Effect of Bright Light Therapy on Depression Symptoms in Adult Inpatients With Cystic Fibrosis (CF) and Chronic Obstructive Pulmonary Disease (COPD)
Phase: NA
Conditions: Cystic Fibrosis, Depressive Symptoms, Chronic Obstructive Pulmonary Disease
Sponsor: Erica Osborn

STUDY TITLE: Effect of Bright Light Therapy on Depression Symptoms in Adult Inpatients
with Cystic Fibrosis (CF) or Chronic Obstructive Pulmonary Disease (COPD)
Final Manuscript, Including Study Protocol and Statistical Analysis Plan
NCT Number: NCT04921332
March 2022
Abstract

Background: Depression is a common comorbidity with chronic illness. Previous studies on
depression treatment in these populations have not focused on bright light therapy (BLT) for
non-seasonal depression. Patients diagnosed with cystic fibrosis (CF) and chronic obstructive
pulmonary disease (COPD) can under-report depressive symptoms under the assumption that
they are an expected part of the disease process. Symptoms of depression can lead to increased
episodes of disease exacerbation and hospitalizations.
Methods: Four adult patients with an existing diagnosis of either CF or COPD were assigned to
the intervention of BLT 30 minutes daily for a goal of seven consecutive days. The primary
outcome observed was depressive symptom changes recorded by subjective completion of
Beck’s Depression Inventory II (BDI-II) pre-intervention and post-intervention. The secondary
outcome was compliance with daily bright light therapy documented via daily logs by the
bedside nurses.
Results: There was not a significant improvement in depressive symptoms pre-intervention
versus post-intervention among both populations (p=0.196). There was no significant correlation
found between number of compliant days with changes in BDI-II scores pre- and
post-intervention (p=0.213). There were no adverse events to be reported with this trial.
Conclusion: BLT is a well-tolerated intervention for the hospitalized adult CF and COPD
population. Larger-scaled studies with a control group may be useful in the future for
establishing validity behind this intervention.
Limitations: Limitations include a small sample size, inconsistency with daily compliance, and
factors surrounding completion of this study during the COVID-19 pandemic.
ClinicalTrials.gov Identifier: NCT04921332
Keywords: cystic fibrosis; chronic obstructive pulmonary disease; depressive symptoms; chronic
illness; affect; bright light therapy
1. Background

Depression in chronic illnesses such as CF and COPD often goes undetected,
undiagnosed, and untreated (American Lung Association, 2021b). Many patients suffering from
chronic illnesses simply assume that depressive symptoms are just a normal part of the disease
process, especially in multifactorial disease such as CF and COPD (American Lung Association,
2021b; Cystic Fibrosis Foundation, 2020).  Previous studies have not always observed a
chronically ill and frequently hospitalized population. Additionally, most studies have only
observed the effects of BLT on seasonal depressive disorders rather than nonseasonal. Focused
studies with the CF or chronically ill populations have been limited by small sample sizes.
Complex and chronic respiratory illnesses encompass a variety of diagnoses, including
CF and COPD. Quittner et al. (2014) examined the presence of depression and anxiety symptoms
among CF patients and their caregivers and found that 29% of adult CF patients had a positive
screening on the Center for Epidemiologic Studies Depression Scale (CES-D) (p<0.001).
Unmanaged depression among patients with CF can result in the individual being less likely to
manage his or her treatment plan, exhibit poor lung function, have a lower body mass index,
higher health care costs, an increased number of hospitalizations, and an overall decrease in his
or her quality of life (Cystic Fibrosis Foundation, 2020). COPD is characterized by long-term
disability, early mortality, and currently has no definitive cure (American Lung Association,
2021). Approximately one-third of patients diagnosed with COPD experience symptoms of
either anxiety or depression (Griffith et al, 2020). Patients with COPD and major depressive
disorder have a 43% increased risk of multiple adverse COPD outcomes, which may include
more frequent disease exacerbations, new anxiety or depression events, and increased mortality
(Marsh & Guck, 2016).
Treatment with daily BLT is known as a first-line therapy for seasonal depression
(Campbell, Miller, & Woesner, 2017). To expand its usage studies investigating the application
of BLT in non-seasonal depression found improvement in non-seasonal depressive symptoms
when applying BLT to multiple populations which included inpatients with major depressive
disorder (MDD) and hospitalized CF patients (Guzel Ozdemir et al. 2015; Kopp et al. 2015; Lam
et al. 2016). BLT is overall well-tolerated, affordable, and effective (Yorguner Kupeli et al.,
2018). Although BLT can take two weeks or more to reach its maximum effect, symptoms can
start to improve within a few days of consistent use (Mayo Clinic Staff, 2017).
The purpose of this project was to apply a daily 30-minute BLT intervention to adult CF
or COPD patients hospitalized for acute pulmonary infection or exacerbation to decrease
symptoms of depression as measured subjectively by depression inventory scoring. The primary
research question being investigated is whether a BLT intervention would be effective in
reducing depressive symptoms among hospitalized adult CF and COPD patients.
2. Methods
Ethical Statement

