- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04201392
Sleep in Psychiatric Inpatients (SPIN)
Prevalence and Characteristics of Sleep Disturbances Among Psychiatric Inpatients
Study Overview
Status
Detailed Description
Sleep disturbances are common among psychiatric patients. In fact, most psychiatric disorders are afflicted with sleep disturbances. Mechanistical underpinnings and associations between sleep disturbances and psychiatric conditions have been an active field of research. Individuals with alcohol or substance abuse reported disrupted sleep efficiency and continuity, as well as rates of insomnia as high as 72%. In schizophrenia, insomnia and other sleep-related abnormalities are also common, with prevalence rates of 30% to 80%. Moreover, individuals with mood disorders describe a range of difficulties with sleep continuity and quality. Another study in depressed individuals reported rates as high as 90% of reported sleep quality complaints. Similarly, anxiety disorders are highly associated with sleep disorders. The fact that sleep disturbance is a diagnostic symptom for disorders such as generalized anxiety disorder and post-traumatic stress disorder (PTSD) underpins the relationship between anxiety and sleep. In PTSD for example, difficulty initiating and maintaining sleep and nightmares affect approximately 70% of individuals afflicted with this disorder. Reexperiencing in the form of distressing dreams and intrusive trauma memories prior to initiating sleep are commonly reported in this group. Taken together, these reports show that sleep problems are common in psychiatric patients. Some theoretical models suggest that certain sleep alterations are specific for certain mental disorders. Newer models, however, suggest a transdiagnostic or dimensional understanding of sleep in mental disorders, assuming sleep as an underlying dimension of mental disorders, with the same sleep alterations occurring in different mental disorders. Few studies comprise large enough numbers to compare different psychiatric diagnoses, however, and thus, few data exist on the specificity of various sleep abnormalities. In a notable exception, a meta-analysis investigated sleep disturbances across psychiatric disorders, reviewing studies using polysomnographic measurements. The authors found that no single sleep variable appeared to have absolute specificity for any particular psychiatric disorder and that patterns of sleep disturbances associated with categories of psychiatric disorders were observed. Additionally, the subtypes of diagnosis groups often differed in their profiles of sleep alterations. Thus, these results support the transdiagnostic view of sleep disturbances in mental disorders. In the light of these findings, however, it is interesting that the period just prior to sleep onset has recently received increased research and clinical interest. Pre-sleep cognitive activity of individuals suffering from insomnia has been shown to be more focused on worries, problems and noises in the environment and less focused on nothing in particular, compared to good sleepers. There is also evidence that rumination prior to sleep is associated with sleep disturbance (increased sleep onset latency, reduced sleep quality, reduced sleep efficiency, and increased wakefulness after sleep onset). Identification of potential disorder-specific as well as transdiagnostic pre-sleep processes would be helpful for diagnosing and treating patients. This is particularly important considering the heavy personal burden associated with psychiatric disorders and sleep disturbances. Most of the studies investigating sleep disturbances in psychiatric disorders have been conducted in psychiatric outpatients. Psychiatric inpatients and the even more severely afflicted patients who often suffer from comorbid diagnoses and possible additional social problems, have so far been mostly excluded. There are a few studies, which investigated sleep problems in psychiatric inpatients and/or patients with severe mental illness. Furthermore, although the period just prior to sleep onset has recently received increased research and clinical interest, a systematic investigation of individuals with diagnosed psychiatric disorders in terms of this specific sleep characteristic is lacking so far. The present study therefore aims to help fill this gap and study sleep problems, including pre-sleep processing in psychiatric inpatients. Additionally, studies investigating sleep disturbances using samples of patients with different psychiatric disorders are lacking. Thus, in order to understand the differences in sleep disturbances between different psychiatric diagnoses or symptom clusters, different studies have to be compared. Since these studies often differ in the samples and methods used, conclusions drawn from these comparisons are limited. For this reason, studies using samples of psychiatric patients with a wide range of psychiatric disorders are warranted.
