Light as an Aid for Recovery in Psychiatric Inpatients

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

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

Study Overview

• Status: Completed
• Conditions: Mental Illness
• Intervention / Treatment: Other: Dynamic lighting

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.

• Study Type: Interventional
• Enrollment (Actual): 54
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Denmark
  • Jylland
    • Risskov, Jylland, Denmark, 8240
      • Department of Affective Disorders, Aarhus University Hospital, Risskov

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 68 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Admission

Exclusion Criteria:

• Inability to provide written consent
• Mania

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time to discharge	Number of days between admission and discharge	Assessed through study completion, an average of 1 month, up to 6 months
Involuntary restraints	Number of participants who experienced involuntary physical and/or medical restraints.	Assessed through study completion, an average of 1 month, up to 6 months
Use of medication from logged activity in the electronic medical record	Use of medication during admission including drug og dosages administered to the participants in mg/day.	Assessed through study completion, an average of 1 month, up to 6 months

Collaborators and Investigators

• Sponsor: University of Aarhus
• Collaborators: Aarhus University Hospital
• Investigators: Principal Investigator: Niels Okkels, MD, Aarhus University Hospital

Publications and helpful links

General Publications

• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): December 15, 2015
• Primary Completion (Actual): January 15, 2017
• Study Completion (Actual): March 15, 2018

Study Registration Dates

• First Submitted: December 4, 2015
• First Submitted That Met QC Criteria: January 11, 2016
• First Posted (Estimate): January 12, 2016

Study Record Updates

• Last Update Posted (Actual): May 3, 2018
• Last Update Submitted That Met QC Criteria: May 2, 2018
• Last Verified: October 1, 2017

More Information

Terms related to this study

• Keywords: Recovery; Sleep; Inpatients; Lighting
• Additional Relevant MeSH Terms: Mental Disorders
• Other Study ID Numbers: QLIGHT

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED