Clinical trial NCT03948217: The Effects of Artificial Lighting on Affective and Core Symptoms of Eating Disorder
Official title: The Effects of Artificial Lighting on Affective and Core Symptoms of Eating Disorder - a Pilot Study
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Anorexia Nervosa
Eating Disorder
Keywords: artificial lighting
Lead sponsor: Mental Health Services in the Capital Region, Denmark
Sponsor class: OTHER
Collaborators: name: Aalborg University
First posted: 2019-05-13
Enrollment: 22
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: Single blind, cross-over, controlled
Primary purpose: TREATMENT

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.

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)

Eligibility criteria: 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

Primary outcomes:
measure: 3 week change in total score of Major Depression Inventory
timeFrame: 3 weeks change from baseline
measure: 3 week change in total score of Eating Disorder Inventory 2
timeFrame: 3 weeks change from baseline
measure: 3 week change in video images based measure of Physical activity
timeFrame: 3 weeks change in physical activity from baseline
Secondary outcomes:
measure: 3 week change in BMI
timeFrame: 3 week change as a measure of weight change
measure: 3 week change in Visual analogue scale of mood
timeFrame: 3 weeks change from baseline
measure: 3 week change in melatonin levels
timeFrame: 3 weeks change from baseline
measure: 3 week change in serotonin levels
timeFrame: 3 weeks change from baseline
measure: 3 week change in cortisol levels
timeFrame: 3 weeks change from baseline
Other outcomes:
Locations:
city: Ballerup
country: Denmark
facility: Mental Health Center
state: Capitol Region
Study officials:
References: