Light as an Aid for Recovery in Psychiatric Inpatients

Mental Illness Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02653040
• Other study ID #: QLIGHT
• Status: Completed
• Phase: N/A
• Start date: December 15, 2015
• Est. completion date: March 15, 2018

Study information

• Verified date: October 2017
• Source: University of Aarhus
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 54
• Est. completion date: March 15, 2018
• Est. primary completion date: January 15, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 68 Years

Eligibility

Inclusion Criteria:

• Admission

Exclusion Criteria:

• Inability to provide written consent

• Mania

Related Conditions & MeSH terms

• Mental Disorders
• Mental Illness

Intervention

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

Locations

Country	Name	City	State
Denmark	Department of Affective Disorders, Aarhus University Hospital, Risskov	Risskov	Jylland

Sponsors (2)

Lead Sponsor	Collaborator
University of Aarhus	Aarhus University Hospital

Country where clinical trial is conducted

Denmark, 

References & Publications (2)

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. Review. — View 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. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Time to discharge	Number of days between admission and discharge	Assessed through study completion, an average of 1 month, up to 6 months
Other	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
Other	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
Primary	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	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
Secondary	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
Secondary	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
Secondary	Sleep diary		Answers from questionnaires are assessed through study completion, an average of 1 month, up to 6 months