This study was reviewed and approved by the University of Pittsburgh’s Internal Review
Board. Informed consent was obtained from each participant. Participation in this project was
completely voluntary for each individual subject. A nurse caregiver referred eligible patients on
the unit to the principal investigator so as to prevent cold-calling. A random identifier was
assigned to each participant to maintain confidentiality of recorded data.
2.1 Sample
This study took place on the pulmonary step-down and transplant unit at a 1,600-bed
academic medical facility in Southwestern Pennsylvania. Recruitment occurred after the nurse
clinician in the pulmonary stepdown unit spoke with the patient and asked if they were
comfortable discussing the study with the principal investigator (PI).
Inclusion criteria were adult patients 18 years of age and older with an existing diagnosis
of either CF or COPD. The BDI-II survey was administered following a waiver to written
consent and only patients with a score of >/= 14 or mild depression symptoms were invited to
participate. This minimum score was determined in order to be high enough to allow visible
changes in depression symptoms following a seven day intervention. Demographics including
diagnosis, education level, ethnicity, and age were recorded for each participant (Table 1).
Exclusion criteria included patients who had pre-existing ophthalmological conditions or
photosensitivity due to the use of a bright light; migraines because the bright light could be a
trigger; those receiving high dose steroids for transplant rejection due to potential for mood
altering qualities; those receiving certain antibiotics that increased light sensitivity; those with
bipolar disorder because light therapy may trigger mania; and admissions anticipated to span less
than 48 hours because this would not be a long enough span for therapy to produce a visible
effect on depressive symptoms. Children were excluded because only adult CF and COPD
subjects are admitted to this hospital and unit. This study only consisted of one admission period
for the inpatient. If the patient were to be readmitted, potential for bias from previous exposure
existed; therefore, re-enrollment was not offered.
The initial target number of patients for this study was 30. With the primary interest being
in feasibility and acceptability of this intervention, this study will assist in providing support for
a larger-scaled study; therefore, a sample size of 30 is appropriate for these purposes. No power
analysis was performed for this study.
.
2.2 Study Design
This was a quasi-experimental, pre- and post- intervention, single group study. No control
group was utilized for comparison. A single bright light lamp was assigned to each individual
patient throughout the duration of the intervention.

