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临床试验/NCT01822197
NCT01822197已完成不适用

Pilot Trial of Phototherapy for Acute Depression in Hospitalized CF Patients

Nationwide Children's Hospital2 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2013年3月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
30
试验地点
2
主要终点
Length of Hospitalization

研究概览

简要总结

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.

详细描述

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).

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Treatment
盲法
None

入排标准

年龄范围
12 Years 至 —(Child, Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients with CF greater than 12 years of age
  • Pulmonary exacerbation

排除标准

  • 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

结局指标

主要结局

Length of Hospitalization

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

Length of stay will be measured in days

次要结局

  • Quality of Life Scoring Post-Treatment (Day 7) and at Admission (Day 0(between day 0 and day 7 of hospitalization)
  • Depressive Symptom Scores Post-Treatment (Day 7) and at Admission (Day 0)(between day 0 and day 7 of hospitalization)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Benjamin Kopp

Principal Investigator

Nationwide Children's Hospital

研究点 (2)

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