The Light Heart Study: Daily Light Box Use for Depressive Symptoms in Patients With Stage B Heart Failure
NCT ID: NCT02691000
Last Updated: 2016-10-27
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
122 participants
INTERVENTIONAL
2015-09-30
2018-09-30
Brief Summary
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Detailed Description
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One hundred twenty-two older adults (≥60 years) with Stage B HF and depressive symptoms (Beck Depression Inventory/BDI score ≥10) will be recruited from several University of California, San Diego (UCSD) and Veteran's Affairs (VA) cardiology clinics. The baseline assessment will include evaluation of depressive symptoms (BDI), quality of life (Quality of Life Enjoyment and Satisfaction questionnaire), subjective functioning (Short Form-36), and an assessment of patient expectations regarding the study intervention (single question, 5 point scale). These measures will be assessed again after 4 and 8 weeks of treatment and at 2 and 4 weeks following the end of the BWL therapy intervention along with side effects (Frequency, Intensity, and Burden of Side Effects Rating).
Participants will be randomized to receive BWL (n=61) or DRL (n=61) light therapy boxes (Litebook® Elite; Litebook® Inc., Medicine Hat, CA) to use at home for 60 minutes each morning for 8 weeks. If participants are currently receiving treatment (e.g. antidepressant therapy), participants will continue their usual treatment while in the study. Participants will be told that the effects of a particular light therapy protocol on mood and functioning is being investigated. Participants will be made aware that there is a treatment condition of interest and a comparison condition and that participants will be randomly assigned to one or the other group. Participants will not be told that different colors of light are being used or that BWL is the treatment of interest. The Litebooks® will look identical except for the color of the light. Weekly telephone calls will encourage compliance, and compliance meters will record when the Litebooks® are turned on or off. A blood sample will also be collected from each patient to assess for biomarkers.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Bright White Light (BWL) Litebook
Participants will be instructed to use the BWL Litebook for an hour every day for 8 weeks.
LiteBook
Light therapy using a Bright White Light Litebook for 1 hour each morning for 8 weeks. This is the experimental intervention.
Dim Red Light (DRL) Litebook
Participants will be instructed to use the DRL (comparison condition) Litebook for an hour every day for 8 weeks.
LiteBook
Light therapy using a Dim Red Light Litebook for 1 hour each morning for 8 weeks. This is the control.
Interventions
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LiteBook
Light therapy using a Bright White Light Litebook for 1 hour each morning for 8 weeks. This is the experimental intervention.
LiteBook
Light therapy using a Dim Red Light Litebook for 1 hour each morning for 8 weeks. This is the control.
Eligibility Criteria
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Inclusion Criteria
* Written informed consent
* BDI score ≥ 10
* Stage B heart failure diagnosis
* no antidepressant pharmacotherapy or on stable dose of antidepressant (\>8 weeks)
* on stable dose of cardiac medications (\>8 weeks)
Exclusion Criteria
* psychiatric diagnoses by Structured Clinical Interview for the Diagnostic and Statistical Manual (DSM) (ie; bipolar disorder, schizophrenia, schizoaffective disorder, major neurocognitive disorder)
* serious suicide or homicide risk (outpatient care judged unsafe)
* recent initiation or change of dose in antidepressant or cardiac medications (within past 8 weeks)
* current use of supplements with putative effects on mood or sleep (e.g St. John's Wort, melatonin)
* recent initiation of evidence based psychotherapy for mood
* prior use of BWL therapy
* unstable medical illness requiring hospitalization
* uncontrolled seizure disorder
* retinopathies
* macular degeneration
* shift work
60 Years
ALL
Yes
Sponsors
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Retirement Research Foundation
OTHER
University of California, San Diego
OTHER
Responsible Party
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Jeanne Maglione
Assistant Clinical Professor
Principal Investigators
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Jeanne Maglione, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
University of California, San Diego
Locations
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University of California, San Diego
La Jolla, California, United States
Countries
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Central Contacts
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Facility Contacts
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Olga Korelova, MD
Role: primary
References
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Abramson J, Berger A, Krumholz HM, Vaccarino V. Depression and risk of heart failure among older persons with isolated systolic hypertension. Arch Intern Med. 2001 Jul 23;161(14):1725-30. doi: 10.1001/archinte.161.14.1725.
