DepressionNCT03405493
Sleep, Wake and Light Therapy for Depression
A study testing Wake and Light Therapy and Sleep and Light Therapy in people with Depression and Depressive Disorder, Major, run by King's College London at 1 site in United Kingdom.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Depression, Depressive Disorder, Major, Depression, Unipolar
- What is being tested?
- Wake and Light Therapy and Sleep and Light Therapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 18 Jan 2018to 23 Sep 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Show all 17Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
South London and Maudsley NHS Foundation Trust
London
About this study
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).
Read the 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.
- Being tested
- Wake and Light Therapy, Sleep and Light Therapy
- Keywords
- Circadian Rhythm, Light Therapy, Wake Therapy, Sleep Phase Advance, Major Depression
- Medical subject headings
- Depression, Depressive Disorder, Major, Depressive Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Wake and Light TherapyBehavioural
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 TherapyBehavioural
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).
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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. Receives: Behavioral: Sleep and Light Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants recruited per month/Adherence to the protocol
To compare the rate of recruitment and adherence to the treatments in both groups
Measured: Week 1
Secondary outcomes (13)
MINI International Neuropsychiatric Interview Version 5.0
To determine diagnosis by DSM-IV criteria
Measured: Baseline
Hamilton Depression Rating Scale
To compare the effects on observer rated depressive symptoms in both groups
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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)
Measured: 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)
Measured: Baseline, and at 1, 2, 4, 8 weeks and 6-month post-randomisation
Daily sleep diary
A subjective measure of total sleep time
Measured: 3 days pre-randomisation and 7 days post-randomisation
Credibility and Expectancy Questionnaire (Devilly, 2000).
A measure of the credibility of the intervention
Measured: Baseline
Morning/Evening Questionnaire
A measure of morning/evening preference
Measured: 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).
Measured: 3 days pre-randomisation and 7 days post-randomisation.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jan 2018
- Study start18 Jan 2018
- Primary completion23 Sep 2019
- Study completion23 Sep 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DepressionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- King's College London
- Sponsor type
- University, hospital or other
- Collaborators
- Kings Health Partners
- Responsible party
- Sponsor
- Investigators
- David Veale, Principal investigator, King's College London
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03405493
- Sponsor's protocol ID
- R&D2017/096
- Status last verified
- Jan 2019
- First submitted
- 5 Jan 2018
- Last updated
- 26 Sep 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 26 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sleep, Wake and Light Therapy for Depression
- ClinicalTrials.gov ID
- NCT03405493
- Acronym / sponsor ID
- R&D2017/096
- Keywords
- Circadian Rhythm, Light Therapy, Wake Therapy, Sleep Phase Advance, Major Depression
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- King's College LondonUniversity, hospital or other
- Collaborators
- Kings Health Partners
- Study start
- 18 Jan 2018 (actual)
- Primary completion
- 23 Sep 2019 (actual)
- Study completion
- 23 Sep 2019 (actual)
- First posted
- 23 Jan 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Wake and Light Therapy | Experimental | Behavioral: Wake and Light TherapyThis 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 |
| Sleep and Light Therapy | Active comparator | Behavioral: Sleep and Light TherapyParticipants will be given information on sleep hygiene and getting a good night's sleep. They are then given Light Therapy daily for 1 week. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (17 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Wake and Light TherapyParticipants 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. | Behavioural | Wake and Light Therapy |
| Sleep and Light TherapyParticipants 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). | Behavioural | Sleep and Light Therapy |
Primary outcome
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
13 secondary outcomes
MINI International Neuropsychiatric Interview Version 5.0
Time frame: Baseline
Hamilton Depression Rating Scale
Time frame: 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
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
Brief Ruminative Response Scale (Topper et al, 2014). Questionnaire
Time frame: 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
Euroquol 5D (1990) Questionnaire
Time frame: 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
To check the amount of current psychotherapy use
Time frame: 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
Credibility and Expectancy Questionnaire (Devilly, 2000).
Time frame: Baseline
Morning/Evening Questionnaire
Time frame: 3 days pre-randomisation
Wrist actigraph from GeneActiv daily (Physiological parameter)
Time frame: 3 days pre-randomisation and 7 days post-randomisation.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Sep 2019.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
David Veale principal investigator
King's College London
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Wake and Light Therapy and Sleep and Light Therapy in people with Depression and Depressive Disorder, Major, run by King's College London at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Sep 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of participants recruited per month/Adherence to the protocol (time frame: Week 1). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Sep 2019.