Insomnia Clinical Trial
— SPINOfficial title:
Prevalence and Characteristics of Sleep Disturbances Among Psychiatric Inpatients
NCT number | NCT04201392 |
Other study ID # | 2017-01297 |
Secondary ID | |
Status | Recruiting |
Phase | |
First received | |
Last updated | |
Start date | August 31, 2018 |
Est. completion date | March 31, 2020 |
Decades of research have shown that sleep disturbances are common among patients with a wide range of psychiatric disorders. Such reported sleep disturbances include disrupted sleep efficiency and continuity, sleep quality complaints, insomnia, and nightmares. While traditional models suggest that certain sleep alterations are specific for certain mental disorders, newer models assume a transdiagnostic or dimensional view of sleep disturbances in mental disorders. Findings of a recent meta-analysis support the transdiagnostic or dimensional association between sleep disorders and psychiatric conditions. Additionally, the period just prior to sleep has recently received increased clinical and research interest, with studies investigating cognitive activity and rumination prior to sleep. However, only few studies compare sleep in different psychiatric diagnoses and the characteristics of sleep in different mental disorders are still not understood well enough for concrete implications for clinical practice. This is especially true for the population of psychiatric inpatients. In this study, the outcome measures and study variables will be measured with standardised and validated questionnaires, structured clinical interview, and a commercially available Fitbit Charge 2 tracker. Participants will be recruited from the inpatient units of the Psychiatric University Hospital Zurich (PUK). Screening will be conducted by the applicant and master's students enrolled in the project, using electronic patient files at the hospital. The patients will be invited to the study by their treating physician or psychologist. Assessments will consist of one interview and filling out of questionnaires (with a 30- to 45-minute duration respectively). A sub-sample will wear fill out a sleep diary for seven consecutive nights as well as wear a Fitbit Charge 2 tracker, which they will return a week later. Each patient will receive participant reimbursement of 30 Swiss francs (CHF) for their participation in the study.
Status | Recruiting |
Enrollment | 120 |
Est. completion date | March 31, 2020 |
Est. primary completion date | March 31, 2020 |
Accepts healthy volunteers | |
Gender | All |
Age group | 18 Years to 65 Years |
Eligibility |
Inclusion Criteria: - Male and Female patients from PUK inpatient units between 18 and 65 years of age - ICD-10 diagnosis of affective disorders (F32, F33, F34.1), substance use disorders (F10.2, F12.2, F14.2), anxiety disorders (F40.0, F40.1, F40.2, F41.0, F41.1), and schizophrenia (F20.0) - Currently receiving inpatient care at the Psychiatric University Hospital Zurich - Fluent in German and able to understand the instructions Exclusion Criteria: - Currently receiving outpatient or day clinic programs at the Psychiatric University Hospital Zurich - ICD-10 diagnosis other than F32, F33, F34.1, F10.2, F12.2, F14.2, F40.0, F40.1, F40.2, F41.0, F41.1, and F20.0 - Patients who are too severely ill to fill in questionnaires - Patients with a one on one or 15- / 30-minute visual control by the nursing personnel because of risk of suicidal tendencies or the risk of harming others - Head injury - Neurological disease - Shift work - Trouble speaking and / or understanding German language |
