Modifying the behaviour of office workers to improve sleep Nervous System Diseases
Conditions
Interventions
The intervention will be delivered to participants through a combination of in-person and video conferencing sessions (e.g., Microsoft Teams). The intervention consists of five sessions conducted over
Sponsors
University of Oxford
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Aged 23-65 years old 2. Currently employed (working for pay/stipend) and intend to remain employed over the next 4 months 3. An “office worker” (work sitting at a desk, indoors, for your working day) 4. Working within Oxford, full-time (“9-5”, Monday-Friday), over the next 4 months 5. Living within Oxford, full-time (Monday-Sunday), over the next 4 months 6. Insomnia symptoms (ISI; =11) 7. Low self-reported levels of environmental exposure 8. An iPhone (iOS 15 or later) smartphone user with a consistent internet connection indoors and outdoors 9. Able to read and understand English 10. Able to follow study procedures as laid out in the participant information sheet
Exclusion criteria
Exclusion criteria: 1. Severe anxiety symptoms (GAD-7; =15) 2. Severe depressive symptoms (PHQ-9; =15) 3. Suicidal ideation/self-harm (PHQ-9 item 9; =1) 4. Diagnosis or being treated for a mental health disorder 5. Shift or night worker in the past 3 months 6. Diagnosis of the following sleep disorders: Sleep-Related Breathing Disorder, Central Disorder of Hypersomnolence, Circadian rhythm Sleep-Wake Disorder, Parasomnia, Sleep-Related Movement Disorder, Other 7. Currently being treated for the following sleep disorders: Sleep-Related Breathing Disorder, Central Disorder of Hypersomnolence, Circadian rhythm Sleep-Wake Disorder, Parasomnia, Sleep-Related Movement Disorder, Other 8. Sleep problem fully explained by caring responsibilities, being woken up by children, noises in your environment, a physical/surgical condition 9. Prescribed or “over the counter” sleep medication 10. Habitual smoker/vape user 11. Photosensitising medication 12. Underweight and obese BMI 13. Planning major surgery in the next 2 months 14. Neurological disorder 15. Serious head injury in the past year 16. Physical disability/health condition/pain preventing moderate exercise [e.g., 30-minute walk] 17. Eye disease 18. Photosensitivity 19. Lactating or pregnant 20. Active implanted stimulator [e.g., pacemaker] 21. Undergone light therapy in the last month/plan to have light therapy within the next 2 months 22. Currently receiving psychological therapy for sleep/plan to start within the next 2 months 23. Currently taking part in a study involving a drug or behavioural intervention/will be taking part in such a study in the next 2 months 24. Another member of your household has taken part in this study/is currently taking part in this study 25. Regularly cover up eyes outdoors for religious/moral reasons (e.g., burqa/burka) 26. Regularly cover up skin outdoors for religious/moral reasons (e.g., burqa/burka) 27. Taken a flight that crossed 3 or more time zones in the last 2-weeks/plan to take one in the next 2 months
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary [Feasibility] Recruitment: 1. Eligibility percentage will be determined using output from the Qualtrics screening survey and screening call. Measured pre-baseline, assessed monthly. Intervention Fidelity: 2. Intervention Fidelity will be measured using audio recordings of the intervention sessions. Measured during each intervention session (1, 2, 3, 4, and 5) and assessed per intervention session. 3. Intervention attendance will be measured using an attendance register during the intervention sessions. Measured during each intervention session (1, 2, 3, 4, and 5) and assessed per intervention session. Data Completeness: 4. Data Completeness will be assessed using output from the REDCap hosted Insomnia Severity Index Questionnaire. Primary end point assessed at 4 weeks post initial delivery of the intervention. Primary [Acceptability] 5. The overall acceptability of the intervention and study procedures will be assessed using a custom Acceptability Questionnaire; the results will be reported as the mean and median Likert values. Additionally, the percentage of participants who selected each Likert option (completely unacceptable, unacceptable, no opinion, acceptable, completely acceptable) will be reported. Measured and assessed at the end of the study. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary outcome measures: 1/2/3. Environmental data will be recorded using the Button device. Objective environmental data will be measured continuously across the 6-week study period. Changes from baseline will be assessed at 1 week following the delivery of the fourth intervention session. 4. Insomnia symptom severity measured using the Insomnia Severity Index (ISI) at the end of Week 2, Week 4, and Week 6 (fortnightly). We will assess changes from baseline at 4-weeks post initial delivery of the intervention. Exploratory outcome measures: 1/2. Objective environmental data measured using the Button device continuously across the 6-week study period, changes assessed at 1 week following the delivery of the fourth intervention session. 3. Subjective time exposed to environmental factors measured using the 'My Day' questionnaire daily across the 6-week study period, rate of change assessed at 1-week post-delivery of the fourth intervention session. 4. Environmental data regularity scores measured using the Button device weekly across the intervention period, compared to baseline. 5. Environmental data mean timing scores measured using the Button device weekly across the intervention period, compared to baseline. 6. Environmental data measured using the Button device continuously across the intervention period, compared to the last week of baseline. 7. Environmental exposure data measured using the Button device and 'My Day' diary across the intervention period, agreement assessed. 8. Insomnia symptom severity measured using the Insomnia Severity Index (ISI) at the end of Week 2, Week 4, and Week 6, changes assessed at 2-weeks post initial delivery of the intervention. 9. Sleep quality (e.g., sleep latency, sleep efficiency, wake after sleep onset), sleep quantity (e.g., total sleep time), and circadian activity rhythms (e.g., inter-daily stability, intra-daily variability, M10, L5, and relative amplitude) measured using ActTrust 2 continuously across the 6-weeks | — |
Countries
England, United Kingdom
Contacts
Public ContactSimon Kyle
Outcome results
None listed