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Remote Guided Caffeine Reduction

Primary Purpose

Caffeine Dependence, Anxiety, Sleep Disturbance

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Caffeine Reduction Manual
Sponsored by
Johns Hopkins University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Caffeine Dependence focused on measuring caffeine, caffeine reduction, online study, manualized treatment, caffeine fading, remote intervention, remote trial

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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 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]

Sites / Locations

  • Behavioral Pharmacology Research Unit, Johns Hopkins Bayview Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Caffeine Reduction Manual, Immediate Treatment Group

Caffeine Reduction Manual, Delayed Treatment Group

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Treatment adherence as assessed by percentage of completed assessments
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
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).

Secondary Outcome Measures

Change in caffeine consumption (in milligrams)
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).
Change in caffeine-related problems as assessed by past-7 days standardized items
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.
Change in anxiety as assessed by the PROMIS-Anxiety-8a
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.
Change in anxiety as assessed by the GAD-7
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.
Change in sleep problems as assessed by the PROMIS Sleep Disturbance 8a
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.
Change in sleep problems as assessed by the PSQI
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.
Change in sleep problems as assessed by the Insomnia Severity Index
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.
Change in gastrointestinal problems as assessed by the PROMIS Reflux-13a/Diarrhea-6a
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.
Change in gastrointestinal problems as assessed by the GSRS
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.
Change in caffeine-related problems between immediate and delayed treatment groups
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.

Full Information

First Posted
September 8, 2020
Last Updated
October 5, 2023
Sponsor
Johns Hopkins University
Collaborators
National Institute on Drug Abuse (NIDA)
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1. Study Identification

Unique Protocol Identification Number
NCT04560595
Brief Title
Remote Guided Caffeine Reduction
Official Title
Remote Guided Caffeine Reduction
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Completed
Study Start Date
September 10, 2020 (Actual)
Primary Completion Date
August 1, 2023 (Actual)
Study Completion Date
October 1, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Johns Hopkins University
Collaborators
National Institute on Drug Abuse (NIDA)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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
Keywords
caffeine, caffeine reduction, online study, manualized treatment, caffeine fading, remote intervention, remote trial

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Caffeine consumption and secondary measures will be examined before, during, and after the caffeine reduction intervention and compared between immediate and delayed treatment groups.
Masking
None (Open Label)
Allocation
Randomized
Enrollment
109 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Caffeine Reduction Manual, Immediate Treatment Group
Arm Type
Experimental
Arm Description
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.
Arm Title
Caffeine Reduction Manual, Delayed Treatment Group
Arm Type
Experimental
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Caffeine Reduction Manual
Other Intervention Name(s)
Johns Hopkins Guide to Caffeine Reduction and Cessation
Intervention Description
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.
Primary Outcome Measure Information:
Title
Treatment adherence as assessed by percentage of completed assessments
Description
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.
Time Frame
Up to 14 weeks post-intervention visit
Title
Treatment acceptability as assessed by treatment acceptability questionnaire
Description
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).
Time Frame
At 7 weeks post-intervention visit
Secondary Outcome Measure Information:
Title
Change in caffeine consumption (in milligrams)
Description
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).
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
Title
Change in caffeine-related problems as assessed by past-7 days standardized items
Description
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.
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
Title
Change in anxiety as assessed by the PROMIS-Anxiety-8a
Description
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.
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
Title
Change in anxiety as assessed by the GAD-7
Description
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.
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
Title
Change in sleep problems as assessed by the PROMIS Sleep Disturbance 8a
Description
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.
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
Title
Change in sleep problems as assessed by the PSQI
Description
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.
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
Title
Change in sleep problems as assessed by the Insomnia Severity Index
Description
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.
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
Title
Change in gastrointestinal problems as assessed by the PROMIS Reflux-13a/Diarrhea-6a
Description
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.
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
Title
Change in gastrointestinal problems as assessed by the GSRS
Description
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.
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
Title
Change in caffeine-related problems between immediate and delayed treatment groups
Description
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.
Time Frame
Baseline, at 7 weeks post-intervention visit, at 14 weeks post-intervention visit

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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]
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dustin Lee, PhD
Organizational Affiliation
Johns Hopkins University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Behavioral Pharmacology Research Unit, Johns Hopkins Bayview Medical Center
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21224
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
There is not currently a plan to make individual participant data available to other researchers.

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Remote Guided Caffeine Reduction

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