Anorexia NervosaMETROPOLISNCT03948217
The Effects of Artificial Lighting on Affective and Core Symptoms of Eating Disorder
A study testing Circadian Lighting regimen in people with Anorexia Nervosa and Eating Disorder, run by Mental Health Centre Copenhagen, Bispebjerg and Frederiksberg Hospital at 1 site in Denmark.
Trial summary
The primary objective of this pilot study is to explore the effect of artificial lighting on affective symptoms, and the secondary aim is to explore the effect of artificial lighting on core symptoms of eating disorders (ED). Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Anorexia Nervosa, Eating Disorder
- What is being tested?
- Circadian Lighting regimen
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 22 participants
- Where
- 1 siteDenmark
- Study dates
- 1 May 2018to 31 Aug 2018
- 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
- Primary diagnosis of Anorexia Nervosa (AN) or Bulimia Nervosa (BN) or Eating Disorder Not Otherwise specified (EDNOS)
- Age ≥18 and <65
Who cannot join
- Forced care
- Non-primary psychiatric disorder other than AN, BN, or EDNOS
- Binge Eating disorder
- Somatic unstable condition
- High suicidal behavior or risk
Trial locations and contacts
1 site in 1 country.
Denmark1 site
Mental Health Center
Ballerup Municipality, Capitol Region, 2750
About this study
Official title: The Effects of Artificial Lighting on Affective and Core Symptoms of Eating Disorder - a Pilot Study
The primary objective of this pilot study is to explore the effect of artificial lighting on affective symptoms, and the secondary aim is to explore the effect of artificial lighting on core symptoms of eating disorders (ED).
Several lines of evidence, albeit from hypothesis generation studies, suggest that artificial lighting may have a positive effect on well-being, mental health and affective symptoms in ED. The rationale of this study is to investigate the effects of artificial lighting on affective symptoms and cores symptoms of ED in inpatients undergoing weight restoration/treatment for ED.
Read more
Study design: Single-blind, controlled, pilot intervention study with circadian light (CL) comparing two CL regimens effects on mood symptoms.
Planned number of subjects: 16 patients with a ICD-10 diagnosis of Anorexia Nervosa, that completes exposure to at least three weeks of the two different CL regimens (L1 and L2) in any order.
Read the detailed description
The primary objective of this pilot study is to explore the effect of artificial lighting on affective symptoms, and the secondary aim is to explore the effect of artificial lighting on core symptoms of eating disorders (ED).
If an effect is indicated, the study will provide information on how to improve light exposure to ED patients in psychiatric treatment units. In addition, the outcomes may help identify a better system for measurement and adjustment of the specific light variables of colour temperature and light intensity.
Several lines of evidence, albeit from hypothesis generation studies, suggest that artificial lighting may have a positive effect on well-being, mental health and affective symptoms in ED. This is the rationale to investigate the effects of artificial lighting on affective symptoms and cores symptoms of ED in inpatients undergoing weight restoration/treatment for ED.
Study design: Single-blind, controlled, pilot intervention study with circadian light (CL) comparing two CL regimens effects on mood symptoms.
Planned number of subjects: 16 patients with a International Classification of Disorders 10 (ICD-10) diagnosis of Anorexia Nervosa, that completes exposure to at least three weeks of the two different CL regimens (L1 and L2) in any order.
Location: Mental Health Center Ballerup, department 14 (currently Department 5).
Diagnostic inventory: Eating Disorder Examination-Questionnaire (EDE-Q)
- Conditions
- Anorexia Nervosa, Eating Disorder
- Being tested
- Circadian Lighting regimen
- Keywords
- artificial lighting
- Medical subject headings
- Anorexia Nervosa, Feeding and Eating Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Circadian Lighting regimenOther
Circadian lighting regimen with one major fluctuation, high light intensity and color
| Study group | Role | What they receive |
|---|---|---|
| L1 | Active comparator | regimen L1 has overall higher intensity, higher color temperature and less light fluctuations Receives: Other: Circadian Lighting regimen |
| L2 | Active comparator | regimen L2 has lower intensity, lower color temperature and more light fluctuations. Receives: Other: Circadian Lighting regimen |
What is being measured
The primary outcome is the main question the study is designed to answer.
3 week change in total score of Major Depression Inventory
depression scoring, change in total score over three weeks. range 0-50. Higher values means more depressed. Mild depression: MDI total score from 21 to 25. Moderate depression: MDI total score from 26 to 30. Severe depression: MDI total score of 31 or higher.
Measured: 3 weeks change from baseline
3 week change in total score of Eating Disorder Inventory 2
Eating disorder symptoms total score change over 3 weeks. range 0-273. Higher score means more Eating disorder symptoms.
Measured: 3 weeks change from baseline
3 week change in video images based measure of Physical activity
video images based measure of quantity of physical activity
Measured: 3 weeks change in physical activity from baseline
Secondary outcomes (5)
3 week change in BMI
change in Body Mass index
Measured: 3 week change as a measure of weight change
3 week change in Visual analogue scale of mood
self assessed measure of mood symptoms, range 1-10. Higher score means more symptoms and feeling worse.
Measured: 3 weeks change from baseline
3 week change in melatonin levels
urinary levels of melatonin
Measured: 3 weeks change from baseline
3 week change in serotonin levels
Blood levels of serotonin
Measured: 3 weeks change from baseline
3 week change in cortisol levels
Urinary levels of cortisol as a measure of stress
Measured: 3 weeks change from baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 May 2019
- Study start1 May 2018
- Primary completion31 Jul 2018
- Study completion31 Aug 2018
Why it stopped: changes to buildings why study was terminated prematurely
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Anorexia NervosaStudies 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
- Crossover
- Model description
- Single blind, cross-over, controlled
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mental Health Centre Copenhagen, Bispebjerg and Frederiksberg Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Aalborg University
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03948217
- Sponsor's protocol ID
- H-17022914
- Acronym
- METROPOLIS
- Status last verified
- Oct 2023
- First submitted
- 3 May 2019
- Last updated
- 23 Oct 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All patient data
Study at a glance
From the registry record, last updated by the sponsor on 23 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Artificial Lighting on Affective and Core Symptoms of Eating Disorder - a Pilot Study
- ClinicalTrials.gov ID
- NCT03948217
- Acronym / sponsor ID
- METROPOLIS / H-17022914
- Conditions
- Anorexia Nervosa, Eating Disorder
- Keywords
- artificial lighting
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: changes to buildings why study was terminated prematurely
- Enrolment
- 22 participants (actual)
- Lead sponsor
- Mental Health Centre Copenhagen, Bispebjerg and Frederiksberg HospitalUniversity, hospital or other
- Collaborators
- Aalborg University
- Study start
- 1 May 2018 (actual)
- Primary completion
- 31 Jul 2018 (actual)
- Study completion
- 31 Aug 2018 (actual)
- First posted
- 13 May 2019 (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 primary objective of this pilot study is to explore the effect of artificial lighting on affective symptoms, and the secondary aim is to explore the effect of artificial lighting on core symptoms of eating disorders (ED).
Several lines of evidence, albeit from hypothesis generation studies, suggest that artificial lighting may have a positive effect on well-being, mental health and affective symptoms in ED. The rationale of this study is to investigate the effects of artificial lighting on affective symptoms and cores symptoms of ED in inpatients undergoing weight restoration/treatment for ED.
Study design: Single-blind, controlled, pilot intervention study with circadian light (CL) comparing two CL regimens effects on mood symptoms.
Planned number of subjects: 16 patients with a ICD-10 diagnosis of Anorexia Nervosa, that completes exposure to at least three weeks of the two different CL regimens (L1 and L2) in any order.
