Porovnání dvou behaviorálních přístupů k odvykání kouření v prostředí duševního zdraví (MTQT)
The study team will conduct a Multisite Randomized Controlled Trial to evaluate the advantages and disadvantages of two approaches for quitting smoking among people with serious mental illness (SMI). The study will compare a novel app tailored to people with SMI, Quit on the Go, to a standard of care smoking cessation intervention. We will test the effectiveness of the Quit on the Go app, an intervention that has demonstrated feasibility and acceptability in the target population, as a tool for smoking cessation in people with SMI. Participants with SMI will be recruited across 3 sites (Duke University, Univ. at Buffalo, and Wake Forest University).
Přehled studie
Postavení
Postavení
Podmínky
Podmínky
Intervence / Léčba
Intervence / Léčba
Detailní popis
Smoking tobacco shortens the lifespan of adults with serious mental illness by 25 years and contributes to 317 billion dollar expenditures in healthcare, indirect loss of earnings and disability benefits. Determining whether it is possible to deliver more effective and wider reaching smoking cessation interventions to individuals with serious mental illness is a high priority. Smartphone apps are a wide-reaching technology that could provide individuals with serious mental illness the necessary skills for quitting. However, our research has shown that apps developed for the general public have inadequate levels usability and engagement in people with serious mental illness.
In a previous pilot trial of a tailored smoking cessation app for people with serious mental illness, Learn to Quit (NCT03069482), we identified successful recruitment and retention methods for smokers with SMI, demonstrated a 4-fold increase in objectively measured interactions of the novel app, obtained promising cessation rates for the experimental app (12% for Quit on the Go formerly "Learn to Quit" versus 3% for NCI QuitGuide), and identified a reliable methodological approach to conduct a fully-powered randomized controlled trial.
Based on this pilot work, we plan to conduct a clinical trial to test this new model in a diverse and representative sample of the SMI population. Specifically, the proposed trial will test whether a tailored smoking cessation app for people with serious mental illness, Quit on the Go, results in higher levels of smoking abstinence compared to a standard of care intervention for this psychiatric population, Brief Advice. Both interventions will receive combined nicotine replacement therapy. The second aim of this trial is to test a mechanistic model of app efficacy by examining mediators of app engagement and treatment outcomes. Finally, the trial will evaluate the cost-effectiveness of these interventions to inform public health policy regard the use of mHealth in this population.
In a multi-site, two-arm randomized controlled trial, 450 individuals with serious mental illness will be randomly assigned to one of two conditions. In the experimental condition, participants will use the Quit on the Go app. In the comparator condition, participants will receive Brief Advice for smoking cessation. Participants in both conditions will receive combined Nicotine Replacement Therapy (standard dosing of nicotine patch plus 5 week course of nicotine gums). Study duration will be 6 months, with 3 follow-up appointments at 1-month, 3-month, and 6-months. Our proposed methods are appropriate given our established procedures during our pilot trial regard to participant assignment, delivery of interventions, data collection and analysis (NCT03069482).
The proposed study meets NIDA's major programmatic priorities of using innovative technologies (e.g., smartphones) and integrating behavioral and pharmacological interventions to improve substance use treatment and outcomes (NOT-DA-10-019). The proposal addresses a serious problem -- high smoking rates in people with SMI -- in a high priority, high cost population, by delivering a novel behavioral intervention for smoking cessation in "real-world" settings. If shown to be effective, the proposed intervention will provide a new model for delivering inexpensive, widely accessible smoking cessation interventions in adults with SMI.
Typ studie
Typ studie
Zápis (Aktuální)
Zápis
Fáze
Fáze
- Nelze použít
Kontakty a umístění
Studijní místa
-
-
New York
-
Buffalo, New York, Spojené státy, 14260-1660
- University at Buffalo
-
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North Carolina
-
Durham, North Carolina, Spojené státy, 27705
- Duke University
-
Winston-Salem, North Carolina, Spojené státy, 27157
- Wake Forest Health Sciences
-
-
Kritéria účasti
Kritéria způsobilosti
Kritéria způsobilosti
Věk způsobilý ke studiu
Přijímá zdravé dobrovolníky
Pohlaví způsobilá ke studiu
Popis
Inclusion Criteria:
- DSM-5 diagnosis of schizophrenia, schizoaffective, bipolar, recurring major depressive disorder or Persistent Depressive Disorder
- Functional impairment as indicated by a score of 2 or greater on the WHODAS 8 item version
- Smoker as indicated by smoking greater than or equal to 5 cigarettes per day over the past 6 months;
- Desire to quit smoking as indicated by self-reported serious intention to quitting tobacco within the next 6 months;
- Age 18 and older;
- Willing and medically eligible to use NRT;
- Currently receiving psychiatric treatment and intent to receive treatment for the duration of the study (therapy, medications, etc.).
