Bright Light Therapy Efficacy for Depressive Symptoms Following Cardiac Surgery or Acute Coronary Syndrome: Pilot Trial

Depressive Symptoms Post Cardiac Surgery or Post Acute Coronary Syndrome Clinical Trial

— BEAM-P  

Official title:

Bright Light Therapy Efficacy for Depressive Symptoms Following Cardiac Surgery or Acute Coronary Syndrome: Pilot Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02621567
• Other study ID #: 15-125
• Status: Completed
• Phase: Phase 4
• First received: November 27, 2015
• Last updated: March 21, 2018
• Start date: January 2016
• Est. completion date: October 20, 2017

Study information

• Verified date: March 2018
• Source: McGill University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Bright Light Therapy Efficacy for Depressive Symptoms Following Cardiac Surgery or Acute Coronary Syndrome: Pilot Trial (BEAM-P) is a randomized controlled trial (RCT) that seeks to assess the feasibility of conducting a full trial which would assess the efficacy of Bright Light Therapy (BLT) for improving depressive symptoms post-cardiac surgery or acute coronary syndrome.

Description:

Overall Study Objective

The Bright Light Therapy Efficacy for Depressive Symptoms Following Cardiac Surgery or Acute Coronary Syndrome: Pilot Trial (BEAM-P) is a randomized controlled trial (RCT) that seeks to assess the feasibility of conducting a full trial which would assess the efficacy of Bright Light Therapy (BLT) for improving depressive symptoms post-cardiac surgery or acute coronary syndrome (ACS).

Specific Objectives

To assess the feasibility of conducting a full trial, including assessment of recruitment rate, retention rate, adherence, process time, and potential additional data values that should be measured.

Rationale

More than 50,000 Canadians undergo coronary artery bypass grafting (the most common cardiac surgery) each year and over 100,000 are hospitalized for an ACS. Of these patients, at least 15-20% experience depression. Depressed cardiac patients have a nearly 20% increased risk of all-cause mortality, increased risk of cardiac death, and increased risk of experiencing future cardiovascular events. Addressing depression and depressive symptoms in cardiac surgery and ACS patients is therefore crucial. BLT could represent a simple, safe, and cost-effective method of reducing depressive symptoms following cardiac surgery or ACS. BLT has been shown to decrease depressive symptoms in individuals with both seasonal affective disorder and non-seasonal depression in the general population, as well as in a few specific patient populations. However, the efficacy of BLT for reducing depressive symptoms post-cardiac surgery or ACS is unknown. The full BEAM Trial will be the first to study the effects of BLT in this patient population. Since BLT has not yet been investigated in cardiac patients, the feasibility of conducting a large trial of BLT in this population must be determined in order to avoid potential pitfalls and enhance the chances of success of a full trial.

Methods

We will conduct an RCT with a treatment period of 4 weeks and 12 week follow-up post-cardiac surgery or ACS. A total of 38 cardiac surgery or ACS participants will be randomized 1:1 to one of two treatment arms: 1) BLT (10,000 lux light intensity) or 2) Dim light (control group; 500 lux light intensity). Study personnel and participants will be blinded as to treatment allocation. Permutated block randomization will help ensure a balance of known and unknown confounders. Informed consent will be obtained in person from all individuals. Participants in both groups will begin using the lamps in-hospital and will continue the treatment at home for the remainder of the 4 weeks post-surgery or ACS. At baseline and day of discharge, participants will complete the Patient Health Questionnaire 9 (PHQ-9), Depression Anxiety Stress Scale short version (DASS-21), and Short Form (36) Health Survey (SF-36) questionnaires in order to determine index levels of depressive symptomology (PHQ-9, DASS-21) and health-related quality of life (SF-36). A case report form, to collect demographic and clinical information, will also be completed at baseline and day of discharge. There will be a clinic visit at week 4, when patients will return their lamp and complete questionnaires, and study personnel will complete a case report form to monitor treatment adherence. At week 12, participants will have the option to complete their questionnaires online or by mail. To compensate participants for expenses incurred due to participation (parking, childcare, opportunity costs, etc.), they will receive $25 at week 4, and a $20 prepaid VISA card after completing the questionnaires at week 12.

