Sleep, wake and light therapy for depression
| ISRCTN | ISRCTN17706836 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN17706836 |
| Secondary identifying numbers | R&D2017/096 |
- Submission date
- 02/01/2018
- Registration date
- 22/01/2018
- Last edited
- 09/12/2021
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Mental and Behavioural Disorders
Plain English summary of protocol
Background and study aims
Depression is a state of low mood and aversion to activity that can affect a person's thoughts, behavior, feelings, and sense of well-being. The aim of this study is to determine if altering sleep patterns combined with light therapy in the morning can speed up the treatment of depression.
Who can participate?
People aged 18-65 with depression
What does the study involve?
Participants are randomly allocated to one of two treatments: Wake and Light Therapy or Sleep and Light Therapy. In the Wake and Light Therapy group, participants are helped to change the pattern of their sleep by depriving them of sleep for one night. On Day 1 they are supported to stay up all night and the following day at the Hospital. They can go to bed by 5pm at their home on Day 2. They need to get up by about 1am and return to the hospital to be supported to stay awake. They then go to bed at 7pm on Day 3. They are asked to sleep until 3am and then stay awake at home until bed at 9pm on Day 4. They then get up by 5am on Day 5 and stay awake until 11pm to resume a normal sleep routine waking by 7am on Day 6. They are also given a light box to use each morning. They are asked to sit about one foot away from a light box. They are free to have breakfast, read or use a computer while facing towards the light. Treatment with a light box lasts 30 minutes. In the Sleep and Light Therapy group, participants are given information and advice on how to get a good night's sleep. They are also given a light box to use in the morning for 1 week as described above. All participants complete various questionnaires and are seen by the research team after 1, 2, 4, 8 weeks and at 6 months after the treatment commences. Both groups may continue with other treatments such as medication or talking therapies. If they are taking anti-depressant medication, there should be no plans by their doctor to change the dose of any medication or to start additional medication for depression in the next 6 months.
What are the possible benefits and risks of participating?
It is not known whether this treatment will help for certain, but it may help some people with depression. Information from this study will help researchers better understand whether it can be a practical treatment in the community and whether it is worth doing a larger study. One of the possible disadvantages may be the time and burden to complete the questionnaires and attend the research interview. The only potential risk of treatment is of triggering an episode of mania, but this should be a rare occurrence as people with bipolar disorder are excluded from this study.
Where is the study run from?
South London and Maudsley NHS Foundation Trust (UK)
When is the study starting and how long is it expected to run for?
January 2017 to August 2019
Who is funding the study?
King's Health Partners (UK)
Who is the main contact?
Dr Clara Humpston
Clara.Humpston@kcl.ac.uk
Contact information
Public
Institute of Psychiatry, Psychology and Neuroscience
King's College London
London
SE5 8AF
United Kingdom
 ORCID ID |
0000-0001-5132-1531 |
|---|---|
| Phone | +44 (0)7553 518853 |
| clara.humpston@kcl.ac.uk |
Study information
| Study design | Multicentre randomised parallel-group single-blind interventional study |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised parallel trial |
| Study setting(s) | Community |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details to request a patient information sheet |
| Scientific title | Sleep, wake and light therapy for depression: a randomised parallel trial |
| Study objectives | To compare the rate of recruitment and adherence to the treatments in both groups. |
| Ethics approval(s) | London - Bromley Research Ethics Committee, 02/12/2017, ref: 17/LO/1567 |
| Health condition(s) or problem(s) studied | Unipolar major depression |
| Intervention | Method of randomisation: stratified block randomisation with fixed block sizes stratified by Season of the Year. Wake and Light Therapy: Participants will be helped to change the pattern of their sleep by depriving them of sleep for one night. On Day 1 they will be supported to stay up all night and the following day at the Hospital. They can go to bed by 5pm at their home on Day 2. They will need to get up by about 1am and return to the hospital to be supported to stay awake. They will then go to bed at 7pm on Day 3. They will be asked to sleep until 3am and then stay awake at home until bed at 9pm on Day 4. They will then get up by 5am on Day 5 and stay awake until 11pm to resume a normal sleep routine waking by 7am on Day 6. They will also be given a light box to use each morning. For the light box, they will be asked to sit about one foot away from a light box. They will be free to have breakfast, read or use a computer while facing towards the light. Treatment with a light box will last 30 minutes. They may continue to have treatment as usual. Sleep and Light Therapy: Participants will be given information and advice on how to get a good night's sleep. They will be also given a light box to use in the morning for 1 week. For the light box, they will be asked to sit about one foot away from a light box. They will be free to have breakfast, read or use a computer while facing towards the light. Treatment with a light box will last 30 minutes when you get up. They may continue to have any treatment as usual (for example medication or talking therapies). As part of the research, participants will need to complete various questionnaires and be seen by the research team after 1, 2, 4, 8 weeks and at 6 months after the treatment commences. |
| Intervention type | Behavioural |
