Smart Sensory Technology in Psychotherapy for Pediatric OCD

NCT05291611 | Completed

• 1 other identifier: 877/2020BO1
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Obsessive-Compulsive Disorder

Keywords

Obsessive-compulsive Disorder; Children and Adolescents; Cognitive-behavioral therapy; Digital sensory device

Outcome Measures

Primary Outcomes (15)

• 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

• 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

• 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)

• 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)

• 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)

• 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)

• 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)

• 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)

• 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)

• 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)

• 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)

• 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)

• 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)

• 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)

• 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 Outcomes (19)

• Children's Yale-Brown Obsessive Compulsive Scale (CY-BOCS)

  Baseline (before treatment (t0)) and after treatment (t1, after 14 weeks)

• Children's Global Assessment Scale (CGAS)

  Baseline (before treatment (t0)) and after treatment (t1, after 14 weeks)

• Clinical Global Impressions-Improvement (CGI-I)

  Baseline (before treatment (t0)) and after treatment (t1, after 14 weeks)

• Clinical Global Impressions-Severity (CGI-S)

  Baseline (before treatment (t0)) and after treatment (t1, after 14 weeks)

• Children's DIPS Open Access: Diagnostic Interview in Childhood and Adolescent Mental Disorders (Kinder-DIPS)

  Baseline (before treatment (t0)) and after treatment (t1, after 14 weeks)

Study Arms (1)

Treatment with cbt

EXPERIMENTAL

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

Behavioral: Online-based Cognitive-behavioral Therapy for OCD

Interventions

Online-based Cognitive-behavioral Therapy for OCD BEHAVIORAL

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

Also known as: Online-based Psychotherapy

Treatment with cbt

Eligibility Criteria

• Age: 12 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University Hospital Tuebingen: lead
• Universität Tübingen: collaborator
• University of Hohenheim: collaborator

Study Sites (1)

Department of Child and Adolescent Psychiatry, Psychosomatics and Psychotherapy

Tübingen, Baden-Wurttemberg, 72076, Germany

Location

Related Publications (5)

• 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.

  PMID: 34432173 BACKGROUND

• Klein CS, Seyboth L, Conzelmann A, Schroder PA, Alt AK, Pascher A, Renner TJ, Gawrilow C, Hollmann K. Moderators of Symptom Self-Ratings in Pediatric Patients with Obsessive-Compulsive Disorder During a Digital Sensor-Assisted Treatment. Child Psychiatry Hum Dev. 2025 Nov 14. doi: 10.1007/s10578-025-01924-1. Online ahead of print.

  PMID: 41236692 DERIVED

• Alt AK, Klein CS, Pascher A, Conzelmann A, Kosel F, Kuhnhausen J, Hollmann K, Renner TJ. Acceptance of a sensor-based online psychotherapy for adolescents with obsessive-compulsive disorder (SSTeP-KiZ). Digit Health. 2025 Mar 28;11:20552076251327046. doi: 10.1177/20552076251327046. eCollection 2025 Jan-Dec.

  PMID: 40162174 DERIVED

• Klein CS, Alt AK, Pascher A, Kuhnhausen J, Seizer L, Ilg W, Thierfelder A, Primbs J, Menth M, Barth GM, Gawrilow C, Conzelmann A, Renner TJ, Hollmann K. Cognitive behavioral therapy for pediatric obsessive-compulsive disorder delivered via internet videoconferencing: a manualized sensor-assisted feasibility approach. Child Adolesc Psychiatry Ment Health. 2024 Dec 4;18(1):154. doi: 10.1186/s13034-024-00844-7.

  PMID: 39633405 DERIVED

• Klein CS, Hollmann K, Kuhnhausen J, Alt AK, Pascher A, Seizer L, Primbs J, Ilg W, Thierfelder A, Severitt B, Passon H, Worz U, Lautenbacher H, Bethge WA, Lochner J, Holderried M, Swoboda W, Kasneci E, Giese MA, Ernst C, Barth GM, Conzelmann A, Menth M, Gawrilow C, Renner TJ. Lessons learned from a multimodal sensor-based eHealth approach for treating pediatric obsessive-compulsive disorder. Front Digit Health. 2024 Sep 24;6:1384540. doi: 10.3389/fdgth.2024.1384540. eCollection 2024.

  PMID: 39381777 DERIVED

MeSH Terms

Conditions

Obsessive-Compulsive Disorder

Condition Hierarchy (Ancestors)

Anxiety Disorders; Mental Disorders

Study Officials

• Annette Conzelmann, Prof.

  University Hospital Tübingen

  PRINCIPAL INVESTIGATOR

• Tobias J Renner, Prof.

  University Hospital Tübingen

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof. Dr. Tobias Renner, Head of Child and Adolescent Psychiatry, Psychosomatics and Psychotherapy

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

Study Record Dates

• First Submitted: December 10, 2021
• First Posted: March 22, 2022
• Study Start: August 1, 2021
• Primary Completion: March 31, 2023
• Study Completion: March 31, 2023
• Last Updated: September 29, 2023

Record last verified: 2023-09

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)