Sleep, Wake and Light Therapy for Depression

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).

Study Overview

• Status: Completed
• Conditions: Depression; Depressive Disorder, Major; Depression, Unipolar; Depression Moderate
• Intervention / Treatment: Behavioral: Wake and Light Therapy; Behavioral: Sleep and Light Therapy

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 Type: Interventional
• Enrollment (Actual): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United Kingdom
  • London, United Kingdom
    • South London and Maudsley NHS Foundation Trust

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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	Behavioral: Wake and Light Therapy; 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.
Active Comparator: 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.	Behavioral: Sleep and Light Therapy; 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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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	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.

Collaborators and Investigators

• Sponsor: King's College London
• Collaborators: Kings Health Partners
• Investigators: Principal Investigator: David Veale, King's College London

Study record dates

Study Major Dates

• Study Start (Actual): January 18, 2018
• Primary Completion (Actual): September 23, 2019
• Study Completion (Actual): September 23, 2019

Study Registration Dates

• First Submitted: January 5, 2018
• First Submitted That Met QC Criteria: January 12, 2018
• First Posted (Actual): January 23, 2018

Study Record Updates

• Last Update Posted (Actual): September 26, 2019
• Last Update Submitted That Met QC Criteria: September 25, 2019
• Last Verified: January 1, 2019

More Information

Terms related to this study

• Keywords: Circadian Rhythm; Major Depression; Light Therapy; Wake Therapy; Sleep Phase Advance
• Additional Relevant MeSH Terms: Behavioral Symptoms; Mental Disorders; Mood Disorders; Depression; Depressive Disorder; Depressive Disorder, Major
• Other Study ID Numbers: R&D2017/096

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No