Exclusion Criteria
- Problematic substance use, as defined by the Addiction Severity Index, within the last 30 days, twice within the past 6 months, or hospitalization for substance abuse within the past year.
- Current acute psychotic episode or unsafe to participate in the study as defined by the Mini International Neuropsychiatric Interview for Psychotic Disorders (Sheehan et al., 1998);
- Being pregnant or the intention to become pregnant in the next 6 months;
- Currently receiving any pharmacological and/or behavioral intervention or counseling for smoking cessation;
- Currently using e-cigarettes or other tobacco products besides cigarettes > 10 days in the past 30 days.
- Unsafe to participate in the study due to moderate or high risk of suicide determined by the Columbia-Suicide Severity Rating Scale (C-SSRS) - Screen Version, defined as answering 'yes' to both question 3 for the last month and 'yes' to question 6 for lifetime (moderate risk), or 'yes' to questions 4 and 5 for the recent month, or 'yes' to question 6 for the last 3 months (high risk).
Studijní plán
Jak je studie koncipována?
Detaily designu
- Primární účel: Léčba
- Přidělení: Randomizované
- Intervenční model: Paralelní přiřazení
- Maskování: Žádné (otevřený štítek)
Počet zbraní
Zbraně a zásahy
Skupina účastníků / ArmSkupina účastníků / Arm |
Intervence / LéčbaIntervence / Léčba |
|---|---|
|
Experimentální: "Quit on the Go" (formerly "Learn to Quit")
A 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. This app intervention is combined with an 8-week course of nicotine replacement therapy (NRT) patches and a 5-10 week course of NRT gum (or Nicotine Lozenges if unable to use gum). Participants also receive technical smartphone coaching for the first 4 weeks of the study. |
A 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. All participants will receive an 8-week course of transdermal nicotine patches. The first 4 weeks of use will be 21mg/24 hours, followed by 2 weeks of 14mg/24 hours patches, and finally 2 weeks of 7mg/24 hours patches.
Ostatní jména:
Participants randomized to the smartphone app intervention will receive 4 weeks of smartphone coaching given by research staff. The coaching is meant to be a time to address any issues that may rise with the participants' study smartphone or app. Each participant enrolled will be given NRT gum (5-10week course) to be taken orally as nicotine cravings arise. Depending on participants' nicotine dependence, they will receive either the 2mg or 4mg (if they smoke within the first 30 minutes of waking) gum pieces per package instructions. We will direct subjects to use them for the first weeks following their quit date, using no more than one every 1-2 hours.
Ostatní jména:
In cases where participants are unable to chew nicotine gum, lozenges will be sent as a replacement of Nicotine gum. Depending on participants' nicotine dependence, they will receive either the 2mg or 4mg (if they smoke within the first 30 minutes of waking) lozenge pieces per package instructions. We will direct subjects to use them for the first weeks following their quit date, using no more than one every 1-2 hours.
Ostatní jména:
|
|
Jiný: Brief Advice (Standard of Care)
Brief Advice and Combined Nicotine Replacement Therapy (patches and gum or lozenges) has been recommended by the US Clinical Practice Guidelines for patients with psychiatric illness. Brief Advice will consist of 20 minutes of guidance about the use of nicotine replacement therapy, and strategies to initiate and maintain a quit attempt. The intervention is combined with an 8-week course of nicotine replacement therapy (NRT) patches and a 5-10 week course of NRT gum (or Nicotine Lozenges if unable to use gum). |
All participants will receive an 8-week course of transdermal nicotine patches. The first 4 weeks of use will be 21mg/24 hours, followed by 2 weeks of 14mg/24 hours patches, and finally 2 weeks of 7mg/24 hours patches.
Ostatní jména:
Each participant enrolled will be given NRT gum (5-10week course) to be taken orally as nicotine cravings arise. Depending on participants' nicotine dependence, they will receive either the 2mg or 4mg (if they smoke within the first 30 minutes of waking) gum pieces per package instructions. We will direct subjects to use them for the first weeks following their quit date, using no more than one every 1-2 hours.
