Pilot Trial of Phototherapy for Acute Depression in Hospitalized Cystic Fibrosis Patients
| Status: | Completed |
|---|---|
| Conditions: | Depression, Pulmonary |
| Therapuetic Areas: | Psychiatry / Psychology, Pulmonary / Respiratory Diseases |
| Healthy: | No |
| Age Range: | 12 - Any |
| Updated: | 7/11/2015 |
| Start Date: | March 2013 |
| End Date: | June 2015 |
Pilot Trial of Phototherapy for Acute Depression in Hospitalized CF Patients
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.
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).
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).
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
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