Shift Worker Intervention for Sleep Health

Official title

Developing a Sleep Health Intervention for Shift Workers

Overview

The aim of this study is to pilot test a comprehensive, personalized, media-augmented telehealth intervention ("SWISH") designed to improve sleep health among shift workers.

Detailed description

Night shift nurses with insomnia who meet all study criteria will receive insomnia therapy, modified for shift workers that is designed to improve sleep health among shift workers by targeting shift workers' unique sleep health problems which manifest during both sleep and wake. Participants will be randomized to either SWISH, a multicomponent behavioral intervention based on cognitive behavioral therapy for insomnia that is individually administered via telehealth across approximately weekly sessions that range in length from 30-60 minutes, or delayed treatment control, which will involve weekly assessments but no active treatment until the delay period is over, at which point they will be offered the intervention. The therapy will be conducted over telehealth by interventionists trained in behavioral sleep medicine.

Interventions

• Behavioral Shift Worker Intervention for Sleep Health
  SWISH, a multicomponent behavioral intervention based on cognitive behavioral therapy for insomnia that is individually administered via telehealth across nine approximately weekly sessions that range in length from 15-60 minutes

Primary outcome measures

• Retention Rate [Time frame: At the post-treatment assessment (occurring at approximately 12 weeks)]
• Session Attendance [Time frame: At the post-treatment assessment (occurring at approximately 12 weeks)]
• Implementation Assessment Measure [Time frame: At the post-treatment assessment (occurring at approximately 12 weeks)]

Secondary outcome measures (12)

• Change in PROMIS Sleep Related Impairment [Time frame: At baseline and at the post-treatment assessment (occurring at approximately 12 weeks)]
• Change in PROMIS Sleep Disturbances [Time frame: At baseline and at the post-treatment assessment (occurring at approximately 12 weeks)]
• Patient Adherence [Time frame: At the post-treatment assessment (occurring at approximately 12 weeks)]
• Acceptability of Study Procedures and SWISH [Time frame: After treatment is completed (occurring at approximately 12 weeks)]
• Change in Fatigue Severity Scale [Time frame: At baseline and the post-treatment assessment (occurring at approximately 12 weeks)]
• Change in Epworth Sleepiness Scale [Time frame: At baseline and the post-treatment assessment (occurring at approximately 12 weeks)]
• Change in sleep efficiency on modified Consensus Sleep Diary [Time frame: At baseline and at the post-treatment assessment (occurring at approximately 12 weeks)]
• Change in sleep duration on modified Consensus Sleep Diary [Time frame: At baseline and at the post-treatment assessment (occurring at approximately 12 weeks)]
• Change in actigraphy-derived sleep efficiency [Time frame: At baseline and at the post-treatment assessment (occurring at approximately 12 weeks)]
• Change in actigraphy-derived sleep duration [Time frame: At baseline and at the post-treatment assessment (occurring at approximately 12 weeks)]
• Change in PROMIS Emotional Distress - Depression [Time frame: At baseline and at the post-treatment assessment (occurring at approximately 12 weeks)]
• Change in cognition [Time frame: At baseline and at the post-treatment assessment (occurring at approximately 12 weeks)]

Eligibility criteria

Inclusion criteria

• Provision of signed and dated informed consent form
• Any gender; Ages 18-65
• Currently employed as a nurse or nursing staff member (e.g., CNA) in the United States
• Currently have shift work schedules (i.e., stable night shift or rotating shifts that include nights, >=2 nights/week) and have worked shift work >=2 nights/week for at least 3 months
• Expect to have a shift work schedule >=2 nights/week over the next 6 months
• endorse poor sleep, as evidenced by T-score >=60 on the PROMIS Sleep Disturbance OR Sleep-Related Impairment measure
• Have daily access to the internet on a smartphone, table, or computer; and
• Can read and write in English.

Exclusion criteria

• Conditions which make study treatment likely to be ineffective. For example, current chronic use of medications that interfere with sleep, alcohol or substance use disorder, or thought disorder (as determined by DIAMOND psychiatric interview), unstable sleep or medical conditions that necessitate additional medical care not provided by study treatments (e.g., known untreated sleep apnea).
• Presence of safety risk or condition in which study participation may result in increased risk to safety (e.g., elevated risk for suicide, self-reported uncontrolled seizure disorder, history of manic or hypomanic episode, current pregnancy),
• Currently receiving non-pharmacological treatment for insomnia (e.g., cognitive behavioral therapy for insomnia) and/or current unstable hypnotic/alerting medication use OR
• Currently participating in other research studies with substantial overlap in terms of methods/procedures (e.g., PI's ongoing study "Piloting an Adaptation of Cognitive Behavioral Therapy for Insomnia for Shift Workers (CBTI-Shift)"

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Crossover

Masking

Double blind

Primary purpose

Treatment

Study locations

United States · 1 center

• Oregon State University — Corvallis

Publications

• Torquati L, Mielke GI, Brown WJ, Kolbe-Alexander T. Shift work and the risk of cardiovascular disease. A systematic review and meta-analysis including dose-response relationship. Scand J Work Environ Health. 2018 May 1;44(3):229-238. doi: 10.5271/sjweh.3700. Epub 2017 Dec 16. PMID 29247501
• Frost P, Kolstad HA, Bonde JP. Shift work and the risk of ischemic heart disease - a systematic review of the epidemiologic evidence. Scand J Work Environ Health. 2009 May;35(3):163-79. doi: 10.5271/sjweh.1319. Epub 2009 Apr 22. PMID 19387517
• Brown DL, Feskanich D, Sanchez BN, Rexrode KM, Schernhammer ES, Lisabeth LD. Rotating night shift work and the risk of ischemic stroke. Am J Epidemiol. 2009 Jun 1;169(11):1370-7. doi: 10.1093/aje/kwp056. Epub 2009 Apr 8. PMID 19357324
• Hansen J, Lassen CF. Nested case-control study of night shift work and breast cancer risk among women in the Danish military. Occup Environ Med. 2012 Aug;69(8):551-6. doi: 10.1136/oemed-2011-100240. Epub 2012 May 29. PMID 22645325
• Jia Y, Lu Y, Wu K, Lin Q, Shen W, Zhu M, Huang S, Chen J. Does night work increase the risk of breast cancer? A systematic review and meta-analysis of epidemiological studies. Cancer Epidemiol. 2013 Jun;37(3):197-206. doi: 10.1016/j.canep.2013.01.005. Epub 2013 Feb 9. PMID 23403128
• Rao D, Yu H, Bai Y, Zheng X, Xie L. Does night-shift work increase the risk of prostate cancer? a systematic review and meta-analysis. Onco Targets Ther. 2015 Oct 5;8:2817-26. doi: 10.2147/OTT.S89769. eCollection 2015. PMID 26491356
• Lin X, Chen W, Wei F, Ying M, Wei W, Xie X. Night-shift work increases morbidity of breast cancer and all-cause mortality: a meta-analysis of 16 prospective cohort studies. Sleep Med. 2015 Nov;16(11):1381-1387. doi: 10.1016/j.sleep.2015.02.543. Epub 2015 May 11. PMID 26498240
• Karlsson B, Knutsson A, Lindahl B. Is there an association between shift work and having a metabolic syndrome? Results from a population based study of 27,485 people. Occup Environ Med. 2001 Nov;58(11):747-52. doi: 10.1136/oem.58.11.747. PMID 11600731

Identifiers

NCT: NCT06384742 · HE-2023-505 · K23HL157698

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