NCT03948217

Brief 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). 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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
22

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started May 2018

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2018

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 31, 2018

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

August 31, 2018

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

May 3, 2019

Completed
10 days until next milestone

First Posted

Study publicly available on registry

May 13, 2019

Completed
Last Updated

October 23, 2023

Status Verified

October 1, 2023

Enrollment Period

3 months

First QC Date

May 3, 2019

Last Update Submit

October 18, 2023

Conditions

Anorexia NervosaEating Disorder

Keywords

artificial lighting

Outcome Measures

Primary Outcomes (3)

  • 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.

    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.

    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

    3 weeks change in physical activity from baseline

Secondary Outcomes (5)

  • 3 week change in BMI

    3 week change as a measure of weight change

  • 3 week change in Visual analogue scale of mood

    3 weeks change from baseline

  • 3 week change in melatonin levels

    3 weeks change from baseline

  • 3 week change in serotonin levels

    3 weeks change from baseline

  • 3 week change in cortisol levels

    3 weeks change from baseline

Study Arms (2)

L1

ACTIVE COMPARATOR

regimen L1 has overall higher intensity, higher color temperature and less light fluctuations

Other: Circadian Lighting regimen

L2

ACTIVE COMPARATOR

regimen L2 has lower intensity, lower color temperature and more light fluctuations.

Other: Circadian Lighting regimen

Interventions

Circadian Lighting regimenOTHER

Circadian lighting regimen with one major fluctuation, high light intensity and color

L1L2

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Primary diagnosis of Anorexia Nervosa (AN) or Bulimia Nervosa (BN) or Eating Disorder Not Otherwise specified (EDNOS)
  • Age ≥18 and \<65

You may not qualify if:

  • Forced care
  • Non-primary psychiatric disorder other than AN, BN, or EDNOS
  • Binge Eating disorder
  • Somatic unstable condition
  • High suicidal behavior or risk

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mental Health Center

Ballerup Municipality, Capitol Region, 2750, Denmark

Location

MeSH Terms

Conditions

Anorexia NervosaFeeding and Eating Disorders

Condition Hierarchy (Ancestors)

Mental DisordersSigns and Symptoms, DigestiveSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, CARE PROVIDER
Masking Details
Patients are unaware of the type of Circadian lighting regimen that is provided
Purpose
TREATMENT
Intervention Model
CROSSOVER
Model Details: Single blind, cross-over, controlled
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 3, 2019

First Posted

May 13, 2019

Study Start

May 1, 2018

Primary Completion

July 31, 2018

Study Completion

August 31, 2018

Last Updated

October 23, 2023

Record last verified: 2023-10

Data Sharing

IPD Sharing
Will share

All patient data

Shared Documents
STUDY PROTOCOL
Time Frame
within 12 months
Access Criteria
open

Locations

DK(1)