Trial Outcomes & Findings for Pilot Trial of Phototherapy for Acute Depression in Hospitalized Cystic Fibrosis Patients (NCT NCT01822197)

Results Overview

Length of stay will be measured in days

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

30 participants

Primary outcome timeframe

participants will be followed for the length of hospital stay, an average of 14 days

Results posted on

2016-12-19

Participant Flow

Participant milestones

Participant milestones
Measure	Phototherapy Bright light phototherapy will be administered for 30 minutes daily over one week in the morning (Days 0-7) Phototherapy: light will be administered at a minimum distance of 12 inches away to provide 10,000 lux
Overall Study STARTED	30
Overall Study COMPLETED	30
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Phototherapy n=30 Participants Bright light phototherapy will be administered for 30 minutes daily over one week in the morning (Days 0-7) Phototherapy: light will be administered at a minimum distance of 12 inches away to provide 10,000 lux
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	30 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants
Age, Continuous	27.7 years STANDARD_DEVIATION 8.5 • n=5 Participants
Gender Female	13 Participants n=5 Participants
Gender Male	17 Participants n=5 Participants
Region of Enrollment United States	30 participants n=5 Participants

PRIMARY outcome

Timeframe: participants will be followed for the length of hospital stay, an average of 14 days

Length of stay will be measured in days

Outcome measures

Outcome measures
Measure	Phototherapy n=30 Participants Bright light phototherapy will be administered for 30 minutes daily over one week in the morning (Days 0-7) Phototherapy: light will be administered at a minimum distance of 12 inches away to provide 10,000 lux
Length of Hospitalization	11 days Standard Deviation 3.6

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Phototherapy n=30 Participants Bright light phototherapy will be administered for 30 minutes daily over one week in the morning (Days 0-7) Phototherapy: light will be administered at a minimum distance of 12 inches away to provide 10,000 lux
Depressive Symptom Scores Post-Treatment (Day 7) and at Admission (Day 0) Post-treatment score	4.5 units on a scale Standard Deviation 2.5
Depressive Symptom Scores Post-Treatment (Day 7) and at Admission (Day 0) Admission score	8.7 units on a scale Standard Deviation 3.6

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Phototherapy n=30 Participants Bright light phototherapy will be administered for 30 minutes daily over one week in the morning (Days 0-7) Phototherapy: light will be administered at a minimum distance of 12 inches away to provide 10,000 lux
Quality of Life Scoring Post-Treatment (Day 7) and at Admission (Day 0 Pre-treatment Health Domain	35.5 units on a scale Standard Deviation 17.1
Quality of Life Scoring Post-Treatment (Day 7) and at Admission (Day 0 Post-treatment health domain	59.7 units on a scale Standard Deviation 16.7

Adverse Events

Phototherapy

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr Ben Kopp

Nationwide Childrens Hospital

Phone: 6147224766

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place