The purpose of this pilot study is to evaluate wether a naturalistic indoor light environment can improve sleep and mood in psychiatric inpatients
Setting: 17 bed inpatient ward at a University Mental Health Hospital Rooms: The dimensions of all 17 rooms are identical with 4,54m x 3,14m, ceiling height 3,15m, a window, a bed, a table, a chair and a bathroom 1,55m x 1,85m. Assignment of interventions: After admission patients are invited to participate in the study. If the patients wish to participate they will go through eligibility screen, sign informed consent and fill out questionnaires on sleep, mood and well-being (-t1). The patients (now participants) are randomly allocated (t0) by sealed envelope technique and the envelope is brought to the staff office and opened by a staff member who then from the computer in the office programs the participant's room to either intervention or control. Randomization: The investigators used random permuted blocks of varying and blinded block size. A third party person created the envelopes and arranged them in blocks. Blinding: The outcome assessor and data analyst is blinded to allocation. Trial participants and care providers are unblinded. Participants may be replaced to another room for practical, clinical reasons. In this case, the intervention/control conditions will follow the patient. Data management: All data will be entered in RedCAP and stored in a electronic online secured database at Aarhus University. Power estimation: Alfa: 0.05. Beta: 0.20. Effect size: change of 4 points in PSQI with a standard deviation estimated to 4. Number of patients in each arm: 17 (x 2 = 34). Number needed to be included accounting for discontinuation: 60 (estimated) Statistics: The investigators will calculate intention-to-treat. Other statistical analyses will include logistic regression for dichotomous outcome data, analysis of covariance for continuous outcome data, and survival analysis for time-to-event outcome data. Interim-analyses during the data-collection period to stop trial if intervention produces larger than expected benefits or harm or if investigators find evidence of no important difference between experimental and control interventions.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
54
Intervention is rooms with light settings imitating natural light conditions with white light at day and low-lux no-blue light at night: 07am-10am: white light, increasing intensity 10am-07pm: white light, full intensity 07pm-11pm: no blue wavelength, low intensity 11pm-07am: no blue wavelength, very low intensity
Department of Affective Disorders, Aarhus University Hospital, Risskov
Risskov, Jylland, Denmark
Sleep quality on the Pittsburgh Sleep Quality Index (PSQI)
Time frame: Answers from questionnaires are assessed through study completion, an average of 1 month, up to 6 months
Depressive symptoms on the Major depression inventory (MDI)
Time frame: Answers from questionnaires are assessed through study completion, an average of 1 month, up to 6 months
Well-being on the World Health Organization measure of well-being (WHO-5)
Time frame: Answers from questionnaires are assessed through study completion, an average of 1 month, up to 6 months
Qualitative assessment using a custom made questionnaire
Number of patients with side-effects.
Time frame: Answers from questionnaires are assessed through study completion, an average of 1 month, up to 6 months
Sleep diary
Time frame: Answers from questionnaires are assessed through study completion, an average of 1 month, up to 6 months
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.