Sleep, Wake and Light Therapy for Depression

Not Applicable

Completed

• Conditions: Depression; Depressive Disorder, Major; Depression, Unipolar; Depression Moderate
• Interventions: Behavioral: Sleep and Light Therapy; Behavioral: Wake and Light Therapy

• Registration Number: NCT03405493
• Lead Sponsor: King's College London

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.

Study Timeline

• Study First Submitted: 2018-01-05
• Study First Submitted QC: 2018-01-12
• Study Start: 2018-01-18
• Study First Posted: 2018-01-23
• Status Verified: 2019-01
• Primary Completion: 2019-09-23
• Study Completion: 2019-09-23
• Last Update Submitted: 2019-09-25
• Last Update Posted: 2019-09-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Sleep and Light Therapy	Sleep and Light Therapy	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.
Wake and Light Therapy	Wake and Light Therapy	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

Primary Outcome Measures

Name	Time	Method
Number of participants recruited per month/Adherence to the protocol	Week 1	To compare the rate of recruitment and adherence to the treatments in both groups

Secondary Outcome Measures

Name	Time	Method
Pittsburgh Sleep Index (Bysse et al., 1999) Questionnaire	Baseline, and at 1, 2, 4, 8 weeks and 6-month post-randomisation	To compare the effects on subjective sleep quality in both groups
Euroquol 5D (1990) Questionnaire	Baseline, and at 1, 2, 4, 8 weeks and 6-month post-randomisation	To compare the effects on subjective general quality of life in both groups
To check the amount of current psychotherapy use	Baseline, and at 1, 2, 4, 8 weeks and 6-month post-randomisation	The amount of Cognitive Behaviour Therapy or any other counselling or psychotherapy (number of hours)
Brief Ruminative Response Scale (Topper et al, 2014). Questionnaire	Baseline, and at 1, 2, 4, 8 weeks and 6-month post-randomisation	To compare the effects on measures of subjective rumination in both groups
Daily sleep diary	3 days pre-randomisation and 7 days post-randomisation	A subjective measure of total sleep time
To check the amount of current antidepressant use	Baseline, and at 1, 2, 4, 8 weeks and 6-month post-randomisation	Amount of antidepressant drugs (in mg of antidepressant equivalents) (Hayasaka et al., 2015) or benzodiazepine drugs (in mg of diazepam equivalents)
Credibility and Expectancy Questionnaire (Devilly, 2000).	Baseline	A measure of the credibility of the intervention
Morning/Evening Questionnaire	3 days pre-randomisation	A measure of morning/evening preference
MINI International Neuropsychiatric Interview Version 5.0	Baseline	To determine diagnosis by DSM-IV criteria
Clinical Global Impression and Improvement Scale (Guy, 1976)	Baseline, and at 1, 2, 4, 8 weeks and 6-month post-randomisation	To compare the effects on observer rated clinical impression in both groups
Quick Inventory of Depressive Symptomatology -SR Version (Triveni et al., 2004) Questionnaire	Baseline, and at 1, 2, 4, 8 weeks and 6-month post-randomisation	To compare the effects on subjective depressive symptoms in both groups
Wrist actigraph from GeneActiv daily (Physiological parameter)	3 days pre-randomisation and 7 days post-randomisation.	A measure of the sleep/wake activity, which correlates with the gold standard of sleep physiology (polysomnography).
Hamilton Depression Rating Scale	Baseline, and at 1, 2, 4, 8 weeks and 6-month post-randomisation	To compare the effects on observer rated depressive symptoms in both groups

Trial Locations

Locations (1)

South London and Maudsley NHS Foundation Trust; 🇬🇧 London, United Kingdom