Sleep, Wake and Light Therapy for Depression

NCT03405493 | Completed

• 1 other identifier: R&D2017/096
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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. 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. 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).

Conditions

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

Keywords

Circadian Rhythm; Light Therapy; Wake Therapy; Sleep Phase Advance; Major Depression

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (13)

• MINI International Neuropsychiatric Interview Version 5.0

  Baseline

• Hamilton Depression Rating Scale

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

• Clinical Global Impression and Improvement Scale (Guy, 1976)

  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

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

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

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

Study Arms (2)

Wake and Light Therapy

EXPERIMENTAL

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

Sleep and Light Therapy

ACTIVE COMPARATOR

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

Interventions

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.

Wake and Light Therapy

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).

Sleep and Light Therapy

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• King's College London: lead
• Kings Health Partners: collaborator

Study Sites (1)

South London and Maudsley NHS Foundation Trust

London, United Kingdom

Location

MeSH Terms

Conditions

Depression; Depressive Disorder, Major; Depressive Disorder

Interventions

Phototherapy; Sleep

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior; Mood Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Therapeutics; Nervous System Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• David Veale

  King's College London

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: * 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.

Study Record Dates

• First Submitted: January 5, 2018
• First Posted: January 23, 2018
• Study Start: January 18, 2018
• Primary Completion: September 23, 2019
• Study Completion: September 23, 2019
• Last Updated: September 26, 2019

Record last verified: 2019-01

Locations

GB (1)