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

Primary Purpose

Depression, Cystic Fibrosis

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Phototherapy
Sponsored by
Nationwide Children's Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Depression focused on measuring Phototherapy

Eligibility Criteria

12 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Nationwide Children's Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Phototherapy

Arm Description

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

Outcomes

Primary Outcome Measures

Length of Hospitalization
Length of stay will be measured in days

Secondary Outcome Measures

Depressive Symptom Scores Post-Treatment (Day 7) and at Admission (Day 0)
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.
Quality of Life Scoring Post-Treatment (Day 7) and at Admission (Day 0
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.

Full Information

First Posted
March 25, 2013
Last Updated
October 26, 2016
Sponsor
Nationwide Children's Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT01822197
Brief Title
Pilot Trial of Phototherapy for Acute Depression in Hospitalized Cystic Fibrosis Patients
Acronym
PHOTO
Official Title
Pilot Trial of Phototherapy for Acute Depression in Hospitalized CF Patients
Study Type
Interventional

2. Study Status

Record Verification Date
October 2016
Overall Recruitment Status
Completed
Study Start Date
March 2013 (undefined)
Primary Completion Date
May 2015 (Actual)
Study Completion Date
June 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Nationwide Children's Hospital

4. Oversight

Data Monitoring Committee
No

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Depression, Cystic Fibrosis
Keywords
Phototherapy

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
30 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Phototherapy
Arm Type
Experimental
Arm Description
Bright light phototherapy will be administered for 30 minutes daily over one week in the morning (Days 0-7)
Intervention Type
Device
Intervention Name(s)
Phototherapy
Other Intervention Name(s)
Nature Bright Sun Touch Plus light box.
Intervention Description
light will be administered at a minimum distance of 12 inches away to provide 10,000 lux
Primary Outcome Measure Information:
Title
Length of Hospitalization
Description
Length of stay will be measured in days
Time Frame
participants will be followed for the length of hospital stay, an average of 14 days
Secondary Outcome Measure Information:
Title
Depressive Symptom Scores Post-Treatment (Day 7) and at Admission (Day 0)
Description
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.
Time Frame
between day 0 and day 7 of hospitalization
Title
Quality of Life Scoring Post-Treatment (Day 7) and at Admission (Day 0
Description
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.
Time Frame
between day 0 and day 7 of hospitalization

10. Eligibility

Sex
All
Minimum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Benjamin T Kopp, MD
Organizational Affiliation
Nationwide Children's Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Nationwide Children's Hospital
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43205
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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