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

Sponsor

Erica Osborn (Other)

Overall Status

Completed

CT.gov ID

NCT04921332

Collaborator

(none)

Enrollment

Locations

Arm

6.4

Actual Duration (Months)

Patients Per Site

0.3

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Cystic Fibrosis Depressive Symptoms Chronic Obstructive Pulmonary Disease	Device: Bright Light Therapy (BLT) Lamp	N/A

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

4 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Intervention Model Description:

This is a non-randomized, single group, pre- and post-intervention project.This is a non-randomized, single group, pre- and post-intervention project.

Masking:

None (Open Label)

Primary Purpose:

Supportive Care

Official Title:

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

Actual Study Start Date :

Sep 7, 2021

Actual Primary Completion Date :

Mar 22, 2022

Actual Study Completion Date :

Mar 22, 2022

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Bright Light Therapy (BLT) The intervention will consist of daily BLT sessions lasting 30 minutes at approximately 10AM (since many CF and COPD patients may not awaken until this time) starting on the day of admission through discharge for a goal of seven consecutive days. The intervention will use a 10,000-lux light box placed approximately 16-24 inches from the patient's face.	Device: Bright Light Therapy (BLT) Lamp With its built in automatic timer shut-off function, the bedside 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. Other Names: Verilux HappyLight Luxe - UV-Free LED Therapy Lamp by Verilux

Arm

Intervention/Treatment

Experimental: Bright Light Therapy (BLT)

The intervention will consist of daily BLT sessions lasting 30 minutes at approximately 10AM (since many CF and COPD patients may not awaken until this time) starting on the day of admission through discharge for a goal of seven consecutive days. The intervention will use a 10,000-lux light box placed approximately 16-24 inches from the patient's face.

Device: Bright Light Therapy (BLT) Lamp

With its built in automatic timer shut-off function, the bedside 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.

Other Names:

Verilux HappyLight Luxe - UV-Free LED Therapy Lamp by Verilux

Outcome Measures

Primary Outcome Measures

Change in pre- and post-intervention Beck's Depression Inventory II Scores (BDI-II) [First at time of admission, second at end of 7 day goal or upon discharge]
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))

Secondary Outcome Measures

Rate of Completion of Daily Bright Light Therapy (BLT) [Daily for duration of intervention period (goal 7 days)]
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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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 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 UPMC Presbyterian hospital

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Pittsburgh Medical Center Presbyterian Hospital	Pittsburgh	Pennsylvania	United States	15213
2	University of Pittsburgh	Pittsburgh	Pennsylvania	United States	15213