Remote Guided Caffeine Reduction

October 5, 2023 updated by: Johns Hopkins University
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Interventional

Enrollment (Actual)

109

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • United States
    • Maryland
      • Baltimore, Maryland, United States, 21224
        • Behavioral Pharmacology Research Unit, Johns Hopkins Bayview Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • 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

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]

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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.
Behavioral: Caffeine Reduction Manual
We will provide participants with a Guide to Caffeine Reduction and Cessation in order to help the reduce their caffeine use and determine their ratings of treatment acceptability.
Other Names:
  • Johns Hopkins Guide to Caffeine Reduction and Cessation
Experimental: 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.
Behavioral: Caffeine Reduction Manual
We will provide participants with a Guide to Caffeine Reduction and Cessation in order to help the reduce their caffeine use and determine their ratings of treatment acceptability.
Other Names:
  • Johns Hopkins Guide to Caffeine Reduction and Cessation

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Treatment adherence as assessed by percentage of completed assessments
Time Frame: Up to 14 weeks post-intervention visit
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.
Up to 14 weeks post-intervention visit
Treatment acceptability as assessed by treatment acceptability questionnaire
Time Frame: At 7 weeks post-intervention visit
At the 7 Weeks Follow-Up video visit, we will use an internally-developed standardized treatment acceptability questionnaire to determine as well as self-reported agreement with the items on the treatment acceptability survey (e.g., "Overall, was the Guide to Caffeine Reduction and Cessation easy to use?"; "Overall, was the guide to Caffeine reduction and Cessation helpful?"). Acceptability questions are scored from 0-3 where lower scores indicate less acceptability (e.g., 0=not at all easy, not at all helpful; 3 = very easy, very helpful).
At 7 weeks post-intervention visit

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in caffeine consumption (in milligrams)
Time Frame: Baseline, at the time of intervention visit (within 1-2 weeks of screening), at 7 weeks post-intervention visit, at 14 weeks post-intervention visit
To determine to what extent participants are successfully able to reduce their caffeine consumption following the remote intervention, we will assess caffeine consumption as determined by the standardized caffeine assessments at 7-and 14-week post-treatment follow-ups and compare this with consumption at the screening and treatment televisits. Based on participant responses to the number, type, and amount of caffeinated beverages, caffeine consumption is calculated at each assessment in milligrams (mg).
Baseline, at the time of intervention visit (within 1-2 weeks of screening), at 7 weeks post-intervention visit, at 14 weeks post-intervention visit
Change in caffeine-related problems as assessed by past-7 days standardized items
Time Frame: Baseline, at the time of intervention visit (within 1-2 weeks of screening), at 7 weeks post-intervention visit, at 14 weeks post-intervention visit
To determine to what extent participants report improvement in common caffeine-related problems following the remote intervention, we have developed a standardized measure of the extent to which common problems related to excessive caffeine consumption bothered participants within the past 7 days, e.g., "During the past 7 days, I have consumed caffeine in larger amounts or over a longer period than I intended." Participants rate the extent to which these problems bothered them on a scale from 0-3 where 0 = not at all a problem and 3 = major problem. Higher sum scores on the measure indicate greater caffeine-related problems.
Baseline, at the time of intervention visit (within 1-2 weeks of screening), at 7 weeks post-intervention visit, at 14 weeks post-intervention visit
Change in anxiety as assessed by the PROMIS-Anxiety-8a
Time Frame: Baseline, at the time of intervention visit (within 1-2 weeks of screening), at 7 weeks post-intervention visit, at 14 weeks post-intervention visit
To determine whether caffeine reduction is accompanied by a reduction in day-to-day anxiety, we will utilize the Patient-Reported Outcomes Measurement Information System (PROMIS) Anxiety 8a assessment. The questionnaire asks the extent to which anxiety-related items affected the participants over the past 7 days on a scale of 1 (never) to 5 (always). Higher scores reflect greater anxiety.
Baseline, at the time of intervention visit (within 1-2 weeks of screening), at 7 weeks post-intervention visit, at 14 weeks post-intervention visit
Change in anxiety as assessed by the GAD-7
Time Frame: Baseline, at the time of intervention visit (within 1-2 weeks of screening), at 7 weeks post-intervention visit, at 14 weeks post-intervention visit
To determine whether caffeine reduction is accompanied by a reduction in day-to-day anxiety, we will utilize the Generalized Anxiety Disorder-7 (GAD-7). The GAD-7 consists of items asking the participant to rate on a scale of 0 (not at all) to 3 (nearly every day) the extent they have experienced anxiety related symptoms where higher scores indicate greater anxiety related symptoms.
Baseline, at the time of intervention visit (within 1-2 weeks of screening), at 7 weeks post-intervention visit, at 14 weeks post-intervention visit
Change in sleep problems as assessed by the PROMIS Sleep Disturbance 8a
Time Frame: Baseline, at the time of intervention visit (within 1-2 weeks of screening), at 7 weeks post-intervention visit, at 14 weeks post-intervention visit
To determine whether caffeine reduction is accompanied by a reduction in sleep problems, we will utilize the PROMIS Sleep Disturbance 8a assessment. The questionnaire asks the extent to which sleep-related items affected the participants over the past 7 days on a scale of 1 (not at all) to 5 (very much). Higher scores reflect greater sleep disturbance.
Baseline, at the time of intervention visit (within 1-2 weeks of screening), at 7 weeks post-intervention visit, at 14 weeks post-intervention visit
Change in sleep problems as assessed by the PSQI
Time Frame: Baseline, at the time of intervention visit (within 1-2 weeks of screening), at 7 weeks post-intervention visit, at 14 weeks post-intervention visit
To determine whether caffeine reduction is accompanied by a reduction in sleep problems, we will utilize the Pittsburgh Sleep Quality Index (PSQI), which contains 19 self-rated items for different components where a score of 0 indicates no difficulty and a score of 3 indicates severe difficulty. Higher global scores indicate greater sleep difficulties.
Baseline, at the time of intervention visit (within 1-2 weeks of screening), at 7 weeks post-intervention visit, at 14 weeks post-intervention visit
Change in gastrointestinal problems as assessed by the PROMIS Reflux-13a/Diarrhea-6a
Time Frame: Baseline, at the time of intervention visit (within 1-2 weeks of screening), at 7 weeks post-intervention visit, at 14 weeks post-intervention visit
To determine whether caffeine reduction is accompanied by a reduction in gastrointestinal problems, we will utilize the PROMIS Reflux-13a/Diarrhea-6a. These items ask the extent to which gastrointestinal-related items affected the participants over the past 7 days on a scale of 1 (never) to 5 (always). Higher scores reflect greater gastrointestinal problems.
Baseline, at the time of intervention visit (within 1-2 weeks of screening), at 7 weeks post-intervention visit, at 14 weeks post-intervention visit
Change in gastrointestinal problems as assessed by the GSRS
Time Frame: Baseline, at the time of intervention visit (within 1-2 weeks of screening), at 7 weeks post-intervention visit, at 14 weeks post-intervention visit
To determine whether caffeine reduction is accompanied by a reduction in gastrointestinal problems, we will utilize the Gastrointestinal Symptoms Rating Scale (GSRS) which consists of 15 items describing gastrointestinal distress where responses range from 0 (no discomfort at all) to 6 (very severe discomfort) and where higher scores indicate more severe gastrointestinal symptoms.
Baseline, at the time of intervention visit (within 1-2 weeks of screening), at 7 weeks post-intervention visit, at 14 weeks post-intervention visit
Change in caffeine-related problems between immediate and delayed treatment groups
Time Frame: Baseline, at 7 weeks post-intervention visit, at 14 weeks post-intervention visit
To determine whether participants randomized to the immediate intervention group (at 7-weeks post enrollment and post-treatment) show greater caffeine change in caffeine-related problems relative to the delayed treatment group at 7-weeks post-enrollment (prior to delayed treatment). This randomization will allow us to compare the initial efficacy of our intervention with caffeine reductions that may occur spontaneously over the same duration.
Baseline, at 7 weeks post-intervention visit, at 14 weeks post-intervention visit
Change in sleep problems as assessed by the Insomnia Severity Index
Time Frame: Baseline, at the time of intervention visit (within 1-2 weeks of screening), at 7 weeks post-intervention visit, at 14 weeks post-intervention visit
To determine whether caffeine reduction is accompanied by a reduction in sleep problems, we will utilize the Insomnia Severity Index (PSQI), which contains 5 self-rated items concerning sleep difficulties.
Baseline, at the time of intervention visit (within 1-2 weeks of screening), at 7 weeks post-intervention visit, at 14 weeks post-intervention visit

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Johns Hopkins University

Collaborators

National Institute on Drug Abuse (NIDA)

Investigators

  • Principal Investigator: Dustin Lee, PhD, Johns Hopkins University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 10, 2020

Primary Completion (Actual)

August 1, 2023

Study Completion (Actual)

October 1, 2023

Study Registration Dates

First Submitted

September 8, 2020

First Submitted That Met QC Criteria

September 17, 2020

First Posted (Actual)

September 23, 2020

Study Record Updates

Last Update Posted (Actual)

October 6, 2023

Last Update Submitted That Met QC Criteria

October 5, 2023

Last Verified

October 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IRB00250925
  • R01DA003890 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

There is not currently a plan to make individual participant data available to other researchers.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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