Clinical trial NCT03405493: Sleep, Wake and Light Therapy for Depression
Official title: Sleep, Wake and Light Therapy for Depression
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Depression
Depressive Disorder, Major
Depression, Unipolar
Depression Moderate
Keywords: Circadian Rhythm
Light Therapy
Wake Therapy
Sleep Phase Advance
Major Depression
Lead sponsor: King's College London
Sponsor class: OTHER
Collaborators: name: Kings Health Partners
First posted: 2018-01-23
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: * Both groups will receive treatment as usual.
* 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.
Primary purpose: TREATMENT

Brief summary: 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).

Detailed description: * 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.

Eligibility criteria: Inclusion Criteria:

* Diagnosis of Depressive Episode (ICD10 F32) or Recurrent Depressive Disorder (F33).
* 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 Seasonal Affective Disorder
* 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.

Primary outcomes:
measure: Number of participants recruited per month/Adherence to the protocol
timeFrame: Week 1
Secondary outcomes:
measure: MINI International Neuropsychiatric Interview Version 5.0
timeFrame: Baseline
measure: Hamilton Depression Rating Scale
timeFrame: Baseline, and at 1, 2, 4, 8 weeks and 6-month post-randomisation
measure: Clinical Global Impression and Improvement Scale (Guy, 1976)
timeFrame: Baseline, and at 1, 2, 4, 8 weeks and 6-month post-randomisation
measure: Quick Inventory of Depressive Symptomatology -SR Version (Triveni et al., 2004) Questionnaire
timeFrame: Baseline, and at 1, 2, 4, 8 weeks and 6-month post-randomisation
measure: Brief Ruminative Response Scale (Topper et al, 2014). Questionnaire
timeFrame: Baseline, and at 1, 2, 4, 8 weeks and 6-month post-randomisation
measure: Pittsburgh Sleep Index (Bysse et al., 1999) Questionnaire
timeFrame: Baseline, and at 1, 2, 4, 8 weeks and 6-month post-randomisation
measure: Euroquol 5D (1990) Questionnaire
timeFrame: Baseline, and at 1, 2, 4, 8 weeks and 6-month post-randomisation
measure: To check the amount of current antidepressant use
timeFrame: Baseline, and at 1, 2, 4, 8 weeks and 6-month post-randomisation
measure: To check the amount of current psychotherapy use
timeFrame: Baseline, and at 1, 2, 4, 8 weeks and 6-month post-randomisation
measure: Daily sleep diary
timeFrame: 3 days pre-randomisation and 7 days post-randomisation
measure: Credibility and Expectancy Questionnaire (Devilly, 2000).
timeFrame: Baseline
measure: Morning/Evening Questionnaire
timeFrame: 3 days pre-randomisation
measure: Wrist actigraph from GeneActiv daily (Physiological parameter)
timeFrame: 3 days pre-randomisation and 7 days post-randomisation.
Other outcomes:
Locations:
city: London
country: United Kingdom
facility: South London and Maudsley NHS Foundation Trust
Study officials:
affiliation: King's College London
name: David Veale
role: PRINCIPAL_INVESTIGATOR
References: