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临床试验/NCT06720090
NCT06720090招募中1 期

Light Therapy for Obsessive-compulsive Disorder: A Circadian Medicine Approach

Washington University School of Medicine2 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2024年12月16日最近更新:
适应症
干预措施

试验速览

阶段
1 期
状态
招募中
入组人数
40
试验地点
2
主要终点
Yale Brown Obsessive-Compulsive Scale (YBOCS)

研究概览

简要总结

The goal of this clinical trial is to test whether light therapy is effective for reducing symptoms in young adults with OCD and late bedtimes (1am or later). The main question[s] it aims to answer are:

Does light therapy reduce OCD symptoms? Does light therapy advance the circadian clock? If there is a comparison group: Researchers will compare a higher dose of light therapy to a lower dose to see if dose amount affects symptom reduction.

Participants will asked to:

  1. Wear light therapy glasses for 1 hour each morning and complete a daily light therapy log for 5 weeks
  2. Track their sleep every day with a wearable monitor and an electronic sleep diary for 5 weeks
  3. Complete a 1-time assessment of sensitivity to light exposure
  4. Complete self-report measures of OCD 4 times/day at baseline (2 weeks), mid-treatment (1 week), and end of treatment (1 week)

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Double (Participant, Outcomes Assessor)

入排标准

年龄范围
17 Years 至 35 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • Primary DSM-5 OCD diagnosis
  • Bedtime 0100 or later
  • English speaking

排除标准

  • Subjects must not be currently participating in another research study that would influence their participation in our study.
  • Diagnostic status
  • Treatment status
  • Night shift work or travel more than 1 time zone outside of Central Standard Time (CST) in the past month
  • Pregnancy status
  • Medication status
  • Regular nicotine or marijuana use

研究组 & 干预措施

Higher dose

Experimental

Participants will be given wearable light therapy devices that emit a higher light intensity.

干预措施: Light therapy (Behavioral)

Lower dose

Sham Comparator

Participants will be given wearable light therapy devices that emit a lower light intensity.

干预措施: Light therapy (Behavioral)

结局指标

主要结局

Yale Brown Obsessive-Compulsive Scale (YBOCS)

时间窗: Administered at baseline, in treatment week 3, and post-treatment (3 administrations over 7 weeks)

A retrospective clinical interview of OCD symptom severity. Score range from 0 to 40 and higher scores indicate more severe OCD symptoms.

Daily Perseverative Thinking Questionnaire

时间窗: Administered 4 times/day for 2 weeks at baseline, 4 times/day for 1 week in treatment week 3, and 4 times/day for 1 week in treatment week 5

Self-report measure of momentary transdiagnostic repetitive negative thinking. Score range from 6 to 42 and higher scores indicate more severe repetitive negative thinking.

次要结局

  • Circadian melatonin phase(At baseline and post-treatment (after 5 weeks of treament))

研究者

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

Rebecca C. Cox

Assistant Professor

Washington University School of Medicine

研究点 (2)

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