The Effects of Artificial Lighting on Affective and Core Symptoms of Eating Disorder

NCT ID: NCT03948217

Last Updated: 2023-10-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

22 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-05-01

Study Completion Date

2018-08-31

Brief Summary

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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

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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

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Anorexia Nervosa Eating Disorder

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Single blind, cross-over, controlled
Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Caregivers
Patients are unaware of the type of Circadian lighting regimen that is provided

Study Groups

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L1

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

Group Type ACTIVE_COMPARATOR

Circadian Lighting regimen

Intervention Type OTHER

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

L2

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

Group Type ACTIVE_COMPARATOR

Circadian Lighting regimen

Intervention Type OTHER

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

Interventions

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Circadian Lighting regimen

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

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

1. Forced care
2. Non-primary psychiatric disorder other than AN, BN, or EDNOS
3. Binge Eating disorder
4. Somatic unstable condition
5. High suicidal behavior or risk
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Aalborg University

OTHER

Sponsor Role collaborator

Mental Health Services in the Capital Region, Denmark

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Mental Health Center

Ballerup Municipality, Capitol Region, Denmark

Site Status

Countries

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Denmark

Other Identifiers

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H-17022914

Identifier Type: -

Identifier Source: org_study_id

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