Clinical trial NCT01822197: Pilot Trial of Phototherapy for Acute Depression in Hospitalized Cystic Fibrosis Patients
Official title: Pilot Trial of Phototherapy for Acute Depression in Hospitalized CF Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Depression
Cystic Fibrosis
Keywords: Phototherapy
Lead sponsor: Nationwide Children's Hospital
Sponsor class: OTHER
First posted: 2013-04-02
Enrollment: 30
Sex: ALL
Minimum age (years): 12
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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).

Eligibility criteria: 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

Primary outcomes:
measure: Length of Hospitalization
timeFrame: participants will be followed for the length of hospital stay, an average of 14 days
Secondary outcomes:
measure: Depressive Symptom Scores Post-Treatment (Day 7) and at Admission (Day 0)
timeFrame: between day 0 and day 7 of hospitalization
measure: Quality of Life Scoring Post-Treatment (Day 7) and at Admission (Day 0
timeFrame: between day 0 and day 7 of hospitalization
Other outcomes:
Locations:
city: Columbus
country: United States
facility: Nationwide Children's Hospital
state: Ohio
Study officials:
affiliation: Nationwide Children's Hospital
name: Benjamin T Kopp, MD
role: PRINCIPAL_INVESTIGATOR
References: