DepressionLight-HeartNCT02691000
The Light Heart Study: Daily Light Box Use for Depressive Symptoms in Patients With Stage B Heart Failure
A study testing LiteBook in people with Depression and Stage B Heart Failure, run by University of California, San Diego at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 60 years and olderHealthy volunteers can take part
- Conditions the study is for
- Depression, Stage B Heart Failure
- What is being tested?
- LiteBook
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 122 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2015to Sep 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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
Show all 12Show fewer
- prior use of BWL therapy
- unstable medical illness requiring hospitalization
- uncontrolled seizure disorder
- retinopathies
- macular degeneration
- shift work
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
University of California, San Diego
La Jolla, California, 929093
Olga Korelova, MD, 858-386-0549, okorelova@ucsd.edu
Jeanne Maglione, MD, PhD
About this study
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.
Read the 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.
- Conditions
- Depression, Stage B Heart Failure
- Being tested
- LiteBook
- Keywords
- depression, depressive symptoms, stage b heart failure, bright white light, light therapy
- Medical subject headings
- Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LiteBookDevice
Light therapy using a Bright White Light Litebook for 1 hour each morning for 8 weeks. This is the experimental intervention.
LiteBookDevice
Light therapy using a Dim Red Light Litebook for 1 hour each morning for 8 weeks. This is the control.
| Study group | Role | What they receive |
|---|---|---|
| Bright White Light (BWL) Litebook | Experimental | Participants will be instructed to use the BWL Litebook for an hour every day for 8 weeks. Receives: Device: LiteBook |
| Dim Red Light (DRL) Litebook | Placebo comparator | Participants will be instructed to use the DRL (comparison condition) Litebook for an hour every day for 8 weeks. Receives: Device: LiteBook |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in depressive symptoms will be assessed with the Beck Depression Inventory.
Measured: baseline and at 8 week
Secondary outcomes (1)
The Short Form (SF)-36 questionnaire will be used to assess QOL and subjective functioning.
Measured: Baseline and at 8 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Feb 2016 (estimated)
- Study startSep 2015
- Primary completionSep 2018 (estimated)
- Study completionSep 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (14)Papers the sponsor has linked to this study.
- Other trials for DepressionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 122 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of California, San Diego
- Sponsor type
- University, hospital or other
- Collaborators
- Retirement Research Foundation
- Responsible party
- Principal investigator, Jeanne Maglione, University of California, San Diego
- Investigators
- Jeanne Maglione, MD, PhD, Principal investigator, University of California, San Diego
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02691000
- Sponsor's protocol ID
- 151558
- Acronym
- Light-Heart
- Status last verified
- Oct 2016
- First submitted
- 29 Jan 2016
- Last updated
- 27 Oct 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Yes: Patient information will remain confidential.
Publications
Abramson J, Berger A, Krumholz HM, Vaccarino V. Depression and risk of heart failure among older persons with isolated systolic hypertension. Arch Intern Med. 2001 Jul 23;161(14):1725-30. doi: 10.1001/archinte.161.14.1725.
PubMed 11485505Ahmedani BK, Solberg LI, Copeland LA, Fang-Hollingsworth Y, Stewart C, Hu J, Nerenz DR, Williams LK, Cassidy-Bushrow AE, Waxmonsky J, Lu CY, Waitzfelder BE, Owen-Smith AA, Coleman KJ, Lynch FL, Ahmed AT, Beck A, Rossom RC, Simon GE. Psychiatric comorbidity and 30-day readmissions after hospitalization for heart failure, AMI, and pneumonia. Psychiatr Serv. 2015 Feb 1;66(2):134-40. doi: 10.1176/appi.ps.201300518. Epub 2014 Nov 1.
PubMed 25642610Cameron IM, Reid IC, MacGillivray SA. Efficacy and tolerability of antidepressants for sub-threshold depression and for mild major depressive disorder. J Affect Disord. 2014 Sep;166:48-58. doi: 10.1016/j.jad.2014.04.078. Epub 2014 May 9.
PubMed 25012410Desan PH, Weinstein AJ, Michalak EE, Tam EM, Meesters Y, Ruiter MJ, Horn E, Telner J, Iskandar H, Boivin DB, Lam RW. A controlled trial of the Litebook light-emitting diode (LED) light therapy device for treatment of Seasonal Affective Disorder (SAD). BMC Psychiatry. 2007 Aug 7;7:38. doi: 10.1186/1471-244X-7-38.
PubMed 17683643Frasure-Smith N, Lesperance F. Depression--a cardiac risk factor in search of a treatment. JAMA. 2003 Jun 18;289(23):3171-3. doi: 10.1001/jama.289.23.3171. No abstract available.
