Clinical trial NCT02621567: Bright Light Therapy Efficacy for Depressive Symptoms Following Cardiac Surgery or Acute Coronary Syndrome: Pilot Trial
Official title: Bright Light Therapy Efficacy for Depressive Symptoms Following Cardiac Surgery or Acute Coronary Syndrome: Pilot Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Depressive Symptoms Post Cardiac Surgery or Post Acute Coronary Syndrome
Lead sponsor: McGill University
Sponsor class: OTHER
First posted: 2015-12-03
Enrollment: 15
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Detailed 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Recruitment rate
timeFrame: Baseline
Secondary outcomes:
measure: Retention rate
timeFrame: 12 week follow-up period
measure: Adherence rate
timeFrame: 4 week follow-up period
Other outcomes:
measure: Determination of process time required
timeFrame: Baseline
Locations:
city: Montreal
country: Canada
facility: Jewish General Hospital
state: Quebec
Study officials:
affiliation: McGill University, Jewish General Hospital
name: Mark J Eisenberg
role: PRINCIPAL_INVESTIGATOR
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