Remote Guided Caffeine Reduction

Johns Hopkins University

Status: Completed

Conditions: Caffeine; Insomnia; Caffeine Abuse; Caffeine-Induced Sleep Disorder, Without Use Disorder; Anxiety Disorders; Anxiety; Caffeine-Induced Anxiety Disorder; Heartburn; Caffeine Withdrawal; Sleep Initiation and Maintenance Disorders; Diarrhea; Caffeine Dependence; Caffeine; Sleep Disorder; Sleep Disorder; Gastrointestinal Dysfunction; Sleep Disturbance

Treatments: Behavioral: Caffeine Reduction Manual

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT04560595

R01DA003890 (U.S. NIH Grant/Contract)

IRB00250925

Details and patient eligibility

About

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.

Full 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.

Enrollment: 109 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: Accepts 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 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]

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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109 participants in 2 patient groups

Caffeine Reduction Manual, Immediate Treatment Group

Experimental group

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.

Treatment:

Behavioral: Caffeine Reduction Manual

Caffeine Reduction Manual, Delayed Treatment Group

Experimental group

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.

Treatment:

Behavioral: Caffeine Reduction Manual