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Sleep, Wake and Light Therapy for Depression

Primary Purpose

Depression, Depressive Disorder, Major, Depression, Unipolar

Status

Completed

Phase

Not Applicable

Locations

United Kingdom

Study Type

Interventional

Intervention

Wake and Light Therapy

Sleep and Light Therapy

About this trial

This is an interventional treatment trial for Depression focused on measuring Circadian Rhythm, Light Therapy, Wake Therapy, Sleep Phase Advance, Major Depression

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

South London and Maudsley NHS Foundation Trust

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Wake and Light Therapy

Sleep and Light Therapy

Arm 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

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.

Outcomes

Primary Outcome Measures

Number of participants recruited per month/Adherence to the protocol

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

Secondary Outcome Measures

MINI International Neuropsychiatric Interview Version 5.0

To determine diagnosis by DSM-IV criteria

Hamilton Depression Rating Scale

To compare the effects on observer rated depressive symptoms in both groups

Clinical Global Impression and Improvement Scale (Guy, 1976)

To compare the effects on observer rated clinical impression in both groups

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

To compare the effects on subjective depressive symptoms in both groups

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

To compare the effects on measures of subjective rumination in both groups

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

To compare the effects on subjective sleep quality in both groups

Euroquol 5D (1990) Questionnaire

To compare the effects on subjective general quality of life in both groups

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)

To check the amount of current psychotherapy use

The amount of Cognitive Behaviour Therapy or any other counselling or psychotherapy (number of hours)

Daily sleep diary

A subjective measure of total sleep time

Credibility and Expectancy Questionnaire (Devilly, 2000).

A measure of the credibility of the intervention

Morning/Evening Questionnaire

A measure of morning/evening preference

Wrist actigraph from GeneActiv daily (Physiological parameter)

A measure of the sleep/wake activity, which correlates with the gold standard of sleep physiology (polysomnography).

Full Information

NCT ID

NCT03405493

First Posted

January 5, 2018

Last Updated

September 25, 2019

Sponsor

King's College London

Collaborators

Kings Health Partners

1. Study Identification

Unique Protocol Identification Number

NCT03405493

Brief Title

Sleep, Wake and Light Therapy for Depression

Official Title

Sleep, Wake and Light Therapy for Depression

Study Type

Interventional

2. Study Status

Record Verification Date

January 2019

Overall Recruitment Status

Completed

Study Start Date

January 18, 2018 (Actual)

Primary Completion Date

September 23, 2019 (Actual)

Study Completion Date

September 23, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

King's College London

Collaborators

Kings Health Partners

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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: 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). 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

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

Keywords

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

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Model Description

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.

Masking

Outcomes Assessor

Allocation

Randomized

Enrollment

60 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Wake and Light Therapy

Arm Type

Experimental

Arm 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

Arm Title

Sleep and Light Therapy

Arm Type

Active Comparator

Arm 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.

Intervention Type

Behavioral

Intervention Name(s)

Wake and Light Therapy

Intervention Description

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.

Intervention Type

Behavioral

Intervention Name(s)

Sleep and Light Therapy

Intervention Description

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 Outcome Measure Information:

Title

Number of participants recruited per month/Adherence to the protocol

Description

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

Time Frame

Week 1

Secondary Outcome Measure Information:

Title

MINI International Neuropsychiatric Interview Version 5.0

Description

To determine diagnosis by DSM-IV criteria

Time Frame

Baseline

Title

Hamilton Depression Rating Scale

Description

To compare the effects on observer rated depressive symptoms in both groups

Time Frame