Clinical trial NCT05031416: Developing and Pilot Testing a Remote Smoking Cessation Digital Therapeutic for Individuals With Serious Mental Illness
Official title: Developing and Pilot Testing a Remote Smoking Cessation Digital Therapeutic for Individuals With Serious Mental Illness
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Smoking Cessation
Lead sponsor: Johns Hopkins University
Sponsor class: OTHER
Collaborators: name: National Institute of Mental Health (NIMH)
First posted: 2021-09-01
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Change in Self reported social support
timeFrame: 13 weeks
measure: App Usability
timeFrame: 13 weeks
measure: Number of user Interactions with the Learn to Quit (LTQ) app
timeFrame: 13 weeks
measure: Duration of user Interactions with the Learn to Quit (LTQ) app
timeFrame: 13 weeks
measure: User Engagement with Facebook groups - Posts
timeFrame: 13 weeks
measure: User Engagement with Facebook groups - Comments
timeFrame: 13 weeks
measure: User Engagement with Facebook groups - Likes
timeFrame: 13 weeks
measure: User Engagement with Facebook groups - Content
timeFrame: 13 weeks
Secondary outcomes:
measure: Change in number of cigarettes smoked per day
timeFrame: Week 5, Week 9, and Week 13
measure: Psychiatric Functioning
timeFrame: Week 5, Week 9, and Week 13
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: Johns Hopkins University School of Medicine
state: Maryland
Study officials:
affiliation: Johns Hopkins University
name: Gail Daumit
role: PRINCIPAL_INVESTIGATOR
References: