Pilot Trial of Phototherapy for Acute Depression in Hospitalized Cystic Fibrosis Patients

Not Applicable

Completed

Conditions: Depression
Cystic Fibrosis

Interventions: Device: Phototherapy

Registration Number: NCT01822197

Lead Sponsor: Nationwide Children's Hospital

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).

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 30

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

Study & Design

Study Type: INTERVENTIONAL

Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Phototherapy	Phototherapy	Bright light phototherapy will be administered for 30 minutes daily over one week in the morning (Days 0-7)

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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.
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.