2.3 Intervention
Procedures following consent began with placing a bright light therapy lamp in the
participant’s room and reviewing verbal instructions on what the subject should anticipate.
Verilux HappyLight ® Luxe UV Free LED Therapy Lamp by Verilux was utilized for the
purposes of this study. This is a 10,000 lux bright light therapy lamp which is a level of intensity
comparable to being outdoors on a sunny but not overly bright day (Sloane, Figueiro, & Cohen,
2008).
Since participants with a history of bipolar mood disorder were excluded from this study,
the 15-item "Mood Disorder Questionnaire" was administered manually from a printed paper
survey during the pre-screening process to determine history of bipolar disorder symptomatology
since this was not able to be determined solely based on medical chart review (Hirschfield,
2006). Basic demographic data including age, disease diagnosis, ethnicity, and education level
was manually collected from each participant via a checklist completed by the PI (Table 1). At
this time, a random identifying code was assigned to the participant for confidentiality. Bright
light therapy began the morning following enrollment. The lamp was placed in a position
approximately 16-24 inches from the subject’s face by the principal investigator initially. Proper
positioning of the lamp was included in bedside nurse education in order to ensure that it was
placed correctly before being turned on each morning. A small reference sheet and disposable
measuring tape was attached to each lamp to ensure continued proper use and distance from the
patient. A preliminary 10-minute session of bright light therapy (BLT) was initiated following
consent in order to ensure no acute reactions or sensitivities were experienced from the light. The
brightness level was set at 10,000 lux. If the participant experienced sensitivity or adverse effects
during this pretest time, which may have included eyestrain, headache, nausea, or irritability,
therapy began at 2,500 lux the following day and gradually increased by 2,500 lux per day as
tolerated by the patient. The PI was responsible for adjusting this setting in these instances. Color
temperature was set to warm white (3,500K), medium white (4,250k), or daylight (5,000k) for
the duration of the study depending on the participant's preference during pretesting. The
participant was able to request that this be changed during the study when the PI would be
present for routine monitoring. The PI also provided contact information to the participant and
nursing staff so that she could be reached if needed. These settings were automatically saved
when the lamp was turned off making it easy to maintain the same settings for seven days of
therapy. The lamp stayed in the subject’s room until the seven-day goal was completed or the
patient was discharged or transferred. The bedside registered nurse turned on the lamp and set
the timer upon entering the room in the morning when the patient would awaken. The automatic
timer on the lamp turned off therapy after 30 minutes. The bedside nurse would initial a log
documenting the day and time therapy was initiated and whether it was initiated on that day. The
PI was responsible for routinely monitoring participants and following up on whether there were
disruptions in therapies during each session (this was not the bedside nurse’s responsibility).
Disruptions may have included the patient self-discontinuing therapy for that day or leaving the

unit for testing, procedures, or hemodialysis. This information was recorded on the compliance
log. The completion of this log was included in education regarding BLT provided to the bedside
nursing staff by the PI.
The subject was responsible for and educated about how to turn off the lamp in the
instance that he or she felt therapy should be disrupted during the 30-minute therapy period. This
procedure did not differ on weekends or holidays since this took place in a 24-hour hospital
facility. If the participant was discharged prior to completing the repeat Beck Depression
Inventory II, he or she would be contacted via phone to verbally administer the inventory as
included in the consent form.
When the bright light lamps were not in use, they were properly cleaned with purple top
PDI wipes per the unit’s infection control representative and stored in a pre-designated locked
cabinet on the pulmonary stepdown unit.
2.4 Measurements
Depressive symptoms were obtained subjectively before and after the seven-day allotted
intervention period utilizing the 21-item BDI-II scoring system (Beck, 1996). This scoring
system considers a total score of 0-13 as minimal, 14-19 as mild depressive symptoms, 20-28 as
moderate, and 29-63 as severe. The BDI-II is most often reported to have a Cronbach’s Alpha
coefficient averaging 0.9 and is shown to be highly reliable with the ability to provide
differentiation between depressed versus non-depressed subjects (Wang & Gorenstein, 2013).
Compliance data was measured via a log posted on the participant’s room door. This log
was completed daily by the assigned bedside nurse and included the data, whether therapy was
initiated (Y/N), what time it was initiated, and whether therapy was interrupted (Y/N). Reason
for interruption could be added as a comment on the log, but there was no designated area in
which to write it. These logs were collected by the principal investigator following completion of
the intervention.
2.5 Statistics
Normality of pre- and post-intervention BDI-II scores was tested using the Shapiro-Wilk test.
Given data normality, a paired student t-test was used to assess the primary outcome data. The
secondary outcome of daily compliance data with the seven-day length intervention was tested
utilizing a Chi-Square test. Final data was recorded as standard deviation with a mean with a
two-tailed 0.05 significance value.
3. Results
3.1 Patient Characteristics

