N/A
N=109
Remote Guided Caffeine Reduction
Caffeine Dependence · Anxiety · Sleep Disturbance · Gastrointestinal Dysfunction · Sleep Initiation and Maintenance Disorders
Bottom Line
View on ClinicalTrials.gov: NCT04560595 ↗Enrolled (actual)
109
Serious AEs
0.0%
Results posted
Jan 2025
Primary outcome: Primary: Number of Participants With Treatment Retention as Assessed by Number of Participants With Completed Assessments — 51; 51; 50; 46 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Caffeine Reduction Manual (Behavioral)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Johns Hopkins University
- Primary completion
- Aug 2023
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Treatment Retention as Assessed by Number of Participants With Completed Assessments |
51; 51; 50; 46; 48; 45 | — |
| PRIMARY Treatment Acceptability as Assessed by Treatment Acceptability Questionnaire |
2.50; 2.55 | — |
| SECONDARY Change in Caffeine Consumption (in Milligrams) |
617.34; 516.30; 602.90; 553.60; 221.58; 173.14 | — |
| SECONDARY Change in Caffeine-related Problems as Assessed by Past-7 Days Standardized Items |
17.85; 19.23; 5.52; 6.28; 4.26; 4.69 | — |
| SECONDARY Change in Anxiety as Assessed by the PROMIS-Anxiety-8a |
57.31; 57.38; 49.78; 49.55; 49.82; 50.6 | — |
| SECONDARY Change in Anxiety as Assessed by the GAD-7 |
6.96; 6.13; 3.76; 3.13; 3.00; 3.24 | — |
| SECONDARY Change in Sleep Problems as Assessed by the PROMIS Sleep Disturbance 8a |
55.54; 53.94; 47.09; 46.57; 45.13; 46.20 | — |
| SECONDARY Change in Sleep Problems as Assessed by the PSQI |
9.21; 8.96; 6.80; 6.15; 5.60; 5.76 | — |
| SECONDARY Change in Gastrointestinal Problems as Assessed by the PROMIS Reflux-13a |
48.35; 49.32; 40.57; 40.73; 40.28; 40.73 | — |
| SECONDARY Change in Gastrointestinal Problems as Assessed by the GSRS |
16.11; 17.64; 8.08; 8.98; 6.96; 9.11 | — |
| SECONDARY Change in Gastrointestinal Problems as Assessed by the PROMIS Diarrhea-6a |
51.31; 50.70; 43.55; 43.61; 44.35; 45.02 | — |
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.
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]
Data sourced from ClinicalTrials.gov (NCT04560595). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.