Randomised Evaluation of Sleep Treatment to Ease Depression (RESTED)
- 1 March 2023 to 31 May 2024
- Status:: In set-up
1) Download and read our participant information sheet by clicking the link
2) If you are interested in taking part click here to see if you might be eligible
OR EMAIL US AT RESTED-TRIAL@PHC.OX.AC.UK OR CALL 01865-617-828
What is the purpose of the study?
Depression is a very common and impairing condition. There are reasons to think that poor sleep is an important contributor to depression and that if sleep could be improved, depression would improve too.
Previous research has shown that we can improve sleep quality using a nurse-supported behavioural treatment. This treatment involves reviewing your current sleep pattern and supporting you to follow a new, personalised sleep schedule.
In this study we want to find out whether using this treatment to improve sleep will improve depression and, if so, how it works.
What Will I have to do?
For this study we are inviting people (aged 18 years and over) who experience depression and frequent difficulty with falling asleep and/or waking up during the night (insomnia).
If you are interested in taking part in this study, we will first ask you to complete a questionnaire (either online, over the phone or in paper format, which will take around 15 minutes) to determine whether the study is suitable for you. The questionnaire will ask about your sleep and your depression as well as your general health.
Once you have completed the questionnaire, a member of the study team will arrange a brief interview with you to check that you meet the eligibility criteria, and to determine if the study is suitable for you.
If you decide to take part in this study, and are considered eligible after completing the questionnaire and interview, you will be invited to meet with one of our researchers. This meeting will either take place at your GP practice or another convenient location, or can be done via video link, such as through Microsoft Teams (or similar), if it is difficult for you to attend your GP practice.
Visit with our researcher
- The researcher will talk to you about the study. They will check that you are happy to take part and give you the opportunity to ask questions. They will then complete a consent form with you.
- The researcher will ask you to complete a questionnaire about your health, daytime functioning, sleep pattern and mood. The researcher will also collect some information about you, including your age, gender, and ethnicity, and access your medical records to record any health conditions that you may have.
- The researcher will also ask you to complete some tasks on a computer. The tasks will ask you to judge different facial expressions and words presented on the screen.
- You will be provided with an actigraph watch, or acti-watch for short, which you will be asked to wear on your wrist for 7 days, 24 hours a day starting from the date of your appointment. An acti-watch is a wrist-worn device similar to a Fitbit that measures movement, allowing us to estimate your sleep-wake pattern.
- The researcher will also ask you to complete a daily sleep and activity diary for the next 7 days starting on the evening of your appointment.
- The researcher will give you instructions on how to use the actigraph watch and what you need to include in the sleep and activity diary at the visit.
- The visit is expected to take approximately one and a half hours to complete.
You will receive a £15 gift voucher for your time.
After the 7 days of you wearing the acti-watch and completing the sleep diary, you will be randomly assigned by a computer to one of two groups. This is done randomly because this is the best way to do a fair comparison of the two different groups. You have approximately a 50/50 chance of being in each group and will be told which group you have been allocated to.
The Randomly Assigned Groups
Group 1 - will continue to receive any treatments and support from their general practitioner (or other local services). That is, there will be no additional treatment provided by the study.
Group 2 – will also continue to receive any treatments and support from their general practitioner, but in addition will also receive a behavioural sleep intervention from a nurse. This will involve meeting with the nurse over 6 weekly sessions, where you will be supported to follow a new personalised sleep schedule with the aim of improving sleep.
Your participation in the study will last for 6 months and follow-up assessments will take place at 1, 2, and 6 months, irrespective of which group (1 or 2) you are allocated to.
The research team will send you either an email or pack in the post at 1, 2 and 6 months after your first visit to ask you to:
- Complete a questionnaire – this can be done either electronically, over the phone with one of our researchers, or in paper form. This is expected to take approximately 5-10 minutes at 1 month and 45 minutes at 2 and 6 months to complete.
- Complete computerised tasks (at 2 and 6 months only).
- Wear the acti-watch for 7 days (at 2 and 6 months only).
- Keep a sleep and activity diary for 7 days (at 2 and 6 months only).
- Send back the acti-watch and diary in a pre-paid envelope or drop off at your GP practice (at 2 and 6 months only).
HOW DO I TAKE PART?
You can take part in 2 easy steps:
1) Download the participant information sheet at the top of this page
2) Complete the eligibility questionnaire at the top of this page, or contact us at email@example.com or on 01865-xxx-xxx