Trial Outcomes & Findings for Remote Guided Caffeine Reduction (NCT NCT04560595)
NCT ID: NCT04560595
Last Updated: 2025-01-14
Results Overview
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.
COMPLETED
NA
109 participants
Treatment Visit, 7-Week Follow-Up, 14-Week Follow-Up
2025-01-14
Participant Flow
Participant milestones
| Measure |
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.
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.
|
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.
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.
|
|---|---|---|
|
Overall Study
STARTED
|
53
|
56
|
|
Overall Study
COMPLETED
|
48
|
45
|
|
Overall Study
NOT COMPLETED
|
5
|
11
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Remote Guided Caffeine Reduction
Baseline characteristics by cohort
| Measure |
Caffeine Reduction Manual, Immediate Treatment Group
n=53 Participants
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.
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.
|
Caffeine Reduction Manual, Delayed Treatment Group
n=56 Participants
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.
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.
|
Total
n=109 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
53 Participants
n=5 Participants
|
56 Participants
n=7 Participants
|
109 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Continuous
|
45.36 years
STANDARD_DEVIATION 15.42 • n=5 Participants
|
41.96 years
STANDARD_DEVIATION 14.14 • n=7 Participants
|
43.61 years
STANDARD_DEVIATION 14.81 • n=5 Participants
|
|
Sex: Female, Male
Female
|
25 Participants
n=5 Participants
|
29 Participants
n=7 Participants
|
54 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
28 Participants
n=5 Participants
|
27 Participants
n=7 Participants
|
55 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
5 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
48 Participants
n=5 Participants
|
55 Participants
n=7 Participants
|
103 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
5 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
42 Participants
n=5 Participants
|
42 Participants
n=7 Participants
|
84 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
3 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
53 Participants
n=5 Participants
|
56 Participants
n=7 Participants
|
109 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Treatment Visit, 7-Week Follow-Up, 14-Week Follow-UpPopulation: All available data analyzed at each timepoint
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.
Outcome measures
| Measure |
Caffeine Reduction Manual, Immediate Treatment Group
n=53 Participants
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.
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.
|
Caffeine Reduction Manual, Delayed Treatment Group
n=56 Participants
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.
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.
|
|---|---|---|
|
Number of Participants With Treatment Retention as Assessed by Number of Participants With Completed Assessments
Treatment Visit
|
51 Participants
|
51 Participants
|
|
Number of Participants With Treatment Retention as Assessed by Number of Participants With Completed Assessments
14-Week Follow-Up
|
48 Participants
|
45 Participants
|
|
Number of Participants With Treatment Retention as Assessed by Number of Participants With Completed Assessments
7-Week Follow-Up
|
50 Participants
|
46 Participants
|
PRIMARY outcome
Timeframe: 7 weeks Follow-Up visitPopulation: Analysis population consists of participants who completed the week 7 end of treatment 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).
Outcome measures
| Measure |
Caffeine Reduction Manual, Immediate Treatment Group
n=49 Participants
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.
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.
|
Caffeine Reduction Manual, Delayed Treatment Group
n=46 Participants
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.
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.
|
|---|---|---|
|
Treatment Acceptability as Assessed by Treatment Acceptability Questionnaire
|
2.50 score on a scale
Standard Deviation 0.52
|
2.55 score on a scale
Standard Deviation 0.50
|
SECONDARY outcome
Timeframe: Baseline, Treatment Visit, 7-Week Follow-Up, 14-Week Follow-UpPopulation: All available data analyzed at each timepoint
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).
Outcome measures
| Measure |
Caffeine Reduction Manual, Immediate Treatment Group
n=53 Participants
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.
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.
|
Caffeine Reduction Manual, Delayed Treatment Group
n=56 Participants
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.
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.
|
|---|---|---|
|
Change in Caffeine Consumption (in Milligrams)
14-Week Follow-Up
|
219.61 milligrams of caffeine
Standard Deviation 199.06
|
195.56 milligrams of caffeine
Standard Deviation 207.39
|
|
Change in Caffeine Consumption (in Milligrams)
Baseline Visit
|
617.34 milligrams of caffeine
Standard Deviation 354.82
|
516.30 milligrams of caffeine
Standard Deviation 218.79
|
|
Change in Caffeine Consumption (in Milligrams)
Treatment Visit
|
602.90 milligrams of caffeine
Standard Deviation 334.29
|
553.60 milligrams of caffeine
Standard Deviation 246.62
|
|
Change in Caffeine Consumption (in Milligrams)
7-Week Follow-Up
|
221.58 milligrams of caffeine
Standard Deviation 235.60
|
173.14 milligrams of caffeine
Standard Deviation 161.72
|
SECONDARY outcome
Timeframe: Baseline, 7-Week Follow-Up, 14-Week Follow-UpPopulation: All available data analyzed at each timepoint
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.
