Optimizing Sleep Health in Nurses

Study Overview
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Brief Summary
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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
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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.

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

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

Intervention / Treatment
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* Behavioral: CBTI
* Behavioral: MRTI


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: CBTI<br>Cognitive Behavioral Therapy for Insomnia | Behavioral: CBTI<br>* Intervention includes education about sleep and behavioral and cognitive strategies to improve sleep<br>* Other names: Cognitive Behavioral Therapy for Insomnia;|
| Other: MRTI<br>Multicomponent Relaxation Therapy for Insomnia | Behavioral: MRTI<br>* Intervention includes education about sleep and behavioral and relaxation strategies to improve sleep<br>* Other names: Multicomponent Relaxation Therapy for Insomnia;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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) | 
| 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) | 
| 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) | 
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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) | 
| 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) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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insomnia, shift work, circadian rhythm, sleep psychology, behavioral sleep medicine