Remote Guided Caffeine Reduction

NCT04560595 | Completed Results

• 2 other identifiers: IRB00250925R01DA003890
• Study Type: interventional
• Target: 109
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

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

Keywords

caffeine; caffeine reduction; online study; manualized treatment; caffeine fading; remote intervention; remote trial

Outcome Measures

Primary Outcomes (2)

• 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.

  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).

  7 weeks Follow-Up visit

Secondary Outcomes (9)

• Change in Caffeine Consumption (in Milligrams)

  Baseline, Treatment Visit, 7-Week Follow-Up, 14-Week Follow-Up

• Change in Caffeine-related Problems as Assessed by Past-7 Days Standardized Items

  Baseline, 7-Week Follow-Up, 14-Week Follow-Up

• Change in Anxiety as Assessed by the PROMIS-Anxiety-8a

  Baseline, 7-Week Follow-Up, 14-Week Follow-Up

• Change in Anxiety as Assessed by the GAD-7

  Baseline, 7-Week Follow-Up, 14-Week Follow-Up

• Change in Sleep Problems as Assessed by the PROMIS Sleep Disturbance 8a

  Baseline, 7-Week Follow-Up, 14-Week Follow-Up

Study Arms (2)

Caffeine Reduction Manual, Immediate Treatment Group

EXPERIMENTAL

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

Caffeine Reduction Manual, Delayed Treatment Group

EXPERIMENTAL

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

Interventions

Caffeine Reduction Manual BEHAVIORAL

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

Caffeine Reduction Manual, Delayed Treatment Group; Caffeine Reduction Manual, Immediate Treatment Group

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

Sponsors & Collaborators

• Johns Hopkins University: lead
• National Institute on Drug Abuse (NIDA): collaborator

Study Sites (1)

Behavioral Pharmacology Research Unit, Johns Hopkins Bayview Medical Center

Baltimore, Maryland, 21224, United States

Location

MeSH Terms

Conditions

Anxiety Disorders; Parasomnias; Sleep Initiation and Maintenance Disorders; Sleep Wake Disorders; Heartburn; Diarrhea

Condition Hierarchy (Ancestors)

Mental Disorders; Nervous System Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Signs and Symptoms, Digestive

Results Point of Contact

• Title: Dr. Dustin C. Lee
• Organization: Johns Hopkins University

dlee214@jhmi.edu

410-550-4035

Study Officials

• Dustin Lee, PhD

  Johns Hopkins University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Caffeine consumption and secondary measures will be examined before, during, and after the caffeine reduction intervention and compared between immediate and delayed treatment groups.

Study Record Dates

• First Submitted: September 8, 2020
• First Posted: September 23, 2020
• Study Start: September 10, 2020
• Primary Completion: August 1, 2023
• Study Completion: October 1, 2023
• Last Updated: January 14, 2025
• Results First Posted: January 14, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)