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

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.

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