Reducing Distress and Tobacco Smoking in Cancer Survivors: a TDCS Telehealth Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 43
- 试验地点
- 2
- 主要终点
- Feasibility and Tolerability Questionnaire (FTQ) score
研究概览
简要总结
The study aims to evaluate the feasibility of using Dorsolateral Prefrontal Cortex (DLPFC) Transcranial Direct Current Stimulation (tDCS) as a tool to decreasing distress and cigarette smoking. 46 participants currently smoking cigarettes, and seeking to decrease cigarette use will be recruited.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Double (Participant, Care Provider)
入排标准
- 年龄范围
- 21 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •21-75 years old
- •Smoke ≥5 cigarettes per day and express interest in quitting smoking in next 30 days
- •Mild to moderate distress defined as K10 scores 10-35
- •Self reported previous diagnosis of cancer
- •Psychotropic medication stable for ≥1 month prior to enrollment and throughout the trial, at the discretion of the study physician
- •Access to a reliable internet connection, able to use mobile device, and complete online questionnaires, competent in instrumental activities of daily living
- •Able to read and understand informed consent and questionnaires in English (WRAT-4 score≥85)
排除标准
- •Inability to effectively use study-provided supplies
- •Chronic non-compliance with study procedures
- •Changes in health information over the course of enrollment in the study which place the participant at higher risk for an adverse event (as determined by Study Physician or Principal Investigator; e.g. medication changes, invasive procedures)
- •Temporary or permanent obstructions to making contact between the electrodes and the scalp (e.g. wig that the participant is not willing to remove)
- •History of traumatic brain injury, brain metastases, seizure disorder, recent (<5 years) seizure history, or a neurodegenerative disease or neurocognitive disorder associated with significant impairment (e.g. Parkinson's, Dementia)
- •Current severe major depressive disorder, lifetime history of psychotic disorders or bipolar disorder type I, or current suicidal ideation
- •Currently meets DSM-5 criteria for severe substance use disorder in the past 6 months for any psychoactive substance other than tobacco
- •Current suicidal ideation (as determined by the MINI)
- •Current use of prescription or over the counter smoking cessation medication, or primary use of non-combustible forms of nicotine/tobacco
- •Currently receiving intravenous chemotherapy or radiation treatments
- •Presence of metal objects in the head/neck
- •Any skin disorder or skin sensitive area near stimulation locations
- •Self-reported pregnancy
- •Enrolled in group or individual therapy for smoking cessation that would be concurrent to intervention
研究组 & 干预措施
Active tDCS + Mindfulness
干预措施: Transcranial Direct Current Stimulation (tDCS) (Device)
Active tDCS + Mindfulness
干预措施: Mindfulness (Other)
Sham tDCS + Mindfulness
干预措施: Mindfulness (Other)
Sham tDCS + Mindfulness
干预措施: Sham - Transcranial Direct Current Stimulation (tDCS) (Other)
结局指标
主要结局
Feasibility and Tolerability Questionnaire (FTQ) score
时间窗: 1 month
The FTQ is a questionnaire is a 10 question survey which will be used to determine the ease and comfort of device use. Each question will be rated on a scale of 1 - 10, with 1 indicating the greatest difficulty or discomfort, and 10 indicating the greatest ease or tolerability. Questions for which the population average is greater than or equal to 5 will be deemed well tolerated.
次要结局
- Weekly cigarette use(1 month)
- Kessler Psychological Distress Scale (K10) Score(1 month)