Outcome
| Type |
Measure |
Description |
Time frame |
Safety issue |
| Primary |
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. |
Up to 14 weeks post-intervention visit |
|
| Primary |
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). |
At 7 weeks post-intervention visit |
|
| Secondary |
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). |
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 |
|
| Secondary |
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. |
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 |
|
| Secondary |
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. |
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 |
|
| Secondary |
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. |
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 |
|
| Secondary |
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. |
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 |
|
| Secondary |
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. |
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 |
|
| Secondary |
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. |
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 |
|
| Secondary |
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. |
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 |
|
| Secondary |
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. |
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 |
|
| Secondary |
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. |
Baseline, at 7 weeks post-intervention visit, at 14 weeks post-intervention visit |
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