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

NCT05031416 | Withdrawn

• 2 other identifiers: IRB00273925P50MH115842
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Smoking Cessation

Outcome Measures

Primary Outcomes (8)

• 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 Outcomes (2)

• Change in number of cigarettes smoked per day

  Week 5, Week 9, and Week 13

• Psychiatric Functioning

  Week 5, Week 9, and Week 13

Study Arms (1)

Consumers who smoke at outpatient community mental health clinic

EXPERIMENTAL

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

Interventions

LTQ COMBINATION_PRODUCT

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

Consumers who smoke at outpatient community mental health clinic

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Women who report being pregnant or have the intention to become pregnant in the 3 months

Sponsors & Collaborators

• Johns Hopkins University: lead
• National Institute of Mental Health (NIMH): collaborator

Study Sites (1)

Johns Hopkins University School of Medicine

Baltimore, Maryland, 21287, United States

Location

MeSH Terms

Conditions

Smoking Cessation

Condition Hierarchy (Ancestors)

Health Behavior; Behavior

Study Officials

• Gail Daumit

  Johns Hopkins University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 12, 2021
• First Posted: September 1, 2021
• Study Start: June 1, 2025
• Primary Completion: December 1, 2025
• Study Completion: December 1, 2025
• Last Updated: April 4, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)