For this study, participants will be recruited from the inpatient units of the Psychiatric University Hospital Zurich (PUK). Consultant psychiatrists and psychologists, as well as nursing personnel in the inpatient units of the PUK will support recruitment and one or two master students will help organise the study. All patients eligible for the study will be recruited consecutively. The applicant and master's students enrolled in the project will screen newly admitted psychiatric inpatients for inclusion and exclusion criteria in the electronic patient files. The information needed for the screening is part of standard assessments at the hospital. The treating psychologists or physicians will then be contacted directly by the applicant or master's students. The treating psychologists and physicians will invite the patients who meet the inclusion and exclusion criteria to the study. Prior to the first session, the applicant or master's students will use the patient's electronic file to document medical information, such as medical history, current primary diagnosis, and current medication. The first session, which will be led by the applicant or master's students, will consist of informed consent, a clinical interview, and a first set of self-report questionnaires, which will assess primary psychiatric diagnoses, measure demographic and personal information, sleep disorders, sleep characteristics, several psychological variables (such as emotional regulation, rumination, and mindfulness) and current symptom severity of the primary diagnosis. A sub-sample of patients will receive a sleep diary and a Fitbit Charge 2 tracker as well as information regarding its application. They will wear the Fitbit tracker on the wrist of their non-dominant hand at all times for a week (except during showers and / or charging). A week later, the questionnaires and/or diary and Fitbit tracker will be collected. Additionally, patients will be asked if they have any questions or whether they ran into any problems. After data collection is completed, each patient will receive participant reimbursement of 30 Swiss francs (CHF) for their participation in the study.
Study Type
Enrollment (Anticipated)
Contacts and Locations
Study Contact
- Name: Birgit Kleim, PhD
- Phone Number: +41443842351
- Email: b.kleim@psychologie.uzh.ch
Study Contact Backup
- Name: Thomas Maeder, M.Sc.
- Phone Number: +41798489793
- Email: thomas.maeder@uzh.ch
Study Locations
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Zurich, Switzerland, 8032
- Recruiting
- Psychiatric University Hospital Zurich
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Contact:
- Birgit Kleim, PhD
- Phone Number: +41443842351
- Email: b.kleim@psychologie.uzh.ch
-
Contact:
- Thomas Maeder, M.Sc.
- Phone Number: +41443842565
- Email: thomas.maeder@uzh.ch
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
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
Study Plan
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Prevalence of sleep disorders
Time Frame: 7 days
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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).
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7 days
|
Characteristics of sleep disturbances: Subjective total sleep time
Time Frame: 7 days
|
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
|
Characteristics of sleep disturbances: Objective total sleep time
Time Frame: 7 days
|
The Fitbit Charge 2 will measure daily objective total sleep time.
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7 days
|
Characteristics of sleep disturbances: Subjective sleep onset latency
Time Frame: 7 days
|
The Pittsburg Sleep Quality Index and the sleep module of the Diagnostische Interview bei psychischen Störungen will measure current subjective sleep onset latency.
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7 days
|
Characteristics of sleep disturbances: Objective sleep onset latency
Time Frame: 7 days
|
The Fitbit Charge 2 will measure daily objective sleep onset latency.
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7 days
|
Characteristics of sleep disturbances: Subjective wake after sleep onset
Time Frame: 7 days
|
The Pittsburg Sleep Quality Index and the sleep module of the Diagnostische Interview bei psychischen Störungen will measure current minutes awake after sleep onset.
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7 days
|
Characteristics of sleep disturbances: Objective wake after sleep onset
Time Frame: 7 days
|
The Fitbit Charge 2 will measure daily minutes awake after sleep onset.
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7 days
|
Characteristics of sleep disturbances: Daily subjective total sleep time
Time Frame: 7 days
|
A sleep diary will measure daily subjective total sleep time.
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7 days
|
Characteristics of sleep disturbances: Daily subjective sleep onset latency
Time Frame: 7 days
|
A sleep diary will measure daily subjective sleep onset latency.
|
7 days
|
Characteristics of sleep disturbances: Daily subjective wake after sleep onset
Time Frame: 7 days
|
A sleep diary will measure minutes awake after sleep onset for each night.
|
7 days
|
Characteristics of sleep disturbances: Subjective sleep quality
Time Frame: 7 days
|
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
|
Characteristics of sleep disturbances: Daytime sleepiness
Time Frame: 7 days
|
Daytime sleepiness will be measured specifically by the Epworth Sleepiness Scale (minimum value: 0, maximum value: 24).
|
7 days
|
Characteristics of sleep disturbances: Subjective sleep efficiency
Time Frame: 7 days
|
The Pittsburg Sleep Quality Index will measure current subjective sleep efficiency.