Country | Name | City | State |
---|---|---|---|
Switzerland | Psychiatric University Hospital Zurich | Zurich |
Lead Sponsor | Collaborator |
---|---|
University of Zurich | Psychiatric University Hospital, Zurich, Swiss National Science Foundation |
Switzerland,
Babson K, Feldner M, Badour C, Trainor C, Blumenthal H, Sachs-Ericsson N, Schmidt N. Posttraumatic stress and sleep: differential relations across types of symptoms and sleep problems. J Anxiety Disord. 2011 Jun;25(5):706-13. doi: 10.1016/j.janxdis.2011.03.007. Epub 2011 Mar 17. — View Citation
Baglioni C, Nanovska S, Regen W, Spiegelhalder K, Feige B, Nissen C, Reynolds CF, Riemann D. Sleep and mental disorders: A meta-analysis of polysomnographic research. Psychol Bull. 2016 Sep;142(9):969-990. Epub 2016 Jul 14. Review. — View Citation
Benca RM, Obermeyer WH, Thisted RA, Gillin JC. Sleep and psychiatric disorders. A meta-analysis. Arch Gen Psychiatry. 1992 Aug;49(8):651-68; discussion 669-70. — View Citation
Carney CE, Edinger JD, Meyer B, Lindman L, Istre T. Symptom-focused rumination and sleep disturbance. Behav Sleep Med. 2006;4(4):228-41. — View Citation
Carney CE, Harris AL, Moss TG, Edinger JD. Distinguishing rumination from worry in clinical insomnia. Behav Res Ther. 2010 Jun;48(6):540-6. doi: 10.1016/j.brat.2010.03.004. Epub 2010 Mar 11. — View Citation
Ford DE, Kamerow DB. Epidemiologic study of sleep disturbances and psychiatric disorders. An opportunity for prevention? JAMA. 1989 Sep 15;262(11):1479-84. — View Citation
Harvey AG, Jones C, Schmidt DA. Sleep and posttraumatic stress disorder: a review. Clin Psychol Rev. 2003 May;23(3):377-407. Review. — View Citation
Harvey AG. Pre-sleep cognitive activity: a comparison of sleep-onset insomniacs and good sleepers. Br J Clin Psychol. 2000 Sep;39(3):275-86. — View Citation
Kamath J, Virdi S, Winokur A. Sleep Disturbances in Schizophrenia. Psychiatr Clin North Am. 2015 Dec;38(4):777-92. doi: 10.1016/j.psc.2015.07.007. Epub 2015 Aug 22. Review. — View Citation
Kaufmann CN, Spira AP, Rae DS, West JC, Mojtabai R. Sleep problems, psychiatric hospitalization, and emergency department use among psychiatric patients with Medicaid. Psychiatr Serv. 2011 Sep;62(9):1101-5. doi: 10.1176/appi.ps.62.9.1101. — View Citation
Krystal AD, Thakur M, Roth T. Sleep disturbance in psychiatric disorders: effects on function and quality of life in mood disorders, alcoholism, and schizophrenia. Ann Clin Psychiatry. 2008 Jan-Mar;20(1):39-46. doi: 10.1080/10401230701844661. Review. — View Citation
Mume, C. O. (2009). Nightmare in schizophrenic and depressed patients, European Journal of Psychiatry, 23(3), 177-183.
Nappi CM, Drummond SP, Hall JM. Treating nightmares and insomnia in posttraumatic stress disorder: a review of current evidence. Neuropharmacology. 2012 Feb;62(2):576-85. doi: 10.1016/j.neuropharm.2011.02.029. Epub 2011 Mar 17. Review. — View Citation
Ohayon MM, Shapiro CM. Sleep disturbances and psychiatric disorders associated with posttraumatic stress disorder in the general population. Compr Psychiatry. 2000 Nov-Dec;41(6):469-78. — View Citation
Roehrs, T., & Roth, T. (2012). Sleep and sleep disorders. In J. C. Verster, K. Brady, M. Galanter, & P. Conrod (Eds.), Drug abuse and addiction in medical illness: Causes, consequences and treatment (S. 375-384). New York: Springer Science + Business Media.
