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

Depression Clinical Trial

— PHOTO  

Official title:

Pilot Trial of Phototherapy for Acute Depression in Hospitalized CF Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01822197
• Other study ID #: IRB13-00044
• Status: Completed
• Phase: N/A
• First received: March 25, 2013
• Last updated: June 15, 2015
• Start date: March 2013
• Est. completion date: June 2015

Study information

• Verified date: June 2015
• Source: Nationwide Children's Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: June 2015
• Est. primary completion date: May 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 12 Years and older

Eligibility

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

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Cystic Fibrosis
• Depression
• Depressive Disorder
• Fibrosis

Intervention

Device:
• Phototherapy
light will be administered at a minimum distance of 12 inches away to provide 10,000 lux

Locations

Country	Name	City	State
United States	Nationwide Children's Hospital	Columbus	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
Nationwide Children's Hospital

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	Change in depressive symptom scoring	changes in depressive symptom scoring from day 0 to day 7 using QIDS-C and QIDS-SR. calculated change will be day 0 minus day 7 score.	between day 0 and day 7 of hospitalization	No
Secondary	Quality of life scoring	Quality of life scoring changes using the CFQ-R. calculated change will be day 0 minus day 7 score.	between day 0 and day 7 of hospitalization	No