Sleep, Wake and Light Therapy for Depression

King's College London

Status: Completed

Conditions: Depression, Unipolar; Depression Moderate; Depressive Disorder, Major; Depression

Treatments: Behavioral: Wake and Light Therapy; Behavioral: Sleep and Light Therapy

Study type: Interventional

Funder types: Other

Identifiers

NCT03405493

R&D2017/096

Details and patient eligibility

About

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).

Full 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.

Enrollment: 60 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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60 participants in 2 patient groups

Wake and Light Therapy

Experimental group

Description:

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

Treatment:

Behavioral: Wake and Light Therapy

Sleep and Light Therapy

Active Comparator group

Description:

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.

Treatment:

Behavioral: Sleep and Light Therapy