Light as an Aid for Recovery in Psychiatric Inpatients
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About
The purpose of this pilot study is to evaluate wether a naturalistic indoor light environment can improve sleep and mood in psychiatric inpatients
Full description
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.
Enrollment
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Inclusion criteria
- Admission
Exclusion criteria
- Inability to provide written consent
- Mania
Trial design
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Interventional model
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54 participants in 2 patient groups
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Data sourced from clinicaltrials.gov
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