An interventional study of Caffeine Reduction Manual in Caffeine Dependence, Anxiety and Sleep Disturbance, sponsored by Johns Hopkins University. Completed at 1 site in United States. Open to participants aged 18 Years to 75 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-01-14.
Sponsored by Johns Hopkins University · Not applicable, Interventional, and Treatment
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.
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.
7,201 studies on the registry are indexed under Anxiety Disorders; 1,682 are open to participants now.
This study's enrollment of 109 is above the median of 80 across 6,057 interventional studies indexed under Anxiety Disorders.
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Exclusion Criteria:
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
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.
Also known as: Johns Hopkins Guide to Caffeine Reduction and Cessation
Number of Participants With Treatment Retention as Assessed by Number of Participants With 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.
Time frame: Treatment Visit, 7-Week Follow-Up, 14-Week Follow-Up
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 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).
Time frame: 7 weeks Follow-Up visit
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 week post-treatment follow-ups and compare this with consumption at the screening televisit. 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, Treatment Visit, 7-Week Follow-Up, 14-Week Follow-Up
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 19-Item Caffeine Use Disorder 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. The total possible scale range is from 0-57 (because the scores of 0-3 are summed for the 19 items). Higher sum scores on the measure indicate greater caffeine-related problems.
Time frame: Baseline, 7-Week Follow-Up, 14-Week Follow-Up
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) with a total raw score range of 8-40 in which higher scores reflect greater anxiety. Raw scores are then translated into a standardized T-score with a mean of 50 and a standard deviation (SD) of 10. A higher PROMIS T-score represents more of the concept being measured. For negatively-worded concepts like anxiety, a T-score of 60 is one SD worse than average. By comparison, an anxiety T-score of 40 is one SD better than average. A score of less than 55 is none to slight, 55.0-59.9 is mild, 60.0-69.9 is moderate, and 70 and over is severe.
Time frame: Baseline, 7-Week Follow-Up, 14-Week Follow-Up
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. The scoring range is 0-21 and higher scores indicate greater anxiety related symptoms.
Time frame: Baseline, 7-Week Follow-Up, 14-Week Follow-Up
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). The raw scoring range is 8-40 and higher scores reflect greater sleep disturbance. Raw scores are then translated into a standardized T-score with a mean of 50 and a standard deviation (SD) of 10. A higher PROMIS T-score represents more of the concept being measured. For negatively-worded concepts like sleep disturbance, a T-score of 60 is one SD worse than average. By comparison, T-score of 40 is one SD better than average. A T-score of 50 or above is often considered a clinically significant level of sleep disturbance.
Time frame: Baseline, 7-Week Follow-Up, 14-Week Follow-Up
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 and 7 sub-scales for different components where a score of 0 indicates no difficulty and a score of 3 indicates severe difficulty. The scoring range is 0-21 and higher global scores indicate greater sleep difficulties.
Time frame: Baseline, 7-Week Follow-Up, 14-Week Follow-Up
Change in Gastrointestinal Problems as Assessed by the PROMIS Reflux-13a
To determine whether caffeine reduction is accompanied by a reduction in gastrointestinal problems, we will utilize the PROMIS Reflux-13a. 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). The scoring range of raw scores is 13-65 and higher scores reflect greater gastrointestinal problems. Raw scores are then translated into a standardized T-score with a mean of 50 and a standard deviation (SD) of 10. A higher PROMIS T-score represents more of the concept being measured. For negatively-worded concepts like reflux, a T-score of 60 is one SD worse than average. By comparison, an anxiety T-score of 40 is one SD better than average.
Time frame: Baseline, 7-Week Follow-Up, 14-Week Follow-Up
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). The scoring range is 0-90 and higher scores indicate more severe gastrointestinal symptoms.
Time frame: Baseline, 7-Week Follow-Up, 14-Week Follow-Up
Change in Gastrointestinal Problems as Assessed by the PROMIS Diarrhea-6a
To determine whether caffeine reduction is accompanied by a reduction in gastrointestinal problems, we will utilize the PROMIS 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). The raw scoring range is 6-30 and higher scores reflect greater gastrointestinal problems. Raw scores are then translated into a standardized T-score with a mean of 50 and a standard deviation (SD) of 10. A higher PROMIS T-score represents more of the concept being measured. For negatively-worded concepts like diarrhea, a T-score of 60 is one SD worse than average. By comparison, an anxiety T-score of 40 is one SD better than average.
