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Completed

NCT Number: NCT02653040

Light as an Aid for Recovery in Psychiatric Inpatients

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

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Key information

Conditions

Mental Illness Mental Disorders

Age range

18 year–68 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Department of Affective Disorders, Aarhus University Hospital, Risskov

Risskov, Jylland, 8240, Denmark

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Admission

Exclusion criteria

  • Inability to provide written consent
  • Mania

Treatment and study plan

Dynamic Lighting

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

Other names: Illumination, lighting design, lighting environment

Primary outcomes

  1. 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 outcomes

  1. 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

  2. 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

  3. Qualitative assessment using a custom made questionnaire

    Time frame: Answers from questionnaires are assessed through study completion, an average of 1 month, up to 6 months

    Number of patients with side-effects.

  4. Sleep diary

    Time frame: Answers from questionnaires are assessed through study completion, an average of 1 month, up to 6 months

Other outcomes

  1. Time to discharge

    Time frame: Assessed through study completion, an average of 1 month, up to 6 months

    Number of days between admission and discharge

  2. Involuntary restraints

    Time frame: Assessed through study completion, an average of 1 month, up to 6 months

    Number of participants who experienced involuntary physical and/or medical restraints.

  3. Use of medication from logged activity in the electronic medical record

    Time frame: Assessed through study completion, an average of 1 month, up to 6 months

    Use of medication during admission including drug og dosages administered to the participants in mg/day.

Sponsors and collaborators

Lead sponsor

University of Aarhus

Other

Collaborators

  • Aarhus University Hospital

Registry information

Official study title

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

Important dates

Study start
2015
Primary completion
2017
Study completion
2018
First posted
Jan 12, 2016
Registry last updated
May 3, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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