Unipolar major depression Mental and Behavioural Disorders
Conditions
Interventions
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
Sponsors
South London and Maudsley NHS Foundation Trust
Eligibility
Sex/Gender
All
Inclusion criteria
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
Exclusion criteria
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Number of participants recruited per month/adherence to the protocol, measured during Week 1 | — |
Secondary
| Measure | Time frame |
|---|---|
| 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, assess | — |
Countries
England, United Kingdom
Contacts
Public ContactClara Humpston
Outcome results
None listed