Bright Light Therapy for Depressed Geriatric Inpatients

Official title

The LIGHT-60 Trial - Light Intervention for Geriatric Patients Hospitalized for Depression Treatment

Overview

Bright light therapy has been shown to be effective for the treatment of both seasonal and non-seasonal unipolar depression as well as bipolar depression, primarily in outpatients under the age of 60. There is a dearth of studies exploring the efficacy of this treatment modality among elderly depressed inpatients, which is our study population.

Detailed description

Investigators are studying the ability of light therapy to reduce depressive symptoms in elderly patients who are hospitalized with unipolar depression (depression that is not due to bipolar disorder). Participants will receive either active light treatment or inactive treatment (also known as placebo).

Interventions

• Device Bright light therapy
  the Verilux® HappyLight® Lumi Plus light therapy box, which delivers UV-free, full-spectrum LED light at an intensity of 10,000 lux
• Device dim red light
  The control group will use the same light box device, configured to emit dim red light. This will be achieved by setting the box to its lowest brightness setting and overlaying a translucent red filter over the light display. This setup is intended to maintain the appearance and experience of light exposure while minimizing any therapeutic effect.

Primary outcome measures

• Study completion rate [Time frame: Up to week 6 (Upon time of discharge from inpatient unit)]
• Adequacy of allocation blinding [Time frame: Up to week 6 (Upon time of discharge from inpatient unit)]

Secondary outcome measures (2)

• Preliminary efficacy data - Mean change in Hamilton Depression Rating Scale 17 item scale (HAMD-17) [Time frame: Day of enrollment, week 1, week 2, week 4, week 6]
• Preliminary efficacy data - Mean change in Beck Depression Inventory II (BDI-II) Score [Time frame: Day of enrollment, week 1, week 2, week 4, week 6]

Eligibility criteria

Inclusion criteria

• A current episode of non-psychotic unipolar depression as the primary reason for psychiatric hospitalization
• Currently hospitalized on the MUSC Senior Care Unit
• Age 60 years or older
• HAMD-17 ≥8

Exclusion criteria

• Any prior use of bright light therapy
• Primary indication for hospitalization is for a disorder other than major depressive disorder (determined by patient's treatment team)
• Photosensitive medical conditions or current use of photosensitizing medications - if patients have been advised by a treating clinician at any point to avoid sunlight because of their current medication regimen or medical condition, they will be considered to have a photosensitive medical condition and will be excluded from this study.
• Treatment with ECT; if a patient's condition deteriorates during study participation such that the treatment team feels ECT would be in their best interest, they will be withdrawn from study participation. For logistical and transport purposes, the study team feels that exclusion of patients receiving ECT will be necessarily. Additionally, these patients would likely be excluded from a future larger RCT given that ECT would likely interfere with signal of BLT efficacy.
• Uncontrolled headaches or any migraines within the last month
• Major neurocognitive disorder
• Severe intellectual disability
• Inability to consent for the study
• Active psychosis
• Inmates

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Double blind

Primary purpose

Treatment

Study locations

United States · 1 center

• Medical University of South Carolina Institute of Psychiatry Senior Care Unit — Charleston

Publications

• Zhao X, Ma J, Wu S, Chi I, Bai Z. Light therapy for older patients with non-seasonal depression: A systematic review and meta-analysis. J Affect Disord. 2018 May;232:291-299. doi: 10.1016/j.jad.2018.02.041. Epub 2018 Feb 17. PMID 29500957
• Geoffroy PA, Schroder CM, Reynaud E, Bourgin P. Efficacy of light therapy versus antidepressant drugs, and of the combination versus monotherapy, in major depressive episodes: A systematic review and meta-analysis. Sleep Med Rev. 2019 Dec;48:101213. doi: 10.1016/j.smrv.2019.101213. Epub 2019 Sep 18. PMID 31600678
• Oldham MA, Ciraulo DA. Bright light therapy for depression: a review of its effects on chronobiology and the autonomic nervous system. Chronobiol Int. 2014 Apr;31(3):305-19. doi: 10.3109/07420528.2013.833935. Epub 2014 Jan 7. PMID 24397276
• Tong H, Dong N, Lam CLM, Lee TMC. The effect of bright light therapy on major depressive disorder: A systematic review and meta-analysis of randomised controlled trials. Asian J Psychiatr. 2024 Sep;99:104149. doi: 10.1016/j.ajp.2024.104149. Epub 2024 Jul 15. PMID 39067131
• Menegaz de Almeida A, Aquino de Moraes FC, Cavalcanti Souza ME, Cavalcanti Orestes Cardoso JH, Tamashiro F, Miranda C, Fernandes L, Kreuz M, Alves Kelly F. Bright Light Therapy for Nonseasonal Depressive Disorders: A Systematic Review and Meta-Analysis. JAMA Psychiatry. 2025 Jan 1;82(1):38-46. doi: 10.1001/jamapsychiatry.2024.2871. PMID 39356500
• Sit DK, McGowan J, Wiltrout C, Diler RS, Dills JJ, Luther J, Yang A, Ciolino JD, Seltman H, Wisniewski SR, Terman M, Wisner KL. Adjunctive Bright Light Therapy for Bipolar Depression: A Randomized Double-Blind Placebo-Controlled Trial. Am J Psychiatry. 2018 Feb 1;175(2):131-139. doi: 10.1176/appi.ajp.2017.16101200. Epub 2017 Oct 3. PMID 28969438

Identifiers

NCT: NCT07002554 · Pro00139703 · R25DA020537

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