Significance

BLT may be a simple, cost-effective, and safe method of decreasing the severity of depression and depressive symptoms in patients following cardiac surgery or ACS. Even a small reduction in depressive symptoms could have a significant effect on the occurrence of cardiovascular events, cardiac death, and all-cause mortality in this high-risk population. The full BEAM Trial will provide regulators, health care professionals, and patients with important new information about the efficacy of BLT to decrease symptoms of depression in this population. Conducting the BEAM-P study will help ensure the success of carrying out the full BEAM Trial.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 15
• Est. completion date: October 20, 2017
• Est. primary completion date: October 20, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Undergoing cardiac surgery or hospitalized for an acute coronary syndrome;

• Age = 18 years;

• Score of = 8 on the Patient Health Questionnaire-9;

• Able to understand and to provide informed consent in English or French; and

• Likely to be available for follow-up.

Exclusion Criteria:

• Pregnant or lactating females;

• Medical condition with a prognosis < 12 weeks;

• History of bipolar disorder, SAD, psychosis, or dementia;

• Medical condition contraindicating use of BLT (ocular or retinal pathology: glaucoma, cataracts, retinal detachment, retinopathy, diabetes);

• Medical condition that increases photosensitivity (e.g. systemic lupus erythematosus, rosacea, psoriasis, albinism);

• Current use of medication that increases photosensitivity (e.g. St John's Wort, lithium, melatonin, tetracycline, Accutane, Benzoyl peroxide, Retin-A);

• Less than one month following previous BLT;

• Light induced epilepsy or migraines; or

• Suicidal ideation.

Related Conditions & MeSH terms

• Acute Coronary Syndrome
• Depression
• Depressive Symptoms Post Cardiac Surgery or Post Acute Coronary Syndrome
• Syndrome

Intervention

Device:
• Bright Light Therapy Lamp
TRAVelite Desk Lamp manufactured by Northern Light Technologies, located in Montreal, Quebec. The light is emitted from a lamp. The florescent tubes in the box are covered with a diffusing screen to ensure even distribution of light and protection from ultraviolet light. These lamps also have a stand which enables users to place the box horizontally or vertically on most surfaces. These lamps emit light of intensity 10,000 lux.
• Modified Dim Lamp
TRAVelite Desk Lamp manufactured by Northern Light Technologies, located in Montreal, Quebec. The light is emitted from a lamp. The florescent tubes in the box are covered with a diffusing screen to ensure even distribution of light and protection from ultraviolet light. These lamps also have a stand which enables users to place the box horizontally or vertically on most surfaces. These lamps have been modified to emit light of intensity 500 lux.

Locations

Country	Name	City	State
Canada	Jewish General Hospital	Montreal	Quebec

Sponsors (1)

Lead Sponsor	Collaborator
McGill University

Country where clinical trial is conducted

Canada, 

References & Publications (22)

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Blumenthal JA. Depression and coronary heart disease: association and implications for treatment. Cleve Clin J Med. 2008 Mar;75 Suppl 2:S48-53. Review. — View Citation

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Frasure-Smith N, Lespérance F, Gravel G, Masson A, Juneau M, Talajic M, Bourassa MG. Depression and health-care costs during the first year following myocardial infarction. J Psychosom Res. 2000 Apr-May;48(4-5):471-8. — View Citation

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Golden RN, Gaynes BN, Ekstrom RD, Hamer RM, Jacobsen FM, Suppes T, Wisner KL, Nemeroff CB. The efficacy of light therapy in the treatment of mood disorders: a review and meta-analysis of the evidence. Am J Psychiatry. 2005 Apr;162(4):656-62. — View Citation

