Light as an Aid for Recovery in Psychiatric Inpatients

NCT ID: NCT02653040

Last Updated: 2018-05-03

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 54 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-12-15
• Study Completion Date: 2018-03-15

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.

Conditions

Mental Illness

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Dynamic lighting

Indoor lighting with low-lux no-blue wavelengths at night.

Group Type: EXPERIMENTAL

Dynamic lighting

Intervention Type: OTHER

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

Treatment as usual

Characterized by full white light with little variation through a day cyclus.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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

Intervention Type: OTHER

Other Intervention Names

Illumination, lighting design, lighting environment

Eligibility Criteria

Inclusion Criteria

• Admission

Exclusion Criteria

• Inability to provide written consent
• Mania

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 68 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Aarhus University Hospital

OTHER

Sponsor Role: collaborator

University of Aarhus

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Niels Okkels, MD

Role: PRINCIPAL_INVESTIGATOR

Aarhus University Hospital

Locations

Department of Affective Disorders, Aarhus University Hospital, Risskov

Risskov, Jylland, Denmark

Countries

Denmark

References

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.

Reference Type: BACKGROUND

PMID: 23711982 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 24917305 (View on PubMed)

Other Identifiers

QLIGHT

Identifier Type: -

Identifier Source: org_study_id