Outcome measures
| Measure |
Caffeine Reduction Manual, Immediate Treatment Group
n=53 Participants
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.
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.
|
Caffeine Reduction Manual, Delayed Treatment Group
n=56 Participants
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.
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.
|
|---|---|---|
|
Change in Caffeine-related Problems as Assessed by Past-7 Days Standardized Items
14-Week Follow-Up
|
4.26 score on a scale
Standard Deviation 6.25
|
4.69 score on a scale
Standard Deviation 5.53
|
|
Change in Caffeine-related Problems as Assessed by Past-7 Days Standardized Items
Baseline
|
17.85 score on a scale
Standard Deviation 10.57
|
19.23 score on a scale
Standard Deviation 10.88
|
|
Change in Caffeine-related Problems as Assessed by Past-7 Days Standardized Items
7-Week Follow-Up
|
5.52 score on a scale
Standard Deviation 4.89
|
6.28 score on a scale
Standard Deviation 5.92
|
SECONDARY outcome
Timeframe: Baseline, 7-Week Follow-Up, 14-Week Follow-UpPopulation: All available data analyzed at each timepoint
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.
Outcome measures
| Measure |
Caffeine Reduction Manual, Immediate Treatment Group
n=53 Participants
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.
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.
|
Caffeine Reduction Manual, Delayed Treatment Group
n=56 Participants
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.
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.
|
|---|---|---|
|
Change in Anxiety as Assessed by the PROMIS-Anxiety-8a
Baseline
|
57.31 T-score
Standard Deviation 7.30
|
57.38 T-score
Standard Deviation 5.96
|
|
Change in Anxiety as Assessed by the PROMIS-Anxiety-8a
14-Week Follow-Up
|
49.82 T-score
Standard Deviation 7.69
|
50.6 T-score
Standard Deviation 8.78
|
|
Change in Anxiety as Assessed by the PROMIS-Anxiety-8a
7-Week Follow-Up
|
49.78 T-score
Standard Deviation 8.62
|
49.55 T-score
Standard Deviation 7.44
|
SECONDARY outcome
Timeframe: Baseline, 7-Week Follow-Up, 14-Week Follow-UpPopulation: All available data analyzed at each timepoint
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.
Outcome measures
| Measure |
Caffeine Reduction Manual, Immediate Treatment Group
n=53 Participants
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.
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.
|
Caffeine Reduction Manual, Delayed Treatment Group
n=56 Participants
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.
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.
|
|---|---|---|
|
Change in Anxiety as Assessed by the GAD-7
Baseline
|
6.96 score on a scale
Standard Deviation 5.79
|
6.13 score on a scale
Standard Deviation 5.39
|
|
Change in Anxiety as Assessed by the GAD-7
7-Week Follow-Up
|
3.76 score on a scale
Standard Deviation 4.84
|
3.13 score on a scale
Standard Deviation 3.20
|
|
Change in Anxiety as Assessed by the GAD-7
14-Week Follow-up
|
3.00 score on a scale
Standard Deviation 4.34
|
3.24 score on a scale
Standard Deviation 4.03
|
SECONDARY outcome
Timeframe: Baseline, 7-Week Follow-Up, 14-Week Follow-UpPopulation: All available data analyzed at each timepoint
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.
Outcome measures
| Measure |
Caffeine Reduction Manual, Immediate Treatment Group
n=53 Participants
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.
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.
|
Caffeine Reduction Manual, Delayed Treatment Group
n=56 Participants
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.
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.
|
|---|---|---|
|
Change in Sleep Problems as Assessed by the PROMIS Sleep Disturbance 8a
Baseline
|
55.54 T-score
Standard Deviation 6.96
|
53.94 T-score
Standard Deviation 6.57
|
|
Change in Sleep Problems as Assessed by the PROMIS Sleep Disturbance 8a
7-Week Follow-Up
|
47.09 T-score
Standard Deviation 9.12
|
46.57 T-score
Standard Deviation 6.74
|
|
Change in Sleep Problems as Assessed by the PROMIS Sleep Disturbance 8a
14-Week Follow-Up
|
45.13 T-score
Standard Deviation 7.17
|
46.20 T-score
Standard Deviation 6.56
|
SECONDARY outcome
Timeframe: Baseline, 7-Week Follow-Up, 14-Week Follow-UpPopulation: All available data analyzed at each timepoint
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.
