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Completed

NCT Number: NCT01822197

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

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.

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Key information

Conditions

Depression Behavior Behavioral Symptoms Congenital, Hereditary, and Neonatal Diseases and Abnormalities Cystic Fibrosis Digestive System Diseases Genetic Diseases, Inborn Infant, Newborn, Diseases Lung Diseases Pancreatic Diseases Respiratory Tract Diseases

Age range

12 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Nationwide Children's Hospital

Columbus, Ohio, 43205, United States

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Phototherapy

Device

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

Other names: Nature Bright Sun Touch Plus light box.

Primary outcomes

  1. Length of Hospitalization

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

    Length of stay will be measured in days

Secondary outcomes

  1. Depressive Symptom Scores Post-Treatment (Day 7) and at Admission (Day 0)

    Time frame: 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.

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

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Nationwide Children's Hospital

Other

Registry information

Official study title

Pilot Trial of Phototherapy for Acute Depression in Hospitalized CF Patients

Acronym: PHOTO

Important dates

Study start
2013
Primary completion
2015
Study completion
2015
First posted
Apr 2, 2013
Registry last updated
Dec 19, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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