Developing and Pilot Testing a Remote Smoking Cessation Digital Therapeutic for Individuals With Serious Mental Illness

Not Applicable

Not yet recruiting

• Conditions: Smoking Cessation
• Interventions: Combination Product: LTQ

• Registration Number: NCT05031416
• Lead Sponsor: Johns Hopkins University

Brief Summary

This is a pilot randomized clinical trial testing an implementation intervention to support delivery of a smoking cessation app tailored to the needs of those individuals with SMI who at community mental health programs.

Detailed Description

Learn to Quit (LTQ), an evidence-based smoking cessation app tailored to the needs of individuals with serious mental illness (SMI) that demonstrated promising smoking cessation outcomes in a recent pilot randomized controlled trial (R00 DA037276). In parallel, several trials demonstrated that widely available social media platforms can be effectively utilized to enhance the effects of standard of care evidence-based smoking cessation treatments. Both approaches capitalize on highly scalable digital technologies, and are therefore likely to have population level impact. Drawing from these two separate programs of research, the central premise of this proposal is that LTQ, a stand-alone smoking cessation app tailored to patients with SMI, can be enhanced with peer-support delivered on social media. Therefore, this proposal seeks to develop and asses the acceptability and feasibility of LTQ-Connect -- the integration of the evidence-based smoking cessation app, LTQ, with social support delivered via social media -- to boost the efficacy and community reach of digital therapeutics tailored for patients with SMI. To achieve this goal, we will:

(1) determine the ideal design requirements of an LTQ-Connect integration among smokers with SMI, and (2) investigate the feasibility of LTQ-Connect in a single group pilot trial. Both interventions will be combined with nicotine replacement therapy, a safe and widely available medication.

Study Timeline

• Study First Submitted: 2021-08-12
• Study First Submitted QC: 2021-08-26
• Study First Posted: 2021-09-01
• Status Verified: 2024-11
• Last Update Submitted: 2024-11-07
• Last Update Posted: 2024-11-08
• Study Start: 2025-02
• Primary Completion: 2025-06
• Study Completion: 2025-07

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 25

Inclusion Criteria

• Must be a mental health consumer at Johns Hopkins Bayview Adult Psychiatry Program
• A regular smoker who is willing to quit
• Own a smart cell phone
• Willing to participate

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Exclusion Criteria

• Women who report being pregnant or have the intention to become pregnant in the 3 months

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Consumers who smoke at outpatient community mental health clinic	LTQ	Consumers with serious mental illness who attend outpatient community mental health clinic will participate in a smoking cessation with the LTQ application and nicotine replacement therapy

Primary Outcome Measures

Name	Time	Method
Change in Self reported social support	13 weeks	An adapted version of Online Social Support (OSS) scale for smokers will be used to evaluate self-reported social support from online smoking cessation treatment (LTQapp + Facebook group) The OSS scale is a 14 item scale with choices - 1 disagree a lot, to 4 agree a lot. Scale range 14- 56 with higher score indicating better outcome.
App Usability	13 weeks	The System Usability Scale (SUS) is a 10-item scale used to evaluate usability of the LTQ-Connect app. Choices range from 1 strongly disagree, to 5 Strongly agree. Scale range 10-50 with higher score indicating more agreement.
User Engagement with Facebook groups - Likes	13 weeks	The Facebook API will be used to extract number of Facebook likes.
Number of user Interactions with the Learn to Quit (LTQ) app	13 weeks	Google Analytics will be used to extract number of daily app interactions and duration of engagement with LTQ app.
User Engagement with Facebook groups - Posts	13 weeks	The Facebook API will be used to extract number of Facebook posts.
User Engagement with Facebook groups - Comments	13 weeks	The Facebook application programming interface (API) will be used to extract number of Facebook comments.
User Engagement with Facebook groups - Content	13 weeks	The Facebook API will be used to extract engagement content of Facebook posts, comments, and 'likes.'
Duration of user Interactions with the Learn to Quit (LTQ) app	13 weeks	Google Analytics will be used to extract daily duration of interactions with LTQ app in minutes.

Secondary Outcome Measures

Name	Time	Method
Change in number of cigarettes smoked per day	Week 5, Week 9, and Week 13	The Smoking timeline follow-back (TLFB) will be used to estimate the number of cigarettes per day
Psychiatric Functioning	Week 5, Week 9, and Week 13	The Brief Symptom Inventory (BSI) assesses distress participants are experiencing. The BSI is a 13 item scale with choices 0=not at all, to 4= Extremely. A higher score indicates more distress. Score range 0-52.

Trial Locations

Locations (1)

Johns Hopkins University School of Medicine; 🇺🇸 Baltimore, Maryland, United States