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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Smoking Cessation

Intervention / Treatment
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* Combination Product: LTQ


Participation Criteria
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Eligibility Criteria
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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 Exclusion Criteria: Women who report being pregnant or have the intention to become pregnant in the 3 months

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Consumers who smoke at outpatient community mental health clinic<br>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 | Combination Product: LTQ<br>* 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<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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. | 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. | 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. | 13 weeks | 
| User Engagement with Facebook groups - Posts | The Facebook API will be used to extract number of Facebook posts. | 13 weeks | 
| User Engagement with Facebook groups - Comments | The Facebook application programming interface (API) will be used to extract number of Facebook comments. | 13 weeks | 
| User Engagement with Facebook groups - Likes | The Facebook API will be used to extract number of Facebook likes. | 13 weeks | 
| User Engagement with Facebook groups - Content | The Facebook API will be used to extract engagement content of Facebook posts, comments, and 'likes.' | 13 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 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. | Week 5, Week 9, and Week 13 |