Schizophrenia Clinical Trial
Official title:
Development and Validation of an Experience Sampling Method Questionnaire (ESM) for Digital Monitoring of Mental State in Psychiatric Hospitalization: Convergence of ESM Reports, Standard Clinical Assessments, and Smartwatch Data
This study presents the development and validation of a unique Digital Experience Sampling Method (ESM) questionnaire specifically adapted for monitoring changes in the mental state of patients during psychiatric hospitalization. The questionnaire was carefully crafted through focus groups involving patients and clinical staff, ensuring its relevance and applicability to the unique characteristics of mental state changes in a hospitalization setting. To evaluate the validity of the ESM questionnaire, symptom severity trends obtained from the questionnaire will be compared with estimates derived from the Positive and Negative Syndrome Scale (PANSS) assessment. Data will be collected from 100 subjects over a 14-day psychiatric hospitalization period. In addition to the ESM questionnaire, smartwatch sensors will monitor physiological indicators. Feasibility and patient compliance will be assessed by examining patients' willingness to use the digital ESM questionnaires and the smartwatch sensors. The study will also cross-reference self-reported sleep quality and activity levels captured in the ESM questionnaires with objective physiological indicators and nursing staff reports, providing insights into the reliability of the patient-reported data. Furthermore, the study will evaluate the impact of the ESM data on clinical decision-making by physicians throughout the 14-day psychiatric hospitalization period. Patient satisfaction and satisfaction among the multidisciplinary team with the monitoring model will also be assessed. This research underscores the potential of digital technologies to enhance patient-centered care and facilitate informed treatment decisions in psychiatric hospitalization settings.
Status | Recruiting |
Enrollment | 130 |
Est. completion date | January 19, 2024 |
Est. primary completion date | January 19, 2024 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years and older |
Eligibility | Focus group no.1 : Inclustion Criteria- - Hospitalized by consent in the psychiatric wards at the Sheba Medical Center. - Signed informed consent to participate in the study. Exclusion Criteria- - Patients with a low level of compliance to treatment. - Patients suffering from a significant active physical illness, intellectual disability, or complex organic conditions including dementia conditions - Patients who cannot read and write in the Hebrew language - Patients who are not qualified to give informed consent. Focus group no.2: Inclusion Criteria: - Staff members work in the inpatient wards and have a valid Israeli license. - Signed informed consent to participate in the study. No Exclusion Criteria. Focus group no.3- Inclustion Criteria: - Hospitalized by consent in the psychiatric wards at the Sheba Medical Center. - Signed informed consent to participate in the study. Exclusion Criteria: - Patients with a low level of compliance to treatment. - Patients suffering from a significant active physical illness, intellectual disability, or complex organic conditions including dementia conditions - Patients who cannot read and write in the Hebrew language - Patients who are not qualified to give informed consent. Monitoring model- The investigators will recruit 100 subjects hospitalized in the inpatient wards. Inclusion criteria: - Adults are consenting hospitalized in a psychiatric hospital at the Sheba Medical Center. - Staying in the open part of the ward. - Owns a mobile smartphone. Exclusion criteria: - Patients with a low level of treatment compliance. - Patients with a developmental or intellectual disability, complex organic conditions including dementia. - Patients who cannot read and write in the Hebrew language - Patients who are incapable of informed consent. The study inclusion criteria for the multi-disciplinary team: - Multi-disciplinary team members who work in the psychiatric inpatient wards at the Sheba Medical Center. - The staff members will have a valid Israeli license (from the professions of medicine, nursing, psychology, social work, and occupational therapy). |
Country | Name | City | State |
---|---|---|---|
Israel | Chaim Sheba Medical Center | Ramat Gan |
Lead Sponsor | Collaborator |
---|---|
Sheba Medical Center |
Israel,
1. Derogatis, L. R. (1992). SCL-90-R: Administration, scoring and procedures manual for the R(evised) version and other instruments of the psychopathology rating scale series.
2. Hektner, J. M., Schmidt, J. A., & Csikszentmihalyi, M. (2007). Experience sampling method: Measuring the quality of everyday life. Sage.
6. Kroenke, K., & Spitzer, R. L. (2002). The PHQ-9: a new depression diagnostic and severity measure. Psychiatric annals, 32(9), 509-515.
7. Stone, A., Shiffman, S., Atienza, A., & Nebeling, L. (2007). The science of real-time data capture: Self-reports in health research. Oxford University Press.
