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The purpose of this study is to determine whether bright light phototherapy can improve depressive symptoms in hospitalized patients with cystic fibrosis (CF) with subsequent effects on quality of life and illness recovery. It is hypothesized that phototherapy will improve depressive symptoms and decrease length of stay in depressed patients with CF who are hospitalized.
Adults and adolescent with CF who are admitted to the hospital for pulmonary exacerbations will be enrolled. Subjects will use a Sun Touch Plus light box that emits 10,000 lux at a minimum distance of 60-80 cm away upon first awakening. Light exposure will last for 30 minutes each day over one week. Nursing staff will ensure compliance and a light sensor attached to the light box will measure use as well. There will not be a placebo during this pilot trial due to recruitment concerns for the sample size required for a single center placebo controlled trial. All light boxes will be sterilized between patient use. Vitamin D levels will be recorded at enrollment from routine clinical measurement. Light boxes do NOT emit UV light and have a negative ionizer.
Depression Screening: Quick Inventory of Depressive Symptomatology self report and clinician administered survey (QIDS-SR and QIDS-C) will be administered at admission (day 0) and completion of light therapy (day 7) to look at changes in depressive symptoms. The QIDS assesses all the criterion symptom domains designated by the American Psychiatry Association Diagnostic and Statistical Manual of Mental Disorders - 4th edition (DSM-IV) to diagnose a major depressive episode. The QIDS is sensitive to change, with medications, psychotherapy, or somatic treatments, making it useful for research purposes. The psychometric properties of both the QIDS has been established in various study samples. Cronbach's alpha was 0.85 (QIDS-C16) and 0.86 (QIDS-SR16) in a reliability study by Triveldi in 2004.
Quality of Life Scoring: The CF questionnaire revised (CFQ-R) will be administered simultaneously with the QIDS at days 0 & 7 as a measure of health related quality of life (HRQOL). This is a well validated measure in the CF population for research studies (Riekert et al., 2007).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Phototherapy | Experimental | Bright light phototherapy will be administered for 30 minutes daily over one week in the morning (Days 0-7) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Phototherapy | Device | light will be administered at a minimum distance of 12 inches away to provide 10,000 lux |
|
| Measure | Description | Time Frame |
|---|---|---|
| Length of Hospitalization | Length of stay will be measured in days | participants will be followed for the length of hospital stay, an average of 14 days |
| Measure | Description | Time Frame |
|---|---|---|
| Depressive Symptom Scores Post-Treatment (Day 7) and at Admission (Day 0) | depressive symptom scoring at day 0 and day 7 using Quick Inventory of Depressive Symptomatology-clinician (QIDS-C) and Quick Inventory of Depressive Symptomatology self-report (QIDS-SR). Day 7 and Day 0 scores will be compared. Score range is 0 to 27. A QIDS score of less than 6 indicates no depression, 6-10 indicates mild depression, 11-15 moderate, 16-20 severe, and 21- 27 very severe depression. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Benjamin T Kopp, MD | Nationwide Children's Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Nationwide Children's Hospital | Columbus | Ohio | 43205 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Phototherapy | Bright light phototherapy will be administered for 30 minutes daily over one week in the morning (Days 0-7) Phototherapy: light will be administered at a minimum distance of 12 inches away to provide 10,000 lux |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Phototherapy | Bright light phototherapy will be administered for 30 minutes daily over one week in the morning (Days 0-7) Phototherapy: light will be administered at a minimum distance of 12 inches away to provide 10,000 lux |
| 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 | Length of Hospitalization | Length of stay will be measured in days | Posted | Mean | Standard Deviation | days | participants will be followed for the length of hospital stay, an average of 14 days |
|
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Phototherapy | Bright light phototherapy will be administered for 30 minutes daily over one week in the morning (Days 0-7) Phototherapy: light will be administered at a minimum distance of 12 inches away to provide 10,000 lux |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr Ben Kopp | Nationwide Childrens Hospital | 6147224766 | benjamin.kopp@nationwidechildrens.org |
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| ID | Term |
|---|---|
| D003863 | Depression |
| D003550 | Cystic Fibrosis |
| ID | Term |
|---|---|
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |
| D010182 | Pancreatic Diseases |
| D004066 | Digestive System Diseases |
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| ID | Term |
|---|---|
| D010789 | Phototherapy |
| ID | Term |
|---|---|
| D013812 | Therapeutics |
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| between day 0 and day 7 of hospitalization |
| Quality of Life Scoring Post-Treatment (Day 7) and at Admission (Day 0 | Quality of life scoring at admission (Day 0) and post-treatment (Day 7) using the CF questionnaire-revised (CFQ-R) as a measure of health related quality of life. Minimally important changes in CFQ-R scoring have been reported at 5-8. Days 0 and 7 will be compared. Score range is 0 to 100. Lower scores indicate worse quality of life. | between day 0 and day 7 of hospitalization |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Gender | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
|
| Secondary | Depressive Symptom Scores Post-Treatment (Day 7) and at Admission (Day 0) | depressive symptom scoring at day 0 and day 7 using Quick Inventory of Depressive Symptomatology-clinician (QIDS-C) and Quick Inventory of Depressive Symptomatology self-report (QIDS-SR). Day 7 and Day 0 scores will be compared. Score range is 0 to 27. A QIDS score of less than 6 indicates no depression, 6-10 indicates mild depression, 11-15 moderate, 16-20 severe, and 21- 27 very severe depression. | Posted | Mean | Standard Deviation | units on a scale | between day 0 and day 7 of hospitalization |
|
|
|
| Secondary | Quality of Life Scoring Post-Treatment (Day 7) and at Admission (Day 0 | Quality of life scoring at admission (Day 0) and post-treatment (Day 7) using the CF questionnaire-revised (CFQ-R) as a measure of health related quality of life. Minimally important changes in CFQ-R scoring have been reported at 5-8. Days 0 and 7 will be compared. Score range is 0 to 100. Lower scores indicate worse quality of life. | Posted | Mean | Standard Deviation | units on a scale | between day 0 and day 7 of hospitalization |
|
|
|
| 0 |
| 30 |
| 0 |
| 30 |
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| D008171 |
| Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D007232 | Infant, Newborn, Diseases |