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

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ClinicalTrials.gov Identifier: NCT02621567
Recruitment Status : Completed
First Posted : December 3, 2015
Last Update Posted : March 22, 2018
Sponsor:
Information provided by (Responsible Party):
Mark Eisenberg, McGill University

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.

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

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 15 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Bright Light Therapy Efficacy for Depressive Symptoms Following Cardiac Surgery or Acute Coronary Syndrome: Pilot Trial
Study Start Date : January 2016
Actual Primary Completion Date : October 20, 2017
Actual Study Completion Date : October 20, 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Surgery

Arm Intervention/treatment
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.




Primary Outcome Measures :
  1. Recruitment rate [ Time Frame: Baseline ]

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

  2. 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:
  1. Determination of process time required [ Time Frame: Baseline ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02621567


Locations
Canada, Quebec
Jewish General Hospital
Montreal, Quebec, Canada, H3T 1E2
Sponsors and Collaborators
McGill University
Investigators
Principal Investigator: Mark J Eisenberg McGill University, Jewish General Hospital

Publications:

Responsible Party: Mark Eisenberg, Professor of Medicine, McGill University
ClinicalTrials.gov Identifier: NCT02621567     History of Changes
Other Study ID Numbers: 15-125
First Posted: December 3, 2015    Key Record Dates
Last Update Posted: March 22, 2018
Last Verified: March 2018

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