The Light Heart Study: Daily Light Box Use for Depressive Symptoms in Patients With Stage B Heart Failure (Light-Heart)

October 26, 2016 updated by: Jeanne Maglione, University of California, San Diego
The Light-Heart study is a randomized, double-blind, controlled trial investigating the effects of bright white light (BWL) therapy on depressive symptoms, quality of life, and functioning in patients with Stage B heart failure. The study is a randomized, double-blind, controlled trial of 8 weeks of morning BWL therapy compared with morning dim red light (DRL) treatment in older (60 years or older) 122 Stage B (early, asymptomatic) HF patients.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

The Light-Heart study is randomized, double-blind, controlled trial of 8 weeks of morning BWL therapy, compared with DRL in older, Stage B HF patients with clinically significant levels of depressive symptoms. The primary hypothesis of the proposed study is that compared to DRL, BWL therapy will be associated with a significantly greater reduction in depressive symptoms. Important information about compliance and tolerability associated with the BWL intervention in Stage B HF patients will also be gathered. The investigators will examine whether BWL therapy is associated with greater improvements in quality of life and subjective functioning compared to DRL. Finally, the researchers will investigate whether BWL is associated with a sustained improvement in depressive symptoms 2 and 4 weeks following the end of the intervention compared to DRL.

One hundred twenty-two older adults (≥60 years) with Stage B HF and depressive symptoms (Beck Depression Inventory/BDI score ≥10) will be recruited from several University of California, San Diego (UCSD) and Veteran's Affairs (VA) cardiology clinics. The baseline assessment will include evaluation of depressive symptoms (BDI), quality of life (Quality of Life Enjoyment and Satisfaction questionnaire), subjective functioning (Short Form-36), and an assessment of patient expectations regarding the study intervention (single question, 5 point scale). These measures will be assessed again after 4 and 8 weeks of treatment and at 2 and 4 weeks following the end of the BWL therapy intervention along with side effects (Frequency, Intensity, and Burden of Side Effects Rating).

Participants will be randomized to receive BWL (n=61) or DRL (n=61) light therapy boxes (Litebook® Elite; Litebook® Inc., Medicine Hat, CA) to use at home for 60 minutes each morning for 8 weeks. If participants are currently receiving treatment (e.g. antidepressant therapy), participants will continue their usual treatment while in the study. Participants will be told that the effects of a particular light therapy protocol on mood and functioning is being investigated. Participants will be made aware that there is a treatment condition of interest and a comparison condition and that participants will be randomly assigned to one or the other group. Participants will not be told that different colors of light are being used or that BWL is the treatment of interest. The Litebooks® will look identical except for the color of the light. Weekly telephone calls will encourage compliance, and compliance meters will record when the Litebooks® are turned on or off. A blood sample will also be collected from each patient to assess for biomarkers.

Study Type

Interventional

Enrollment (Anticipated)

122

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • La Jolla, California, United States, 929093
        • Recruiting
        • University of California, San Diego
        • Contact:
        • Principal Investigator:
          • Jeanne Maglione, MD, PhD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

60 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • age ≥ 60 years
  • Written informed consent
  • BDI score ≥ 10
  • Stage B heart failure diagnosis
  • no antidepressant pharmacotherapy or on stable dose of antidepressant (>8 weeks)
  • on stable dose of cardiac medications (>8 weeks)

Exclusion Criteria:

  • self-reported history of bipolar disorder
  • psychiatric diagnoses by Structured Clinical Interview for the Diagnostic and Statistical Manual (DSM) (ie; bipolar disorder, schizophrenia, schizoaffective disorder, major neurocognitive disorder)
  • serious suicide or homicide risk (outpatient care judged unsafe)
  • recent initiation or change of dose in antidepressant or cardiac medications (within past 8 weeks)
  • current use of supplements with putative effects on mood or sleep (e.g St. John's Wort, melatonin)
  • recent initiation of evidence based psychotherapy for mood
  • prior use of BWL therapy
  • unstable medical illness requiring hospitalization
  • uncontrolled seizure disorder
  • retinopathies
  • macular degeneration
  • shift work

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Bright White Light (BWL) Litebook
Participants will be instructed to use the BWL Litebook for an hour every day for 8 weeks.
Device: LiteBook
Light therapy using a Bright White Light Litebook for 1 hour each morning for 8 weeks. This is the experimental intervention.
Device: LiteBook
Light therapy using a Dim Red Light Litebook for 1 hour each morning for 8 weeks. This is the control.
Placebo Comparator: Dim Red Light (DRL) Litebook
Participants will be instructed to use the DRL (comparison condition) Litebook for an hour every day for 8 weeks.
Device: LiteBook
Light therapy using a Bright White Light Litebook for 1 hour each morning for 8 weeks. This is the experimental intervention.
Device: LiteBook
Light therapy using a Dim Red Light Litebook for 1 hour each morning for 8 weeks. This is the control.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Change in depressive symptoms will be assessed with the Beck Depression Inventory.
Time Frame: baseline and at 8 week
baseline and at 8 week

Secondary Outcome Measures

Outcome Measure
Time Frame
The Short Form (SF)-36 questionnaire will be used to assess QOL and subjective functioning.
Time Frame: Baseline and at 8 week
Baseline and at 8 week

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of California, San Diego

Collaborators

Retirement Research Foundation

Investigators

  • Principal Investigator: Jeanne Maglione, MD, PhD, University of California, San Diego

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2015

Primary Completion (Anticipated)

September 1, 2018

Study Completion (Anticipated)

September 1, 2018

Study Registration Dates

First Submitted

January 29, 2016

First Submitted That Met QC Criteria

February 23, 2016

First Posted (Estimate)

February 24, 2016

Study Record Updates

Last Update Posted (Estimate)

October 27, 2016

Last Update Submitted That Met QC Criteria

October 26, 2016

Last Verified

October 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 151558

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Patient information will remain confidential.

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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