Clinical trial NCT04921332: Bright Light Therapy for Depression Symptoms in Adults With Cystic Fibrosis (CF) and COPD
Official title: Effect of Bright Light Therapy on Depression Symptoms in Adult Inpatients With Cystic Fibrosis (CF) and Chronic Obstructive Pulmonary Disease (COPD)
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Cystic Fibrosis
Depressive Symptoms
Chronic Obstructive Pulmonary Disease
Keywords: cystic fibrosis
depression
bright light therapy
adult
copd
Lead sponsor: University of Pittsburgh
Sponsor class: OTHER
First posted: 2021-06-10
Enrollment: 4
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: This is a non-randomized, single group, pre- and post-intervention project.
Primary purpose: SUPPORTIVE_CARE

Brief summary: This is a project that will determine whether the use of daily bright light therapy has an effect on depressive symptoms experienced by adult inpatients with CF and COPD. The purpose of this project is to apply a daily 30-minute BLT intervention to hospitalized adult CF and COPD patients in order to decrease symptoms of depression as measured by depression inventory scoring.

Detailed description: This project will occur on a 29-bed pulmonary step-down unit at a 1,600-bed academic medical center. This unit commonly treats patients with CF, COPD, and other pulmonary complications. The unit's patient care staff will be educated on the bright light lamps in order to prevent interruptions and to encourage compliance.

Eligibility criteria: Inclusion Criteria:

* Diagnosed with cystic fibrosis or chronic obstructive pulmonary disease (COPD)
* Adult age 18 or older
* Admitted to the pulmonary step-down and transplant unit
* Score greater than zero on pre-intervention Beck's Depression Inventory-II (BDI-II)

Exclusion Criteria:

* Pre-existing ophthalmological conditions or photosensitivity
* Migraines
* Receiving high dose steroids for transplant rejection (due to mood altering qualities),
* Antibiotics that increase light sensitivity
* Diagnosed with bipolar disorder (light therapy may trigger mania)
* Admissions anticipated to span less than 48 hours
* Children are being excluded due to the fact that only adult CF and COPD subjects are admitted to University of Pittsburgh Medical Center (UPMC) Presbyterian hospital

Primary outcomes:
measure: Change in Pre- and Post-intervention Beck's Depression Inventory II Scores (BDI-II)
timeFrame: First at time of admission, second at end of 7 day goal or upon discharge.
Secondary outcomes:
measure: Number of Days Until Completion of Daily Bright Light Therapy (BLT)
timeFrame: Daily for duration of intervention period (goal/maximum of 7 days).
Other outcomes:
Locations:
city: Pittsburgh
country: United States
facility: University of Pittsburgh Medical Center Presbyterian Hospital
state: Pennsylvania
city: Pittsburgh
country: United States
facility: University of Pittsburgh
state: Pennsylvania
Study officials:
affiliation: University of Pittsburgh
name: Erica Osborn, BSN
role: PRINCIPAL_INVESTIGATOR
References:
citation: Kopp BT, Hayes D Jr, Ghera P, Patel A, Kirkby S, Kowatch RA, Splaingard M. Pilot trial of light therapy for depression in hospitalized patients with cystic fibrosis. J Affect Disord. 2016 Jan 1;189:164-8. doi: 10.1016/j.jad.2015.08.056. Epub 2015 Sep 28.
citation: Guzel Ozdemir P, Boysan M, Smolensky MH, Selvi Y, Aydin A, Yilmaz E. Comparison of venlafaxine alone versus venlafaxine plus bright light therapy combination for severe major depressive disorder. J Clin Psychiatry. 2015 May;76(5):e645-54. doi: 10.4088/JCP.14m09376.
citation: Lam RW, Levitt AJ, Levitan RD, Michalak EE, Cheung AH, Morehouse R, Ramasubbu R, Yatham LN, Tam EM. Efficacy of Bright Light Treatment, Fluoxetine, and the Combination in Patients With Nonseasonal Major Depressive Disorder: A Randomized Clinical Trial. JAMA Psychiatry. 2016 Jan;73(1):56-63. doi: 10.1001/jamapsychiatry.2015.2235.