The aim of this study is to determine if altering the pattern of one's sleep and having light therapy can speed up the treatment of depression. In the UK, the large majority of patients with depression in the NHS are treated in the community, and one of the major objectives of the study one is to determine if this therapy is a practical treatment in the community. We will be comparing two treatments: 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).
* Participants will be given a wristband (Actigraph) * 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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
60
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.
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).
South London and Maudsley NHS Foundation Trust
London, United Kingdom
Number of participants recruited per month/Adherence to the protocol
To compare the rate of recruitment and adherence to the treatments in both groups
Time frame: Week 1
MINI International Neuropsychiatric Interview Version 5.0
To determine diagnosis by DSM-IV criteria
Time frame: Baseline
Hamilton Depression Rating Scale
To compare the effects on observer rated depressive symptoms in both groups
Time frame: Baseline, and at 1, 2, 4, 8 weeks and 6-month post-randomisation
Clinical Global Impression and Improvement Scale (Guy, 1976)
To compare the effects on observer rated clinical impression in both groups
Time frame: Baseline, and at 1, 2, 4, 8 weeks and 6-month post-randomisation
Quick Inventory of Depressive Symptomatology -SR Version (Triveni et al., 2004) Questionnaire
To compare the effects on subjective depressive symptoms in both groups
Time frame: Baseline, and at 1, 2, 4, 8 weeks and 6-month post-randomisation
Brief Ruminative Response Scale (Topper et al, 2014). Questionnaire
To compare the effects on measures of subjective rumination in both groups
Time frame: Baseline, and at 1, 2, 4, 8 weeks and 6-month post-randomisation
Pittsburgh Sleep Index (Bysse et al., 1999) Questionnaire
To compare the effects on subjective sleep quality in both groups
Time frame: Baseline, and at 1, 2, 4, 8 weeks and 6-month post-randomisation
Euroquol 5D (1990) Questionnaire
To compare the effects on subjective general quality of life in both groups
Time frame: Baseline, and at 1, 2, 4, 8 weeks and 6-month post-randomisation
To check the amount of current antidepressant use
Amount of antidepressant drugs (in mg of antidepressant equivalents) (Hayasaka et al., 2015) or benzodiazepine drugs (in mg of diazepam equivalents)
Time frame: Baseline, and at 1, 2, 4, 8 weeks and 6-month post-randomisation
To check the amount of current psychotherapy use
The amount of Cognitive Behaviour Therapy or any other counselling or psychotherapy (number of hours)
Time frame: Baseline, and at 1, 2, 4, 8 weeks and 6-month post-randomisation
Daily sleep diary
A subjective measure of total sleep time
Time frame: 3 days pre-randomisation and 7 days post-randomisation
Credibility and Expectancy Questionnaire (Devilly, 2000).
A measure of the credibility of the intervention
Time frame: Baseline
Morning/Evening Questionnaire
A measure of morning/evening preference
Time frame: 3 days pre-randomisation
Wrist actigraph from GeneActiv daily (Physiological parameter)
A measure of the sleep/wake activity, which correlates with the gold standard of sleep physiology (polysomnography).
Time frame: 3 days pre-randomisation and 7 days post-randomisation.
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