PubMed 12813125Jiang W, Alexander J, Christopher E, Kuchibhatla M, Gaulden LH, Cuffe MS, Blazing MA, Davenport C, Califf RM, Krishnan RR, O'Connor CM. Relationship of depression to increased risk of mortality and rehospitalization in patients with congestive heart failure. Arch Intern Med. 2001 Aug 13-27;161(15):1849-56. doi: 10.1001/archinte.161.15.1849.
PubMed 11493126Jimenez JA, Mills PJ. Neuroimmune mechanisms of depression in heart failure. Methods Mol Biol. 2012;934:165-82. doi: 10.1007/978-1-62703-071-7_9.
PubMed 22933146Leppamaki SJ, Partonen TT, Hurme J, Haukka JK, Lonnqvist JK. Randomized trial of the efficacy of bright-light exposure and aerobic exercise on depressive symptoms and serum lipids. J Clin Psychiatry. 2002 Apr;63(4):316-21.
PubMed 12000205Lieverse R, Van Someren EJ, Nielen MM, Uitdehaag BM, Smit JH, Hoogendijk WJ. Bright light treatment in elderly patients with nonseasonal major depressive disorder: a randomized placebo-controlled trial. Arch Gen Psychiatry. 2011 Jan;68(1):61-70. doi: 10.1001/archgenpsychiatry.2010.183.
PubMed 21199966Loving RT, Kripke DF, Elliott JA, Knickerbocker NC, Grandner MA. Bright light treatment of depression for older adults [ISRCTN55452501]. BMC Psychiatry. 2005 Nov 9;5:41. doi: 10.1186/1471-244X-5-41.
PubMed 16283925Naus T, Burger A, Malkoc A, Molendijk M, Haffmans J. Is there a difference in clinical efficacy of bright light therapy for different types of depression? A pilot study. J Affect Disord. 2013 Dec;151(3):1135-7. doi: 10.1016/j.jad.2013.07.017. Epub 2013 Aug 7.
PubMed 23972661Rutledge T, Reis VA, Linke SE, Greenberg BH, Mills PJ. Depression in heart failure a meta-analytic review of prevalence, intervention effects, and associations with clinical outcomes. J Am Coll Cardiol. 2006 Oct 17;48(8):1527-37. doi: 10.1016/j.jacc.2006.06.055. Epub 2006 Sep 26.
PubMed 17045884Terman M, Terman JS. Light therapy for seasonal and nonseasonal depression: efficacy, protocol, safety, and side effects. CNS Spectr. 2005 Aug;10(8):647-63; quiz 672. doi: 10.1017/s1092852900019611.
PubMed 16041296Tuunainen A, Kripke DF, Endo T. Light therapy for non-seasonal depression. Cochrane Database Syst Rev. 2004;2004(2):CD004050. doi: 10.1002/14651858.CD004050.pub2.
PubMed 15106233
Study at a glance
From the registry record, last updated by the sponsor on 27 Oct 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Light Heart Study: Daily Light Box Use for Depressive Symptoms in Patients With Stage B Heart Failure
- ClinicalTrials.gov ID
- NCT02691000
- Acronym / sponsor ID
- Light-Heart / 151558
- Conditions
- Depression, Stage B Heart Failure
- Keywords
- depression, depressive symptoms, stage b heart failure, bright white light, light therapy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 122 participants (estimated)
- Lead sponsor
- University of California, San DiegoUniversity, hospital or other
- Collaborators
- Retirement Research Foundation
- Study start
- Sep 2015
- Primary completion
- Sep 2018 (estimated)
- Study completion
- Sep 2018 (estimated)
- First posted
- 24 Feb 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Bright White Light (BWL) Litebook | Experimental | Device: LiteBookParticipants will be instructed to use the BWL Litebook for an hour every day for 8 weeks. |
| Dim Red Light (DRL) Litebook | Placebo comparator | Device: LiteBookParticipants will be instructed to use the DRL (comparison condition) Litebook for an hour every day for 8 weeks. |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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)
Key exclusion criteria (12 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| LiteBookLight therapy using a Bright White Light Litebook for 1 hour each morning for 8 weeks. This is the experimental intervention. | Device | Bright White Light (BWL) Litebook |
| LiteBookLight therapy using a Dim Red Light Litebook for 1 hour each morning for 8 weeks. This is the control. | Device | Dim Red Light (DRL) Litebook |
Primary outcome
Change in depressive symptoms will be assessed with the Beck Depression Inventory.
Time frame: baseline and at 8 week
1 secondary outcome
The Short Form (SF)-36 questionnaire will be used to assess QOL and subjective functioning.
Time frame: Baseline and at 8 week
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Oct 2016.
