Recruiting

Light Box

Sponsor:

UCLA

Code:

NCT02691000

Conditions

Depression

Stage B Heart Failure

Eligibility Criteria

Sex: All

Age: 60+

Healthy Volunteers: Accepted

Interventions

LiteBook

LiteBook

Study Details

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.

Conditions

Depression

Stage B Heart Failure

Study ID

NCT02691000

Start date

Sep, 2015

Status verified date

Oct, 2016

Completion date

Sep, 2018

Anticipated

Primary completion date

Sep, 2018

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 60+

Healthy Volunteers: Accepted

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 Design

Enrollment

122 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Bright White Light (BWL) Litebook

Participants will be instructed to use the BWL Litebook for an hour every day for 8 weeks.

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.

Interventions

LiteBook

Light therapy using a Bright White Light Litebook for 1 hour each morning for 8 weeks. This is the experimental intervention.

LiteBook

Light therapy using a Dim Red Light Litebook for 1 hour each morning for 8 weeks. This is the control.

Primary outcome measure

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

Central Contacts and Locations

Central contacts

Olga Korelova, MD

8583860549okorelova@ucsd.edu

Locations

University of California, San Diego

Recruiting

La Jolla, California, United States, 929093

Contacts

Olga Korelova, MD

858-386-0549okorelova@ucsd.edu

Principal Investigator:

Jeanne Maglione, MD, PhD

More Information

Sponsor

University of California, San Diego

Last update posted

Oct 27, 2016

Last verified

Oct, 2016

Keywords

  • depression
  • depressive symptoms
  • stage b heart failure
  • bright white light
  • light therapy

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of California, San Diego on 2016-10-27.