Sleep, Wake and Light Therapy for Depression

September 25, 2019 updated by: King's College London

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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
60

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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
Week 1

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
MINI International Neuropsychiatric Interview Version 5.0
Time Frame: Baseline
To determine diagnosis by DSM-IV criteria
Baseline
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
Baseline, and at 1, 2, 4, 8 weeks and 6-month post-randomisation
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
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
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
Baseline, and at 1, 2, 4, 8 weeks and 6-month post-randomisation
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
Baseline, and at 1, 2, 4, 8 weeks and 6-month post-randomisation
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
Baseline, and at 1, 2, 4, 8 weeks and 6-month post-randomisation
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
Baseline, and at 1, 2, 4, 8 weeks and 6-month post-randomisation
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)
Baseline, and at 1, 2, 4, 8 weeks and 6-month post-randomisation
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)
Baseline, and at 1, 2, 4, 8 weeks and 6-month post-randomisation
Daily sleep diary
Time Frame: 3 days pre-randomisation and 7 days post-randomisation
A subjective measure of total sleep time
3 days pre-randomisation and 7 days post-randomisation
Credibility and Expectancy Questionnaire (Devilly, 2000).
Time Frame: Baseline
A measure of the credibility of the intervention
Baseline
Morning/Evening Questionnaire
Time Frame: 3 days pre-randomisation
A measure of morning/evening preference
3 days pre-randomisation
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).
3 days pre-randomisation and 7 days post-randomisation.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
King's College London

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Kings Health Partners

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: David Veale, King's College London

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 18, 2018

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 23, 2019

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 23, 2019

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 5, 2018

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 12, 2018

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 23, 2018

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 26, 2019

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 25, 2019

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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