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

Primary Purpose

Cystic Fibrosis, Depressive Symptoms, Chronic Obstructive Pulmonary Disease

Status

Terminated

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Bright Light Therapy (BLT) Lamp

About this trial

This is an interventional supportive care trial for Cystic Fibrosis focused on measuring cystic fibrosis, depression, bright light therapy, adult, copd

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

University of Pittsburgh Medical Center Presbyterian Hospital
University of Pittsburgh

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Bright Light Therapy (BLT)

Arm Description

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.

Outcomes

Primary Outcome Measures

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).

Secondary Outcome Measures

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.

Full Information

NCT ID

NCT04921332

First Posted

June 2, 2021

Last Updated

February 26, 2023

Sponsor

Erica Osborn

1. Study Identification

Unique Protocol Identification Number

NCT04921332

Brief Title

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

2. Study Status

Record Verification Date

February 2023

Overall Recruitment Status

Terminated

Why Stopped

Study was stopped secondary to principal investigator needing to analyze data and present prior to graduating. Target enrollment not able to be reached prior to this.

Study Start Date

September 7, 2021 (Actual)

Primary Completion Date

March 22, 2022 (Actual)

Study Completion Date

March 22, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor-Investigator

Name of the Sponsor

Erica Osborn

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Yes

Device Product Not Approved or Cleared by U.S. FDA

Yes

Data Monitoring Committee

5. 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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Cystic Fibrosis, Depressive Symptoms, Chronic Obstructive Pulmonary Disease

Keywords

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

7. Study Design

Primary Purpose

Supportive Care

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Model Description

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

Masking

None (Open Label)

Allocation

N/A

Enrollment

4 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Bright Light Therapy (BLT)

Arm Type

Experimental

Arm Description

Intervention Type

Device

Intervention Name(s)

Bright Light Therapy (BLT) Lamp

Other Intervention Name(s)

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

Intervention Description

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.

Primary Outcome Measure Information:

Title

Change in Pre- and Post-intervention Beck's Depression Inventory II Scores (BDI-II)

Description

Time Frame

First at time of admission, second at end of 7 day goal or upon discharge.

Secondary Outcome Measure Information:

Title

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

Description

Time Frame

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

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Erica Osborn, BSN

Organizational Affiliation

University of Pittsburgh

Official's Role

Principal Investigator

Facility Information:

Facility Name

University of Pittsburgh Medical Center Presbyterian Hospital

City

Pittsburgh

State/Province

Pennsylvania

ZIP/Postal Code

15213

Country

United States

Facility Name

University of Pittsburgh

City

Pittsburgh

State/Province

Pennsylvania

ZIP/Postal Code

15213

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

Yes

IPD Sharing Plan Description

Data produced from this project may be shared with investigators conducting research on a similar topic within the University of Pittsburgh and outside. Shared information from this project will be de-identified under an approved DUA.

IPD Sharing Time Frame

Results and data from this study will be available immediately and maintained for seven years following completion.

IPD Sharing Access Criteria

Investigators conducting research on a similar topic within the University of Pittsburgh and outside

Citations:

PubMed Identifier

26433764

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.

Results Reference

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PubMed Identifier

26035199

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.

Results Reference

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PubMed Identifier

26580307

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.

Results Reference

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

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