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OpenTrials
Completed

NCT Number: NCT05965609

Optimizing Sleep Health in Nurses

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

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Key information

Conditions

Circadian Rhythm Sleep-Wake Disorders, Shift Work Type Dyssomnias Mental Disorders Nervous System Diseases Sleep Disorders, Intrinsic Sleep Initiation and Maintenance Disorders Sleep Wake Disorders

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Oregon State University

Corvallis, Oregon, 97331, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

CBTI

Behavioral

Intervention includes education about sleep and behavioral and cognitive strategies to improve sleep

Other names: Cognitive Behavioral Therapy for Insomnia

MRTI

Behavioral

Intervention includes education about sleep and behavioral and relaxation strategies to improve sleep

Other names: Multicomponent Relaxation Therapy for Insomnia

Primary outcomes

  1. Change in Insomnia Severity Index

    Time frame: At baseline and at the post-treatment assessment (occurring at approximately 10 weeks)

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

  2. Retention Rate

    Time frame: At the post-treatment assessment (occurring at approximately 10 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

    Time frame: At the post-treatment assessment (occurring at approximately 10 weeks)

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

  4. Implementation Assessment Measure

    Time frame: At the post-treatment assessment (occurring at approximately 10 weeks)

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

Secondary outcomes

  1. Change in Fatigue Severity Scale

    Time frame: At baseline and at the post-treatment assessment (occurring at approximately 10 weeks)

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

  2. Change in PROMIS Sleep Related Impairment 8 item

    Time frame: At baseline and at the post-treatment assessment (occurring at approximately 10 weeks)

    Validated questionnaire; total score range between 8-40, with higher numbers indicating greater sleep-related wake time impairment

Sponsors and collaborators

Lead sponsor

Oregon State University

Other

Collaborators

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

Registry information

Official study title

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

Acronym: OSHIN

Important dates

Study start
2023
Primary completion
2026
Study completion
2026
First posted
Jul 28, 2023
Registry last updated
Apr 6, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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