Ahmedani BK, Solberg LI, Copeland LA, Fang-Hollingsworth Y, Stewart C, Hu J, Nerenz DR, Williams LK, Cassidy-Bushrow AE, Waxmonsky J, Lu CY, Waitzfelder BE, Owen-Smith AA, Coleman KJ, Lynch FL, Ahmed AT, Beck A, Rossom RC, Simon GE. Psychiatric comorbidity and 30-day readmissions after hospitalization for heart failure, AMI, and pneumonia. Psychiatr Serv. 2015 Feb 1;66(2):134-40. doi: 10.1176/appi.ps.201300518. Epub 2014 Nov 1.
Cameron IM, Reid IC, MacGillivray SA. Efficacy and tolerability of antidepressants for sub-threshold depression and for mild major depressive disorder. J Affect Disord. 2014 Sep;166:48-58. doi: 10.1016/j.jad.2014.04.078. Epub 2014 May 9.
Desan PH, Weinstein AJ, Michalak EE, Tam EM, Meesters Y, Ruiter MJ, Horn E, Telner J, Iskandar H, Boivin DB, Lam RW. A controlled trial of the Litebook light-emitting diode (LED) light therapy device for treatment of Seasonal Affective Disorder (SAD). BMC Psychiatry. 2007 Aug 7;7:38. doi: 10.1186/1471-244X-7-38.
Frasure-Smith N, Lesperance F. Depression--a cardiac risk factor in search of a treatment. JAMA. 2003 Jun 18;289(23):3171-3. doi: 10.1001/jama.289.23.3171. No abstract available.
Jiang W, Alexander J, Christopher E, Kuchibhatla M, Gaulden LH, Cuffe MS, Blazing MA, Davenport C, Califf RM, Krishnan RR, O'Connor CM. Relationship of depression to increased risk of mortality and rehospitalization in patients with congestive heart failure. Arch Intern Med. 2001 Aug 13-27;161(15):1849-56. doi: 10.1001/archinte.161.15.1849.
Jimenez JA, Mills PJ. Neuroimmune mechanisms of depression in heart failure. Methods Mol Biol. 2012;934:165-82. doi: 10.1007/978-1-62703-071-7_9.
Leppamaki SJ, Partonen TT, Hurme J, Haukka JK, Lonnqvist JK. Randomized trial of the efficacy of bright-light exposure and aerobic exercise on depressive symptoms and serum lipids. J Clin Psychiatry. 2002 Apr;63(4):316-21.
Lieverse R, Van Someren EJ, Nielen MM, Uitdehaag BM, Smit JH, Hoogendijk WJ. Bright light treatment in elderly patients with nonseasonal major depressive disorder: a randomized placebo-controlled trial. Arch Gen Psychiatry. 2011 Jan;68(1):61-70. doi: 10.1001/archgenpsychiatry.2010.183.
Loving RT, Kripke DF, Elliott JA, Knickerbocker NC, Grandner MA. Bright light treatment of depression for older adults [ISRCTN55452501]. BMC Psychiatry. 2005 Nov 9;5:41. doi: 10.1186/1471-244X-5-41.
Naus T, Burger A, Malkoc A, Molendijk M, Haffmans J. Is there a difference in clinical efficacy of bright light therapy for different types of depression? A pilot study. J Affect Disord. 2013 Dec;151(3):1135-7. doi: 10.1016/j.jad.2013.07.017. Epub 2013 Aug 7.
Rutledge T, Reis VA, Linke SE, Greenberg BH, Mills PJ. Depression in heart failure a meta-analytic review of prevalence, intervention effects, and associations with clinical outcomes. J Am Coll Cardiol. 2006 Oct 17;48(8):1527-37. doi: 10.1016/j.jacc.2006.06.055. Epub 2006 Sep 26.
Terman M, Terman JS. Light therapy for seasonal and nonseasonal depression: efficacy, protocol, safety, and side effects. CNS Spectr. 2005 Aug;10(8):647-63; quiz 672. doi: 10.1017/s1092852900019611.
Tuunainen A, Kripke DF, Endo T. Light therapy for non-seasonal depression. Cochrane Database Syst Rev. 2004;2004(2):CD004050. doi: 10.1002/14651858.CD004050.pub2.
Other Identifiers
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151558
Identifier Type: -
Identifier Source: org_study_id