Optimizing Sleep Health in Nurses

Not Applicable

Recruiting

• Conditions: Sleep Initiation and Maintenance Disorders; Circadian Rhythm Sleep-Wake Disorders, Shift Work Type

• Registration Number: NCT05965609
• Lead Sponsor: Oregon State University

Brief Summary

The aim of the proposed study is to pilot test two behavioral sleep intervention strategies for improving insomnia among night shift working nurses.

Detailed Description

Night shift nurses with insomnia who meet all study criteria will receive one of two insomnia therapies. The specific therapy for insomnia will be determine by chance (like a flip of a coin), with an equal chance to receive either cognitive-behavioral therapy for insomnia or multicomponent relaxation therapy for insomnia, both modified for shift workers. Both therapies will be conducted over telehealth by interventionists trained in behavioral sleep medicine.

Study Timeline

• Study First Submitted: 2023-07-12
• Study First Submitted QC: 2023-07-19
• Study First Posted: 2023-07-28
• Study Start: 2023-12-08
• Status Verified: 2025-03
• Last Update Submitted: 2025-03-17
• Last Update Posted: 2025-03-20
• Primary Completion: 2026-01
• Study Completion: 2026-06

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

• Current shift working nursing staff in Oregon
• Expect to continue on shift work schedule during the study
• Meets criteria for an insomnia disorder
• Elevated insomnia symptoms
• Have daily access to internet on a smartphone, tablet, or computer; and
• Can read and write in English

Exclusion Criteria

• People with uncontrolled medical conditions
• Presence of safety risk or condition in which study participation may be ineffective or result in increased risk to safety
• Some current treatments for insomnia
• Permanent day, evening, or rotating shift schedule
• History of seizures or manic episode; or
• Current/expected pregnancy during the study period

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Change in Insomnia Severity Index	At baseline and at the post-treatment assessment (occurring at approximately 10 weeks)	Validated questionnaire; total score range between 0 and 28, with higher numbers representing greater insomnia severity
Retention Rate	At the post-treatment assessment (occurring at approximately 10 weeks)	Defined as \[number of participants who complete minimal therapeutic dose (at least 4 sessions)\] / \[number of randomized participants in treatment arm\]
Session Attendance	At the post-treatment assessment (occurring at approximately 10 weeks)	For enrolled participants, attendance rates will be calculated as \[number of visits attended\] / \[number of total visits\]
Implementation Assessment Measure	At the post-treatment assessment (occurring at approximately 10 weeks)	Validated questionnaire; total score range between 12 and 60, with higher numbers representing greater feasibility, acceptability, and appropriateness.

Secondary Outcome Measures

Name	Time	Method
Change in PROMIS Sleep Related Impairment 8 item	At baseline and at the post-treatment assessment (occurring at approximately 10 weeks)	Validated questionnaire; total score range between 8-40, with higher numbers indicating greater sleep-related wake time impairment
Change in Fatigue Severity Scale	At baseline and at the post-treatment assessment (occurring at approximately 10 weeks)	Validated questionnaire; total score range between 9 and 63, with higher numbers representing greater fatigue.

Trial Locations

Locations (1)

Oregon State University; 🇺🇸 Corvallis, Oregon, United States