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Supporting employees with insomnia and emotional regulation problems

Supporting employees with insomnia and emotional regulation problems: a multicentre interventional waitlist randomised-controlled trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN13596153
Enrollment
156
Registered
2021-06-08
Start date
2021-06-11
Completion date
Unknown
Last updated
2026-08-03

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

Conditions

Insomnia, anxiety and depression Mental and Behavioural Disorders Nonorganic insomnia, Anxiety disorder, unspecified, Depressive episode, unspecified

Interventions

Participants are randomly allocated through blocked randomisation with stratification into the SLEEP intervention or a waitlist control group with a 1:1 allocation ratio. The researchers will stratify

Sponsors

University of Warwick
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 110 Years

Inclusion criteria

Inclusion criteria: 1. Able to give informed consent 2. English-speaking 3. In employment (including being on furlough) 4. Insomnia Severity Index score: x >8 5. General Anxiety Disorder-7 score: x >5 or Patient Health Questionnaire-9 score: x >5 6. =18 years of age

Exclusion criteria

Exclusion criteria: 1. Currently receiving treatment (psychological or pharmacological) from mental health services (e.g. GP, Improving Access to Psychological Therapies (IAPT), specialist and community mental health services) 2. Not pregnant 3. Current substance abuse/misuse problems, epilepsy, neurological conditions (e.g. Parkinson’s or Alzheimer’s), psychosis, bipolar disorder, or any other circadian rhythm and sleep disorders (e.g. sleep apnoea, periodic limb movement syndrome/restless leg syndrome, circadian rhythm disorders) 4. Retiring in the next 10 months 5. Currently taking part in other psychological intervention trials 6. In shift work

Design outcomes

Primary

MeasureTime frame
1. Insomnia measured using the Insomnia Severity Index at baseline, post-intervention (8 weeks) and follow-up (12 weeks) 2. Anxiety measured using the General Anxiety Disorder-7 at baseline, post-intervention (8 weeks) and follow-up (12 weeks) 3. Depression measured using the Patient Health Questionnaire-9 at baseline, post-intervention (8 weeks) and follow-up (12 weeks)

Secondary

MeasureTime frame
Current secondary outcome measures as of 26/10/2021: 1. Sleep quality parameters measured using Camntech MotionWatch actigraphy trackers and self-reported sleep diary data at week 1 (pre-intervention) and week 8 (post-intervention) 2. Work productivity measured using the Work Productivity and Activity Impairment: General Health v2.0 at baseline, post-intervention (8 weeks) and follow up (12 weeks) 3. Job satisfaction measured using the Indiana Job Satisfaction Scale at baseline, post-intervention (8 weeks) and follow up (12 weeks) 4. Well-being measured using the Warwick-Edinburgh Mental Health Well-being Scale at baseline, post-intervention (8 weeks) and follow up (12 weeks) 5. Quality of life measured using the EuroQOL EQ-5D-5L questionnaire at baseline, post-intervention (8 weeks) and follow up (12 weeks) 6. User experience behaviour of platform usage collected as the counts of activities completed on the platform as well as the average duration of time spent on each topic over the 8-week intervention period. _____ Previous secondary outcome measures: 1. Sleep quality parameters measured using Camntech MotionWatch actigraphy trackers at week 1 (pre-intervention) and week 8 (post-intervention) 2. Job productivity measured using the Work Productivity and Activity Impairment: General Health v2.0 at baseline, post-intervention (8 weeks) and follow up (12 weeks) 3. Job satisfaction measured using the Indiana Job Satisfaction Scale at baseline, post-intervention (8 weeks) and follow up (12 weeks) 4. Well-being measured using the Warwick-Edinburgh Mental Health Well-being Scale at baseline, post-intervention (8 weeks) and follow up (12 weeks) 5. Quality of life measured using the EuroQOL EQ-5D-5L questionnaire at baseline, post-intervention (8 weeks) and follow up (12 weeks) 6. User experience behaviour of platform usage collected as the number of log-ins and counts of activities completed on the platform over the 8-week intervention period. These will be downloade

Countries

England, United Kingdom

Contacts

Public ContactCharlotte Kershaw
Charlotte.Kershaw@warwick.ac.uk

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Aug 9, 2026