Outcome measures
| Measure |
Caffeine Reduction Manual, Immediate Treatment Group
n=53 Participants
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.
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.
|
Caffeine Reduction Manual, Delayed Treatment Group
n=56 Participants
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.
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.
|
|---|---|---|
|
Change in Sleep Problems as Assessed by the PSQI
Baseline
|
9.21 score on a scale
Standard Deviation 3.64
|
8.96 score on a scale
Standard Deviation 3.16
|
|
Change in Sleep Problems as Assessed by the PSQI
7-Week Follow-Up
|
6.80 score on a scale
Standard Deviation 3.56
|
6.15 score on a scale
Standard Deviation 2.97
|
|
Change in Sleep Problems as Assessed by the PSQI
14-Week Follow-Up
|
5.60 score on a scale
Standard Deviation 3.39
|
5.76 score on a scale
Standard Deviation 2.80
|
SECONDARY outcome
Timeframe: Baseline, 7-Week Follow-Up, 14-Week Follow-UpPopulation: All available data analyzed at each timepoint.
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.
Outcome measures
| Measure |
Caffeine Reduction Manual, Immediate Treatment Group
n=53 Participants
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.
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.
|
Caffeine Reduction Manual, Delayed Treatment Group
n=56 Participants
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.
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.
|
|---|---|---|
|
Change in Gastrointestinal Problems as Assessed by the PROMIS Reflux-13a
Baseline
|
48.35 T-score
Standard Deviation 8.71
|
49.32 T-score
Standard Deviation 7.49
|
|
Change in Gastrointestinal Problems as Assessed by the PROMIS Reflux-13a
7-Week Follow-Up
|
40.57 T-score
Standard Deviation 7.17
|
40.73 T-score
Standard Deviation 5.88
|
|
Change in Gastrointestinal Problems as Assessed by the PROMIS Reflux-13a
14-Week Follow-Up
|
40.28 T-score
Standard Deviation 7.32
|
40.73 T-score
Standard Deviation 6.34
|
SECONDARY outcome
Timeframe: Baseline, 7-Week Follow-Up, 14-Week Follow-UpPopulation: All available data analyzed at each timepoint.
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.
Outcome measures
| Measure |
Caffeine Reduction Manual, Immediate Treatment Group
n=53 Participants
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.
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.
|
Caffeine Reduction Manual, Delayed Treatment Group
n=56 Participants
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.
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.
|
|---|---|---|
|
Change in Gastrointestinal Problems as Assessed by the GSRS
Baseline
|
16.11 score on a scale
Standard Deviation 12.84
|
17.64 score on a scale
Standard Deviation 15.60
|
|
Change in Gastrointestinal Problems as Assessed by the GSRS
7-Week Follow-Up
|
8.08 score on a scale
Standard Deviation 8.28
|
8.98 score on a scale
Standard Deviation 8.86
|
|
Change in Gastrointestinal Problems as Assessed by the GSRS
14-Week Follow-Up
|
6.96 score on a scale
Standard Deviation 9.36
|
9.11 score on a scale
Standard Deviation 9.11
|
SECONDARY outcome
Timeframe: Baseline, 7-Week Follow-Up, 14-Week Follow-UpPopulation: All available data analyzed at each timepoint.
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.
Outcome measures
| Measure |
Caffeine Reduction Manual, Immediate Treatment Group
n=53 Participants
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.
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.
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Caffeine Reduction Manual, Delayed Treatment Group
n=56 Participants
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.
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.
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Change in Gastrointestinal Problems as Assessed by the PROMIS Diarrhea-6a
Baseline
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51.31 T-score
Standard Deviation 9.07
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50.70 T-score
Standard Deviation 8.81
|
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Change in Gastrointestinal Problems as Assessed by the PROMIS Diarrhea-6a
7-Week Follow-Up
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43.55 T-score
Standard Deviation 7.05
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43.61 T-score
Standard Deviation 5.92
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Change in Gastrointestinal Problems as Assessed by the PROMIS Diarrhea-6a
14-Week Follow-Up
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44.35 T-score
Standard Deviation 7.59
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45.02 T-score
Standard Deviation 6.91
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Adverse Events
Caffeine Reduction Manual, Immediate Treatment Group
Caffeine Reduction Manual, Delayed Treatment Group
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place