The Light Heart Study: Daily Light Box Use for Depressive Symptoms in Patients With Stage B Heart Failure

NCT02691000 | Unknown

• 1 other identifier: 151558
• Study Type: interventional
• Target: 122
• Locations: 1 country
• Sites: 1

Brief Summary

The Light-Heart study is a randomized, double-blind, controlled trial investigating the effects of bright white light (BWL) therapy on depressive symptoms, quality of life, and functioning in patients with Stage B heart failure. The study is a randomized, double-blind, controlled trial of 8 weeks of morning BWL therapy compared with morning dim red light (DRL) treatment in older (60 years or older) 122 Stage B (early, asymptomatic) HF patients.

Conditions

Depression; Stage B Heart Failure

Keywords

depression; depressive symptoms; stage b heart failure; bright white light; light therapy

Outcome Measures

Primary Outcomes (1)

• Change in depressive symptoms will be assessed with the Beck Depression Inventory.

  baseline and at 8 week

Secondary Outcomes (1)

• The Short Form (SF)-36 questionnaire will be used to assess QOL and subjective functioning.

  Baseline and at 8 week

Study Arms (2)

Bright White Light (BWL) Litebook

EXPERIMENTAL

Participants will be instructed to use the BWL Litebook for an hour every day for 8 weeks.

Device: LiteBook

Dim Red Light (DRL) Litebook

PLACEBO COMPARATOR

Participants will be instructed to use the DRL (comparison condition) Litebook for an hour every day for 8 weeks.

Device: LiteBook

Interventions

LiteBook DEVICE

Light therapy using a Bright White Light Litebook for 1 hour each morning for 8 weeks. This is the experimental intervention.

Bright White Light (BWL) Litebook

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• age ≥ 60 years
• 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)

You may not qualify if:

• self-reported history of bipolar disorder
• 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

Sponsors & Collaborators

• University of California, San Diego: lead
• Retirement Research Foundation: collaborator

Study Sites (1)

University of California, San Diego

La Jolla, California, 929093, United States

RECRUITING

Related Publications (14)

• 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.

  PMID: 11485505 BACKGROUND

• 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.

  PMID: 25642610 BACKGROUND

• 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.

  PMID: 25012410 BACKGROUND

• 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.

  PMID: 17683643 BACKGROUND

• 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.

  PMID: 12813125 BACKGROUND

• 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.

  PMID: 11493126 BACKGROUND

• 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.

  PMID: 22933146 BACKGROUND

• 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.

  PMID: 12000205 BACKGROUND

• 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.

  PMID: 21199966 BACKGROUND

• 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.

  PMID: 16283925 BACKGROUND

• 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.

  PMID: 23972661 BACKGROUND

• 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.

  PMID: 17045884 BACKGROUND

• 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.

  PMID: 16041296 BACKGROUND

• 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.

  PMID: 15106233 BACKGROUND

MeSH Terms

Conditions

Depression

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior

Study Officials

• Jeanne Maglione, MD, PhD

  University of California, San Diego

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Olga Korelova, MD

CONTACT

8583860549; okorelova@ucsd.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Clinical Professor

Study Record Dates

• First Submitted: January 29, 2016
• First Posted: February 24, 2016
• Study Start: September 1, 2015
• Primary Completion: September 1, 2018
• Study Completion: September 1, 2018
• Last Updated: October 27, 2016

Record last verified: 2016-10

Data Sharing

• IPD Sharing: Will share

Locations

US (1)