Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
60 participants
INTERVENTIONAL
2018-01-18
2019-09-23
Brief Summary
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1. Sleep Therapy and a Light Box: Participants will be given information and advice on how to get a good night's sleep. Participants will be given a light box to use in the morning for 1 week. Treatment with a light box will last 30 minutes when a person gets up. Participants may continue to have any treatment as usual (for example medication or talking therapies).
2. Wake therapy and a Light Box: Participants will be helped to change the pattern of sleep by depriving participants of sleep for one night. Participants will go bed at 5pm on the following day for 8 hours and get up at 1am. Participants' sleep will then be advanced by 2 hours each night for the next three nights. Participants will be also given a light box to use in the morning for 1 week. Treatment with a light box will last 30 minutes when participants get up. Participants may continue to have any treatment as usual (for example medication or talking therapies).
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Detailed Description
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* Participants will be asked to complete various questionnaires and be interviewed at 1 week, 2 weeks, 4 weeks, 8 weeks and at 6 months after starting.
* Participants will be asked to make 6 extra visits to the research team at the hospital over and above those needed for normal care.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
* Triple Chronotherapy. This consists of (a) Total Sleep Deprivation with group support on days one and two; (b) Phase Advance of Sleep over 5 days and daily Light Therapy. (c) Bright Light Therapy is given on Day 2 onwards daily.
* Comparator Intervention: Participants will be given information on sleep hygiene and getting a good night's sleep in a written leaflet and given the opportunity to ask questions. They are then given Dim Amber Light Therapy daily for 1 week.
TREATMENT
SINGLE
Study Groups
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Wake and Light Therapy
This consists of (a) Total Sleep Deprivation with group support on days one and two; (b) Phase Advance of Sleep over 5 days and daily Light Therapy. (c) Light Therapy is given daily
Wake and Light Therapy
Participants will be helped to change the pattern sleep by depriving participants of sleep for one night. On Day 1 participants will be supported to stay up all night and the following day at the Hospital. Participants can go to bed by 5pm at home on Day 2. Participants will need to get up by about 1am and return to the hospital to be supported to stay awake. Participants will then go to bed at 7pm on Day 3. Participants will be asked to sleep until 3am and then stay awake at home until bed at 9pm on Day 4. Participants 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. Participants will also be given a light box to use each morning. For the light box, participants will be asked to sit about one foot away from a light box. You 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. Participants may continue to have treatment as usual.
Sleep and Light Therapy
Participants will be given information on sleep hygiene and getting a good night's sleep. They are then given Light Therapy daily for 1 week.
Sleep and Light Therapy
Participants will be given information and advice on how to get a good night's sleep. Participants will be also given a light box to use in the morning for 1 week. For the light box, participants will be asked to sit about one foot away from a light box. Participants 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. Participants may continue to have any treatment as usual (for example medication or talking therapies).
Interventions
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Wake and Light Therapy
Participants will be helped to change the pattern sleep by depriving participants of sleep for one night. On Day 1 participants will be supported to stay up all night and the following day at the Hospital. Participants can go to bed by 5pm at home on Day 2. Participants will need to get up by about 1am and return to the hospital to be supported to stay awake. Participants will then go to bed at 7pm on Day 3. Participants will be asked to sleep until 3am and then stay awake at home until bed at 9pm on Day 4. Participants 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. Participants will also be given a light box to use each morning. For the light box, participants will be asked to sit about one foot away from a light box. You 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. Participants 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. Participants will be also given a light box to use in the morning for 1 week. For the light box, participants will be asked to sit about one foot away from a light box. Participants 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. Participants may continue to have any treatment as usual (for example medication or talking therapies).
Eligibility Criteria
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Inclusion Criteria
* Minimum score of 8 or more on the Hamilton Depression Rating Scale (6 item) (Range 0-22) (Bech,1981).
* Age 18-65
* Able to give informed consent
* Women of child bearing age may be included and no methods of contraception is required to enable inclusion into the trial.
Exclusion Criteria
* Current diagnosis of anorexia nervosa or bulimia.
* Current diagnosis of an obsessive compulsive or related disorder
* Current diagnosis of post-traumatic stress disorder
* History of schizophrenia, schizoaffective disorder or bipolar disorder
* Severe cognitive impairment, dementia, intellectual disability or organic brain disorder.
* History of stimulant or hallucinogenic misuse, alcohol or substance misuse or dependence in past 3 months.
* Borderline Personality Disorder or other personality disorder considered to be the main problem.
* Duration of depression more than 2 years.
* Significant risk of suicide that requires hospitalisation.
* Severe eye disease or cataracts or traumatic injury or visual impairment affecting both eyes.
* History of epilepsy, uncontrolled severe headaches, or stroke as this may lower seizure threshold through sleep deprivation.
* Unstable medical condition that would make wake therapy intolerable
* Untreated sleep disorder such as obstructive sleep apnoea or narcolepsy
* Use of photo-sensitizing drugs.
* Current night-shift work.
* Non-English speaker.
18 Years
65 Years
ALL
No
Sponsors
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Kings Health Partners
OTHER
King's College London
OTHER
Responsible Party
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Principal Investigators
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David Veale
Role: PRINCIPAL_INVESTIGATOR
King's College London
Locations
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South London and Maudsley NHS Foundation Trust
London, , United Kingdom
Countries
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Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Document Type: Informed Consent Form
Other Identifiers
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R&D2017/096
Identifier Type: -
Identifier Source: org_study_id
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