Clinical trial NCT02691000: The Light Heart Study: Daily Light Box Use for Depressive Symptoms in Patients With Stage B Heart Failure
Official title: The Light Heart Study: Daily Light Box Use for Depressive Symptoms in Patients With Stage B Heart Failure
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Depression
Stage B Heart Failure
Keywords: depression
depressive symptoms
stage b heart failure
bright white light
light therapy
Lead sponsor: University of California, San Diego
Sponsor class: OTHER
Collaborators: name: Retirement Research Foundation
First posted: 2016-02-24
Enrollment: 122
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Change in depressive symptoms will be assessed with the Beck Depression Inventory.
timeFrame: baseline and at 8 week
Secondary outcomes:
measure: The Short Form (SF)-36 questionnaire will be used to assess QOL and subjective functioning.
timeFrame: Baseline and at 8 week
Other outcomes:
Locations:
city: La Jolla
country: United States
facility: University of California, San Diego
state: California
Study officials:
affiliation: University of California, San Diego
name: Jeanne Maglione, MD, PhD
role: PRINCIPAL_INVESTIGATOR
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