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

Depression Clinical Trial

— Light-Heart  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02691000
• Other study ID #: 151558
• Status: Recruiting
• Phase: N/A
• First received: January 29, 2016
• Last updated: October 26, 2016
• Start date: September 2015
• Est. completion date: September 2018

Study information

• Verified date: October 2016
• Source: University of California, San Diego
• Contact: Olga Korelova, MD
• Phone: 8583860549
• Email: okorelova[@]ucsd.edu
• Is FDA regulated: No
• Health authority: USA: Retirement Research Foundation
• Study type: Interventional

Clinical Trial 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.

Description:

The Light-Heart study is randomized, double-blind, controlled trial of 8 weeks of morning BWL therapy, compared with DRL in older, Stage B HF patients with clinically significant levels of depressive symptoms. The primary hypothesis of the proposed study is that compared to DRL, BWL therapy will be associated with a significantly greater reduction in depressive symptoms. Important information about compliance and tolerability associated with the BWL intervention in Stage B HF patients will also be gathered. The investigators will examine whether BWL therapy is associated with greater improvements in quality of life and subjective functioning compared to DRL. Finally, the researchers will investigate whether BWL is associated with a sustained improvement in depressive symptoms 2 and 4 weeks following the end of the intervention compared to DRL.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 122
• Est. completion date: September 2018
• Est. primary completion date: September 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 60 Years and older

Eligibility

Inclusion Criteria:

• 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)

Exclusion Criteria:

• 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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Depression
• Heart Failure
• Stage B Heart Failure

Intervention

Device:
• 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.

Locations

Country	Name	City	State
United States	University of California, San Diego	La Jolla	California

Sponsors (2)

Lead Sponsor	Collaborator
University of California, San Diego	Retirement Research Foundation

Country where clinical trial is conducted

United States, 

References & 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. — View Citation

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. — View Citation

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. Review. — View Citation

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. — View Citation

Frasure-Smith N, Lespérance F. Depression--a cardiac risk factor in search of a treatment. JAMA. 2003 Jun 18;289(23):3171-3. — View Citation

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. — View Citation

Jiménez 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. — View Citation

Leppämäki SJ, Partonen TT, Hurme J, Haukka JK, Lönnqvist 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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. Epub 2006 Sep 26. — View Citation

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. Review. — View Citation

Tuunainen A, Kripke DF, Endo T. Light therapy for non-seasonal depression. Cochrane Database Syst Rev. 2004;(2):CD004050. Review. — View Citation

* Note: There are 14 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in depressive symptoms will be assessed with the Beck Depression Inventory.		baseline and at 8 week	No
Secondary	The Short Form (SF)-36 questionnaire will be used to assess QOL and subjective functioning.		Baseline and at 8 week	No