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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT04921332
Other study ID # STUDY20110407
Secondary ID
Status Terminated
Phase N/A
First received
Last updated
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
Health authority
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

Study Design


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).
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