Ostatní jména:
In cases where participants are unable to chew nicotine gum, lozenges will be sent as a replacement of Nicotine gum. Depending on participants' nicotine dependence, they will receive either the 2mg or 4mg (if they smoke within the first 30 minutes of waking) lozenge pieces per package instructions. We will direct subjects to use them for the first weeks following their quit date, using no more than one every 1-2 hours.
Ostatní jména:
Brief Advice will consist of 20 minutes of guidance about the use of nicotine replacement therapy, and strategies to initiate and maintain a quit attempt. |
Co je měření studie?
Primární výstupní opatření
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
Bio-verified 7-day point-prevalence abstinence at 24 weeks
Časové okno: At 24 weeks from Baseline
|
Abstinence is binary, and requires both (a) self-report of no smoking at all for at least 7 days prior to week 24; and (b) biochemical verification [either expired CO breath test reading of < 5 ppm using the Belfont Micro+® Smokerlyzer test, or of < 6 ppm if using the iCOquit® Smokerlyzer test, or a cotinine level of less than or equal to 30 ng/ml if using an Alere iScreen saliva test]. If the participant does not meet both criteria, they are not considered abstinent. As per convention, participants are assumed to be smoking if they report smoking at the time-point, cannot be reached to provide data at the time-point, or fail to provide a breath and saliva sample at the time-point. |
At 24 weeks from Baseline
|
Sekundární výstupní opatření
Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
Change in average number of cigarettes smoked per day
Časové okno: At 24 weeks from Baseline
|
Change in self-reported number of cigarettes smoked per day, averaged within groups. |
At 24 weeks from Baseline
|
|
Average number of 24-hr quit attempts per group
Časové okno: At 24 weeks from Baseline
|
Average number of quit attempts self-reported per group between baseline and week 24. Quit attempts are defined by no smoking at all for 24 hours or more. |
At 24 weeks from Baseline
|
|
7-day point prevalence abstinence rates
Časové okno: At 12 weeks from Baseline
|
Percent of subjects in each group self-reporting no smoking at all for greater or equal to 7 days prior to the timepoint. |
At 12 weeks from Baseline
|
|
7-day point prevalence abstinence rates
Časové okno: At 24 weeks from Baseline
|
Percent of subjects in each group self-reporting no smoking at all for greater or equal to 7 days prior to the timepoint. |
At 24 weeks from Baseline
|
|
30-day point prevalence abstinence rates
Časové okno: At 12 weeks from Baseline
|
Percent of subjects in each group self-reporting no smoking at all for greater or equal to 30 days prior to the timepoint. |
At 12 weeks from Baseline
|
|
30-day point prevalence abstinence rates
Časové okno: At 24 weeks from Baseline
|
Percent of subjects in each group self-reporting no smoking at all for greater or equal to 30 days prior to the timepoint. |
At 24 weeks from Baseline
|
|
Biochemically confirmed 7-day point prevalence abstinence rates
Časové okno: At 12 weeks from Baseline
|
Percent of subjects in each group self-reporting no smoking at all for greater or equal to 7 days prior to the time point. Abstinence requires both (a) self-report of no smoking at all for at least 7 days prior to week 24; and (b) biochemical verification [either expired CO breath test reading of < 5 ppm using the Belfont Micro+® Smokerlyzer test, or of < 6 ppm if using the iCOquit® Smokerlyzer test, or a cotinine level of less than or equal to 30 ng/ml if using an Alere iScreen saliva test]. If the participant does not meet both criteria, they are not considered abstinent. |
At 12 weeks from Baseline
|
Další výstupní opatření
Další výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
Average frequency of app use
Časové okno: Weeks 0-24
|
Average frequency of app use over the 24-week study period. Measured by average number of app openings. |
Weeks 0-24
|
|
Average duration of app use
Časové okno: Weeks 0-24
|
Average duration of app use over the 24-week study period. |
Weeks 0-24
|
|
Average number of app modules completed
Časové okno: Weeks 0-24
|
Average number of app modules completed over the 24-week study period. |
Weeks 0-24
|
|
Average app usability scores