Rumble ME, White KH, Benca RM. Sleep Disturbances in Mood Disorders. Psychiatr Clin North Am. 2015 Dec;38(4):743-59. doi: 10.1016/j.psc.2015.07.006. Review. — View Citation
Staner L. Sleep and anxiety disorders. Dialogues Clin Neurosci. 2003 Sep;5(3):249-58. — View Citation
Takano K, Iijima Y, Tanno Y. Repetitive thought and self-reported sleep disturbance. Behav Ther. 2012 Dec;43(4):779-89. doi: 10.1016/j.beth.2012.04.002. Epub 2012 Apr 19. — View Citation
Thomsen, D. K., Mehlsen, M. Y., Christensen, S., & Zachariae, R. (2003). Rumination: Relationship with negative mood and sleep quality, Personality and Individual Differences, 34(7), 1293-1301. doi: 10.1016/S0191-8869(02)00120-4
Tsuno N, Besset A, Ritchie K. Sleep and depression. J Clin Psychiatry. 2005 Oct;66(10):1254-69. Review. — View Citation
* Note: There are 20 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Demographic and personal information | A questionnaire will measure demographic and medical background information, such as sex, age, nationality, marital status, residence permit status, children, life situation, highest education, current or last work situation, current social situation, socioeconomic status. | 7 days | |
Other | Current medication | As a potential confounder, a medication protocol will measure current medication, especially medication, which has been reported to have an effect on sleep, will be documented. | 7 days | |
Primary | Prevalence of sleep disorders | The Sleep Disorders Symptom Checklist and the sleep module of the Diagnostische Interview bei psychischen Störungen will measure current sleep disorders as listed in the DSM-IV-TR and DSM-V (sleep apnea, insomnia, narcolepsy, restless legs/PLMD, circadian rhythm sleep disorder, sleepwalking, nightmares, factors influencing sleep, and the impact of sleep complaints on daily functioning). | 7 days | |
Primary | Characteristics of sleep disturbances: Subjective total sleep time | The Pittsburg Sleep Quality Index and the sleep module of the Diagnostische Interview bei psychischen Störungen will measure current subjective total sleep time. | 7 days | |
Primary | Characteristics of sleep disturbances: Objective total sleep time | The Fitbit Charge 2 will measure daily objective total sleep time. | 7 days | |
Primary | Characteristics of sleep disturbances: Subjective sleep onset latency | The Pittsburg Sleep Quality Index and the sleep module of the Diagnostische Interview bei psychischen Störungen will measure current subjective sleep onset latency. | 7 days | |
Primary | Characteristics of sleep disturbances: Objective sleep onset latency | The Fitbit Charge 2 will measure daily objective sleep onset latency. | 7 days | |
Primary | Characteristics of sleep disturbances: Subjective wake after sleep onset | The Pittsburg Sleep Quality Index and the sleep module of the Diagnostische Interview bei psychischen Störungen will measure current minutes awake after sleep onset. | 7 days | |
Primary | Characteristics of sleep disturbances: Objective wake after sleep onset | The Fitbit Charge 2 will measure daily minutes awake after sleep onset. | 7 days | |
Primary | Characteristics of sleep disturbances: Daily subjective total sleep time | A sleep diary will measure daily subjective total sleep time. | 7 days | |
Primary | Characteristics of sleep disturbances: Daily subjective sleep onset latency | A sleep diary will measure daily subjective sleep onset latency. | 7 days | |
Primary | Characteristics of sleep disturbances: Daily subjective wake after sleep onset | A sleep diary will measure minutes awake after sleep onset for each night. | 7 days | |
Primary | Characteristics of sleep disturbances: Subjective sleep quality | The Pittsburg Sleep Quality Index will measure current sleep quality. Higher Pittsburgh Sleep Quality Index scores indicate lower sleep quality (minimum value: 0, maximum value: 21). | 7 days | |
Primary | Characteristics of sleep disturbances: Daytime sleepiness | Daytime sleepiness will be measured specifically by the Epworth Sleepiness Scale (minimum value: 0, maximum value: 24). | 7 days | |
Primary | Characteristics of sleep disturbances: Subjective sleep efficiency | The Pittsburg Sleep Quality Index will measure current subjective sleep efficiency. | 7 days | |
Primary | Characteristics of sleep disturbances: Chronotype | The Munich Chronotype Questionnaire will measure chronotype based on the midpoint of a person's sleep. | 7 days | |
