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临床试验/NCT02898233
NCT02898233终止不适用

Augmenting Internet-Based Cognitive Behavioral Therapy for Major Depressive Disorder With Low-Level Light Therapy

University of Texas at Austin2 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2016年2月最近更新:
适应症

试验速览

阶段
不适用
状态
终止
入组人数
20
试验地点
2
主要终点
Quick Inventory of Depressive Symptomatology - Self-Report (QIDS-SR)

研究概览

简要总结

The purpose of this study is to better understand how low-level light therapy (LLLT) can be used to augment the antidepressant effects of Deprexis, an internet-based treatment program for depression, for participants with current major depressive disorder. The researchers will administer active and placebo LLLT to the right forehead of participants who show an improvement of at least 10% in depressive symptoms from baseline after two weeks of Deprexis treatment.

Hypothesis: Participants who receive active LLLT will show a greater reduction of depressive symptoms than participants who receive placebo LLLT.

详细描述

  1. Online screening Following a digital informed consent, all participants will complete a brief online screening questionnaire to determine the severity level of their depression, using the Center for Epidemiological Studies - Depression Scale (CES-D). Initial consent and screening procedures will be conducted online via Research Electronic Data Capture (REDCap), a secure, on-line assessment tool designed to collect self-report questionnaire data for research studies. Participants with a CES-D score of 16 or higher will be eligible to continue with the study. At this initial screening, eligible participants will also provide contact information (name, email address, and phone number) for a follow-up phone screening.
  2. Phone screening Following the online screening, eligible participants will complete a phone screening, the Mini International Neuropsychiatric Interview (MINI), conducted by researchers in the Mood Disorders Laboratory. The phone screening will be audio recorded for quality control purposes. Participants will be eligible to continue on in the study if they meet criteria for current Major Depression without any comorbid disorders, excluding anxiety disorders. Next, participants will complete the Colombia-Suicide Severity Rating Scale (C-SSRS) to assess for suicidality. Any participant who endorses suicidal intent, with or without plan, (i.e., items 4 or 5) within the last six months, will be deemed ineligible. Researchers will provide resources to any participant endorsing suicidal ideation, and will contact authorities if necessary. At the end of the phone screening, eligible participants will be scheduled to come into the Mood Disorders Laboratory for their initial study meeting within a week.
  3. Initial meeting

Participants deemed eligible by the online and phone screenings will come into the Mood Disorders Laboratory within a week of their phone screening. The initial meeting will last approximately one hour. The initial meeting will have several objectives:

First, participants will provide informed consent. Research personnel will provide participants with detailed oral and written description of all study procedures in order to ensure understanding of all components of the study. Participants will provide informed consent for completing the Deprexis program, pre-treatment questionnaires, daily questionnaires, weekly questionnaires, and post-treatment questionnaires. All questionnaires will be accessed online via REDCap.

Next, participants will complete several pre-treatment questionnaires. Also, researchers will introduce the Deprexis program, and participants will receive an access code that will allow them immediate access to the Deprexis site. Information about the Deprexis program is detailed below.

Participants will also complete an eye tracking/pupil dilation task during the meeting. Pupil dilation response to emotional stimuli has been shown to be related to depression. In this pupil dilation task, participants will passively view emotional and neutral stimuli (images). More details about the task are below. 4. Pre-treatment questionnaires Participants eligible to take part in the Deprexis program will complete several pre-treatment questionnaires at the initial meeting. 5. Deprexis All Deprexis treatment will be provided via the Deprexis website: http://deprexis.com/. Participants will have access to this website for twelve weeks. They can access this website as often as they would like. The Deprexis program is self-guided, so participants determine how often they access the material (see below for a description of the Deprexis treatment).

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
Single (Participant)

入排标准

年龄范围
18 Years 至 45 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • ability to speak, read, and understand English fluently
  • owns a smartphone and able to receive emails on their phone and access REDCap on a web browser on their phone
  • current depressive episode as determined by the Center for Epidemiological Studies - Depression Screening (CES-D) and Mini International Neuropsychiatric Interview (MINI)

排除标准

  • serious medical complications, including conditions that change electrical functioning in the brain (e.g., cancer, diabetes, epilepsy, head trauma, history of brain surgery, neurocognitive impairment, stroke, transient ischemic attack)
  • comorbid psychiatric disorders, excluding anxiety disorders, as determined by Mini International Neuropsychiatric Interview (MINI)

结局指标

主要结局

Quick Inventory of Depressive Symptomatology - Self-Report (QIDS-SR)

时间窗: Week 0 to Week 12, one time per week

Change in QIDS-SR score from Week 0 to Week 12

次要结局

  • Deprexis usage(through study completion; an average of 540 minutes of usage over 12 weeks)
  • Inventory of Depression and Anxiety Symptoms (IDAS)(Week 0, Week 12)
  • Sheehan Disability Scale (SDS)(Week 0, Week 12)
  • Perseverative Thinking Questionnaire (PTQ)(Week 0, Week 12)
  • Tridimensional Personality Questionnaire (TPQ)(Week 0, Week 12)
  • Massachusetts General Hospital Antidepressant Treatment Questionnaire (ATRQ)(Week 0, Week 12)
  • Questionnaire about daily activities and mood(once per day throughout course of study; daily beginning Week 0 until Week 12)
  • Colombia Suicide Severity Rating Scale(through study completion, once during phone screening, thereafter up to once per week, an average of 2 times total)

研究者

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

Christopher G. Beevers

Professor

University of Texas at Austin

研究点 (2)

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