An interventional study of Bright Light Therapy (BLT) Lamp in Cystic Fibrosis, Depressive Symptoms and Chronic Obstructive Pulmonary Disease, sponsored by Erica Osborn. Terminated at 2 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-02-28.
Sponsored by Erica Osborn · Not applicable, Interventional, and Supportive care
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.
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.
1,581 studies on the registry are indexed under Cystic Fibrosis; 190 are open to participants now.
This study's enrollment of 4 is below the median of 36 across 1,034 interventional studies indexed under Cystic Fibrosis.
Browse Cystic Fibrosis studies →This is the only study on the registry with Erica Osborn as lead sponsor.
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Exclusion Criteria:
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 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
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).
Time frame: First at time of admission, second at end of 7 day goal or upon discharge.
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.
Time frame: Daily for duration of intervention period (goal/maximum of 7 days).
| Milestone | Bright Light Therapy (BLT) |
|---|---|
| Started | 4 |
| Completed | 4 |
| Not completed | 0 |
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).
| score on a scale | Bright Light Therapy (BLT) |
|---|---|
| Change in Pre- and Post-intervention Beck's Depression Inventory II Scores (BDI-II) | 8.750 ± 10.63 |
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.
| days | Bright Light Therapy Compliance (Secondary Outcome) |
|---|---|
| Number of Days Until Completion of Daily Bright Light Therapy (BLT) | 4.5 ± 5 |
Collected over Adverse events were monitored for and collected over the implementation period of this study which spanned over 7 months.. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Bright Light Therapy (BLT) | 0/4 (0%) | 0/4 (0%) | 0/4 (0%) |
| Age, Categorical(Participants) | Bright Light Therapy (BLT) |
|---|---|
| <=18 years | 0 |
| Between 18 and 65 years | 2 |
| >=65 years | 2 |
| Age, Continuous(years) | Bright Light Therapy (BLT) |
|---|---|
| Mean | 56.25 ± 20.25 |
| Sex: Female, Male(Participants) | Bright Light Therapy (BLT) |
|---|---|
| Female | 3 |
| Male | 1 |
| Ethnicity (NIH/OMB)(Participants) | Bright Light Therapy (BLT) |
|---|---|
| Hispanic or Latino | 0 |
| Not Hispanic or Latino | 4 |
| Unknown or Not Reported | 0 |
| Race (NIH/OMB)(Participants) | Bright Light Therapy (BLT) |
|---|---|
| American Indian or Alaska Native | 0 |
| Asian | 0 |
| Native Hawaiian or Other Pacific Islander | 0 |
| Black or African American | 0 |
| White | 4 |
| More than one race | 0 |
| Unknown or Not Reported | 0 |
| Region of Enrollment(participants) | Bright Light Therapy (BLT) |
|---|---|
| United States | 4 |
| Diagnosis(Participants) | Bright Light Therapy (BLT) |
|---|---|
| Cystic Fibrosis | 3 |
| Chronic Obstructive Pulmonary Disease | 1 |
| Pre-intervention BDI-II Scoring(Score on a scale) | Bright Light Therapy (BLT) |
|---|---|
| Mean | 24.75 ± 8.995 |
Documents are hosted by the registry — open the source record to download them.
Plan to share: Yes — 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.
Supporting information: Csr
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