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

Primary Purpose

Smoking Cessation

Status
Not yet recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
LTQ
Sponsored by
Johns Hopkins University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Smoking Cessation

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Johns Hopkins University School of Medicine

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Consumers who smoke at outpatient community mental health clinic

Arm Description

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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
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.

Full Information

First Posted
August 12, 2021
Last Updated
October 6, 2023
Sponsor
Johns Hopkins University
Collaborators
National Institute of Mental Health (NIMH)
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1. Study Identification

Unique Protocol Identification Number
NCT05031416
Brief Title
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

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
November 2023 (Anticipated)
Primary Completion Date
February 2024 (Anticipated)
Study Completion Date
February 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Johns Hopkins University
Collaborators
National Institute of Mental Health (NIMH)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Smoking Cessation

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
25 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Consumers who smoke at outpatient community mental health clinic
Arm Type
Experimental
Arm Description
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 Type
Combination Product
Intervention Name(s)
LTQ
Intervention Description
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
Primary Outcome Measure Information:
Title
Change in Self reported social support
Description
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.
Time Frame
13 weeks
Title
App Usability
Description
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.
Time Frame
13 weeks
Title
Number of user Interactions with the Learn to Quit (LTQ) app
Description
Google Analytics will be used to extract number of daily app interactions and duration of engagement with LTQ app.
Time Frame
13 weeks
Title
Duration of user Interactions with the Learn to Quit (LTQ) app
Description
Google Analytics will be used to extract daily duration of interactions with LTQ app in minutes.
Time Frame
13 weeks
Title
User Engagement with Facebook groups - Posts
Description
The Facebook API will be used to extract number of Facebook posts.
Time Frame
13 weeks
Title
User Engagement with Facebook groups - Comments
Description
The Facebook application programming interface (API) will be used to extract number of Facebook comments.
Time Frame
13 weeks
Title
User Engagement with Facebook groups - Likes
Description
The Facebook API will be used to extract number of Facebook likes.
Time Frame
13 weeks
Title
User Engagement with Facebook groups - Content
Description
The Facebook API will be used to extract engagement content of Facebook posts, comments, and 'likes.'
Time Frame
13 weeks
Secondary Outcome Measure Information:
Title
Change in number of cigarettes smoked per day
Description
The Smoking timeline follow-back (TLFB) will be used to estimate the number of cigarettes per day
Time Frame
Week 5, Week 9, and Week 13
Title
Psychiatric Functioning
Description
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.
Time Frame
Week 5, Week 9, and Week 13

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Joseph Gennusa
Phone
410-281-1130
Email
jgennus1@jhmi.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gail Daumit
Organizational Affiliation
Johns Hopkins University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Johns Hopkins University School of Medicine
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21287
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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