Remote Guided Caffeine Reduction
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 109
- 试验地点
- 1
- 主要终点
- Number of Participants With Treatment Retention as Assessed by Number of Participants With Completed Assessments
研究概览
简要总结
The purpose of this online research study is to determine whether or not a gradual caffeine reduction program developed at Johns Hopkins can help people reduce their caffeine use. The investigators will provide materials to help guide caffeine reduction and ask questions to track caffeine use over several weeks. The investigators will also assess how reducing caffeine may benefit common caffeine-related problems such as anxiety, sleep disturbances, and gastrointestinal distress. The study will also determine whether or not people like participating in this caffeine reduction program in an online format.
详细描述
There is emerging evidence that some individuals have difficulty cutting down or eliminating caffeine consumption in spite of clinically significant problems exacerbated by caffeine use. This study will evaluate whether a caffeine reduction program developed at Johns Hopkins can help people reduce their caffeine use in an online format. Volunteers will participate in an intervention study conducted entirely online, including video visits for screening, instructions for caffeine reduction, and follow up. The study also involves filling out online surveys sent via email and text message. During screening, participants will be asked questions about their personal characteristics including demographic information, weekly caffeine consumption, and general medical history. Participants who are determined to be eligible after screening will be randomized to either the immediate or delayed treatment group. Those in the immediate treatment group will have their next session immediately after screening while those in the delayed treatment group will have their next session 7 weeks after screening. At this session, participants receive a digital copy of a caffeine reduction manual and instructions on how to gradually cut down caffeine. After this, participants will complete weekly online surveys over six weeks. Participants will complete two follow-up video visits at 7 and 14 weeks after participants received the caffeine reduction instructions. The investigators will measure caffeine consumption over time using the online surveys and interview questions during video visits, and the investigators will also measure how various caffeine related problems may improve during caffeine reduction, such as sleep problems, gastrointestinal issues, and anxiety. During the end of study sessions, participants will answer questions related to acceptability of the online format and report on participants' current caffeine use.
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
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •18-75 years old
- •Reside in the United States
- •Read, write, and speak English fluently
- •Able to access a video camera on a smart phone, tablet, or other computer
- •Able to receive text messages or emails (or both)
- •Suitable caffeine consumption
- •Indicate suitable reason for caffeine reduction
- •Interested in getting help to gradually reduce or eliminate caffeine consumption as part of a research study
排除标准
- •Any current medical or psychiatric disorder or symptoms that, in the opinion of the investigators, may interfere with or preclude completion of the study [many psychiatric or medical concerns such as insomnia or anxiety are not anticipated to interfere with study participation and will not generally be exclusionary]
研究组 & 干预措施
Caffeine Reduction Manual, Immediate Treatment Group
Weekly caffeine consumption is to be measured before and after using the caffeine reduction program, which has been summarized in a "Guide to Caffeine Reduction and Cessation" manual to help people reduce their caffeine use. Those in the immediate treatment group will receive the guide immediately after screening.
干预措施: Caffeine Reduction Manual (Behavioral)
Caffeine Reduction Manual, Delayed Treatment Group
Weekly caffeine consumption is to be measured before and after using the caffeine reduction program, which has been summarized in a "Guide to Caffeine Reduction and Cessation" manual to help people reduce their caffeine use. Those in the delayed treatment group will receive the guide seven weeks after screening.
干预措施: Caffeine Reduction Manual (Behavioral)
结局指标
主要结局
Number of Participants With Treatment Retention as Assessed by Number of Participants With Completed Assessments
时间窗: Treatment Visit, 7-Week Follow-Up, 14-Week Follow-Up
To determine to what extent participants will engage with a remote caffeine reduction intervention for caffeine-related problems and find it acceptable, we will calculate the percentage of completed assessments for each video visit among eligible participants.
Treatment Acceptability as Assessed by Treatment Acceptability Questionnaire
时间窗: 7 weeks Follow-Up visit
At the 7 Weeks Follow-Up video visit, we will use an internally-developed standardized treatment acceptability questionnaire to determine self-reported agreement with two items on the treatment acceptability survey (i.e., "Overall, was the Guide to Caffeine Reduction and Cessation easy to use?", and "Overall, was the guide to Caffeine reduction and Cessation helpful?"). Each question is scored on a scale from 0-3, for a total score range of 0-6, where lower scores indicate less acceptability (e.g., 0=not at all easy, not at all helpful; 3 = very easy, very helpful).
次要结局
- Change in Caffeine Consumption (in Milligrams)(Baseline, Treatment Visit, 7-Week Follow-Up, 14-Week Follow-Up)
- Change in Caffeine-related Problems as Assessed by Past-7 Days Standardized Items(Baseline, 7-Week Follow-Up, 14-Week Follow-Up)
- Change in Anxiety as Assessed by the PROMIS-Anxiety-8a(Baseline, 7-Week Follow-Up, 14-Week Follow-Up)
- Change in Anxiety as Assessed by the GAD-7(Baseline, 7-Week Follow-Up, 14-Week Follow-Up)
- Change in Gastrointestinal Problems as Assessed by the GSRS(Baseline, 7-Week Follow-Up, 14-Week Follow-Up)
- Change in Gastrointestinal Problems as Assessed by the PROMIS Diarrhea-6a(Baseline, 7-Week Follow-Up, 14-Week Follow-Up)
- Change in Sleep Problems as Assessed by the PROMIS Sleep Disturbance 8a(Baseline, 7-Week Follow-Up, 14-Week Follow-Up)
- Change in Sleep Problems as Assessed by the PSQI(Baseline, 7-Week Follow-Up, 14-Week Follow-Up)
- Change in Gastrointestinal Problems as Assessed by the PROMIS Reflux-13a(Baseline, 7-Week Follow-Up, 14-Week Follow-Up)