire, change is assessed between baseline and the last session.	Baseline (before treatment (t0)) and after treatment (t1, after 14 weeks)
Primary	Change in Quality of Life: EQ-5D-3L (European Quality of Life Five Dimensions Questionnaire)	Questionnaire to capture costs and time spent on online-based treatments: Questionnaire to capture costs and time spent on online-based treatments, measured by European Quality of Life Five Dimensions Questionnaire Three Level Version (EQ-5D-3L).	Baseline (before treatment (t0)) and after treatment (t1, after 14 weeks)
Primary	Change in costs spent on online interventions: CIIQ (Caregiver Indirect and Informal Care Cost Assessment Questionnaire)	Questionnaire to capture costs and time spent on online-based treatments: Caregiver Indirect and Informal Care Cost Assessment Questionnaire (CIIQ)	Baseline (before treatment (t0)) and after treatment (t1, after 14 weeks)
Primary	Change in affinity for technology (TA-EG)	Technology Affinity Questionnaire (TA-EG): The TA-EG can be answered by patients and their parents and contains 19 items. It measures the attitude towards and use of electronic devices.	Baseline (before treatment (t0)) and after treatment (t1, after 14 weeks)
Primary	Change in attitudes toward and satisfaction with telemedicine psychotherapy (EZtP)	Questionnaire on the Attitude and Satisfaction of Telemedicine Psychotherapy (EZtP). The EZtP is a self-developed questionnaire that measures attitudes to and satisfaction with telemedicine psychotherapy. It can be answered by both the adolescents and the parents.	Baseline (before treatment (t0)) and after treatment (t1, after 14 weeks)
Primary	Barriers to Treatment Participation Scale (BTPS)	The Barriers to Treatment Participation Scale, is a 44 item rating of how much parents agree with statements about their expectancies of barriers to treatment participation for their child, using a 5-point Likert scale (1=totally disagree, 5= totally agree).	Once after treatment (t1, after 14 weeks)
Primary	Measures of feasibility: Manual Rating Form (MRF)	The Manual Rating Form (MRF) is used to assess feasibility of the manual.	Once after treatment (t1, after 14 weeks)
Primary	Measures of feasibility: Summary Therapist Feedback Form (STFF)	The Summary Therapist Feedback Form (STFF) is used to assess the ease of manual implementation completed after each case.	Once after treatment (t1, after 14 weeks)
Primary	Implementation and satisfaction questionnaire for the children	We designed an implementation and satisfaction questionnaire for the children. It covers the subject's dosage, quality, adaption, responsiveness and program differentiation.	Once after treatment (t1, after 14 weeks)
Primary	Implementation and satisfaction questionnaire for the parents	We designed an implementation and satisfaction questionnaire for the parents. It covers the subject's dosage, quality, adaption, responsiveness and program differentiation.	Once after treatment (t1, after 14 weeks)
Primary	Implementation and satisfaction questionnaire for the therapist	We designed an implementation and satisfaction questionnaire for the therapist. Questions regarding whether the intervention was being delivered as written (adherence) and the representativeness of the participants (reach) were implemented in the therapist's questionnaire covering questions like "The psychoeducation/relapse prophylaxis/exposure sessions were carried out as planned." and a checklist regarding information e.g. about the socioeconomic status, age, gender or IQ.	Once after treatment (t1, after 14 weeks)
Secondary	Children's Yale-Brown Obsessive Compulsive Scale (CY-BOCS)	The CY-BOCS is a clinician-administered instrument that evaluates obsessions and compulsions separately on time consumed, distress, interference, resistance, and control. A score higher than 16 describes clinical relevant obsessive-compulsive symptoms. The short form of the CY-BOCS is conducted daily on the app as part of the mobile assessment.	Baseline (before treatment (t0)) and after treatment (t1, after 14 weeks)
Secondary	Children's Global Assessment Scale (CGAS)	The CGAS is a clinician's rating of the patient's overall level of functional strain.	Baseline (before treatment (t0)) and after treatment (t1, after 14 weeks)
Secondary	Clinical Global Impressions-Improvement (CGI-I)	The CGI-I is used to assess overall clinical improvement based on symptoms observed and impairment reported. The clinical-rated scale has been used successfully in patients with OCD.	Baseline (before treatment (t0)) and after treatment (t1, after 14 weeks)