Four participants were successfully enrolled in this study. Due to potential candidates who met
one or more of the exclusion criteria, intensive care unit transfers, and those being transferred to
alternative units after becoming COVID-19 positive, only four participants successfully
completed the pre- and post- BDI-II scoring.
Twenty additional potential participants were screened and considered for enrollment in this
study but met various exclusion criteria. These exclusion criteria included anticipated disposition
in less than 48 hours (n=8), pre-existing ophthalmological conditions (n=2), did not meet initial
depression inventory score minimum of 14 or greater (n=1), had a history of migraines (n=2),
were receiving pulse dose steroids (n=1), and those who expressed general disinterest in
participating in the intervention (6) (Table 3). Among these patients, 15 were diagnosed with CF
and five were diagnosed with COPD.
Among the four who were successfully enrolled and completed the intervention three were
diagnosed with CF and one was diagnosed with COPD. Ages ranged from 36 to 70 years old,
with an average of 56.25± 20.25 years. All participants were of Caucasian race. Total admission
lengths spanned from 14 to 55 days among participants with the average being 31.25 days.
3.2 Depression Inventory Effects
Changes in individual’s BDI-II score were calculated and recorded in Table 2. The Shapiro-Wilk
test yielded data normality among the BDI-II pre-intervention and post-intervention scoring;
therefore, the paired student t-test via Statistical Package for the Social Sciences (SPSS) V. 26
was utilized to analyze this data (Table 4 & 5). There was not a statistically significant difference
found between pre- and post-intervention scoring (p=0.196).
3.3 Therapy Compliance
The goal duration of therapy was seven consecutive days of bright light therapy. Among the final
recorded four participants, one completed seven days of consecutive therapy, one completed six
days of consecutive therapy, one completed two days of nonconsecutive therapy, and one
completed three days of nonconsecutive therapy. Chi square statistical analysis was performed to
assess whether significance existed between the days of therapy participated in and change in
BDI-II scores from pre- to post-intervention (Table 6). There was no significant association
found between days of compliance and the changes in BDI-II scores pre- versus
post-intervention (p=0.213).
3.4 Adverse Effects
Potential adverse effects were identified at the beginning of this study that could possibly result
from exposure to bright light therapy. These effects included eyestrain, headache, nausea,

irritability or agitation, and breach of confidentiality. There was no occurrence of adverse events
to disclose for this project.
4. Discussion
The primary outcome of this study was the mean scoring of the BDI-II pre- and post-
intervention had a reduction; however, this reduction was not statistically significant based on
the yielded p-value. It is fair to consider whether a seven day intervention period is long enough
to produce a change in pre- and post-BDI-II scores. It is also difficult to differentiate internal
factors that may have altered the subjective scores for patients. There are many other factors that
could impact depressive symptoms aside from bright light therapy especially in a complex and
chronically ill patient. A drawback of this intervention is that the trigger of score changes would
be virtually impossible to differentiate as bright light therapy or other external or internal factors,
such as changes in the participant’s prognosis, hospital discharge plan, or personal life. This
would also make clinical significance of this intervention difficult to decipher.
The secondary outcome of compliance data was recorded as a “Y” or “N” for each
individual day across the seven-day intervention period. Among subjects, there was
inconsistency with both the number of days of consecutive treatment. Following statistical
evaluation using a chi-square test, there was no association between days of compliance and
changes in BDI-II scores pre- and post-intervention.
Depression symptoms continue to be prevalent among the chronically and complex ill
population. Such pathology is associated with increased general hospitalization risk, longer
length of hospital stays, and an elevated risk of readmission (Prina et al., 2015). The average
length of stay among the participants in this study was 31.25 days. The average cost of a general
hospital stay per day, not specifically for complex respiratory disease management, is $2,607
(Fay, 2021). Considering this information, reducing depressive symptoms can have not only a
subjective impact on depressive symptoms, but also an impact on subject quality of life as well
as a financial impact secondary to the additional cost per hospital day caused by increased
lengths of hospital stays and readmission rates. Future studies may be useful in examining these
factors as secondary outcomes.
5. Limitations
This study had several limitations. According to Doctor Joseph Pilewski, the primary CF
physician at UPMC Presbyterian, the recent use of the medication Trikafta ® for CF is reducing
the number of hospitalizations among this patient population. This new therapy has recently been
FDA approved and has shown in two clinical trials to improve components of pulmonary
function (U.S. Food and Drug Administration, 2019). This decreased the potential candidate pool
on the inpatient unit. This reduction in candidate availability resulted in the COPD population
being included approximately halfway through the data collection period.

