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OSHIN: Optimizing Sleep Health in Nurses

Sponsor
Oregon State University (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05965609
Collaborator
American Academy of Sleep Medicine (Other), Monash University (Other), Stanford University (Other)
60
Enrollment
1
Location
2
Arms
23.9
Anticipated Duration (Months)
2.5
Patients Per Site Per Month

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: CBTI
  • Behavioral: MRTI
 N/A

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 Design

Study Type:
Interventional
Anticipated Enrollment :
60 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Investigator, Outcomes 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.
Primary Purpose:
Treatment
Official Title:
Piloting an Adaption of Cognitive Behavioral Therapy for Insomnia for Shift Workers (CBTI-Shift)
Anticipated Study Start Date :
Aug 15, 2023
Anticipated Primary Completion Date :
Jan 14, 2025
Anticipated Study Completion Date :
Aug 11, 2025

Arms and Interventions

Arm Intervention/Treatment
Other: CBTI

Cognitive Behavioral Therapy for Insomnia

Behavioral: CBTI
Intervention includes education about sleep and behavioral and cognitive strategies to improve sleep
Other Names:
  • Cognitive Behavioral Therapy for Insomnia

    		•
    Other: MRTI

    Multicomponent Relaxation Therapy for Insomnia

    Behavioral: MRTI
    Intervention includes education about sleep and behavioral and relaxation strategies to improve sleep
    Other Names:
  • Multicomponent Relaxation Therapy for Insomnia

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Change in Insomnia Severity Index [At baseline and at the post-treatment assessment (occurring at approximately 21 weeks)]

      Validated questionnaire; total score range between 0 and 28, with higher numbers representing greater insomnia severity

    2. Retention Rate [At the post-treatment assessment (occurring at approximately 21 weeks)]

      Defined as [number of participants who complete minimal therapeutic dose (at least 4 sessions)] / [number of randomized participants in treatment arm]

    3. Session Attendance [At the post-treatment assessment (occurring at approximately 21 weeks)]

      For enrolled participants, attendance rates will be calculated as [number of visits attended] / [number of total visits]

    4. Implementation Assessment Measure [At the post-treatment assessment (occurring at approximately 21 weeks)]

      Validated questionnaire; total score range between 12 and 60, with higher numbers representing greater feasibility, acceptability, and appropriateness.

    Secondary Outcome Measures

    1. Change in Fatigue Severity Scale [At baseline and at the post-treatment assessment (occurring at approximately 21 weeks)]

      Validated questionnaire; total score range between 9 and 63, with higher numbers representing greater fatigue.

    2. Change in Epworth Sleepiness Scale [At baseline and at the post-treatment assessment (occurring at approximately 21 weeks)]

      Validated questionnaire; total score range between 0 and 24, with higher numbers representing greater sleepiness propensity

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Oregon State University Corvallis Oregon United States 97331

    Sponsors and Collaborators

    • Oregon State University
    • American Academy of Sleep Medicine
    • Monash University
    • Stanford University

    Investigators

    • Principal Investigator: Jessica Dietch, PhD, Oregon State University

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    Responsible Party:
    Jessee Dietch, Principal Investigator, Oregon State University
    ClinicalTrials.gov Identifier:
    NCT05965609
    Other Study ID Numbers:
    • IRB-2021-1200
    First Posted:
    Jul 28, 2023
    Last Update Posted:
    Jul 28, 2023
    Last Verified:
    Jul 1, 2023
    Individual Participant Data (IPD) Sharing Statement:
    Yes
    Plan to Share IPD:
    Yes
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Jessee Dietch, Principal Investigator, Oregon State University
    insomnia
    shift work
    circadian rhythm
    sleep psychology
    behavioral sleep medicine
    Additional relevant MeSH terms:
    Sleep Initiation and Maintenance Disorders
    Sleep Wake Disorders
    Sleep Disorders, Circadian Rhythm

    Study Results

    No Results Posted as of Jul 28, 2023