Secondary	Clinical Global Impressions-Severity (CGI-S)	Is a clinical rating of symptom severity. The CGI-S correlates strongly with the CY-BOCS total score in pediatric OCD patients, and is widely used and has been shown to be treatment sensitive.	Baseline (before treatment (t0)) and after treatment (t1, after 14 weeks)
Secondary	Children's DIPS Open Access: Diagnostic Interview in Childhood and Adolescent Mental Disorders (Kinder-DIPS)	The Kinder-DIPS is a structured clinical interview for the diagnosis of mental disorders. There is a child version and a parent version. Both, the child version and the parent version, are performed.	Baseline (before treatment (t0)) and after treatment (t1, after 14 weeks)
Secondary	Brief Self-Control Scale	Patients will be given questions concerning self-control (Brief Self-Control Scale, German Version (Sproesser et al., 2011))	After week 1, week 7 and week 14
Secondary	Self-efficacy	Patients answer questions regarding self-efficacy according to the questionnaire of Schwarzer & Jerusalem (1999).	After week 1, week 7 and week 14
Secondary	Coping strategies	Patients answer questions regarding coping strategies according to the questionnaire of Schwarzer & Jerusalem (1999).	After week 1, week 7 and week 14
Secondary	Self-regulation	Patients answer questions regarding self-regulation according to the questionnaire of Schwarzer & Jerusalem (1999).	After week 1, week 7 and week 14
Secondary	Procrastination	Patients answer questions regarding procrastination according to the questionnaire of Schwarzer & Jerusalem (1999).	After week 1, week 7 and week 14
Secondary	Child Behavior Checklist (CBCL)	The Child Behaviour Checklist (CBCL/6-18R) is used to record behavioural problems, emotional problems, somatic complaints as well as social competences of children and adolescents of school age from the parents' point of view.	Baseline (before treatment (t0)) and after treatment (t1, after 14 weeks)
Secondary	Youth Self-Report (YSR)	The YSR/11-18R (youth version) was derived directly from the CBCL and allows an assessment of the largely identical characteristics from the perspective of adolescents.	Baseline (before treatment (t0)) and after treatment (t1, after 14 weeks)
Secondary	Child Obsessive-Compulsive Impact Scale (COIS-RC)	The COIS-RC Culture includes a parent and a child report. It is a 33-item questionnaire designed to assess the impact of OCD symptoms on the psychosocial functioning of children and adolescent in home, social, and academic environments.	Baseline (before treatment (t0)) and after treatment (t1, after 14 weeks)
Secondary	Fair Intelligence Test (CFT 20-R)	The CFT 20-R records the basic intelligence according to the general fluid ability.	Baseline (t0) before treatment
Secondary	Questionnaire for self-assessment of depressive disorders (DISYPS-III SBB- DES)	The SBB-DES (DYSIPS-III) is a self-report questionnaire for adolescents (11 to 18 years) and part of the Diagnostic System for Mental Disorders according to ICD-10 and DSM-5 for children and adolescents. It records the different symptoms of a depressive disorder, the extent of distress and the competencies of the adolescent.	Baseline (before treatment (t0)) and after treatment (t1, after 14 weeks)
Secondary	Screen for Child Anxiety Related Emotional Disorders (SCARED)	The SCARED is a psychometrically sound child- and parent-report questionnaire which assesses the presence of DSM-IV anxiety symptoms.	Baseline (before treatment (t0)) and after treatment (t1, after 14 weeks)
Secondary	Questionnaire for Measuring Health-Related Quality of Life in Children and Adolescents (KIDSCREEN)	The questionnaires can be used to assess the subjective health and well-being of children and adolescents aged 8 to 18 years. A corresponding parent version is available for parents.	Baseline (before treatment (t0)) and after treatment (t1, after 14 weeks)
Secondary	Ulm Quality of Life Inventory for Parents of Chronically Ill Children (ULQUIE)	The ULQUIE was used to record the quality of life of the parents.	Baseline (before treatment (t0)) and after treatment (t1, after 14 weeks)
Secondary	Affect questionnaire	The emotional state of the patients is recorded daily by the app (ambulatory assessment)	Daily after each therapy session (approximately 5-10 minutes), for a time period of 14 weeks of therapy