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

NCT04921332 | Terminated Results FDA Device

• 1 other identifier: STUDY20110407
• Study Type: interventional
• Target: 4
• Locations: 1 country
• Sites: 2

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.

Conditions

Cystic Fibrosis; Depressive Symptoms; Chronic Obstructive Pulmonary Disease

Keywords

cystic fibrosis; depression; bright light therapy; adult; copd

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Number of Days Until Completion of Daily Bright Light Therapy (BLT)

  Daily for duration of intervention period (goal/maximum of 7 days).

Study Arms (1)

Bright Light Therapy (BLT)

EXPERIMENTAL

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

Interventions

Bright Light Therapy (BLT) Lamp DEVICE

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.

Also known as: Verilux HappyLight Luxe - UV-Free LED Therapy Lamp by Verilux

Bright Light Therapy (BLT)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Erica Osborn: lead

Study Sites (2)

University of Pittsburgh Medical Center Presbyterian Hospital

Pittsburgh, Pennsylvania, 15213, United States

Location

University of Pittsburgh

Pittsburgh, Pennsylvania, 15213, United States

Location

Related Publications (3)

• 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.

  PMID: 26433764 BACKGROUND

• 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.

  PMID: 26035199 BACKGROUND

• 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.

  PMID: 26580307 BACKGROUND

MeSH Terms

Conditions

Cystic Fibrosis; Depression; Pulmonary Disease, Chronic Obstructive

Interventions

Ultraviolet Therapy

Condition Hierarchy (Ancestors)

Pancreatic Diseases; Digestive System Diseases; Lung Diseases; Respiratory Tract Diseases; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Infant, Newborn, Diseases; Behavioral Symptoms; Behavior; Lung Diseases, Obstructive; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Phototherapy; Therapeutics

Limitations and Caveats

Limitations include a smaller than needed sample size to reach statistically reliable results, inconsistency with daily compliance among participants, limited nursing staff availability, potential bias (patient's knew the purpose of the study, this was not blind), lack of generalizability (e.g. risk of participant bias, single site location, situational factors, working with specialty population), and factors surrounding completion of this study during the COVID-19 pandemic.

Results Point of Contact

• Title: Erica Osborn DNP, CRNP
• Organization: University of Pittsburgh

elo25@pitt.edu

814-282-9793

Study Officials

• Erica Osborn, BSN

  University of Pittsburgh

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

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

Study Record Dates

• First Submitted: June 2, 2021
• First Posted: June 10, 2021
• Study Start: September 7, 2021
• Primary Completion: March 22, 2022
• Study Completion: March 22, 2022
• Last Updated: February 28, 2023
• Results First Posted: February 28, 2023

Record last verified: 2023-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: CSR
• Time Frame: Results and data from this study will be available immediately and maintained for seven years following completion.
• Access Criteria: Investigators conducting research on a similar topic within the University of Pittsburgh and outside

Locations

US (2)