Primary | Characteristics of sleep disturbances: Dream experiences and believes | The Mannheim Dream Questionnaire will measure dream experiences and believes. | 7 days | |
Primary | Characteristics of sleep disturbances: Nightmare frequency | The Mannheim Dream Questionnaire will measure current nightmare frequency. | 7 days | |
Primary | Characteristics of sleep disturbances: Nightmare distress | The Mannheim Dream Questionnaire will measure nightmare distress. | 7 days | |
Primary | Characteristics of sleep disturbances: Daily nightmare frequency | A sleep diary will measure daily prospective nightmare frequency. | 7 days | |
Primary | Characteristics of sleep disturbances: Daily nightmare distress | A sleep diary will measure daily prospective nightmare distress. | 7 days | |
Primary | Characteristics of sleep disturbances: Heart rate during sleep | A Fitbit device will measure average heart rate (bpm) during sleep. | 7 days | |
Primary | Processes of psychopathology other than sleep: Trait mindfulness | The Mindful Attention Awareness Scale will measure current trait mindfulness. Higher Mindful Attention Awareness Scale scores indicate higher trait mindfulness (minimum value: 15, maximum value: 90). | 7 days | |
Primary | Processes of psychopathology other than sleep: State mindfulness | A sleep diary will measure daily state mindfulness. | 7 days | |
Primary | Processes of psychopathology other than sleep: Trait rumination | The Response Styles Questionnaire will measure trait rumination. Higher Response Styles Questionnaire scores indicate higher trait rumination, divided into a brooding and a reflection score (minimum brooding and reflection values: 5, maximum brooding and reflection values: 20). | 7 days | |
Primary | Processes of psychopathology other than sleep: State rumination | A sleep diary will measure daily state rumination. | 7 days | |
Primary | Processes of psychopathology other than sleep: Emotional regulation | The Emotion Regulation Questionnaire will measure emotional regulation divided into two emotion regulation processes: Reappraisal and suppression. Higher values indicate higher tendencies for reappraisal (minimum value: 6, maximum value: 42) or suppression (minimum value: 4, maximum value: 28). | 7 days | |
Secondary | Psychiatric diagnosis | The Mini International Neuropsychiatric Interview is a diagnostic interview, which will measure, which psychiatric diagnosis / diagnoses are met according to the International Classification of Diseases (ICD-10) and the Diagnostic and Statistical Manual of Mental Disorders (DSM 4). | 1 day | |
Secondary | Current severity of depressive symptoms | The Beck Depression Inventory will measure current severity of depressive symptoms (minimum value: 0, maximum value: 63). Higher scores indicate a higher severity. | 7 days | |
Secondary | Current severity of anxiety symptoms | The Beck Anxiety Inventory will measure current severity of anxiety symptoms (minimum value: 0, maximum value: 63). Higher scores indicate a higher severity. | 7 days | |
Secondary | Current severity of alcohol use | The Alcohol Use Disorders Identification Test will measure current severity of alcohol use (minimum value: 0, maximum value: 40). Higher scores indicate a higher severity. | 7 days | |
Secondary | Current severity of drug use | The Drug Use Disorders Identification Test will measure current severity of drug use (minimum value: 0, maximum value: 44). Higher scores indicate a higher severity. | 7 days | |
Secondary | Current severity of PTSD symptoms | The PTSD Checklist for DSM-5 will measure current severity of PTSD symptoms (minimum value: 0, maximum value: 80). Higher scores indicate a higher severity. | 7 days | |
Secondary | Current severity of psychotic symptoms | The Community Assessment of Psychic Experiences will measure current severity of psychotic symptoms (frequency and distress score with minimum value: 0, maximum value: 126). Higher scores indicate a higher severity. | 7 days | |
Secondary | Current severity of schizophrenia symptoms | The Positive and Negative Syndrom Scale will measure current severity of schizophrenia symptoms (minimum value: 30, maximum value: 210). Higher scores indicate a higher severity. | 7 days |
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