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Completed

NCT Number: NCT03405493

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).

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Key information

Conditions

Depression Behavior Behavioral Symptoms Depression Moderate Depression, Unipolar Depressive Disorder Depressive Disorder, Major Mental Disorders Mood Disorders

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

South London and Maudsley NHS Foundation Trust

London, United Kingdom

About this study

  • 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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Wake and Light Therapy

Behavioral

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.

Sleep and Light Therapy

Behavioral

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).

Primary outcomes

  1. Number of participants recruited per month/Adherence to the protocol

    Time frame: Week 1

    To compare the rate of recruitment and adherence to the treatments in both groups

Secondary outcomes

  1. MINI International Neuropsychiatric Interview Version 5.0

    Time frame: Baseline

    To determine diagnosis by DSM-IV criteria

  2. Hamilton Depression Rating Scale

    Time frame: 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

  3. Clinical Global Impression and Improvement Scale (Guy, 1976)

    Time frame: 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

  4. Quick Inventory of Depressive Symptomatology -SR Version (Triveni et al., 2004) Questionnaire

    Time frame: Baseline, and at 1, 2, 4, 8 weeks and 6-month post-randomisation

    To compare the effects on subjective depressive symptoms in both groups

  5. Brief Ruminative Response Scale (Topper et al, 2014). Questionnaire

    Time frame: 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

  6. Pittsburgh Sleep Index (Bysse et al., 1999) Questionnaire

    Time frame: Baseline, and at 1, 2, 4, 8 weeks and 6-month post-randomisation

    To compare the effects on subjective sleep quality in both groups

  7. Euroquol 5D (1990) Questionnaire

    Time frame: 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

  8. To check the amount of current antidepressant use

    Time frame: 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)

  9. To check the amount of current psychotherapy use

    Time frame: 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)

  10. Daily sleep diary

    Time frame: 3 days pre-randomisation and 7 days post-randomisation

    A subjective measure of total sleep time

  11. Credibility and Expectancy Questionnaire (Devilly, 2000).

    Time frame: Baseline

    A measure of the credibility of the intervention

  12. Morning/Evening Questionnaire

    Time frame: 3 days pre-randomisation

    A measure of morning/evening preference

  13. Wrist actigraph from GeneActiv daily (Physiological parameter)

    Time frame: 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).

Sponsors and collaborators

Lead sponsor

King's College London

Other

Collaborators

  • Kings Health Partners

Registry information

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Jan 23, 2018
Registry last updated
Sep 26, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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