Obsessive-Compulsive DisorderSSTeP-KiZNCT05291611
Smart Sensory Technology in Psychotherapy for Pediatric OCD
A study testing Online-based Cognitive-behavioral Therapy for OCD in people with Obsessive-Compulsive Disorder, run by University Hospital Tuebingen at 1 site in Germany.
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. Read more about this study
- Who is it for?
- Ages 12 to 18 years
- Conditions the study is for
- Obsessive-Compulsive Disorder
- What is being tested?
- Online-based Cognitive-behavioral Therapy for OCD
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteGermany
- Study dates
- 1 Aug 2021to 31 Mar 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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
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- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Germany1 site
Department of Child and Adolescent Psychiatry, Psychosomatics and Psychotherapy
Tübingen, Baden-Wurttemberg, 72076
About this study
Official title: Smart Sensory Technology in Telepsychotherapy for the Treatment of Obsessive-compulsive Disorder in Children and Adolescents
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.
Read the 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:
- Development of a prototype for a multisensory therapy system in healthy children and adaptation to mentally ill children with an obsessive-compulsive disorder.
- 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
- Obsessive-Compulsive Disorder
- Being tested
- Online-based Cognitive-behavioral Therapy for OCD
- Keywords
- Obsessive-compulsive Disorder, Children and Adolescents, Cognitive-behavioral therapy, Digital sensory device
- Medical subject headings
- Obsessive-Compulsive Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Online-based Cognitive-behavioral Therapy for OCDBehavioural
Also called Online-based Psychotherapy
26 patients with obsessive-compulsive disorder (OCD) receive treatment with cognitive-behavioral therapy. 14 sessions will take place via the internet.
| Study group | Role | What they receive |
|---|---|---|
| Treatment with cbt | Experimental | Treatment for 26 patients with obsessive-compulsive disorder, 14 sessions, each about 90 minutes. Receives: Behavioral: Online-based Cognitive-behavioral Therapy for OCD |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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
Measured: 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.
Measured: 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.
Measured: 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).
Measured: 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)
Measured: 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.
Measured: 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.
Measured: 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).
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Once after treatment (t1, after 14 weeks)
Secondary outcomes (19)
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.
Measured: Baseline (before treatment (t0)) and after treatment (t1, after 14 weeks)
Children's Global Assessment Scale (CGAS)
The CGAS is a clinician's rating of the patient's overall level of functional strain.
Measured: Baseline (before treatment (t0)) and after treatment (t1, after 14 weeks)
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.
Measured: Baseline (before treatment (t0)) and after treatment (t1, after 14 weeks)
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.
Measured: 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)
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.
Measured: Baseline (before treatment (t0)) and after treatment (t1, after 14 weeks)
Brief Self-Control Scale
Patients will be given questions concerning self-control (Brief Self-Control Scale, German Version (Sproesser et al., 2011))
Measured: After week 1, week 7 and week 14
Self-efficacy
Patients answer questions regarding self-efficacy according to the questionnaire of Schwarzer \& Jerusalem (1999).
Measured: After week 1, week 7 and week 14
Coping strategies
Patients answer questions regarding coping strategies according to the questionnaire of Schwarzer \& Jerusalem (1999).
Measured: After week 1, week 7 and week 14
Self-regulation
Patients answer questions regarding self-regulation according to the questionnaire of Schwarzer \& Jerusalem (1999).
Measured: After week 1, week 7 and week 14
Procrastination
Patients answer questions regarding procrastination according to the questionnaire of Schwarzer \& Jerusalem (1999).
Measured: After week 1, week 7 and week 14
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.
Measured: Baseline (before treatment (t0)) and after treatment (t1, after 14 weeks)
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.
Measured: Baseline (before treatment (t0)) and after treatment (t1, after 14 weeks)
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.
Measured: Baseline (before treatment (t0)) and after treatment (t1, after 14 weeks)
Fair Intelligence Test (CFT 20-R)
The CFT 20-R records the basic intelligence according to the general fluid ability.
Measured: Baseline (t0) before treatment
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.
Measured: Baseline (before treatment (t0)) and after treatment (t1, after 14 weeks)
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.
Measured: Baseline (before treatment (t0)) and after treatment (t1, after 14 weeks)
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.
Measured: Baseline (before treatment (t0)) and after treatment (t1, after 14 weeks)
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.
Measured: Baseline (before treatment (t0)) and after treatment (t1, after 14 weeks)
Affect questionnaire
The emotional state of the patients is recorded daily by the app (ambulatory assessment)
Measured: Daily after each therapy session (approximately 5-10 minutes), for a time period of 14 weeks of therapy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Mar 2022
- Study start1 Aug 2021
- Primary completion31 Mar 2023
- Study completion31 Mar 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Obsessive-Compulsive DisorderStudies of the same condition, open and under way.
- More trials run by University Hospital TuebingenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- All participants will be treated with cognitive behavioural therapy during our feasibility study.
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital Tuebingen
- Sponsor type
- University, hospital or other
- Collaborators
- Universität Tübingen, University of Hohenheim
- Responsible party
- Principal investigator, Prof. Dr. Tobias Renner, University Hospital Tuebingen
- Investigators
- Annette Conzelmann, Prof., Principal investigator, University Hospital TuebingenTobias J Renner, Prof., Principal investigator, University Hospital Tuebingen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05291611
- Sponsor's protocol ID
- 877/2020BO1
- Acronym
- SSTeP-KiZ
- Status last verified
- Sep 2023
- First submitted
- 10 Dec 2021
- Last updated
- 29 Sep 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 34432173Klein 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.
PubMed 41236692Alt 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.
PubMed 40162174Klein 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.
PubMed 39633405Klein 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.
PubMed 39381777
Study at a glance
From the registry record, last updated by the sponsor on 29 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Smart Sensory Technology in Telepsychotherapy for the Treatment of Obsessive-compulsive Disorder in Children and Adolescents
- ClinicalTrials.gov ID
- NCT05291611
- Acronym / sponsor ID
- SSTeP-KiZ / 877/2020BO1
- Conditions
- Obsessive-Compulsive Disorder
- Keywords
- Obsessive-compulsive Disorder, Children and Adolescents, Cognitive-behavioral therapy, Digital sensory device
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- University Hospital TuebingenUniversity, hospital or other
- Collaborators
- Universität Tübingen, University of Hohenheim
- Study start
- 1 Aug 2021 (actual)
- Primary completion
- 31 Mar 2023 (actual)
- Study completion
- 31 Mar 2023 (actual)
- First posted
- 22 Mar 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- Development of a prototype for a multisensory therapy system in healthy children and adaptation to mentally ill children with an obsessive-compulsive disorder.
- 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- All participants will be treated with cognitive behavioural therapy during our feasibility study.
| Arm | Type | Receives |
|---|---|---|
| Treatment with cbt | Experimental | Behavioral: Online-based Cognitive-behavioral Therapy for OCDTreatment for 26 patients with obsessive-compulsive disorder, 14 sessions, each about 90 minutes. |
Who may qualify
- Ages
- 12 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (9 listed)
- 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)
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Online-based Cognitive-behavioral Therapy for OCDAlso: Online-based Psychotherapy26 patients with obsessive-compulsive disorder (OCD) receive treatment with cognitive-behavioral therapy. 14 sessions will take place via the internet. | Behavioural | Treatment with cbt |
Primary outcome
System Usability Scale (SUS) - assessment of the change in the handling of the technical equipment during treatment
Time frame: After week 1, week 7 and week 14
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.
Therapy Process Questionnaire (TPQ) - assessing the stability of the therapeutic relationship and possible changes in the treatment process
Time frame: Weekly after each therapy session, for 14 weeks of therapy
Patients are to rate how they perceive the therapeutic process.
Client Satisfaction Questionnaire-8 (CSQ-8)
Time frame: After the last session in week 14 (post treatment)
We assess participant's perceptions of the value of the treatment they received
Questionnaire for the evaluation of the treatment (FBB)
Time frame: After the last session in week 14 (post treatment)
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.
Change in Health Care Utilization, measured by HCU-Q (Health Care Utilization-Questionnaire)
Time frame: Baseline (before treatment (t0)) and after treatment (t1, after 14 weeks)
Questionnaire to capture costs and time spent on online-based treatments; Health Care Utilization-Questionnaire, change is assessed between baseline and the last session.
Change in Quality of Life: EQ-5D-3L (European Quality of Life Five Dimensions Questionnaire)
Time frame: Baseline (before treatment (t0)) and after treatment (t1, after 14 weeks)
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).
Change in costs spent on online interventions: CIIQ (Caregiver Indirect and Informal Care Cost Assessment Questionnaire)
Time frame: Baseline (before treatment (t0)) and after treatment (t1, after 14 weeks)
Questionnaire to capture costs and time spent on online-based treatments: Caregiver Indirect and Informal Care Cost Assessment Questionnaire (CIIQ)
Change in affinity for technology (TA-EG)
Time frame: Baseline (before treatment (t0)) and after treatment (t1, after 14 weeks)
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.
