Cystic Fibrosis, Depression
Conditions
Keywords
Phototherapy
Brief summary
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.
Detailed description
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).
Interventions
DEVICEPhototherapy
light will be administered at a minimum distance of 12 inches away to provide 10,000 lux
Sponsors
Nationwide Children's Hospital
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
12 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patients with CF greater than 12 years of age * Pulmonary exacerbation
Exclusion criteria
* planned admission less than 24 hours * suicidal ideation * Bipolar depression * known retinal disorder/photosensitivity * light induced epilepsy or migraines * age less than 12 years of age
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Length of Hospitalization | participants will be followed for the length of hospital stay, an average of 14 days | Length of stay will be measured in days |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Depressive Symptom Scores Post-Treatment (Day 7) and at Admission (Day 0) | between day 0 and day 7 of hospitalization | 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. |
| Quality of Life Scoring Post-Treatment (Day 7) and at Admission (Day 0 | between day 0 and day 7 of hospitalization | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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 | 30 |
| Total | 30 |
Baseline characteristics
| Characteristic | Phototherapy |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 30 Participants |
| Age, Continuous | 27.7 years STANDARD_DEVIATION 8.5 |
| Gender Female | 13 Participants |
| Gender Male | 17 Participants |
| Region of Enrollment United States | 30 participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 0 / 30 |
| serious Total, serious adverse events | 0 / 30 |
Outcome results
Primary
Length of Hospitalization
Length of stay will be measured in days
Time frame: participants will be followed for the length of hospital stay, an average of 14 days
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Phototherapy | Length of Hospitalization | 11 days | Standard Deviation 3.6 |
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.
Time frame: between day 0 and day 7 of hospitalization
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Phototherapy | Depressive Symptom Scores Post-Treatment (Day 7) and at Admission (Day 0) | Post-treatment score | 4.5 units on a scale | Standard Deviation 2.5 |
| Phototherapy | Depressive Symptom Scores Post-Treatment (Day 7) and at Admission (Day 0) | Admission score | 8.7 units on a scale | Standard Deviation 3.6 |
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.
Time frame: between day 0 and day 7 of hospitalization
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Phototherapy | Quality of Life Scoring Post-Treatment (Day 7) and at Admission (Day 0 | Pre-treatment Health Domain | 35.5 units on a scale | Standard Deviation 17.1 |
| Phototherapy | Quality of Life Scoring Post-Treatment (Day 7) and at Admission (Day 0 | Post-treatment health domain | 59.7 units on a scale | Standard Deviation 16.7 |