Časové okno: At 4 weeks from baseline
|
Average self-reported scores of usability on the 10-item System Usability Scale. Scores range from 0-100 with higher scores indicating higher usability of the app. |
At 4 weeks from baseline
|
|
Average user experience scores
Časové okno: At 4 weeks from baseline
|
Average self-reported scores of user experience using the User Experience Questionnaire - Short Version. |
At 4 weeks from baseline
|
|
Average user experience scores
Časové okno: At 12 weeks from baseline
|
Average self-reported scores of user experience using the User Experience Questionnaire - Short Version. |
At 12 weeks from baseline
|
|
Average user experience scores
Časové okno: At 24 weeks from baseline
|
Average self-reported scores of user experience using the User Experience Questionnaire - Short Version. |
At 24 weeks from baseline
|
|
Average acceptance of physical smoking cravings
Časové okno: At 4 weeks from baseline
|
Average self-reported scores of acceptance of cravings on the physical sensations subscale of the Avoidance and Inflexibility Scale. Scores range from 4-20 with lower scores indicating more acceptance of smoking cravings. |
At 4 weeks from baseline
|
|
Average acceptance of physical smoking cravings
Časové okno: At 12 weeks from baseline
|
Average self-reported scores of acceptance of cravings on the physical sensations subscale of the Avoidance and Inflexibility Scale. Scores range from 4-20 with lower scores indicating more acceptance of smoking cravings. |
At 12 weeks from baseline
|
|
Average acceptance of physical smoking cravings
Časové okno: At 24 weeks from baseline
|
Average self-reported scores of acceptance of cravings on the physical sensations subscale of the Avoidance and Inflexibility Scale. Scores range from 4-20 with lower scores indicating more acceptance of smoking cravings. |
At 24 weeks from baseline
|
|
Nicotine patch use
Časové okno: At 12 weeks from baseline
|
Average number of days (out of 56 possible) per arm that participants used the nicotine patch. |
At 12 weeks from baseline
|
|
Nicotine gum use
Časové okno: At 12 weeks from baseline
|
Average number of nicotine gum used per arm. |
At 12 weeks from baseline
|
|
Smoking Costs at 4 Weeks
Časové okno: At 4 weeks from baseline
|
Average costs of smoking per group as measured by the Smoking Costs Questionnaire |
At 4 weeks from baseline
|
|
Smoking Costs at 12 Weeks
Časové okno: At 12 weeks from baseline
|
Average costs of smoking per group as measured by the Smoking Costs Questionnaire |
At 12 weeks from baseline
|
|
Smoking Costs at 24 Weeks
Časové okno: At 24 weeks from baseline
|
Average costs of smoking per group as measured by the Smoking Costs Questionnaire |
At 24 weeks from baseline
|
|
Costs of technical coaching
Časové okno: At 24 weeks from baseline
|
Cost of technical coaching calls estimated by number of technical coaching calls to assist with the use of the QoG DTx |
At 24 weeks from baseline
|
|
Experiences of racism at week 4
Časové okno: At 4 weeks from baseline
|
Self-reported experiences of racism per group as measured by the Everyday Discrimination Scale |
At 4 weeks from baseline
|
|
Experiences of racism at week 12
Časové okno: At 12 weeks from baseline
|
Self-reported experiences of racism per group as measured by the Everyday Discrimination Scale |
At 12 weeks from baseline
|
|
Experiences of racism at week 24
Časové okno: At 24 weeks from baseline
|
Self-reported experiences of racism per group as measured by the Everyday Discrimination Scale |
At 24 weeks from baseline
|
|
Quality of Life at week 4
Časové okno: At 4 weeks from baseline
|
Self-reported quality of life per group as measured by the World Health Organization Quality of Life Scale - BREF |
At 4 weeks from baseline
|
|
Quality of Life at week 12
Časové okno: At 12 weeks from baseline
|
Self-reported quality of life per group as measured by the World Health Organization Quality of Life Scale - BREF |
At 12 weeks from baseline
|
|
Quality of Life at week 24
Časové okno: At 24 weeks from baseline
|
Self-reported quality of life per group as measured by the World Health Organization Quality of Life Scale - BREF |
At 24 weeks from baseline
|
|
Frequency of e-cigarette use at Week 4
Časové okno: At 4 weeks from baseline
|
Average number of days of e-cigarette use per group as measured by a Timeline Follow Back Interview |