Time frame: Baseline, 7-Week Follow-Up, 14-Week Follow-Up
| Milestone | Caffeine Reduction Manual, Immediate Treatment Group | Caffeine Reduction Manual, Delayed Treatment Group |
|---|---|---|
| Started | 53 | 56 |
| Completed | 48 | 45 |
| Not completed | 5 | 11 |
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.
| Participants | Caffeine Reduction Manual, Immediate Treatment Group | Caffeine Reduction Manual, Delayed Treatment Group |
|---|---|---|
| Treatment Visit | 51 | 51 |
| 7-Week Follow-Up | 50 | 46 |
| 14-Week Follow-Up | 48 | 45 |
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).
| score on a scale | Caffeine Reduction Manual, Immediate Treatment Group | Caffeine Reduction Manual, Delayed Treatment Group |
|---|---|---|
| Treatment Acceptability as Assessed by Treatment Acceptability Questionnaire | 2.50 ± 0.52 | 2.55 ± 0.50 |
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 week post-treatment follow-ups and compare this with consumption at the screening televisit. Based on participant responses to the number, type, and amount of caffeinated beverages, caffeine consumption is calculated at each assessment in milligrams (mg).
| milligrams of caffeine | Caffeine Reduction Manual, Immediate Treatment Group | Caffeine Reduction Manual, Delayed Treatment Group |
|---|---|---|
| Baseline Visit | 617.34 ± 354.82 | 516.30 ± 218.79 |
| Treatment Visit | 602.90 ± 334.29 | 553.60 ± 246.62 |
| 7-Week Follow-Up | 221.58 ± 235.60 | 173.14 ± 161.72 |
| 14-Week Follow-Up | 219.61 ± 199.06 | 195.56 ± 207.39 |
To determine to what extent participants report improvement in common caffeine-related problems following the remote intervention, we have developed a standardized 19-Item Caffeine Use Disorder 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. The total possible scale range is from 0-57 (because the scores of 0-3 are summed for the 19 items). Higher sum scores on the measure indicate greater caffeine-related problems.
| score on a scale | Caffeine Reduction Manual, Immediate Treatment Group | Caffeine Reduction Manual, Delayed Treatment Group |
|---|---|---|
| Baseline | 17.85 ± 10.57 | 19.23 ± 10.88 |
| 7-Week Follow-Up | 5.52 ± 4.89 | 6.28 ± 5.92 |
| 14-Week Follow-Up | 4.26 ± 6.25 | 4.69 ± 5.53 |
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) with a total raw score range of 8-40 in which higher scores reflect greater anxiety. Raw scores are then translated into a standardized T-score with a mean of 50 and a standard deviation (SD) of 10. A higher PROMIS T-score represents more of the concept being measured. For negatively-worded concepts like anxiety, a T-score of 60 is one SD worse than average. By comparison, an anxiety T-score of 40 is one SD better than average. A score of less than 55 is none to slight, 55.0-59.9 is mild, 60.0-69.9 is moderate, and 70 and over is severe.
| T-score | Caffeine Reduction Manual, Immediate Treatment Group | Caffeine Reduction Manual, Delayed Treatment Group |
|---|---|---|
| Baseline | 57.31 ± 7.30 | 57.38 ± 5.96 |
| 7-Week Follow-Up | 49.78 ± 8.62 | 49.55 ± 7.44 |
| 14-Week Follow-Up | 49.82 ± 7.69 | 50.6 ± 8.78 |
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. The scoring range is 0-21 and higher scores indicate greater anxiety related symptoms.
| score on a scale | Caffeine Reduction Manual, Immediate Treatment Group | Caffeine Reduction Manual, Delayed Treatment Group |
|---|---|---|
| Baseline | 6.96 ± 5.79 | 6.13 ± 5.39 |
| 7-Week Follow-Up | 3.76 ± 4.84 | 3.13 ± 3.20 |
| 14-Week Follow-up | 3.00 ± 4.34 | 3.24 ± 4.03 |
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). The raw scoring range is 8-40 and higher scores reflect greater sleep disturbance. Raw scores are then translated into a standardized T-score with a mean of 50 and a standard deviation (SD) of 10. A higher PROMIS T-score represents more of the concept being measured. For negatively-worded concepts like sleep disturbance, a T-score of 60 is one SD worse than average. By comparison, T-score of 40 is one SD better than average. A T-score of 50 or above is often considered a clinically significant level of sleep disturbance.
| T-score | Caffeine Reduction Manual, Immediate Treatment Group | Caffeine Reduction Manual, Delayed Treatment Group |
|---|---|---|
| Baseline | 55.54 ± 6.96 | 53.94 ± 6.57 |
| 7-Week Follow-Up | 47.09 ± 9.12 | 46.57 ± 6.74 |
| 14-Week Follow-Up | 45.13 ± 7.17 | 46.20 ± 6.56 |
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 and 7 sub-scales for different components where a score of 0 indicates no difficulty and a score of 3 indicates severe difficulty. The scoring range is 0-21 and higher global scores indicate greater sleep difficulties.
| score on a scale | Caffeine Reduction Manual, Immediate Treatment Group | Caffeine Reduction Manual, Delayed Treatment Group |
|---|---|---|
| Baseline | 9.21 ± 3.64 | 8.96 ± 3.16 |
| 7-Week Follow-Up | 6.80 ± 3.56 | 6.15 ± 2.97 |
| 14-Week Follow-Up | 5.60 ± 3.39 | 5.76 ± 2.80 |
To determine whether caffeine reduction is accompanied by a reduction in gastrointestinal problems, we will utilize the PROMIS Reflux-13a. 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). The scoring range of raw scores is 13-65 and higher scores reflect greater gastrointestinal problems. Raw scores are then translated into a standardized T-score with a mean of 50 and a standard deviation (SD) of 10. A higher PROMIS T-score represents more of the concept being measured. For negatively-worded concepts like reflux, a T-score of 60 is one SD worse than average. By comparison, an anxiety T-score of 40 is one SD better than average.