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7 days
|
Characteristics of sleep disturbances: Chronotype
Time Frame: 7 days
|
The Munich Chronotype Questionnaire will measure chronotype based on the midpoint of a person's sleep.
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7 days
|
Characteristics of sleep disturbances: Dream experiences and believes
Time Frame: 7 days
|
The Mannheim Dream Questionnaire will measure dream experiences and believes.
|
7 days
|
Characteristics of sleep disturbances: Nightmare frequency
Time Frame: 7 days
|
The Mannheim Dream Questionnaire will measure current nightmare frequency.
|
7 days
|
Characteristics of sleep disturbances: Nightmare distress
Time Frame: 7 days
|
The Mannheim Dream Questionnaire will measure nightmare distress.
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7 days
|
Characteristics of sleep disturbances: Daily nightmare frequency
Time Frame: 7 days
|
A sleep diary will measure daily prospective nightmare frequency.
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7 days
|
Characteristics of sleep disturbances: Daily nightmare distress
Time Frame: 7 days
|
A sleep diary will measure daily prospective nightmare distress.
|
7 days
|
Characteristics of sleep disturbances: Heart rate during sleep
Time Frame: 7 days
|
A Fitbit device will measure average heart rate (bpm) during sleep.
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7 days
|
Processes of psychopathology other than sleep: Trait mindfulness
Time Frame: 7 days
|
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
|
Processes of psychopathology other than sleep: State mindfulness
Time Frame: 7 days
|
A sleep diary will measure daily state mindfulness.
|
7 days
|
Processes of psychopathology other than sleep: Trait rumination
Time Frame: 7 days
|
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).
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7 days
|
Processes of psychopathology other than sleep: State rumination
Time Frame: 7 days
|
A sleep diary will measure daily state rumination.
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7 days
|
Processes of psychopathology other than sleep: Emotional regulation
Time Frame: 7 days
|
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).
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7 days
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Psychiatric diagnosis
Time Frame: 1 day
|
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).
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1 day
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Current severity of depressive symptoms
Time Frame: 7 days
|
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
|
Current severity of anxiety symptoms
Time Frame: 7 days
|
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
|
Current severity of alcohol use
Time Frame: 7 days
|
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
|
Current severity of drug use
Time Frame: 7 days
|
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
|
Current severity of PTSD symptoms
Time Frame: 7 days
|
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
|
Current severity of psychotic symptoms
Time Frame: 7 days
|
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
|
Current severity of schizophrenia symptoms
Time Frame: 7 days
|
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
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Demographic and personal information
Time Frame: 7 days
|
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
|
Current medication
Time Frame: 7 days
|
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
|
Collaborators and Investigators
Sponsor
Publications and helpful links
General Publications
- 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. doi: 10.1001/archpsyc.1992.01820080059010.
- Mume, C. O. (2009). Nightmare in schizophrenic and depressed patients, European Journal of Psychiatry, 23(3), 177-183.
- 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. doi: 10.1053/comp.2000.16568.
- 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.
- 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.
- Harvey AG, Jones C, Schmidt DA. Sleep and posttraumatic stress disorder: a review. Clin Psychol Rev. 2003 May;23(3):377-407. doi: 10.1016/s0272-7358(03)00032-1.
- Tsuno N, Besset A, Ritchie K. Sleep and depression. J Clin Psychiatry. 2005 Oct;66(10):1254-69. doi: 10.4088/jcp.v66n1008.
- 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. doi: 10.1037/bul0000053. Epub 2016 Jul 14.
- 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.
- Ford DE, Kamerow DB. Epidemiologic study of sleep disturbances and psychiatric disorders. An opportunity for prevention? JAMA. 1989 Sep 15;262(11):1479-84. doi: 10.1001/jama.262.11.1479.
- 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. doi: 10.1348/014466500163284.
- 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
- 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.
- Carney CE, Edinger JD, Meyer B, Lindman L, Istre T. Symptom-focused rumination and sleep disturbance. Behav Sleep Med. 2006;4(4):228-41. doi: 10.1207/s15402010bsm0404_3.
- 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.
- 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.
- 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.
- Staner L. Sleep and anxiety disorders. Dialogues Clin Neurosci. 2003 Sep;5(3):249-58. doi: 10.31887/DCNS.2003.5.3/lstaner.
- 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.
- 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.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2017-01297
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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