At 4 weeks from baseline
|
|
Frequency of e-cigarette use at Week 12
Časové okno: At 12 weeks from baseline
|
Average number of days of e-cigarette use per group as measured by a Timeline Follow Back Interview |
At 12 weeks from baseline
|
|
Frequency of e-cigarette use at Week 24
Časové okno: At 24 weeks from baseline
|
Average number of days of e-cigarette use per group as measured by a Timeline Follow Back Interview |
At 24 weeks from baseline
|
|
Frequency of use of other tobacco products at week 4
Časové okno: At 4 weeks from baseline
|
Average number of days of use of other tobacco products per group as measured by a Timeline Follow Back Interview. |
At 4 weeks from baseline
|
|
Frequency of use of other tobacco products at week 12
Časové okno: At 12 weeks from baseline
|
Average number of days of use of other tobacco products per group as measured by a Timeline Follow Back Interview. |
At 12 weeks from baseline
|
|
Frequency of use of other tobacco products at week 24
Časové okno: At 24 weeks from baseline
|
Average number of days of use of other tobacco products per group as measured by a Timeline Follow Back Interview. |
At 24 weeks from baseline
|
|
Frequency of use of cannabis at week 4
Časové okno: At 4 weeks from baseline
|
Average number of days of cannabis per group as measured by a Timeline Follow Back Interview. |
At 4 weeks from baseline
|
|
Frequency of use of cannabis at week 12
Časové okno: At 12 weeks from baseline
|
Average number of days of cannabis per group as measured by a Timeline Follow Back Interview. |
At 12 weeks from baseline
|
|
Frequency of use of cannabis at week 24
Časové okno: At 24 weeks from baseline
|
Average number of days of cannabis per group as measured by a Timeline Follow Back Interview. |
At 24 weeks from baseline
|
|
Frequency of use of alcohol at week 4
Časové okno: At 4 weeks from baseline
|
Average number of days of alcohol use per group as measured by a Timeline Follow Back Interview. |
At 4 weeks from baseline
|
|
Frequency of use of alcohol at week 12
Časové okno: At 12 weeks from baseline
|
Average number of days of alcohol use per group as measured by a Timeline Follow Back Interview. |
At 12 weeks from baseline
|
|
Frequency of use of alcohol at week 24
Časové okno: At 24 weeks from baseline
|
Average number of days of alcohol use per group as measured by a Timeline Follow Back Interview. |
At 24 weeks from baseline
|
Spolupracovníci a vyšetřovatelé
Sponzor
Sponzor
Spolupracovníci
Spolupracovníci
Vyšetřovatelé
Vyšetřovatelé
- Vrchní vyšetřovatel: Roger Vilardaga, PhD, Wake Forest University
Termíny studijních záznamů
Hlavní termíny studia
Začátek studia (Aktuální)
Začátek studia
Primární dokončení (Aktuální)
Primární dokončení
Dokončení studie (Aktuální)
Dokončení studie
Termíny zápisu do studia
První předloženo
První předloženo
První předloženo, které splnilo kritéria kontroly kvality
První předloženo, které splnilo kritéria kontroly kvality
První zveřejněno (Aktuální)
První zveřejněno
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
Poslední zveřejněná aktualizace
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
Naposledy ověřeno
Naposledy ověřeno
Více informací
Termíny související s touto studií
Další relevantní podmínky MeSH
- Bipolární a příbuzné poruchy
- Schizofrenní spektrum a jiné psychotické poruchy
- Poruchy související s látkami
- Chemicky indukované poruchy
- Poruchy nálady
- Schizofrenie
- Psychotické poruchy
- Bipolární porucha
- Porucha užívání tabáku
- Duševní poruchy
- Terapeutika
- Jídlo
- Strava, jídlo a výživa
- Fyziologické jevy
- Jídlo a nápoje
- Uhlohydráty
- Psychoterapie
- Disciplíny a činnosti chování
- Polymery
- Makromolekulární látky
- Polysacharidy
- Biopolymery
- Rostlinné dásně
- Bonbón
- Žvýkačka
- Krizová intervence
- Zařízení pro ukončení tabáku
- Nicotinová žvýkačka
Další identifikační čísla studie
Další identifikační čísla studie
- IRB00110770
- R01DA047301 (Grant/smlouva NIH USA)
Plán pro data jednotlivých účastníků (IPD)
Plánujete sdílet data jednotlivých účastníků (IPD)?
Informace o lécích a zařízeních, studijní dokumenty
Studuje lékový produkt regulovaný americkým FDA
Studuje produkt zařízení regulovaný americkým úřadem FDA
produkt vyrobený a vyvážený z USA
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