Pilot Trial of Phototherapy for Acute Depression in Hospitalized Cystic Fibrosis Patients
PHOTO
1 other identifier
interventional
30
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable depression
Started Mar 2013
Typical duration for not_applicable depression
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2013
CompletedFirst Submitted
Initial submission to the registry
March 25, 2013
CompletedFirst Posted
Study publicly available on registry
April 2, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2015
CompletedResults Posted
Study results publicly available
September 7, 2016
CompletedDecember 19, 2016
October 1, 2016
2.2 years
March 25, 2013
July 25, 2016
October 26, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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
Secondary Outcomes (2)
Depressive Symptom Scores Post-Treatment (Day 7) and at Admission (Day 0)
between day 0 and day 7 of hospitalization
Quality of Life Scoring Post-Treatment (Day 7) and at Admission (Day 0
between day 0 and day 7 of hospitalization
Study Arms (1)
Phototherapy
EXPERIMENTALBright light phototherapy will be administered for 30 minutes daily over one week in the morning (Days 0-7)
Interventions
light will be administered at a minimum distance of 12 inches away to provide 10,000 lux
Eligibility Criteria
You may qualify if:
- Patients with CF greater than 12 years of age
- Pulmonary exacerbation
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Nationwide Children's Hospital
Columbus, Ohio, 43205, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Dr Ben Kopp
- Organization
- Nationwide Childrens Hospital
Study Officials
- PRINCIPAL INVESTIGATOR
Benjamin T Kopp, MD
Nationwide Children's Hospital
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
March 25, 2013
First Posted
April 2, 2013
Study Start
March 1, 2013
Primary Completion
May 1, 2015
Study Completion
June 1, 2015
Last Updated
December 19, 2016
Results First Posted
September 7, 2016
Record last verified: 2016-10
Data Sharing
- IPD Sharing
- Will not share