Feasibility Trial of a Tailored Smoking Cessation App for People With Serious Mental Illness
2 other identifiers
interventional
63
1 country
1
Brief Summary
Quitting smoking has important health benefits for people with serious mental illness, more than half of whom are smokers. Smoking reductions in this population, in turn, could contribute to saving billions of dollars in healthcare expenditures. Finding ways to deliver more effective and wider reaching smoking cessation interventions to individuals with serious mental illness is a pressing priority. Smartphone apps are a wide reaching technology that could provide a viable platform to deliver smoking cessation interventions for individuals with serious mental illness. However, do smoking cessation apps need to be tailored for people with serious mental illness to ensure their success? Or can providers simply use standard and freely available smoking cessation mobile health treatments designed for the general population? Furthermore, is it feasible to conduct mHealth trials in this population? Therefore, this trial will test whether (1) a tailored smoking cessation app for people with serious mental illness results in higher levels of engagement with smoking cessation content as compared to an app designed for the general population and (2) smoking cessation mHealth trials can be feasibly conducted in this population.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1
Started May 2017
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 22, 2017
CompletedFirst Posted
Study publicly available on registry
March 3, 2017
CompletedStudy Start
First participant enrolled
May 15, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 17, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
January 17, 2019
CompletedResults Posted
Study results publicly available
March 23, 2020
CompletedNovember 10, 2020
October 1, 2020
1.7 years
February 22, 2017
January 17, 2020
October 21, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (10)
Days of App Use
Frequency of app openings in each group
Daily throughout study duration, 4 months
Duration of App Use
Mean duration of app use in each group over the course of study participation (4 months)
Daily throughout study duration, 4 months
Feasibility as Measured by Study Accrual Relative to Recruitment Goal
Percent of subjects consented into study relative to study recruitment goal (N=90).92 subjects signed consent prior to eligibility determination and randomization.
Approximately 15 months
Feasibility as Measured by Study Attrition
Number and percentage of subjects who complete 4-month follow up assessment
4-months
Recruitment Yield Effort
Percent of subjects responding to ads and clinician referrals
Approximately 15 months
Feasibility of Measurement Strategy
Percent completion of assessment measures. Assessment measures include surveys, questionnaires, and cognitive tasks.
Approximately 19 months
Usability of App Design as Measured by the System Usability Scale (SUS)
10-item scale giving a global assessment of systems usability using a 5-point Likert Scale with a composite score ranging from 0-100. Higher scores indicate higher usability rating.
1-month follow-up
Usability of App Design as Measured by the System Usability Scale (SUS)
10-item scale giving a global assessment of systems usability using a 5-point Likert Scale with a composite score ranging from 0-100. Higher scores indicate higher usability rating.
2-month follow-up
Usability of App Design as Measured by the System Usability Scale (SUS)
10-item scale giving a global assessment of systems usability using a 5-point Likert Scale with a composite score ranging from 0-100. Higher scores indicate higher usability rating.
3-month follow-up
Usability of App Design as Measured by the System Usability Scale (SUS)
10-item scale giving a global assessment of systems usability using a 5-point Likert Scale with a composite score ranging from 0-100. Higher scores indicate higher usability rating.
4-month follow-up
Secondary Outcomes (45)
Biochemically Confirmed 7-day Point Prevalence Abstinence
1 month follow-up
Biochemically Confirmed 7-day Point Prevalence Abstinence
2 month follow-up
Biochemically Confirmed 7-day Point Prevalence Abstinence
3 month follow-up
Biochemically Confirmed 7-day Point Prevalence Abstinence
4 month follow-up
Biochemically Confirmed Prolonged Abstinence Rates
1 month follow up
- +40 more secondary outcomes
Study Arms (2)
Learn to Quit
EXPERIMENTALA smartphone app developed by the research team designed for people with serious mental illness, that provides Acceptance and Commitment Therapy skills to address (a) smoking cessation and (b) mental health symptoms.
NCI QuitGuide
ACTIVE COMPARATORA smartphone app developed by the National Cancer Institute which uses smoking cessation recommendations contained in the US DHHS Clinical Practice Guidelines.
Interventions
A smartphone app designed for individuals with serious mental illness. The main intervention components of the app are skills based on an intervention called Acceptance and Commitment Therapy that will (a) teach smoking cessation skills and (b) help cope with mental health symptoms. The app incorporates gaming features to keep users engaged, and a tracking component to record smoking habits and moods.
Participants enrolled in the study will be given an 8-week course of Nicotine patches. The 8-week course of trans-dermal nicotine patches starting at 21mg/24h for 4 weeks, then transitioning to 14mg/24h for 2 weeks, and finally to 7mg/24h for the last 2 weeks. This dosing will follow recommendations contained in the US DHHS Clinical Practice Guidelines.
Each participant will be given a 1-week course of 4mg Nicotine lozenges to be taken orally as nicotine cravings arise (about 10 lozenges per day). They will be directed to use them for the week following their quit date, using no more than once every 1-2 hours. This dosing will follow recommendations contained in the US DHHS Clinical Practice Guidelines.
Coaching to assist the user on the use of each assigned smartphone app. This coaching will be delivered by research staff following a coaching procedure. These in-person coaching meetings will be brief (\~15 minutes), done on a weekly basis for 4 weeks, and will have a focus on providing technical assistance.
A smartphone app developed by the National Cancer Institute which uses recommendations contained in the US DHHS Clinical Practice Guidelines and smokefree.gov. NCI QuitGuide has the following intervention components: (a) psycho-education about the impact of smoking in health, (b) tracking of smoking habits, and (c) Tips for quitting (e.g., distraction strategies).
Eligibility Criteria
You may qualify if:
- ICD-10 diagnosis of schizophrenia, schizoaffective, bipolar or recurring depressive disorder
- Smoking ≥ 5 cigarettes per day over the past 30 days
- Desire to quit smoking in the next 30 days
- Willing and medically eligible to use Nicotine Replacement Therapy
- Fluent in spoken and written English
- Working email, mailing address, or alternative contact person
- Taking psychiatric medications as prescribed by their provider
- Stable housing
You may not qualify if:
- Problematic alcohol or illicit drug use in the last 30 days
- Acute psychotic episode, unsafe to participate in the study, or psychiatrically unstable
- Pregnant, breastfeeding, or having the intention to become pregnant in the next 4 months
- Hearing, comprehension, or visual limitations that preclude study participation
- Currently receiving any pharmacological and/or behavioral intervention or counseling for smoking cessation
- Using non-cigarette forms of tobacco as the primary source of nicotine (e.g. e-cigarettes, chew)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Duke Universitylead
- National Institute on Drug Abuse (NIDA)collaborator
Study Sites (1)
Duke University
Durham, North Carolina, 27705, United States
Related Publications (1)
Browne J, Halverson TF, Vilardaga R. Engagement with a digital therapeutic for smoking cessation designed for persons with psychiatric illness fully mediates smoking outcomes in a pilot randomized controlled trial. Transl Behav Med. 2021 Sep 15;11(9):1717-1725. doi: 10.1093/tbm/ibab100.
PMID: 34347865DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Limitations and Caveats
NRT adherence measure relied on self-report. Participant stratification did not successfully balance presence of mood vs. psychotic disorders in each group. 26% of outcomes measures collected via phone or web survey due to transportation barriers.
Results Point of Contact
- Title
- Dr. Roger Vilardaga
- Organization
- Duke University Psychiatry & Behavioral Sciences
Study Officials
- PRINCIPAL INVESTIGATOR
Roger Vilardaga, PhD
Duke University
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 22, 2017
First Posted
March 3, 2017
Study Start
May 15, 2017
Primary Completion
January 17, 2019
Study Completion
January 17, 2019
Last Updated
November 10, 2020
Results First Posted
March 23, 2020
Record last verified: 2020-10