Remote Guided Caffeine Reduction

  • STATUS
    Recruiting
  • End date
    Aug 25, 2023
  • participants needed
    100
  • sponsor
    Johns Hopkins University
Updated on 25 April 2022
anxiety
sleep disturbances
caffeine
Accepts healthy volunteers

Summary

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.

Description

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.

Details
Condition Caffeine Dependence, Anxiety, Sleep Disturbance, Gastrointestinal Dysfunction, Sleep Initiation and Maintenance Disorders, Caffeine; Sleep Disorder, Caffeine, Caffeine-Induced Anxiety Disorder, Caffeine Withdrawal, Caffeine-Induced Sleep Disorder, Without Use Disorder, Caffeine Abuse, Insomnia, Anxiety Disorders, Sleep Disorder, Heartburn, Diarrhea
Treatment Caffeine Reduction Manual
Clinical Study IdentifierNCT04560595
SponsorJohns Hopkins University
Last Modified on25 April 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

-75 years old
Reside in the United States
Read, write, and speak English fluently
Able to access a video camera on a smartphone, 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

Exclusion Criteria

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]
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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