Chronic Obstructive Pulmonary Disease, Cystic Fibrosis, Depressive Symptoms
Conditions
Keywords
cystic fibrosis, depression, bright light therapy, adult, copd
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.
Interventions
DEVICEBright 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.
Sponsors
Erica Osborn
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Intervention model description
This is a non-randomized, single group, pre- and post-intervention project.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Pre- and Post-intervention Beck's Depression Inventory II Scores (BDI-II) | First at time of admission, second at end of 7 day goal or upon discharge. | 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
| Measure | Time frame | Description |
|---|---|---|
| Number of Days Until Completion of Daily Bright Light Therapy (BLT) | Daily for duration of intervention period (goal/maximum of 7 days). | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 4 |
| Total | 4 |
Baseline characteristics
| Characteristic | Bright Light Therapy (BLT) |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 2 Participants |
| Age, Categorical Between 18 and 65 years | 2 Participants |
| Age, Continuous | 56.25 years STANDARD_DEVIATION 20.25 |
| Diagnosis Chronic Obstructive Pulmonary Disease | 1 Participants |
| Diagnosis Cystic Fibrosis | 3 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 4 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Pre-intervention BDI-II Scoring | 24.75 Score on a scale STANDARD_DEVIATION 8.995 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 4 Participants |
| Region of Enrollment United States | 4 participants |
| Sex: Female, Male Female | 3 Participants |
| Sex: Female, Male Male | 1 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 4 |
| other Total, other adverse events | 0 / 4 |
| serious Total, serious adverse events | 0 / 4 |
Outcome results
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).
Time frame: First at time of admission, second at end of 7 day goal or upon discharge.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Bright Light Therapy (BLT) | Change in Pre- and Post-intervention Beck's Depression Inventory II Scores (BDI-II) | 8.750 score on a scale | Standard Deviation 10.63 |
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.
Time frame: Daily for duration of intervention period (goal/maximum of 7 days).
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Bright Light Therapy (BLT) | Number of Days Until Completion of Daily Bright Light Therapy (BLT) | 4.5 days | Standard Deviation 5 |