Clinical trial NCT02653040: Light as an Aid for Recovery in Psychiatric Inpatients
Official title: Light as an Aid for Recovery in Psychiatric Inpatients: A Pragmatic Randomized Controlled Pilot Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Mental Illness
Keywords: Lighting
Inpatients
Recovery
Sleep
Lead sponsor: University of Aarhus
Sponsor class: OTHER
Collaborators: name: Aarhus University Hospital
First posted: 2016-01-12
Enrollment: 54
Sex: ALL
Minimum age (years): 18
Maximum age (years): 68
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Eligibility criteria: Inclusion Criteria:

* Admission

Exclusion Criteria:

* Inability to provide written consent
* Mania

Primary outcomes:
measure: Sleep quality on the Pittsburgh Sleep Quality Index (PSQI)
timeFrame: Answers from questionnaires are assessed through study completion, an average of 1 month, up to 6 months
Secondary outcomes:
measure: Depressive symptoms on the Major depression inventory (MDI)
timeFrame: Answers from questionnaires are assessed through study completion, an average of 1 month, up to 6 months
measure: Well-being on the World Health Organization measure of well-being (WHO-5)
timeFrame: Answers from questionnaires are assessed through study completion, an average of 1 month, up to 6 months
measure: Qualitative assessment using a custom made questionnaire
timeFrame: Answers from questionnaires are assessed through study completion, an average of 1 month, up to 6 months
measure: Sleep diary
timeFrame: Answers from questionnaires are assessed through study completion, an average of 1 month, up to 6 months
Other outcomes:
measure: Time to discharge
timeFrame: Assessed through study completion, an average of 1 month, up to 6 months
measure: Involuntary restraints
timeFrame: Assessed through study completion, an average of 1 month, up to 6 months
measure: Use of medication from logged activity in the electronic medical record
timeFrame: Assessed through study completion, an average of 1 month, up to 6 months
Locations:
city: Risskov
country: Denmark
facility: Department of Affective Disorders, Aarhus University Hospital, Risskov
state: Jylland
Study officials:
affiliation: Aarhus University Hospital
name: Niels Okkels, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Bedrosian TA, Nelson RJ. Influence of the modern light environment on mood. Mol Psychiatry. 2013 Jul;18(7):751-7. doi: 10.1038/mp.2013.70. Epub 2013 May 28.
citation: LeGates TA, Fernandez DC, Hattar S. Light as a central modulator of circadian rhythms, sleep and affect. Nat Rev Neurosci. 2014 Jul;15(7):443-54. doi: 10.1038/nrn3743. Epub 2014 Jun 11.