Light as an Aid for Recovery in Psychiatric Inpatients
Condition: Mental Illness
MeSH terms: Mental Disorders
Study type: Interventional

Summary: 
      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: 
      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.
    

Intervention name(s): Dynamic lighting
Intervention type(s): Other
Intervention description(s): 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
Other intervention name(s): Illumination, lighting design, lighting environment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Lighting; Inpatients; Recovery; Sleep