NCT04201392

Brief Summary

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
120

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Aug 2018

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 31, 2018

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

October 3, 2019

Completed
3 months until next milestone

First Posted

Study publicly available on registry

December 17, 2019

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 31, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 31, 2020

Completed
Last Updated

December 17, 2019

Status Verified

December 1, 2019

Enrollment Period

1.6 years

First QC Date

October 3, 2019

Last Update Submit

December 12, 2019

Conditions

Keywords

Psychiatric inpatient care

Outcome Measures

Primary Outcomes (25)

  • 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

  • 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

  • Characteristics of sleep disturbances: Objective total sleep time

    The Fitbit Charge 2 will measure daily objective total sleep time.

    7 days

  • 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

  • Characteristics of sleep disturbances: Objective sleep onset latency

    The Fitbit Charge 2 will measure daily objective sleep onset latency.

    7 days

  • 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

  • Characteristics of sleep disturbances: Objective wake after sleep onset

    The Fitbit Charge 2 will measure daily minutes awake after sleep onset.

    7 days

  • Characteristics of sleep disturbances: Daily subjective total sleep time

    A sleep diary will measure daily subjective total sleep time.

    7 days

  • Characteristics of sleep disturbances: Daily subjective sleep onset latency

    A sleep diary will measure daily subjective sleep onset latency.

    7 days

  • 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

  • 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

  • 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

  • Characteristics of sleep disturbances: Subjective sleep efficiency

    The Pittsburg Sleep Quality Index will measure current subjective sleep efficiency.

    7 days

  • Characteristics of sleep disturbances: Chronotype

    The Munich Chronotype Questionnaire will measure chronotype based on the midpoint of a person's sleep.

    7 days

  • Characteristics of sleep disturbances: Dream experiences and believes

    The Mannheim Dream Questionnaire will measure dream experiences and believes.

    7 days

  • Characteristics of sleep disturbances: Nightmare frequency

    The Mannheim Dream Questionnaire will measure current nightmare frequency.

    7 days

  • Characteristics of sleep disturbances: Nightmare distress

    The Mannheim Dream Questionnaire will measure nightmare distress.

    7 days

  • Characteristics of sleep disturbances: Daily nightmare frequency

    A sleep diary will measure daily prospective nightmare frequency.

    7 days

  • Characteristics of sleep disturbances: Daily nightmare distress

    A sleep diary will measure daily prospective nightmare distress.

    7 days

  • Characteristics of sleep disturbances: Heart rate during sleep

    A Fitbit device will measure average heart rate (bpm) during sleep.

    7 days

  • 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

  • Processes of psychopathology other than sleep: State mindfulness

    A sleep diary will measure daily state mindfulness.

    7 days

  • 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

  • Processes of psychopathology other than sleep: State rumination

    A sleep diary will measure daily state rumination.

    7 days

  • 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 Outcomes (8)

  • Psychiatric diagnosis

    1 day

  • Current severity of depressive symptoms

    7 days

  • Current severity of anxiety symptoms

    7 days

  • Current severity of alcohol use

    7 days

  • Current severity of drug use

    7 days

  • +3 more secondary outcomes

Other Outcomes (2)

  • Demographic and personal information

    7 days

  • Current medication

    7 days

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

For this study, participants will be recruited from the inpatient units at the Psychiatric University Hospital Zurich (PUK). It is aimed to recruit patients from each of the following diagnostic groups: Affective disorders, substance use disorders, anxiety disorders, and schizophrenia. These groups have been chosen, because they are the biggest patient groups in the hospital. Within the groups, the most common diagnoses among inpatients at the PUK will be investigated (F32, F33, F34.1, F10.2, F12.2, F14.2, F40.0, F40.1, F40.2, F41.0, F41.1, and F20.0). A sub-sample from the same sample will be recruited for Fitbit tracker measurements. Participation in the research will be fully independent of their treatment.

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Psychiatric University Hospital Zurich

Zurich, 8032, Switzerland

RECRUITING

Related Publications (20)

  • 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.

    PMID: 26600106BACKGROUND
  • 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.

    PMID: 2769898BACKGROUND
  • 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.

    PMID: 1386215BACKGROUND
  • 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.

    PMID: 18297585BACKGROUND
  • 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.

    PMID: 27416139BACKGROUND
  • 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.

    PMID: 11033749BACKGROUND
  • 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

    BACKGROUND
  • 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.

    PMID: 23046780BACKGROUND
  • 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.

    PMID: 17083303BACKGROUND
  • 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.

    PMID: 20362977BACKGROUND
  • 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.

    BACKGROUND
  • 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.

    PMID: 26600108BACKGROUND
  • Tsuno N, Besset A, Ritchie K. Sleep and depression. J Clin Psychiatry. 2005 Oct;66(10):1254-69. doi: 10.4088/jcp.v66n1008.

    PMID: 16259539BACKGROUND
  • Staner L. Sleep and anxiety disorders. Dialogues Clin Neurosci. 2003 Sep;5(3):249-58. doi: 10.31887/DCNS.2003.5.3/lstaner.

    PMID: 22033804BACKGROUND
  • 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.

    PMID: 11086154BACKGROUND
  • 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.

    PMID: 21396945BACKGROUND
  • 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.

    PMID: 21482065BACKGROUND
  • 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.

    PMID: 12729678BACKGROUND
  • Mume, C. O. (2009). Nightmare in schizophrenic and depressed patients, European Journal of Psychiatry, 23(3), 177-183.

    BACKGROUND
  • 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.

    PMID: 21885593BACKGROUND

MeSH Terms

Conditions

ParasomniasSleep Wake DisordersSleep Initiation and Maintenance DisordersDisorders of Excessive SomnolenceMental Disorders

Condition Hierarchy (Ancestors)

Nervous System DiseasesNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsSleep Disorders, IntrinsicDyssomnias

Central Study Contacts

Thomas Maeder, M.Sc.

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 3, 2019

First Posted

December 17, 2019

Study Start

August 31, 2018

Primary Completion

March 31, 2020

Study Completion

March 31, 2020

Last Updated

December 17, 2019

Record last verified: 2019-12

Locations