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Light as an Aid for Recovery in Psychiatric Inpatients

Primary Purpose

Mental Illness

Status
Completed
Phase
Not Applicable
Locations
Denmark
Study Type
Interventional
Intervention
Dynamic lighting
Sponsored by
University of Aarhus
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Mental Illness focused on measuring Lighting, Inpatients, Recovery, Sleep

Eligibility Criteria

18 Years - 68 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Admission

Exclusion Criteria:

  • Inability to provide written consent
  • Mania

Sites / Locations

  • Department of Affective Disorders, Aarhus University Hospital, Risskov

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Dynamic lighting

Treatment as usual

Arm Description

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

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

Outcomes

Primary Outcome Measures

Sleep quality on the Pittsburgh Sleep Quality Index (PSQI)

Secondary Outcome Measures

Depressive symptoms on the Major depression inventory (MDI)
Well-being on the World Health Organization measure of well-being (WHO-5)
Qualitative assessment using a custom made questionnaire
Number of patients with side-effects.
Sleep diary

Full Information

First Posted
December 4, 2015
Last Updated
May 2, 2018
Sponsor
University of Aarhus
Collaborators
Aarhus University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT02653040
Brief Title
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

2. Study Status

Record Verification Date
October 2017
Overall Recruitment Status
Completed
Study Start Date
December 15, 2015 (Actual)
Primary Completion Date
January 15, 2017 (Actual)
Study Completion Date
March 15, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Aarhus
Collaborators
Aarhus University Hospital

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Mental Illness
Keywords
Lighting, Inpatients, Recovery, Sleep

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
InvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
54 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Dynamic lighting
Arm Type
Experimental
Arm Description
Indoor lighting with low-lux no-blue wavelengths at night.
Arm Title
Treatment as usual
Arm Type
No Intervention
Arm Description
Characterized by full white light with little variation through a day cyclus.
Intervention Type
Other
Intervention Name(s)
Dynamic lighting
Other Intervention Name(s)
Illumination, lighting design, lighting environment
Intervention Description
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
Primary Outcome Measure Information:
Title
Sleep quality on the Pittsburgh Sleep Quality Index (PSQI)
Time Frame
Answers from questionnaires are assessed through study completion, an average of 1 month, up to 6 months
Secondary Outcome Measure Information:
Title
Depressive symptoms on the Major depression inventory (MDI)
Time Frame
Answers from questionnaires are assessed through study completion, an average of 1 month, up to 6 months
Title
Well-being on the World Health Organization measure of well-being (WHO-5)
Time Frame
Answers from questionnaires are assessed through study completion, an average of 1 month, up to 6 months
Title
Qualitative assessment using a custom made questionnaire
Description
Number of patients with side-effects.
Time Frame
Answers from questionnaires are assessed through study completion, an average of 1 month, up to 6 months
Title
Sleep diary
Time Frame
Answers from questionnaires are assessed through study completion, an average of 1 month, up to 6 months
Other Pre-specified Outcome Measures:
Title
Time to discharge
Description
Number of days between admission and discharge
Time Frame
Assessed through study completion, an average of 1 month, up to 6 months
Title
Involuntary restraints
Description
Number of participants who experienced involuntary physical and/or medical restraints.
Time Frame
Assessed through study completion, an average of 1 month, up to 6 months
Title
Use of medication from logged activity in the electronic medical record
Description
Use of medication during admission including drug og dosages administered to the participants in mg/day.
Time Frame
Assessed through study completion, an average of 1 month, up to 6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
68 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Admission Exclusion Criteria: Inability to provide written consent Mania
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Niels Okkels, MD
Organizational Affiliation
Aarhus University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Affective Disorders, Aarhus University Hospital, Risskov
City
Risskov
State/Province
Jylland
ZIP/Postal Code
8240
Country
Denmark

12. IPD Sharing Statement

Plan to Share IPD
Undecided
Citations:
PubMed Identifier
23711982
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.
Results Reference
background
PubMed Identifier
24917305
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.
Results Reference
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Light as an Aid for Recovery in Psychiatric Inpatients

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