Developing and Pilot Testing a Remote Smoking Cessation Digital Therapeutic for Individuals With Serious Mental Illness
Trial Snapshot
- Phase
- Not Applicable
- Status
- Withdrawn
- Sponsor
- Johns Hopkins University
- Enrollment
- 25
- Locations
- 1
- Primary Endpoint
- Change in Self reported social support
Study Overview
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 Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
Consumers who smoke at outpatient community mental health clinic
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
Intervention: LTQ (Combination Product)
Outcomes
Primary Outcomes
Change in Self reported social support
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 13 weeks
The Facebook API will be used to extract number of Facebook posts.
User Engagement with Facebook groups - Comments
Time Frame: 13 weeks
The Facebook application programming interface (API) will be used to extract number of Facebook comments.
User Engagement with Facebook groups - Content
Time Frame: 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
Time Frame: 13 weeks
Google Analytics will be used to extract daily duration of interactions with LTQ app in minutes.
Secondary Outcomes
- Change in number of cigarettes smoked per day(Week 5, Week 9, and Week 13)
- Psychiatric Functioning(Week 5, Week 9, and Week 13)