Back to resultsOptimizing Sleep Health in Nurses (OSHIN)
Primary Purpose
Circadian Rhythm Sleep-Wake Disorders, Shift Work Type, Sleep Initiation and Maintenance Disorders
Status
Not yet recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
CBTI
MRTI
Sponsored by
About this trial
This is an interventional treatment trial for Circadian Rhythm Sleep-Wake Disorders, Shift Work Type focused on measuring insomnia, shift work, circadian rhythm, sleep psychology, behavioral sleep medicine
Eligibility Criteria
Inclusion Criteria: Current shift working nurse 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
Sites / Locations
- Oregon State University
Arms of the Study
Arm 1
Arm 2
Arm Type
Other
Other
Arm Label
CBTI
MRTI
Arm Description
Cognitive Behavioral Therapy for Insomnia
Multicomponent Relaxation Therapy for Insomnia
Outcomes
Primary Outcome Measures
Change in Insomnia Severity Index
Validated questionnaire; total score range between 0 and 28, with higher numbers representing greater insomnia severity
Retention Rate
Defined as [number of participants who complete minimal therapeutic dose (at least 4 sessions)] / [number of randomized participants in treatment arm]
Session Attendance
For enrolled participants, attendance rates will be calculated as [number of visits attended] / [number of total visits]
Implementation Assessment Measure
Validated questionnaire; total score range between 12 and 60, with higher numbers representing greater feasibility, acceptability, and appropriateness.
Secondary Outcome Measures
Change in Fatigue Severity Scale
Validated questionnaire; total score range between 9 and 63, with higher numbers representing greater fatigue.
Change in Epworth Sleepiness Scale
Validated questionnaire; total score range between 0 and 24, with higher numbers representing greater sleepiness propensity
Full Information
NCT ID
NCT05965609
First Posted
July 12, 2023
Last Updated
July 19, 2023
Sponsor
Oregon State University
Collaborators
American Academy of Sleep Medicine, Monash University, Stanford University
1. Study Identification
Unique Protocol Identification Number
NCT05965609
Brief Title
Optimizing Sleep Health in Nurses
Acronym
OSHIN
Official Title
Piloting an Adaption of Cognitive Behavioral Therapy for Insomnia for Shift Workers (CBTI-Shift)
Study Type
Interventional
2. Study Status
Record Verification Date
July 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
August 15, 2023 (Anticipated)
Primary Completion Date
January 14, 2025 (Anticipated)
Study Completion Date
August 11, 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Oregon State University
Collaborators
American Academy of Sleep Medicine, Monash University, Stanford University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Circadian Rhythm Sleep-Wake Disorders, Shift Work Type, Sleep Initiation and Maintenance Disorders
Keywords
insomnia, shift work, circadian rhythm, sleep psychology, behavioral sleep medicine
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
InvestigatorOutcomes Assessor
Masking Description
Participants are asked to refrain from mentioning any information about the treatment they receive when interacting with the investigator or outcomes assessors. Participants are asked not to share details of their treatment with other individuals at their workplace.
Allocation
Randomized
Enrollment
60 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
CBTI
Arm Type
Other
Arm Description
Cognitive Behavioral Therapy for Insomnia
Arm Title
MRTI
Arm Type
Other
Arm Description
Multicomponent Relaxation Therapy for Insomnia
Intervention Type
Behavioral
Intervention Name(s)
CBTI
Other Intervention Name(s)
Cognitive Behavioral Therapy for Insomnia
Intervention Description
Intervention includes education about sleep and behavioral and cognitive strategies to improve sleep
Intervention Type
Behavioral
Intervention Name(s)
MRTI
Other Intervention Name(s)
Multicomponent Relaxation Therapy for Insomnia
Intervention Description
Intervention includes education about sleep and behavioral and relaxation strategies to improve sleep
Primary Outcome Measure Information:
Title
Change in Insomnia Severity Index
Description
Validated questionnaire; total score range between 0 and 28, with higher numbers representing greater insomnia severity
Time Frame
At baseline and at the post-treatment assessment (occurring at approximately 21 weeks)
Title
Retention Rate
Description
Defined as [number of participants who complete minimal therapeutic dose (at least 4 sessions)] / [number of randomized participants in treatment arm]
Time Frame
At the post-treatment assessment (occurring at approximately 21 weeks)
Title
Session Attendance
Description
For enrolled participants, attendance rates will be calculated as [number of visits attended] / [number of total visits]
Time Frame
At the post-treatment assessment (occurring at approximately 21 weeks)
Title
Implementation Assessment Measure
Description
Validated questionnaire; total score range between 12 and 60, with higher numbers representing greater feasibility, acceptability, and appropriateness.
Time Frame
At the post-treatment assessment (occurring at approximately 21 weeks)
Secondary Outcome Measure Information:
Title
Change in Fatigue Severity Scale
Description
Validated questionnaire; total score range between 9 and 63, with higher numbers representing greater fatigue.
Time Frame
At baseline and at the post-treatment assessment (occurring at approximately 21 weeks)
Title
Change in Epworth Sleepiness Scale
Description
Validated questionnaire; total score range between 0 and 24, with higher numbers representing greater sleepiness propensity
Time Frame
At baseline and at the post-treatment assessment (occurring at approximately 21 weeks)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Current shift working nurse 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jessica R Dietch, PhD
Phone
541-737-1358
Email
jessee.dietch@oregonstate.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Lucy Kozii, MD, MPH
Email
koziil@oregonstate.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jessica Dietch, PhD
Organizational Affiliation
Oregon State University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Oregon State University
City
Corvallis
State/Province
Oregon
ZIP/Postal Code
97331
Country
United States
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jessee Dietch, PhD
Phone
541-737-1358
Email
jessee.dietch@oregonstate.edu
First Name & Middle Initial & Last Name & Degree
Jessee Dietch, PhD
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
De-identified data may be uploaded to a data repository to make it accessible for publication.
IPD Sharing Time Frame
Data will become available within 2 years after the publication of the results pertaining to the primary aims and will be available for at least 2 years.
IPD Sharing Access Criteria
Data will be shared only with investigators who have a clear and rigorous analytic plan and who sign a data use agreement with the principal investigator.
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Optimizing Sleep Health in Nurses
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