Depressive Symptoms Post Cardiac Surgery or Post Acute Coronary Syndrome Clinical Trial
Official title:
Bright Light Therapy Efficacy for Depressive Symptoms Following Cardiac Surgery or Acute Coronary Syndrome: Pilot Trial
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.
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.
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