Optimizing Sleep Health in Nurses

Sleep Initiation and Maintenance Disorders Clinical Trial

— OSHIN  

Official title:

Piloting an Adaption of Cognitive Behavioral Therapy for Insomnia for Shift Workers (CBTI-Shift)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05965609
• Other study ID #: IRB-2021-1200
• Status: Recruiting
• Phase: N/A
• Start date: December 8, 2023
• Est. completion date: August 11, 2025

Study information

• Verified date: February 2024
• Source: Oregon State University
• Contact: Jessica R Dietch, PhD
• Phone: 541-737-1358
• Email: jessee.dietch[@]oregonstate.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: August 11, 2025
• Est. primary completion date: January 14, 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Sleep Disorders, Circadian Rhythm
• Sleep Initiation and Maintenance Disorders
• Sleep Wake Disorders

Intervention

Behavioral:
• CBTI
Intervention includes education about sleep and behavioral and cognitive strategies to improve sleep
• MRTI
Intervention includes education about sleep and behavioral and relaxation strategies to improve sleep

Locations

Country	Name	City	State
United States	Oregon State University	Corvallis	Oregon

Sponsors (4)

Lead Sponsor	Collaborator
Oregon State University	American Academy of Sleep Medicine, Monash University, Stanford University

Country where clinical trial is conducted

United States, 

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* Note: There are 85 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Insomnia Severity Index	Validated questionnaire; total score range between 0 and 28, with higher numbers representing greater insomnia severity	At baseline and at the post-treatment assessment (occurring at approximately 10 weeks)
Primary	Retention Rate	Defined as [number of participants who complete minimal therapeutic dose (at least 4 sessions)] / [number of randomized participants in treatment arm]	At the post-treatment assessment (occurring at approximately 10 weeks)
Primary	Session Attendance	For enrolled participants, attendance rates will be calculated as [number of visits attended] / [number of total visits]	At the post-treatment assessment (occurring at approximately 10 weeks)
Primary	Implementation Assessment Measure	Validated questionnaire; total score range between 12 and 60, with higher numbers representing greater feasibility, acceptability, and appropriateness.	At the post-treatment assessment (occurring at approximately 10 weeks)
Secondary	Change in Fatigue Severity Scale	Validated questionnaire; total score range between 9 and 63, with higher numbers representing greater fatigue.	At baseline and at the post-treatment assessment (occurring at approximately 10 weeks)
Secondary	Change in PROMIS Sleep Related Impairment 8 item	Validated questionnaire; total score range between 8-40, with higher numbers indicating greater sleep-related wake time impairment	At baseline and at the post-treatment assessment (occurring at approximately 10 weeks)