- Background: PubMed 11485505Abramson J, Berger A, Krumholz HM, Vaccarino V. Depression and risk of heart failure among older persons with isolated systolic hypertension. Arch Intern Med. 2001 Jul 23;161(14):1725-30. doi: 10.1001/archinte.161.14.1725.
- Background: PubMed 25642610Ahmedani BK, Solberg LI, Copeland LA, Fang-Hollingsworth Y, Stewart C, Hu J, Nerenz DR, Williams LK, Cassidy-Bushrow AE, Waxmonsky J, Lu CY, Waitzfelder BE, Owen-Smith AA, Coleman KJ, Lynch FL, Ahmed AT, Beck A, Rossom RC, Simon GE. Psychiatric comorbidity and 30-day readmissions after hospitalization for heart failure, AMI, and pneumonia. Psychiatr Serv. 2015 Feb 1;66(2):134-40. doi: 10.1176/appi.ps.201300518. Epub 2014 Nov 1.
- Background: PubMed 25012410Cameron IM, Reid IC, MacGillivray SA. Efficacy and tolerability of antidepressants for sub-threshold depression and for mild major depressive disorder. J Affect Disord. 2014 Sep;166:48-58. doi: 10.1016/j.jad.2014.04.078. Epub 2014 May 9.
- Background: PubMed 17683643Desan PH, Weinstein AJ, Michalak EE, Tam EM, Meesters Y, Ruiter MJ, Horn E, Telner J, Iskandar H, Boivin DB, Lam RW. A controlled trial of the Litebook light-emitting diode (LED) light therapy device for treatment of Seasonal Affective Disorder (SAD). BMC Psychiatry. 2007 Aug 7;7:38. doi: 10.1186/1471-244X-7-38.
- Background: PubMed 12813125Frasure-Smith N, Lesperance F. Depression--a cardiac risk factor in search of a treatment. JAMA. 2003 Jun 18;289(23):3171-3. doi: 10.1001/jama.289.23.3171. No abstract available.
- Background: PubMed 11493126Jiang W, Alexander J, Christopher E, Kuchibhatla M, Gaulden LH, Cuffe MS, Blazing MA, Davenport C, Califf RM, Krishnan RR, O'Connor CM. Relationship of depression to increased risk of mortality and rehospitalization in patients with congestive heart failure. Arch Intern Med. 2001 Aug 13-27;161(15):1849-56. doi: 10.1001/archinte.161.15.1849.
- Background: PubMed 22933146Jimenez JA, Mills PJ. Neuroimmune mechanisms of depression in heart failure. Methods Mol Biol. 2012;934:165-82. doi: 10.1007/978-1-62703-071-7_9.
- Background: PubMed 12000205Leppamaki SJ, Partonen TT, Hurme J, Haukka JK, Lonnqvist JK. Randomized trial of the efficacy of bright-light exposure and aerobic exercise on depressive symptoms and serum lipids. J Clin Psychiatry. 2002 Apr;63(4):316-21.
- Background: PubMed 21199966Lieverse R, Van Someren EJ, Nielen MM, Uitdehaag BM, Smit JH, Hoogendijk WJ. Bright light treatment in elderly patients with nonseasonal major depressive disorder: a randomized placebo-controlled trial. Arch Gen Psychiatry. 2011 Jan;68(1):61-70. doi: 10.1001/archgenpsychiatry.2010.183.
- Background: PubMed 16283925Loving RT, Kripke DF, Elliott JA, Knickerbocker NC, Grandner MA. Bright light treatment of depression for older adults [ISRCTN55452501]. BMC Psychiatry. 2005 Nov 9;5:41. doi: 10.1186/1471-244X-5-41.
- Background: PubMed 23972661Naus T, Burger A, Malkoc A, Molendijk M, Haffmans J. Is there a difference in clinical efficacy of bright light therapy for different types of depression? A pilot study. J Affect Disord. 2013 Dec;151(3):1135-7. doi: 10.1016/j.jad.2013.07.017. Epub 2013 Aug 7.
- Background: PubMed 17045884Rutledge T, Reis VA, Linke SE, Greenberg BH, Mills PJ. Depression in heart failure a meta-analytic review of prevalence, intervention effects, and associations with clinical outcomes. J Am Coll Cardiol. 2006 Oct 17;48(8):1527-37. doi: 10.1016/j.jacc.2006.06.055. Epub 2006 Sep 26.
- Individual participant dataSharing planned: Yes. Patient information will remain confidential.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jeanne Maglione, MD, PhD principal investigator
University of California, San Diego
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing LiteBook in people with Depression and Stage B Heart Failure, run by University of California, San Diego at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 27 Oct 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Olga Korelova, MD (8583860549, okorelova@ucsd.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in depressive symptoms will be assessed with the Beck Depression Inventory. (time frame: baseline and at 8 week). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02691000, which also lists 14 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Oct 2016.