Light as an Aid for Recovery in Psychiatric Inpatients

Study Overview
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Brief Summary
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The purpose of this pilot study is to evaluate wether a naturalistic indoor light environment can improve sleep and mood in psychiatric inpatients

Detailed Description
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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.

Official Title
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Light as an Aid for Recovery in Psychiatric Inpatients: A Pragmatic Randomized Controlled Pilot Trial

Conditions
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Mental Illness

Intervention / Treatment
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* Other: Dynamic lighting


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Admission Exclusion Criteria: Inability to provide written consent Mania

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 68 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Dynamic lighting<br>Indoor lighting with low-lux no-blue wavelengths at night. | Other: Dynamic lighting<br>* 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<br>* Other names: Illumination, lighting design, lighting environment;|
| No Intervention: Treatment as usual<br>Characterized by full white light with little variation through a day cyclus. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sleep quality on the Pittsburgh Sleep Quality Index (PSQI) |  | Answers from questionnaires are assessed through study completion, an average of 1 month, up to 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Depressive symptoms on the Major depression inventory (MDI) |  | 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) |  | 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. | Answers from questionnaires are assessed through study completion, an average of 1 month, up to 6 months | 
| Sleep diary |  | Answers from questionnaires are assessed through study completion, an average of 1 month, up to 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Lighting, Inpatients, Recovery, Sleep