Change in attitudes toward and satisfaction with telemedicine psychotherapy (EZtP)
Time frame: Baseline (before treatment (t0)) and after treatment (t1, after 14 weeks)
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.
Barriers to Treatment Participation Scale (BTPS)
Time frame: Once after treatment (t1, after 14 weeks)
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).
Measures of feasibility: Manual Rating Form (MRF)
Time frame: Once after treatment (t1, after 14 weeks)
The Manual Rating Form (MRF) is used to assess feasibility of the manual.
Measures of feasibility: Summary Therapist Feedback Form (STFF)
Time frame: Once after treatment (t1, after 14 weeks)
The Summary Therapist Feedback Form (STFF) is used to assess the ease of manual implementation completed after each case.
Implementation and satisfaction questionnaire for the children
Time frame: Once after treatment (t1, after 14 weeks)
We designed an implementation and satisfaction questionnaire for the children. It covers the subject's dosage, quality, adaption, responsiveness and program differentiation.
Implementation and satisfaction questionnaire for the parents
Time frame: Once after treatment (t1, after 14 weeks)
We designed an implementation and satisfaction questionnaire for the parents. It covers the subject's dosage, quality, adaption, responsiveness and program differentiation.
Implementation and satisfaction questionnaire for the therapist
Time frame: Once after treatment (t1, after 14 weeks)
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.
19 secondary outcomes
Children's Yale-Brown Obsessive Compulsive Scale (CY-BOCS)
Time frame: Baseline (before treatment (t0)) and after treatment (t1, after 14 weeks)
Children's Global Assessment Scale (CGAS)
Time frame: Baseline (before treatment (t0)) and after treatment (t1, after 14 weeks)
Clinical Global Impressions-Improvement (CGI-I)
Time frame: Baseline (before treatment (t0)) and after treatment (t1, after 14 weeks)
Clinical Global Impressions-Severity (CGI-S)
Time frame: 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)
Time frame: Baseline (before treatment (t0)) and after treatment (t1, after 14 weeks)
Brief Self-Control Scale
Time frame: After week 1, week 7 and week 14
Self-efficacy
Time frame: After week 1, week 7 and week 14
Coping strategies
Time frame: After week 1, week 7 and week 14
Self-regulation
Time frame: After week 1, week 7 and week 14
Procrastination
Time frame: After week 1, week 7 and week 14
Child Behavior Checklist (CBCL)
Time frame: Baseline (before treatment (t0)) and after treatment (t1, after 14 weeks)
Youth Self-Report (YSR)
Time frame: Baseline (before treatment (t0)) and after treatment (t1, after 14 weeks)
Child Obsessive-Compulsive Impact Scale (COIS-RC)
Time frame: Baseline (before treatment (t0)) and after treatment (t1, after 14 weeks)
Fair Intelligence Test (CFT 20-R)
Time frame: Baseline (t0) before treatment
Questionnaire for self-assessment of depressive disorders (DISYPS-III SBB- DES)
Time frame: Baseline (before treatment (t0)) and after treatment (t1, after 14 weeks)
Screen for Child Anxiety Related Emotional Disorders (SCARED)
Time frame: Baseline (before treatment (t0)) and after treatment (t1, after 14 weeks)
Questionnaire for Measuring Health-Related Quality of Life in Children and Adolescents (KIDSCREEN)
Time frame: Baseline (before treatment (t0)) and after treatment (t1, after 14 weeks)
Ulm Quality of Life Inventory for Parents of Chronically Ill Children (ULQUIE)
Time frame: Baseline (before treatment (t0)) and after treatment (t1, after 14 weeks)
Affect questionnaire
Time frame: Daily after each therapy session (approximately 5-10 minutes), for a time period of 14 weeks of therapy
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Sep 2023.
- Background: PubMed 34432173Hollmann 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.
- Derived from this study: PubMed 41236692Klein 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.
- Derived from this study: PubMed 40162174Alt 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.
- Derived from this study: PubMed 39633405Klein 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.
- Derived from this study: PubMed 39381777Klein 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Annette Conzelmann, Prof. principal investigator
University Hospital Tuebingen
Tobias J Renner, Prof. principal investigator
University Hospital Tuebingen
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Online-based Cognitive-behavioral Therapy for OCD in people with Obsessive-Compulsive Disorder, run by University Hospital Tuebingen at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
System Usability Scale (SUS) - assessment of the change in the handling of the technical equipment during treatment (time frame: After week 1, week 7 and week 14). The study lists 15 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05291611, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Sep 2023.