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

Smoking Cessation Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05031416
• Other study ID #: IRB00273925
• Secondary ID: P50MH115842
• Status: Not yet recruiting
• Phase: N/A
• Start date: November 2024
• Est. completion date: April 2025

Study information

• Verified date: March 2024
• Source: Johns Hopkins University
• Contact: Joseph Gennusa
• Phone: 410-281-1130
• Email: jgennus1[@]jhmi.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 25
• Est. completion date: April 2025
• Est. primary completion date: March 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Mental Disorders
• Smoking Cessation

Intervention

Combination Product:
• LTQ
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

Locations

Country	Name	City	State
United States	Johns Hopkins University School of Medicine	Baltimore	Maryland

Sponsors (2)

Lead Sponsor	Collaborator
Johns Hopkins University	National Institute of Mental Health (NIMH)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Primary	User Engagement with Facebook groups - Posts	The Facebook API will be used to extract number of Facebook posts.	13 weeks
Primary	User Engagement with Facebook groups - Comments	The Facebook application programming interface (API) will be used to extract number of Facebook comments.	13 weeks
Primary	User Engagement with Facebook groups - Likes	The Facebook API will be used to extract number of Facebook likes.	13 weeks
Primary	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	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
Secondary	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