Shift Worker Intervention for Sleep Health
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-65
SponsorOregon State University
About this trial
The aim of this study is to pilot test a comprehensive, personalized, media-augmented telehealth intervention ("SWISH") designed to improve sleep health among shift workers.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Provision of signed and dated informed consent form
Any gender; Ages 18-65
Currently employed as a nurse or nursing staff member (e.g., CNA) in the United States
Currently have shift work schedules (i.e., stable night shift or rotating shifts that include nights, >=2 nights/week) and have worked shift work >=2 nights/week for at least 3 months
Disqualifiers
Conditions which make study treatment likely to be ineffective. For example, current chronic use of medications that interfere with sleep, alcohol or substance use disorder, or thought disorder (as determined by DIAMOND psychiatric interview), unstable sleep or medical conditions that necessitate additional medical care not provided by study treatments (e.g., known untreated sleep apnea).
Presence of safety risk or condition in which study participation may result in increased risk to safety (e.g., elevated risk for suicide, self-reported uncontrolled seizure disorder, history of manic or hypomanic episode, current pregnancy),
Currently receiving non-pharmacological treatment for insomnia (e.g., cognitive behavioral therapy for insomnia) and/or current unstable hypnotic/alerting medication use OR
Currently participating in other research studies with substantial overlap in terms of methods/procedures (e.g., PI's ongoing study "Piloting an Adaptation of Cognitive Behavioral Therapy for Insomnia for Shift Workers (CBTI-Shift)"
Trial design
Design model
Crossover
Treatments tested in this trial
Shift Worker Intervention for Sleep Health
BehavioralSWISH, a multicomponent behavioral intervention based on cognitive behavioral therapy for insomnia that is individually administered via telehealth across nine approximately weekly sessions that range in length from 15-60 minutes
Treatment groups
60 Participants
are divided into 2 treatment groupsGroup A: SWISHExperimental treatment 1 intervention
Group B: WLCNo intervention 0 interventions
Trial outcomes
Primary outcomes
1
Retention Rate
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 12 weeks)2
Session Attendance
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 12 weeks)3
Implementation Assessment Measure
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 12 weeks)Secondary outcomes
1
Change in PROMIS Sleep Related Impairment
A validated 8-item Common Data Element measures which assess sleep health broadly as manifested during wake. Validated questionnaire; total score range between 8-40, with higher numbers indicating greater sleep-related wake time impairment
Time frame
At baseline and at the post-treatment assessment (occurring at approximately 12 weeks)2
Change in PROMIS Sleep Disturbances
A validated 8-item Common Data Element measures which assess sleep health broadly as manifested during sleep. Validated questionnaire; total score range between 8-40, with higher numbers indicating greater sleep disturbances.
Time frame
At baseline and at the post-treatment assessment (occurring at approximately 12 weeks)3
Patient Adherence
Self-rated adherence to recommendations (items added to standard sleep diary)
Time frame
At the post-treatment assessment (occurring at approximately 12 weeks)4
Acceptability of Study Procedures and SWISH
Enrollment percent, number of study assessment visits completed.
Time frame
After treatment is completed (occurring at approximately 12 weeks)Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Oregon State University
Lead sponsor
National Heart, Lung, and Blood Institute (NHLBI)
Collaborator
Source ClinicalTrials.gov