Optimizing Sleep Health in Nurses (OSHIN)

February 8, 2024 updated by: Jessee Dietch, Oregon State University

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

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

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Estimated)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • United States
    • Oregon
      • Corvallis, Oregon, United States, 97331
        • Recruiting
        • Oregon State University
        • Contact:
        • Principal Investigator:
          • Jessee Dietch, PhD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
At baseline and at the post-treatment assessment (occurring at approximately 10 weeks)
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]
At the post-treatment assessment (occurring at approximately 10 weeks)
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]
At the post-treatment assessment (occurring at approximately 10 weeks)
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.
At the post-treatment assessment (occurring at approximately 10 weeks)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
At baseline and at the post-treatment assessment (occurring at approximately 10 weeks)
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
At baseline and at the post-treatment assessment (occurring at approximately 10 weeks)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Oregon State University

Collaborators

Monash University
Stanford University
American Academy of Sleep Medicine

Investigators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 8, 2023

Primary Completion (Estimated)

January 14, 2025

Study Completion (Estimated)

August 11, 2025

Study Registration Dates

First Submitted

July 12, 2023

First Submitted That Met QC Criteria

July 19, 2023

First Posted (Actual)

July 28, 2023

Study Record Updates

Last Update Posted (Actual)

February 12, 2024

Last Update Submitted That Met QC Criteria

February 8, 2024

Last Verified

February 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IRB-2021-1200

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD 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.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Sleep Initiation and Maintenance Disorders

Clinical Trials on CBTI

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Hong Kong

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe