Clinical trial NCT05965609: Optimizing Sleep Health in Nurses
Official title: Piloting an Adaption of Cognitive Behavioral Therapy for Insomnia for Shift Workers (CBTI-Shift)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Circadian Rhythm Sleep-Wake Disorders, Shift Work Type
Sleep Initiation and Maintenance Disorders
Keywords: insomnia
shift work
circadian rhythm
sleep psychology
behavioral sleep medicine
Lead sponsor: Oregon State University
Sponsor class: OTHER
Collaborators: name: American Academy of Sleep Medicine
name: Monash University
name: Stanford University
First posted: 2023-07-28
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Change in Insomnia Severity Index
timeFrame: At baseline and at the post-treatment assessment (occurring at approximately 10 weeks)
measure: Retention Rate
timeFrame: At the post-treatment assessment (occurring at approximately 10 weeks)
measure: Session Attendance
timeFrame: At the post-treatment assessment (occurring at approximately 10 weeks)
measure: Implementation Assessment Measure
timeFrame: At the post-treatment assessment (occurring at approximately 10 weeks)
Secondary outcomes:
measure: Change in Fatigue Severity Scale
timeFrame: At baseline and at the post-treatment assessment (occurring at approximately 10 weeks)
measure: Change in PROMIS Sleep Related Impairment 8 item
timeFrame: At baseline and at the post-treatment assessment (occurring at approximately 10 weeks)
Other outcomes:
Locations:
city: Corvallis
country: United States
facility: Oregon State University
state: Oregon
Study officials:
affiliation: Oregon State University
name: Jessica Dietch, PhD
role: PRINCIPAL_INVESTIGATOR
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