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| ID | Type | Description | Link |
|---|---|---|---|
| R25DA020537 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institutes of Health (NIH) | NIH |
| National Institute on Drug Abuse (NIDA) | NIH |
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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.
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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Bright light therapy | Experimental | Participants in the intervention group will receive bright light therapy (BLT) consisting of 10,000 lux of bright white light administered for 30 minutes each morning, ideally within 30 minutes of awakening. Participants in both arms will continue to receive other treatment as usual (group therapy and medication management) as deemed appropriate by their treating clinicians. |
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| Dim Red light | Sham Comparator | Participants in the control group will receive a placebo condition using an identical light box fitted with a translucent red screen to emit dim red light at an intensity of less than 2,500 lux, which lacks efficacy for depression treatment based on prior research. Participants in both arms will continue to receive other treatment as usual (group therapy and medication management) as deemed appropriate by their treating clinicians. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Bright light therapy | Device | the Verilux® HappyLight® Lumi Plus light therapy box, which delivers UV-free, full-spectrum LED light at an intensity of 10,000 lux |
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| Measure | Description | Time Frame |
|---|---|---|
| Study completion rate | Percentage of patients who complete the study while psychiatrically hospitalized | Up to week 6 (Upon time of discharge from inpatient unit) |
| Adequacy of allocation blinding | assessed by the proportion of participants who correctly identify their study arm allocation. Blinding will be considered adequate if the proportion of correct guesses does not significantly exceed chance levels | Up to week 6 (Upon time of discharge from inpatient unit) |
| Measure | Description | Time Frame |
|---|---|---|
| Preliminary efficacy data - Mean change in Hamilton Depression Rating Scale 17 item scale (HAMD-17) | HAMD-17 is a commonly used clinician rating scale for depressive symptoms | Day of enrollment, week 1, week 2, week 4, week 6 |
| Preliminary efficacy data - Mean change in Beck Depression Inventory II (BDI-II) Score |
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Inclusion criteria:
Exclusion criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Rindy Fernandes, DO | Medical University of South Carolina | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Medical University of South Carolina Institute of Psychiatry Senior Care Unit | Charleston | South Carolina | 29425 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29500957 | Background | 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. | |
| 31600678 | Background | 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. |
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| ID | Term |
|---|---|
| D003866 | Depressive Disorder |
| D003863 | Depression |
| D040921 | Stress Disorders, Traumatic |
| ID | Term |
|---|---|
| D019964 | Mood Disorders |
| D001523 | Mental Disorders |
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |
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| ID | Term |
|---|---|
| D014467 | Ultraviolet Therapy |
| D010789 | Phototherapy |
| ID | Term |
|---|---|
| D013812 | Therapeutics |
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| dim red light | Device | 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. |
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BDI-II is a commonly used self-report rating scale for depressive symptoms |
| Day of enrollment, week 1, week 2, week 4, week 6 |
| 24397276 | Background | 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. |
| 39067131 | Background | 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. |
| 39356500 | Background | 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. |
| 28969438 | Background | 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. |
| D000068099 |
| Trauma and Stressor Related Disorders |