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.
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 Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
The investigators will test the LTQ-Connect application and a standard 10-week course of nicotine replacement therapy (NRT) nicotine patches, and Facebook groups, which will run for a total of 3 months with research study participants
Johns Hopkins University School of Medicine
Baltimore, Maryland, United States
Change in Self reported social support
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.
Time frame: 13 weeks
App Usability
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.
Time frame: 13 weeks
Number of user Interactions with the Learn to Quit (LTQ) app
Google Analytics will be used to extract number of daily app interactions and duration of engagement with LTQ app.
Time frame: 13 weeks
Duration of user Interactions with the Learn to Quit (LTQ) app
Google Analytics will be used to extract daily duration of interactions with LTQ app in minutes.
Time frame: 13 weeks
User Engagement with Facebook groups - Posts
The Facebook API will be used to extract number of Facebook posts.
Time frame: 13 weeks
User Engagement with Facebook groups - Comments
The Facebook application programming interface (API) will be used to extract number of Facebook comments.
Time frame: 13 weeks
User Engagement with Facebook groups - Likes
The Facebook API will be used to extract number of Facebook likes.
Time frame: 13 weeks
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User Engagement with Facebook groups - Content
The Facebook API will be used to extract engagement content of Facebook posts, comments, and 'likes.'
Time frame: 13 weeks
Change in number of cigarettes smoked per day
The Smoking timeline follow-back (TLFB) will be used to estimate the number of cigarettes per day
Time frame: Week 5, Week 9, and Week 13
Psychiatric Functioning
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.
Time frame: Week 5, Week 9, and Week 13