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| Name | Class |
|---|---|
| Kings Health Partners | OTHER |
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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:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Wake and Light Therapy | Experimental | 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 |
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| Sleep and Light Therapy | Active Comparator | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Wake and Light Therapy | Behavioral | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of participants recruited per month/Adherence to the protocol | To compare the rate of recruitment and adherence to the treatments in both groups | Week 1 |
| Measure | Description | Time Frame |
|---|---|---|
| MINI International Neuropsychiatric Interview Version 5.0 | To determine diagnosis by DSM-IV criteria | Baseline |
| Hamilton Depression Rating Scale | To compare the effects on observer rated depressive symptoms in both groups |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| David Veale | King's College London | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| South London and Maudsley NHS Foundation Trust | London | United Kingdom |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jul 1, 2017 | Jan 11, 2018 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Jul 1, 2017 | Jan 11, 2018 | ICF_001.pdf |
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| ID | Term |
|---|---|
| D003863 | Depression |
| D003865 | Depressive Disorder, Major |
| D003866 | Depressive Disorder |
| ID | Term |
|---|---|
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |
| D019964 | Mood Disorders |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| D010789 | Phototherapy |
| D012890 | Sleep |
| ID | Term |
|---|---|
| D013812 | Therapeutics |
| D009424 | Nervous System Physiological Phenomena |
| D055687 | Musculoskeletal and Neural Physiological Phenomena |
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| Sleep and Light Therapy | Behavioral | 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). |
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| 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 | 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 | 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 | 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 | 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 | 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) | 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) | Baseline, and at 1, 2, 4, 8 weeks and 6-month post-randomisation |
| Daily sleep diary | A subjective measure of total sleep time | 3 days pre-randomisation and 7 days post-randomisation |
| Credibility and Expectancy Questionnaire (Devilly, 2000). | A measure of the credibility of the intervention | Baseline |
| Morning/Evening Questionnaire | A measure of morning/evening preference | 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). | 3 days pre-randomisation and 7 days post-randomisation. |