| T-score | Caffeine Reduction Manual, Immediate Treatment Group | Caffeine Reduction Manual, Delayed Treatment Group |
|---|---|---|
| Baseline | 48.35 ± 8.71 | 49.32 ± 7.49 |
| 7-Week Follow-Up | 40.57 ± 7.17 | 40.73 ± 5.88 |
| 14-Week Follow-Up | 40.28 ± 7.32 | 40.73 ± 6.34 |
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). The scoring range is 0-90 and higher scores indicate more severe gastrointestinal symptoms.
| score on a scale | Caffeine Reduction Manual, Immediate Treatment Group | Caffeine Reduction Manual, Delayed Treatment Group |
|---|---|---|
| Baseline | 16.11 ± 12.84 | 17.64 ± 15.60 |
| 7-Week Follow-Up | 8.08 ± 8.28 | 8.98 ± 8.86 |
| 14-Week Follow-Up | 6.96 ± 9.36 | 9.11 ± 9.11 |
To determine whether caffeine reduction is accompanied by a reduction in gastrointestinal problems, we will utilize the PROMIS 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). The raw scoring range is 6-30 and higher scores reflect greater gastrointestinal problems. Raw scores are then translated into a standardized T-score with a mean of 50 and a standard deviation (SD) of 10. A higher PROMIS T-score represents more of the concept being measured. For negatively-worded concepts like diarrhea, a T-score of 60 is one SD worse than average. By comparison, an anxiety T-score of 40 is one SD better than average.
| T-score | Caffeine Reduction Manual, Immediate Treatment Group | Caffeine Reduction Manual, Delayed Treatment Group |
|---|---|---|
| Baseline | 51.31 ± 9.07 | 50.70 ± 8.81 |
| 7-Week Follow-Up | 43.55 ± 7.05 | 43.61 ± 5.92 |
| 14-Week Follow-Up | 44.35 ± 7.59 | 45.02 ± 6.91 |
Collected over Up to 14 weeks. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Caffeine Reduction Manual, Immediate Treatment Group | 0/53 (0%) | 0/53 (0%) | 0/53 (0%) |
| Caffeine Reduction Manual, Delayed Treatment Group | 0/56 (0%) | 0/56 (0%) | 0/56 (0%) |
| Age, Categorical(Participants) | Caffeine Reduction Manual, Immediate Treatment Group | Caffeine Reduction Manual, Delayed Treatment Group | Total |
|---|---|---|---|
| <=18 years | 0 | 0 | 0 |
| Between 18 and 65 years | 53 | 56 | 109 |
| >=65 years | 0 | 0 | 0 |
| Age, Continuous(years) | Caffeine Reduction Manual, Immediate Treatment Group | Caffeine Reduction Manual, Delayed Treatment Group | Total |
|---|---|---|---|
| Mean | 45.36 ± 15.42 | 41.96 ± 14.14 | 43.61 ± 14.81 |
| Sex: Female, Male(Participants) | Caffeine Reduction Manual, Immediate Treatment Group | Caffeine Reduction Manual, Delayed Treatment Group | Total |
|---|---|---|---|
| Female | 25 | 29 | 54 |
| Male | 28 | 27 | 55 |
| Ethnicity (NIH/OMB)(Participants) | Caffeine Reduction Manual, Immediate Treatment Group | Caffeine Reduction Manual, Delayed Treatment Group | Total |
|---|---|---|---|
| Hispanic or Latino | 5 | 1 | 6 |
| Not Hispanic or Latino | 48 | 55 | 103 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Race (NIH/OMB)(Participants) | Caffeine Reduction Manual, Immediate Treatment Group | Caffeine Reduction Manual, Delayed Treatment Group | Total |
|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 |
| Asian | 5 | 5 | 10 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Black or African American | 2 | 2 | 4 |
| White | 42 | 42 | 84 |
| More than one race | 3 | 6 | 9 |
| Unknown or Not Reported | 1 | 1 | 2 |
| Region of Enrollment(Participants) | Caffeine Reduction Manual, Immediate Treatment Group | Caffeine Reduction Manual, Delayed Treatment Group | Total |
|---|---|---|---|
| United States | 53 | 56 | 109 |
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: No — There is not currently a plan to make individual participant data available to other researchers.
Ran from Sep 2020 to primary completion in Aug 2023, 34 months.
Results were first posted in Jan 2025, 1 year 5 months after primary completion.
Of 3,836 non-industry interventional studies with no phase under Anxiety Disorders, half reached primary completion within 12 months of starting (the median), counting those still running; a quarter within 5 and three quarters within 28. This study's 34 months is above that.
Counting every sponsor, half of 3,938 studies reached it within 12 months; a quarter within 5 and three quarters within 28.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Jan 2025. You cannot join it, but the record below documents what was studied.
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