The limited availability of nursing staff also impacted this study. Oftentimes, the
principal investigator would have difficulty locating the usual caregiver to approach the patient
and ask permission to speak with him or her. There was additional difficulty with nursing staff
consistently offering bright light therapy to enrolled patients daily. As an attempt to improve the
consistency of applying the intervention, education was provided to the staff during monthly
staff meetings prior to study initiation and at the halfway point. Despite this additional training,
the staff had trouble initiating the intervention due to altered workloads and staffing due to the
COVID-19 pandemic.
This study occurred during the COVID-19 pandemic. Some patients were apprehensive
about having an extra, unnecessary individual in their room. Many patients were encouraged to
avoid hospitalization if possible, during the COVID-19 pandemic. Only one site and one patient
care unit were used for recruitment.
It was also challenging for participants to complete the 30-minute bright light therapy
sessions due to needing to complete off unit testing and treatment requirements. The patients on
this particular unit are still acutely ill and being actively treated while hospitalized. Many are
dependent on hemodialysis scheduled early in the mornings, diagnostic procedures, and surgical
procedures. This decreased the likelihood that bright light therapy would be completed
consistently for those particular days.
This study was not blinded. All participants were aware that they were receiving this
intervention. This left opportunity for participant bias on the pre- and post-depression inventory
surveys. This also impacted the generalizability of the study given the risk of participant bias,
being at a single site, situational factors, and working with specialty populations.
Future studies like this would benefit from a greater length of time for the data collection
period, more study team members used during the consent process, and recruitment from
multiple sites and units. Future implications for bright light therapy are promising, since this
intervention is relatively safe and inexpensive to implement (Mayo Clinic, 2017). Larger scaled
studies would be needed prior to implementing bright light therapy in usual care or daily
practice.
Author statement
The principal investigator, EO, designed this study, made statistical analysis, performed the
study, and drafted the manuscript. Dianxu Ren provided guidance for appropriate statistical test
application. All other authors listed commented on the manuscript and provided approval prior to
submission of the final draft.
Funding/support

The bright light lamps for this study were personally funded by the principal investigator. This
research did not receive any specific grant from funding agencies in the public, commercial, or
not-for-profit sectors.
Declaration of competing interest
No conflict of interest declared.
References

American Lung Association. (2021a, March 5). COPD and Emotional Health.
https://www.lung.org/lung-health-diseases/lung-disease-lookup/copd/living-with-copd/co
ping-with-emotions
American Lung Association. (2021b, March 5). Learn About COPD.
https://www.lung.org/lung-health-diseases/lung-disease-lookup/copd/learn-about-copd
Beck, A. (1996). Beck's Depression Inventory II.
https://www.kdheks.gov/c-f/integration_toolkits/Beck_Depression_Inventory_II.pdf
Campbell, P. D., Miller, A. M., & Woesner, M. E. (2017). Bright Light Therapy: Seasonal
Affective Disorder and Beyond. The Einstein Journal of Biology and Medicine, 32,
E13-E25. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6746555/
Cystic Fibrosis Foundation. (2020). Depression.
https://www.cff.org/LifeWith-CF/DailyLife/Emotional-Wellness/Depression-and-CF/
Fay, B. (2021, October 12). Hospital and surgery costs – Paying for medical treatment. Debt.org.
https://www.debt.org/medical/hospital-surgery-costs/#:%7E:text=Total%20health%20car
e%20spending%20in,(%243%2C271)%20for%20most%20expensive
Griffith, M. F., Chen, H. P., Bekelman, D. B., Feemster, L. C., Spece, L. J., Donovan, L. M., Au,
D. H., & Carey, E. P. (2021). Comorbid anxiety and depression, though Underdiagnosed,
are not associated with high rates of low-value care in patients with chronic obstructive
pulmonary disease. Annals of the American Thoracic Society, 18(3), 442-451.
https://doi.org/10.1513/annalsats.201912-877oc
Özdemir, P. G., Boysan, M., Smolensky, M. H., Selvi, Y., Aydin, A., & Yilmaz, E. (2015).
Comparison of Venlafaxine alone versus Venlafaxine plus bright light therapy
combination for severe major depressive disorder. The Journal of Clinical Psychiatry,
76(05), e645-e654. https://doi.org/10.4088/jcp.14m09376
Hirschfield, R. (2006). Mood Disorder Questionnaire (MDQ). Mood Disorder Questionnaire.
https://www.ohsu.edu/sites/default/files/2019-06/cms-quality-bipolar_disorder_mdq_scre
ener.pdf
Kopp, B. T., Hayes, D., Ghera, P., Patel, A., Kirkby, S., Kowatch, R. A., & Splaingard, M.
(2016). Pilot trial of light therapy for depression in hospitalized patients with cystic
fibrosis. Journal of Affective Disorders, 189, 164-168.
https://doi.org/10.1016/j.jad.2015.08.056
Lam, R. W., Levitt, A. J., Levitan, R. D., Michalak, E. E., Cheung, A. H., Morehouse, R.,
Ramasubbu, R., Yatham, L. N., & Tam, E. M. (2016). Efficacy of bright light treatment,
fluoxetine, and the combination in patients with Nonseasonal major depressive disorder.
JAMA Psychiatry, 73(1), 56. https://doi.org/10.1001/jamapsychiatry.2015.2235
Marsh, S., & Guck, T. P. (2016). Anxiety and depression: Easing the burden in COPD patients.
Journal of Family Practice, 65(4), 246-256.

