Bright Light Therapy for Depression Symptoms in Adults With Cystic Fibrosis (CF) and COPD

Chronic Obstructive Pulmonary Disease Clinical Trial

Official title:

Effect of Bright Light Therapy on Depression Symptoms in Adult Inpatients With Cystic Fibrosis (CF) and Chronic Obstructive Pulmonary Disease (COPD)

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT04921332
• Other study ID #: STUDY20110407
• Status: Terminated
• Phase: N/A
• Start date: September 7, 2021
• Est. completion date: March 22, 2022

Study information

• Verified date: February 2023
• Source: University of Pittsburgh
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 4
• Est. completion date: March 22, 2022
• Est. primary completion date: March 22, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Chronic Obstructive Pulmonary Disease
• Cystic Fibrosis
• Depression
• Depressive Symptoms
• Fibrosis
• Lung Diseases
• Lung Diseases, Obstructive
• Pulmonary Disease, Chronic Obstructive

Intervention

Device:
• Bright Light Therapy (BLT) Lamp
With its built in automatic timer shut-off function, the bedside registered nurse (RN) would not need to return to the room to turn off this lamp after 30 minutes because the lamp will automatically shut off on its own.

Locations

Country	Name	City	State
United States	University of Pittsburgh	Pittsburgh	Pennsylvania
United States	University of Pittsburgh Medical Center Presbyterian Hospital	Pittsburgh	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
Erica Osborn

Country where clinical trial is conducted

United States, 

References & Publications (3)

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. — View 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. — View 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. Erratum In: JAMA Psychiatry. 2016 Jan;73(1):90. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Pre- and Post-intervention Beck's Depression Inventory II Scores (BDI-II)	Change between pre-intervention and post-intervention self-reported answer totals to the 21 scored items on BDI-II (minimum score obtainable=0 (absent symptoms); maximum score obtainable=63 (most severe symptoms).	First at time of admission, second at end of 7 day goal or upon discharge.
Secondary	Number of Days Until Completion of Daily Bright Light Therapy (BLT)	The RN will sign a daily log indicating what time therapy was initiated and if therapy was refused. These logs will be collected from patient doors at the end of each week by the principal investigator (PI) in order to measure compliance with completion of therapy on a daily basis.	Daily for duration of intervention period (goal/maximum of 7 days).