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Testing a sleep improvement programme for shift workers

Developing and testing an intervention for shift work sleep disorder in NHS workers: a feasibility and acceptability study

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN86601865
Enrollment
35
Registered
2025-06-13
Start date
2025-06-23
Completion date
Unknown
Last updated
2026-03-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Shift work sleep disorder Mental and Behavioural Disorders

Interventions

The aim of our study is to develop and test a new behavioural intervention for NHS shift workers who experience sleep problems due to working shifts. This feasibility study will examine whether the in
first through an online screening questionnaire, followed by a brief interview with the research team (for those identified as potentially eligible from stage 1). Baseline assessments (online or over

Sponsors

University of Oxford
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 70 Years

Inclusion criteria

Inclusion criteria: 1. Willing and able to give informed consent for participation in the study 2. Aged 18 years or above 3. Employed by the NHS 4. Meets criteria for SWD according to self-reported items on the shift work disorder index (SWDI) and semi-structured interview: 4.1. Evidence of insomnia and/or sleepiness attributed to shift work 4.2. Evidence of distress or impairment to occupational/social functioning 4.3. Working non-standard hours (defined as shifts that involve working after 6 pm or before 7 am) for a minimum of 1-3 times a week for at least 3 months 5. Has stable internet access Facilitators must be willing and able to give informed consent to participate in the follow-up interviews

Exclusion criteria

Exclusion criteria: 1. Sleep difficulty explained by another co-occurring health condition or other factor (e.g., caring responsibilities) 2. Not currently working (e.g. long-term absence due to illness or paternity/maternity) 3. Currently receiving formal psychological treatment for sleep difficulties from a healthcare professional 4. Untreated co-morbid sleep disorder (e.g., sleep disordered breathing or sleep-related movement disorder). Comorbid sleep disorders are permitted provided they are actively managed. 5. Diagnosis of bipolar disorder or schizophrenia-spectrum disorders 6. Diagnosis of mild cognitive impairment or dementia 7. Current suicidal ideation with intent OR attempted suicide within the past 12 months 8. Currently pregnant or pregnancy planned in the next 5 months 9. Currently receiving cancer treatment 10. Planned major surgery during the next 5 months 11. Unable to understand spoken or written English 12. Taking part in another research study that may affect the outcomes of the present study 13. Unable or unwilling to provide informed consent for the study 14. Unable or unwilling to comply with the study procedures and/or intervention 15. Non-NHS employed staff (e.g., agency staff, students on placement, honorary staff, contractors) There are no specific exclusion criteria for the facilitators to participate in the follow-up interviews.

Design outcomes

Primary

MeasureTime frame
Feasibility: 1. Participant recruitment will be measured by the number of participants recruited per month and the total time taken to reach full recruitment at the end of the study 2. Participant retention will be measured by the proportion of participants who complete the end-of-study assessments at the end of the study 3. Intervention engagement will be measured by the proportion of sessions attended by participants at the end of the study 4. Intervention fidelity will be measured by the proportion of the intervention components covered by the facilitators during the delivery of the intervention at the end of the study

Secondary

MeasureTime frame
Acceptability and experiences: 1. Acceptability will be measured by the adapted theoretical framework of acceptability (TFA) questionnaire at post-intervention 2. Adverse events will be measured by the custom adverse events questionnaire at post-intervention 3. Experiences of participants will be explored through semi-structured interviews at the end of the study 4. Experience of facilitators will be explored through semi-structured interviews at the end of the study Process measures: 1. Pre-sleep arousal will be measured by the Pre-Sleep Arousal Scale (PSAS) at baseline and post-intervention 2. Sleep hygiene behaviours will be measured by the Sleep Hygiene Index (SHI) at baseline and post-intervention Indicators of clinical effectiveness: 1. Self-rated insomnia severity will be measured by the Insomnia Severity Index (ISI) at baseline and post-intervention 2. Self-rated sleepiness will be measured by the Epworth Sleepiness Scale (ESS) at baseline and post-intervention 3. Self-rated fatigue will be measured by the Flinders Fatigue Scale (FFS) at baseline and post-intervention 4. Self-rated health-related quality of life (HRQoL) will be measured by the EuroQoL (EQ-5D-5L) plus the sleep bolt-on at baseline and post-intervention 5. Self-reported depression symptoms will be measured by the Patient Health Questionnaire-9 (PHQ-9) at baseline and post-intervention 6. Impairment will be measured by the Work Productivity and Activity Impairment questionnaire (WPAI) at baseline and post-intervention 7. Sleep onset latency (SOL), wake time after sleep onset (WASO), total sleep time (TST), time in bed (TIB), sleep efficiency (SE), and sleep quality (Likert scale) will be obtained from the sleep diaries at baseline and post-intervention 8. Sleep onset latency (SOL), wake-time after sleep onset (WASO), total sleep time (TST), time in bed (TIB), and sleep efficiency (SE) will be obtained from the acti-watches at baseline and post-intervention 9. Measures of time in bed regularit

Countries

England, United Kingdom

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Mar 14, 2026