NCT03585231

Brief Summary

Conversational agents (CAs) are computer-powered digital coaches designed to form long-term social-emotional connections with users through conversations. We have developed a CA for cigarette smoking cessation. In a pilot randomized trial (N = 415), we will compare the experimental messaging program (n = 155) with the standard of care national government smoking cessation messaging program (n = 157), and then we will compare immediate (n=51) versus delayed (n=51) access to the the experimental messaging program, to assess 12-week usability, receptivity, and preliminary cessation results in adults in western Washington State and nationally across the US who want to quit smoking.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
404

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Sep 2018

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 29, 2018

Completed
13 days until next milestone

First Posted

Study publicly available on registry

July 12, 2018

Completed
2 months until next milestone

Study Start

First participant enrolled

September 17, 2018

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 6, 2019

Completed
12 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 2, 2020

Completed
Last Updated

December 8, 2020

Status Verified

December 1, 2020

Enrollment Period

1.2 years

First QC Date

June 29, 2018

Last Update Submit

December 7, 2020

Conditions

Smoking Cessation

Keywords

SmokingChatbotConversational agentChatbot for quitting smokingMessagingText messagingSMS

Outcome Measures

Primary Outcomes (1)

  • 30-day point prevalence abstinence

    No smoking in the past 30 days, as reported 3 month post treatment.

    3 months post randomization

Study Arms (3)

Experimental

EXPERIMENTAL

This is the experimental arm of the study. This includes receiving immediate access to the novel/experimental smoking cessation messaging program. Therapy description withheld to protect the integrity of the study.

Behavioral: Immediate access to novel messaging program intervention

Control

ACTIVE COMPARATOR

This is the control arm of the study. This includes receiving receiving immediate access to the standard of care smoking cessation messaging program. Therapy description withheld to protect the integrity of the study.

Behavioral: Immediate access to standard of care messaging program intervention

Delayed Control

ACTIVE COMPARATOR

This is the second control arm of the study. This includes receiving the novel/experimental smoking cessation messaging program after completing the 3-month follow-up survey. Therapy description withheld to protect the integrity of the study.

Behavioral: Delayed access to novel novel messaging program intervention

Interventions

Immediate access to novel messaging program interventionBEHAVIORAL

The experimental arm includes an immediate intervention using a novel messaging program for smoking cessation.

Experimental
Immediate access to standard of care messaging program interventionBEHAVIORAL

The immediate control intervention uses a standard of care messaging program for smoking cessation.

Control
Delayed access to novel novel messaging program interventionBEHAVIORAL

The delayed control intervention uses the novel messaging program for smoking cessation.

Delayed Control

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • age 18 or older
  • smokes at least five cigarettes daily for at least past 12 months
  • wants to quit cigarette smoking in the next 14 days
  • if concurrently using any other nicotine or tobacco products, wants to quit using them within the next 14days
  • resides in western Washington State (in the following counties: Clallam, Grays Harbor, Island, Jefferson, King, Kitsap, Mason, Pierce, San Juan, Skagit, Snohomish, Thurston, and Whatcom)
  • interested in learning skills to quit smoking
  • willing to be randomly assigned to either condition
  • has at least daily access to their own personal smartphone
  • has and uses both text messaging and Facebook Messenger on their smartphone
  • willing and able to read in English
  • not using other smoking cessation interventions (including apps or our other intervention studies).
  • willing to complete one 3-month follow-up survey
  • willing to provide email, phone, and mailing address.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Fred Hutchinson Cancer Research Center

Seattle, Washington, 98109, United States

Location

Related Publications (1)

  • Bricker JB, Sullivan B, Mull K, Santiago-Torres M, Lavista Ferres JM. Conversational Chatbot for Cigarette Smoking Cessation: Results From the 11-Step User-Centered Design Development Process and Randomized Controlled Trial. JMIR Mhealth Uhealth. 2024 Jul 23;12:e57318. doi: 10.2196/57318.

    PMID: 38913882DERIVED

MeSH Terms

Conditions

Smoking CessationSmoking

Condition Hierarchy (Ancestors)

Health BehaviorBehavior

Study Officials

  • Jonathan Bricker, PhD

    Fred Hutchinson Cancer Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 29, 2018

First Posted

July 12, 2018

Study Start

September 17, 2018

Primary Completion

December 6, 2019

Study Completion

December 2, 2020

Last Updated

December 8, 2020

Record last verified: 2020-12

Data Sharing

IPD Sharing
Will not share

Locations

US(1)