Johnson EI, Grondin O, Barrault M, Faytout M, Helbig S, Husky M, Granholm EL, Loh C, Nadeau L, Wittchen HU, Swendsen J. Computerized ambulatory monitoring in psychiatry: a multi-site collaborative study of acceptability, compliance, and reactivity. Int J Methods Psychiatr Res. 2009;18(1):48-57. doi: 10.1002/mpr.276. — View Citation
Myin-Germeys I, Oorschot M, Collip D, Lataster J, Delespaul P, van Os J. Experience sampling research in psychopathology: opening the black box of daily life. Psychol Med. 2009 Sep;39(9):1533-47. doi: 10.1017/S0033291708004947. Epub 2009 Feb 12. — View Citation
Pilkonis PA, Choi SW, Reise SP, Stover AM, Riley WT, Cella D; PROMIS Cooperative Group. Item banks for measuring emotional distress from the Patient-Reported Outcomes Measurement Information System (PROMIS(R)): depression, anxiety, and anger. Assessment. 2011 Sep;18(3):263-83. doi: 10.1177/1073191111411667. Epub 2011 Jun 21. — View Citation
Spitzer RL, Kroenke K, Williams JB, Lowe B. A brief measure for assessing generalized anxiety disorder: the GAD-7. Arch Intern Med. 2006 May 22;166(10):1092-7. doi: 10.1001/archinte.166.10.1092. — View Citation
Verhagen SJ, Hasmi L, Drukker M, van Os J, Delespaul PA. Use of the experience sampling method in the context of clinical trials. Evid Based Ment Health. 2016 Aug;19(3):86-9. doi: 10.1136/ebmental-2016-102418. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Investigation of the feasibility and compliance of patients in responding to self-report questionnaires. | The responsiveness to participation in the monitoring model - The extent of responding to the self-report questionnaires over 14 days multiplied by three times a day. | 14 days | |
Other | Investigation of the feasibility of patients in participating in the study. | The responsiveness to participation in the study - The number of subjects who agreed to participate in the study out of the subjects we offered to participate. | 14 days | |
Other | Investigation of the feasibility and compliance of patients with different diagnoses in participating in the study. | The responsiveness to participation in the monitoring model - The number of subjects who agreed to participate in the study out of the subjects we offered to participate.
The degree of difference between subjects with different psychiatric diagnoses (psychotic spectrum, depression, mania, and personality disorders) in their adherence and responsiveness to agree to participate in the study, answer the self-report ESM questionnaires and wear and charge the smartwatch. |
14 days | |
Other | The validity of subjects' self-reports on sleep quality and activity level will be assessed by comparing the self-report ESM data with the physiological indicators collected by the smartwatch. | The ESM indices will be compared to reports from the nursing staff on the ward. Furthermore, we will explore whether these comparisons yield different outcomes among subjects with different psychiatric diagnoses. | 14 days | |
Other | Testing the effectiveness of the monitoring model. | The effectiveness will be assessed by examining the impact of exposing the psychiatrists to ESM data, as well as the physiological indicators collected by the smartwatch, on the decision-making process regarding changes in the patient's medication plan during psychiatric hospitalization. | 14 days | |
Other | Assessing patient satisfaction with the monitoring model used throughout their 14-day hospitalization. | Following the monitoring period, subjects will be asked to provide feedback on their satisfaction levels through questionnaires. | 14 days | |
Other | Assessing the satisfaction of the multi-disciplinary teams. | At the end of the study, the teams will report through questionnaires on their satisfaction with using this monitoring model and its influence on the team's clinical decision-making. | 14 days | |
Other | Investigation of the feasibility and compliance of patients to instructions of smartwatch use. | The degree of responsiveness to instructions regarding the use of the smartwatch for 14 days. | 14 days | |
Primary | The primary objective of this study is to validate the ESM questionnaire by comparing the trends in symptom severity as reported through the ESM questionnaire with the PANSS assessment of symptom severity. | The positive and negative syndrome scale (PANSS) for schizophrenia is measuring the severity of symptoms in patients with schizophrenia spectrum disorders. It is conducted through a brief interview rather than a self-report.
The ESM (Experience Sampling Method) is a method Structured based on a diary, in which the subjects are asked to report their thoughts, feelings, and symptoms during their daily life, as well as to describe the context in which the report takes place. The validation of the ESM questionnaire will be conducted by comparing the change trends in the questionnaire indices during a 14-day psychiatric hospitalization period to the change trends in four different measurements of psychiatric symptoms assessed by the PANSS diagnostic tool, which is widely recognized as the gold standard in psychiatric symptom assessment. The subject's assessment using PANSS will be conducted at three different time points. |
14 days. | |
Secondary | Development of the monitoring questionnaire - Content validity phase. | The subjects' point of view regarding the psychiatric symptoms they suffered from during their hospitalization was examined during a free discussion. Emphasis was placed on the symptoms that change daily throughout the hospitalization and how much they indicate a change in their mental state. We also investigated what information they would like to report to the treatment team about their mental state throughout the hospitalization. After the free discussion, the position of the subjects was examined regarding the criteria for assessing mental state as they emerged from the monitoring scales of the PROM questionnaires.
After a qualitative analysis of the information collected at this stage, the main themes of the ESM questionnaire were formulated. According to the themes found, suggestions were developed for the questionnaire items while noting how the patient's symptoms were worded. A professional transcriber transcribed the discussion. |
14 days |
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