Detailed description
The primary objective of this pilot study is to explore the effect of artificial lighting on affective symptoms, and the secondary aim is to explore the effect of artificial lighting on core symptoms of eating disorders (ED).
If an effect is indicated, the study will provide information on how to improve light exposure to ED patients in psychiatric treatment units. In addition, the outcomes may help identify a better system for measurement and adjustment of the specific light variables of colour temperature and light intensity.
Several lines of evidence, albeit from hypothesis generation studies, suggest that artificial lighting may have a positive effect on well-being, mental health and affective symptoms in ED. This is the rationale to investigate the effects of artificial lighting on affective symptoms and cores symptoms of ED in inpatients undergoing weight restoration/treatment for ED.
Study design: Single-blind, controlled, pilot intervention study with circadian light (CL) comparing two CL regimens effects on mood symptoms.
Planned number of subjects: 16 patients with a International Classification of Disorders 10 (ICD-10) diagnosis of Anorexia Nervosa, that completes exposure to at least three weeks of the two different CL regimens (L1 and L2) in any order.
Location: Mental Health Center Ballerup, department 14 (currently Department 5).
Diagnostic inventory: Eating Disorder Examination-Questionnaire (EDE-Q)
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
- Model description
- Single blind, cross-over, controlled
| Arm | Type | Receives |
|---|---|---|
| L1 | Active comparator | Other: Circadian Lighting regimenregimen L1 has overall higher intensity, higher color temperature and less light fluctuations |
| L2 | Active comparator | Other: Circadian Lighting regimenregimen L2 has lower intensity, lower color temperature and more light fluctuations. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Primary diagnosis of Anorexia Nervosa (AN) or Bulimia Nervosa (BN) or Eating Disorder Not Otherwise specified (EDNOS)
- Age ≥18 and <65
Key exclusion criteria (5 listed)
- Forced care
- Non-primary psychiatric disorder other than AN, BN, or EDNOS
- Binge Eating disorder
- Somatic unstable condition
- High suicidal behavior or risk
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 |
|---|---|---|
| Circadian Lighting regimenCircadian lighting regimen with one major fluctuation, high light intensity and color | Other | L1, L2 |
Primary outcome
3 week change in total score of Major Depression Inventory
Time frame: 3 weeks change from baseline
depression scoring, change in total score over three weeks. range 0-50. Higher values means more depressed. Mild depression: MDI total score from 21 to 25. Moderate depression: MDI total score from 26 to 30. Severe depression: MDI total score of 31 or higher.
3 week change in total score of Eating Disorder Inventory 2
Time frame: 3 weeks change from baseline
Eating disorder symptoms total score change over 3 weeks. range 0-273. Higher score means more Eating disorder symptoms.
3 week change in video images based measure of Physical activity
Time frame: 3 weeks change in physical activity from baseline
video images based measure of quantity of physical activity
5 secondary outcomes
3 week change in BMI
Time frame: 3 week change as a measure of weight change
3 week change in Visual analogue scale of mood
Time frame: 3 weeks change from baseline
3 week change in melatonin levels
Time frame: 3 weeks change from baseline
3 week change in serotonin levels
Time frame: 3 weeks change from baseline
3 week change in cortisol levels
Time frame: 3 weeks change from baseline
Results and safety
The study was stopped early (reason given: changes to buildings why study was terminated prematurely). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Oct 2023.
- Individual participant dataSharing planned: Yes. All patient data
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Circadian Lighting regimen in people with Anorexia Nervosa and Eating Disorder, run by Mental Health Centre Copenhagen, Bispebjerg and Frederiksberg Hospital at 1 site in Denmark.
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 2 inclusion and 5 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: stopped early, as of the sponsor's last update on 23 Oct 2023. 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 Denmark. 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 was stopped early (reason given: changes to buildings why study was terminated prematurely). Results are not available in the source record.
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?
3 week change in total score of Major Depression Inventory (time frame: 3 weeks change from baseline). The study lists 3 primary outcomes in all. 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 23 Oct 2023.