Huffman JC, Celano CM, Beach SR, Motiwala SR, Januzzi JL. Depression and cardiac disease: epidemiology, mechanisms, and diagnosis. Cardiovasc Psychiatry Neurol. 2013;2013:695925. doi: 10.1155/2013/695925. Epub 2013 Apr 7. — View Citation

Kripke DF, Mullaney DJ, Klauber MR, Risch SC, Gillin JC. Controlled trial of bright light for nonseasonal major depressive disorders. Biol Psychiatry. 1992 Jan 15;31(2):119-34. — View Citation

Kripke DF. Light treatment for nonseasonal depression: speed, efficacy, and combined treatment. J Affect Disord. 1998 May;49(2):109-17. — 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

Manea L, Gilbody S, McMillan D. Optimal cut-off score for diagnosing depression with the Patient Health Questionnaire (PHQ-9): a meta-analysis. CMAJ. 2012 Feb 21;184(3):E191-6. doi: 10.1503/cmaj.110829. Epub 2011 Dec 19. — 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

Niederhofer H, von Klitzing K. Bright light treatment as mono-therapy of non-seasonal depression for 28 adolescents. Int J Psychiatry Clin Pract. 2012 Sep;16(3):233-7. doi: 10.3109/13651501.2011.625123. Epub 2012 Jul 19. — View Citation

Pincus HA, Pettit AR. The societal costs of chronic major depression. J Clin Psychiatry. 2001;62 Suppl 6:5-9. Review. — View Citation

Rastad C, Ulfberg J, Lindberg P. Improvement in Fatigue, Sleepiness, and Health-Related Quality of Life with Bright Light Treatment in Persons with Seasonal Affective Disorder and Subsyndromal SAD. Depress Res Treat. 2011;2011:543906. doi: 10.1155/2011/543906. Epub 2011 Jun 13. — View Citation

Reeves GM, Nijjar GV, Langenberg P, Johnson MA, Khabazghazvini B, Sleemi A, Vaswani D, Lapidus M, Manalai P, Tariq M, Acharya M, Cabassa J, Snitker S, Postolache TT. Improvement in depression scores after 1 hour of light therapy treatment in patients with seasonal affective disorder. J Nerv Ment Dis. 2012 Jan;200(1):51-5. doi: 10.1097/NMD.0b013e31823e56ca. — View Citation

Shirani A, St Louis EK. Illuminating rationale and uses for light therapy. J Clin Sleep Med. 2009 Apr 15;5(2):155-63. Review. — View Citation

Stewart WF, Ricci JA, Chee E, Hahn SR, Morganstein D. Cost of lost productive work time among US workers with depression. JAMA. 2003 Jun 18;289(23):3135-44. Erratum in: JAMA. 2003 Oct 22;290(16):2218. — 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

Tully PJ, Baker RA. Depression, anxiety, and cardiac morbidity outcomes after coronary artery bypass surgery: a contemporary and practical review. J Geriatr Cardiol. 2012 Jun;9(2):197-208. doi: 10.3724/SP.J.1263.2011.12221. — View Citation

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

Wirz-Justice A, Bader A, Frisch U, Stieglitz RD, Alder J, Bitzer J, Hösli I, Jazbec S, Benedetti F, Terman M, Wisner KL, Riecher-Rössler A. A randomized, double-blind, placebo-controlled study of light therapy for antepartum depression. J Clin Psychiatry. 2011 Jul;72(7):986-93. doi: 10.4088/JCP.10m06188blu. Epub 2011 Apr 5. — View Citation

* Note: There are 22 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Determination of process time required		Baseline
Primary	Recruitment rate		Baseline
Secondary	Retention rate	Percentage of participants who remain in the study at week 12	12 week follow-up period
Secondary	Adherence rate	Percentage of participants who used their lamp on =60% of mornings within an hour of waking for at least 25 minutes throughout the 4 week treatment period	4 week follow-up period