Mayo Clinic. (2017, February 8). Light therapy.
https://www.mayoclinic.org/tests-procedures/light-therapy/about/pac-20384604#:%7E:te
xt=Light%20therapy%20can%20start%20weeks
Prina, A. M., Cosco, T. D., Dening, T., Beekman, A., Brayne, C., & Huisman, M. (2015). The
association between depressive symptoms in the community, non-psychiatric hospital
admission and hospital outcomes: A systematic review. Journal of Psychosomatic
Research, 78(1), 25–33. https://doi.org/10.1016/j.jpsychores.2014.11.002
Sloane, P. D., Figueiro, M., & Cohen, L. (2008). Light as therapy for sleep disorders and
depression in older adults. Clinical Geriatrics, 16(3), 25-31.
Quittner, A. L., Goldbeck, L., Abbott, J., Duff, A., Lambrecht, P., Solé, A., Tibosch, M. M.,
Bergsten Brucefors, A., Yüksel, H., Catastini, P., Blackwell, L., & Barker, D. (2014).
Prevalence of depression and anxiety in patients with cystic fibrosis and parent
caregivers: Results of the international depression epidemiological study across nine
countries. Thorax, 69(12), 1090-1097. https://doi.org/10.1136/thoraxjnl-2014-205983
U.S. Food and Drug Administration. (2019, October 21). FDA approves new breakthrough
therapy for cystic fibrosis.
https://www.fda.gov/news-events/press-announcements/fda-approves-new-breakthrough-
therapy-cystic-fibrosis
Wang, Y., & Gorenstein, C. (2013). Psychometric properties of the Beck depression Inventory-II:
A comprehensive review. Revista Brasileira de Psiquiatria, 35(4), 416-431.
https://doi.org/10.1590/1516-4446-2012-1048
Yorguner Kupeli, N., Bulut, N. S., Carkaxhiu Bulut, G., Kurt, E., & Kora, K. (2018). Efficacy of
bright light therapy in bipolar depression. Psychiatry Research, 260, 432-438.
https://doi.org/10.1016/j.psychres.2017.12.020
Tables
Table 1. Demographics
Number of participants
4
Diagnosis
CF (%)
3 (75)
COPD (%)
1 (25)
Ethnicity
Caucasian (%)
4 (100)

Age (mean in years)
56.25 ± 20.25
Education Level
High School (%)
2 (50)
College (%)
2 (50)
Table 2. Pre- and Post- BDI-II Scores
*this figure will need color in order to see which color indicates pre- versus post-
Table 3. Reasons for Participant Exclusion

Table 4 & 5. BDI-II Analysis (Primary Outcome)
Table 6. Daily Compliance Analysis (Secondary Outcome)