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Bright Light Therapy Efficacy for Depressive Symptoms Following Cardiac Surgery or Acute Coronary Syndrome: Pilot Trial (BEAM-P)

This study is currently recruiting participants.
See Contacts and Locations
Verified September 2016 by Mark Eisenberg, McGill University
Sponsor:
Information provided by (Responsible Party):
Mark Eisenberg, McGill University
ClinicalTrials.gov Identifier:
NCT02621567
First received: November 27, 2015
Last updated: September 14, 2016
Last verified: September 2016
  Purpose
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.

Condition Intervention Phase
Depressive Symptoms Post Cardiac Surgery or Post Acute Coronary Syndrome Device: Bright Light Therapy Lamp Device: Modified Dim Lamp Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Bright Light Therapy Efficacy for Depressive Symptoms Following Cardiac Surgery or Acute Coronary Syndrome: Pilot Trial

Resource links provided by NLM:


Further study details as provided by Mark Eisenberg, McGill University:

Primary Outcome Measures:
  • Recruitment rate [ Time Frame: Baseline ]

Secondary Outcome Measures:
  • Retention rate [ Time Frame: 12 week follow-up period ]
    Percentage of participants who remain in the study at week 12

  • Adherence rate [ Time Frame: 4 week follow-up period ]
    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


Other Outcome Measures:
  • Determination of process time required [ Time Frame: Baseline ]

Estimated Enrollment: 38
Study Start Date: January 2016
Estimated Study Completion Date: October 2017
Estimated Primary Completion Date: August 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Bright Light Therapy Group
Participants in this group will receive bright light therapy lamps and will be instructed to use them for 30 minutes every morning within an hour of waking up, everyday for 4 weeks.
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.
Placebo Comparator: Dim Light Group
Participants in this group will receive modified dim lamps and will be instructed to use them for 30 minutes every morning within an hour of waking up, everyday for 4 weeks.
Device: 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.

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02621567

Contacts
Contact: Bettina Habib, MSc, MScPH 514 340-7564 ext 2228 bettina.habib@ladydavis.ca

Locations
Canada, Quebec
Jewish General Hospital Recruiting
Montreal, Quebec, Canada, H3T 1E2
Contact: Bettina Habib, MSc, MScPH    5140340-8222 ext 2228    bettina.habib@ladydavis.ca   
Principal Investigator: Mark J Eisenberg, MD, MPH         
Sponsors and Collaborators
McGill University
Investigators
Principal Investigator: Mark J Eisenberg, MD, MPH McGill University, Jewish General Hospital
  More Information

Publications:

Responsible Party: Mark Eisenberg, Professor of Medicine, McGill University
ClinicalTrials.gov Identifier: NCT02621567     History of Changes
Other Study ID Numbers: 15-125
Study First Received: November 27, 2015
Last Updated: September 14, 2016

Additional relevant MeSH terms:
Syndrome
Acute Coronary Syndrome
Depression
Disease
Pathologic Processes
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases
Behavioral Symptoms

ClinicalTrials.gov processed this record on July 24, 2017