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

NCT ID: NCT04921332

Last Updated: 2023-02-28

Study Results

Results available

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Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

4 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-09-07

Study Completion Date

2022-03-22

Brief Summary

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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

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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.

Conditions

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Cystic Fibrosis Depressive Symptoms Chronic Obstructive Pulmonary Disease

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

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

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

Bright Light Therapy (BLT) Lamp

Intervention Type 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.

Interventions

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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.

Intervention Type DEVICE

Other Intervention Names

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

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Erica Osborn

OTHER

Sponsor Role lead

Responsible Party

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Erica Osborn

Principal Investigator

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Erica Osborn, BSN

Role: PRINCIPAL_INVESTIGATOR

University of Pittsburgh

Locations

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University of Pittsburgh Medical Center Presbyterian Hospital

Pittsburgh, Pennsylvania, United States

Site Status

University of Pittsburgh

Pittsburgh, Pennsylvania, United States

Site Status

Countries

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United States

References

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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.

Reference Type BACKGROUND
PMID: 26433764 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 26035199 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 26580307 (View on PubMed)

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

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STUDY20110407

Identifier Type: -

Identifier Source: org_study_id

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