Light-dark and activity rhythm therapy for sleep: a study to explore the practicality of delivering the therapy, and participant's experiences and views of whether the intervention is acceptable, in people with schizophrenia spectrum disorders

Plain English Summary

Background and study aims
The researchers have been looking at existing evidence and surveying the views of relevant experts on how to improve sleep-wake patterns in people with schizophrenia and related disorders. From this work they have designed a therapy, with the help and involvement of people with relevant lived experience along the way. The aim of this study is to test whether they can deliver the therapy as planned, how acceptable people find it, and how much they are able to stick to it.

Who can participate?
People aged over 18 with a diagnosis of schizophrenia spectrum disorder (schizophrenia, schizoaffective disorder, delusional disorder, schizotypal disorder), who also have problems with falling asleep, staying asleep, sleep timing, or sleep quality.

What does the study involve?
An occupational therapist sees each participant for 6-9 sessions plus 3-6 phone calls to give Light-Dark and Activity Rhythm Therapy (L-DART). L-DART focuses on light exposure patterns across the day, the type of activities people are doing and when, and when people go to bed and get up. It includes education about sleep and the body clock, homework activities, using wearable technology to track and alter light exposure and activity timing, and making changes to the home environment. The researchers measure things that they hope to possibly improve through the intervention, like sleep, daytime functioning, wellbeing, and mental health symptoms, but the main purpose in this study is to see how acceptable and practical the sleep therapy is to deliver and test. A big part of this will be based on individual interviews with participants after they have received the intervention.

What are the possible benefits and risks of participating?
Payment is offered for time spent completing measures on three occasions (3 x £10), up to 45 minutes each. The researchers can’t pay travel expenses, but can come to participants or meet somewhere convenient for them. There may be no benefit to participants. The aim is that this research will help others with similar problems in future. Participants will receive an activity tracking watch, a wake-up light alarm, and a light box if relevant (if they find these helpful they can keep them at the end of the study). Participants receive blackout curtains and net curtains if they need them (which they can keep). It is hoped that L-DART will help participants improve their sleep, but the researchers don’t currently have evidence to say that this therapy will improve sleep because it is new. It is hoped that even if L-DART doesn’t improve sleep, that participants might be pleased with some of the changes they make to their daytime activity routines. It is possible that answering questions about their sleep could cause participants to think about or discuss something distressing. They can take a break at any time, or ask for support. It is possible that by making changes designed to improve their sleep in the long term, might mean that participants get less sleep in the short term. Using light therapy boxes can give some people a feeling of eye strain or a headache, this should go away if they stop using the light box. Some people get used to the light box so that it no longer causes them discomfort, or sit farther away to reduce the brightness. Light therapy boxes don’t cause sunburn, but the sun can. The researchers will talk about how to avoid sunburn when they talk about going outside more. Shortening time in bed and increasing light exposure could possibly cause mania, so far research shows this is rare, but the researchers will monitor this especially if the participants have had mania before. The opposite - too long in bed and too little light - can contribute to low mood and low energy, so there is a balance to be struck. Pushing participants outside of their usual routine can feel risky or anxiety provoking, but the researchers think this is positive risk taking. They will support participants to choose the right level of challenge and to set goals which suit them, so that risks and effort are more worth it. The researchers have some smartphones they can lend to people who need them. Participants don’t have to be very technical to use the app, as it just shows activity graphs.

Where is the study run from?
1. Greater Manchester Mental Health NHS Foundation Trust (UK)
2. Pennine Care NHS Foundation Trust (UK)
3. University of Manchester (UK)

When is the study starting and how long is it expected to run for?
September 2019 to July 2022 (updated 04/03/2022, previously: March 2022; updated 05/01/2021, previously: January 2021)
The survey begins recruiting in January 2021 and intervention study in April 2021 (added 05/01/2021)

Who is funding the study?
National Institute for Health Research (UK)

Who is the main contact?
Sophie Faulkner
sophie.faulkner@manchester.ac.uk

Study website

Contact information

Ms Sophie Faulkner
Public

3.306 Jean McFarlane Building
University of Manchester
Oxford Road
Manchester
M13 9PL
United Kingdom

ORCID ID	0000-0003-1549-0922
Phone	+44 (0)161 275 5970
Email	sophie.faulkner@manchester.ac.uk

Study information

Eligibility

Locations

Countries of recruitment

• England
• United Kingdom

Study participating centres

Sponsor information

Funders

Funder type

Government

Results and Publications

Study outputs

Editorial Notes

27/12/2023: Publication reference added.
20/09/2023: A link to the HRA research summary was added.
10/08/2023: The intention to publish date was changed from 28/02/2023 to 15/12/2023.
04/03/2022: The following changes have been made:
1. The overall trial end date has been changed from 31/03/2022 to 31/07/2022 and the plain English summary has been updated to reflect this change.
2. The intention to publish date has been changed from 30/07/2022 to 28/02/2023.
3. The total final enrolment number has been added.
05/01/2021: The following changes were made to the trial record:
1. The recruitment start date was changed from 02/03/2020 to 09/01/2021.
2. The recruitment end date was changed from 30/01/2021 to 31/03/2022.
3. The overall end date was changed from 30/01/2021 to 31/03/2022.
4. The intention to publish date was changed from 30/11/2021 to 30/07/2022.
5. The inclusion criteria were updated.
6. The exclusion criteria were updated.
7. The target number of participants was changed from "15-20 feasibility study participants (+250 staff survey participants)" to "10 feasibility study participants (+250 staff survey participants, +250 anonymous service user survey participants)".
8. The link to the participant information sheet was added.
9. The ethics approval was added.
10. The plain English summary was updated to reflect these changes.
03/04/2020: Due to current public health guidance, recruitment for this study has been paused.
17/02/2020: Trial's existence confirmed by the NIHR.