| Primary outcome measure | Number of participants recruited per month/adherence to the protocol, measured during Week 1 |
| Secondary outcome measures | 1. Depressive symptom severity, assessed using Hamilton Depression Rating Scale – observer rated at baseline, 1, 2, 4, 8 weeks and 6 months post-randomisation 2. Overall clinical impression, assessed using Clinical Global Impression and Improvement Scale (Guy, 1976) – observer rated at baseline, 1, 2, 4, 8 weeks and 6 months post-randomisation 3. Subjective feelings of depression, assessed using Quick Inventory of Depressive Symptomatology - self rated version (Triveni et al, 2004) at baseline, 1, 2, 4, 8 weeks and 6 months post-randomisation 4. Tendency to engage in ruminative thoughts, assessed using the Brief Ruminative Response Scale (Topper et al, 2014) – self rated at baseline, 1, 2, 4, 8 weeks and 6 months post-randomisation 5. Sleep quality, assessed using the Pittsburgh Sleep Index (Bysse et al, 1999) – self rated at baseline, 1, 2, 4, 8 weeks and 6 months post-randomisation 6. General health, assessed using Euroquol 5D (EQ5-D) (1990) – self rated at baseline, 1, 2, 4, 8 weeks and 6 months post-randomisation 7. Amount of anti-depressant drugs (in mg of anti-depressant equivalents) (Hayasaka et al, 2015) or benzodiazepine drugs (in mg of diazepam equivalents) at baseline, 1, 2, 4, 8 weeks and 6 months post-randomisation 8. Amount of Cognitive Behaviour Therapy or any other counselling or psychotherapy (number of hours) at baseline, 1, 2, 4, 8 weeks and 6 months post-randomisation 9. Total sleep time, measured using a daily sleep diary at 3 days pre-randomisation and 7 days post-randomisation 10. The credibility of the intervention and expectation of whether their mood will improve rapidly (Devilly, 2000), measured at baseline 11. Sleep/wake activity, measured with wrist actigraph from GeneActiv daily at 3 days pre-randomisation and 7 days post-randomisation 12. DSM-IV diagnoses, assessed using MINI International Neuropsychiatric Interview Version 5.0 – observer rated at baseline 13. Morning/evening preference, assessed using Morning and Evening Questionnaire – self rated at baseline |
| Overall study start date | 08/01/2017 |
| Completion date | 31/08/2019 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Upper age limit | 65 Years |
| Sex | Both |
| Target number of participants | 60 |
| Total final enrolment | 93 |
| Key inclusion criteria | 1. Diagnosis of Depressive Episode (ICD10 F32) or Recurrent Depressive Disorder (F33) 2. Minimum score of 8 or more on the Hamilton Depression Rating Scale (6 item) (Range 0-22) (Bech,1981) 3. Age 18-65 4. Able to give informed consent 5. Women of child bearing age may be included and no methods of contraception is required to enable inclusion into the trial |
| Key exclusion criteria | 1. Current diagnosis of Seasonal Affective Disorder 2. Current diagnosis of anorexia nervosa or bulimia 3. Current diagnosis of an obsessive compulsive or related disorder 4. Current diagnosis of post-traumatic stress disorder 5. History of schizophrenia, schizoaffective disorder or bipolar disorder 6. Severe cognitive impairment, dementia, intellectual disability or organic brain disorder 7. History of stimulant or hallucinogenic misuse, alcohol or substance misuse or dependence in past 3 months 8. Borderline Personality Disorder or other personality disorder considered to be the main problem 9. Duration of depression more than 2 years 10. Significant risk of suicide that requires hospitalisation 11. Severe eye disease or cataracts or traumatic injury or visual impairment affecting both eyes 12. History of epilepsy, uncontrolled severe headaches, or stroke as this may lower seizure threshold through sleep deprivation 13. Unstable medical condition that would make wake therapy intolerable 14. Untreated sleep disorder such as obstructive sleep apnoea or narcolepsy 15. Use of photo-sensitizing drugs 16. Current night-shift work 17. Non-English speaker |
| Date of first enrolment | 08/01/2018 |
| Date of final enrolment | 22/02/2019 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
King's College London
16 De Crespigny Park
Denmark Hill
London
SE5 8AF
United Kingdom
Sponsor information
University/education
Joint R&D Office of South London and Maudsley NHS Foundation Trust
and Institute of Psychiatry, Psychology & Neuroscience (IoPPN)
Box P005, Institute of Psychiatry, Psychology & Neuroscience (IoPPN)
De Crespigny Park
London
SE5 8AF
England
United Kingdom
"ROR" |
https://ror.org/015803449 |
|---|
Funders
Funder type
Hospital/treatment centre
Private sector organisation / Universities (academic only)
- Location
- United Kingdom
Results and Publications
| Intention to publish date | 31/12/2021 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| Publication and dissemination plan | Protocol with statistical analysis plan will be made available on request. Publications in peer-reviewed journals planned for 2019, approximately one year after the trial’s completion. Results disseminated at national and international conferences in 2019. |
| IPD sharing plan | The datasets generated and analysed during the current study will be available upon request from Prof. David Veale (david.veale@kcl.ac.uk). Anonymised data (with consent from participants) will be shared with researchers from Universities and not the general public for secondary analyses. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | 24/11/2021 | 09/12/2021 | Yes | No | |
| HRA research summary | 28/06/2023 | No | No |
Editorial Notes
09/12/2021: Publication reference added.
19/08/2021: The intention to publish date was changed from 28/02/2021 to 31/12/2021.
14/09/2020: IPD sharing statement added.
03/09/2020: The intention to publish date was changed from 31/08/2020 to 28/02/2021.
11/03/2019: The final total enrolment number has been added.
25/02/2019: The recruitment end date was changed from 28/02/2019 to 22/02/2019
08/02/2019: The following changes were made to the trial record:
1. The recruitment end date has been changed from 31/01/2019 to 28/02/2019
2. The intention to publish date has been changed from 31/12/2019 to 31/08/2020
