Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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). |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Erica Osborn, BSN | University of Pittsburgh | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Pittsburgh Medical Center Presbyterian Hospital | Pittsburgh | Pennsylvania | 15213 | United States | ||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26433764 | Background | 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. | |
| 26035199 | 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. |
Not provided
Not provided
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.
Results and data from this study will be available immediately and maintained for seven years following completion.
Investigators conducting research on a similar topic within the University of Pittsburgh and outside
Not provided
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | 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. Bright Light Therapy (BLT) Lamp: With its built in automatic timer shut-off function, the bedside 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | 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. Bright Light Therapy (BLT) Lamp: With its built in automatic timer shut-off function, the bedside 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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). | Posted | Mean | Standard Deviation | score on a scale | First at time of admission, second at end of 7 day goal or upon discharge. |
|
Adverse events were monitored for and collected over the implementation period of this study which spanned over 7 months.
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. Bright Light Therapy (BLT) Lamp: With its built in automatic timer shut-off function, the bedside 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. |
Not provided
Not provided
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.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Erica Osborn DNP, CRNP | University of Pittsburgh | 814-282-9793 | elo25@pitt.edu |
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Mar 30, 2022 | Jan 25, 2023 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Dec 28, 2021 | Feb 26, 2023 | ICF_002.pdf |
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D003550 | Cystic Fibrosis |
| D003863 | Depression |
| D029424 | Pulmonary Disease, Chronic Obstructive |
| ID | Term |
|---|---|
| D010182 | Pancreatic Diseases |
| D004066 | Digestive System Diseases |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D014467 | Ultraviolet Therapy |
| ID | Term |
|---|---|
| D010789 | Phototherapy |
| D013812 | Therapeutics |
Not provided
Not provided
This is a non-randomized, single group, pre- and post-intervention project.
Not provided
Not provided
Not provided
Not provided
|
| University of Pittsburgh |
| Pittsburgh |
| Pennsylvania |
| 15213 |
| United States |
| 26580307 | 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. |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Diagnosis | Count of Participants | Participants |
|
| Pre-intervention BDI-II Scoring | Self-reported answer total to the 21 scored items on BDI-II (minimum score obtainable=0 (absent symptoms); maximum score obtainable=63 (most severe symptoms). Higher score=worse outcome. | Mean | Standard Deviation | Score on a scale |
|
|
|
| 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. | Posted | Mean | Standard Deviation | days | Daily for duration of intervention period (goal/maximum of 7 days). |
|
|
|
| 0 |
| 4 |
| 0 |
| 4 |
| 0 |
| 4 |
Not provided
Not provided
| D030342 |
| Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D007232 | Infant, Newborn, Diseases |
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |
| D008173 | Lung Diseases, Obstructive |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |