Brief Summary
This study aims to develop a Mindfulness Smartphone Intervention with Contingency Management (MSI-CM) for smoking cessation that can be readily available to depressed smokers receiving outpatient psychiatric treatment. This project is expected to result in the development of an effective intervention that will produce preliminary data showing increased short-term cessation success in depressed smokers receiving outpatient psychiatric treatment. It is anticipated that this smoking cessation intervention will have potential for broad reach to outpatient psychiatric treatment programs and have a significant overall impact in reducing smoking-related morbidity and mortality by enhancing smoking cessation rates in at-risk populations.
Brief Title
Smoking Cessation Intervention for Smokers With Depression Receiving Outpatient Psychiatric Treatment
Detailed Description
The proposed study will develop a Mindfulness Smartphone Intervention with Contingency Management (MSI-CM) for smoking cessation that can be readily available to depressed smokers receiving outpatient psychiatric treatment. The intervention will involve a series of brief mindfulness training that will be delivered via smartphone, that prompts patients to practice a mindfulness exercise multiple times a day while abstinent: 1) 10-days prior to their target quit date and 2) during the 2-week incentivized abstinence period (using CM) plus an additional 2 weeks (without CM) following their target quit date. We will use CM as an adjunct strategy to enhance the efficacy of mindfulness training due to its utility in producing short-term abstinence, so as to provide opportunities to practice mindfulness without smoking in one's natural environment. We will accomplish this objective by pursuing the following specific aims (in 2 phases):
Phase 1: To develop the MSI-CM intervention intended to improve smoking cessation success among depressed smokers receiving outpatient psychiatric treatment.
1a. We will collaborate with TelASK, Inc. to develop a prototype of a smartphone intervention (MSI-CM).
1b. We will conduct preliminary pilot testing of MSI-CM, in an iterative fashion, with 10 smokers receiving outpatient psychiatric treatment for depression.
Phase 2: To conduct a preliminary, randomized controlled trial (RCT) with depressed 60 smokers receiving outpatient psychiatric treatment.
Phase 1: To develop the MSI-CM intervention intended to improve smoking cessation success among depressed smokers receiving outpatient psychiatric treatment.
1a. We will collaborate with TelASK, Inc. to develop a prototype of a smartphone intervention (MSI-CM).
1b. We will conduct preliminary pilot testing of MSI-CM, in an iterative fashion, with 10 smokers receiving outpatient psychiatric treatment for depression.
Phase 2: To conduct a preliminary, randomized controlled trial (RCT) with depressed 60 smokers receiving outpatient psychiatric treatment.
Categories
Completion Date
Completion Date Type
Actual
Conditions
Smoking Cessation
Eligibility Criteria
Inclusion Criteria:
* be 18 years of age
* be current daily smokers (i.e., at least 5 cigarettes for the past 6 months)
* English-speaking
* motivated to quit smoking (i.e., "intent to quit in the next 3 months")
* have a diagnosis of depressive or bipolar disorders
* engaged in outpatient psychiatric treatment (i.e., has been receiving outpatient psychiatric treatment for at least 3 months AND has received counseling from social worker at outpatient psychiatric treatment clinic at least 3 times in the past 3 months)
Exclusion Criteria:
* acute psychiatric symptomatology which precludes study participation including current active suicidal ideation
* diagnosis of psychotic disorders
* current diagnosis of dementia or cognitive impairment sufficient to impair provision of informed consent or study participation
* patient's inability to provide consent for study participation due to his/her inability to demonstrate an understanding of study procedures as contained in the statement of informed consent, after no more than two explanations
* current clinical diagnosis of intellectual development disorder or autistic disorder
* current (non-nicotine) substance use disorder with the exception of individuals holding 6 months of sobriety and/or receiving treatment including counseling and medications (i.e. methadone, suboxone)
* intention to quit smoking using pharmacotherapy other than transdermal nicotine patches
* pregnant, breastfeeding, or planning to become pregnant within 6 months
* significant history of cardiovascular disease (a standard contraindication for nicotine patch use),
* patient does not have a stable home address where the research team could reliably reach patient, or
* regular (3 or more times in the past month) use of other tobacco products (i.e., cigars, cigarillos, chewing tobacco) or marijuana
* be 18 years of age
* be current daily smokers (i.e., at least 5 cigarettes for the past 6 months)
* English-speaking
* motivated to quit smoking (i.e., "intent to quit in the next 3 months")
* have a diagnosis of depressive or bipolar disorders
* engaged in outpatient psychiatric treatment (i.e., has been receiving outpatient psychiatric treatment for at least 3 months AND has received counseling from social worker at outpatient psychiatric treatment clinic at least 3 times in the past 3 months)
Exclusion Criteria:
* acute psychiatric symptomatology which precludes study participation including current active suicidal ideation
* diagnosis of psychotic disorders
* current diagnosis of dementia or cognitive impairment sufficient to impair provision of informed consent or study participation
* patient's inability to provide consent for study participation due to his/her inability to demonstrate an understanding of study procedures as contained in the statement of informed consent, after no more than two explanations
* current clinical diagnosis of intellectual development disorder or autistic disorder
* current (non-nicotine) substance use disorder with the exception of individuals holding 6 months of sobriety and/or receiving treatment including counseling and medications (i.e. methadone, suboxone)
* intention to quit smoking using pharmacotherapy other than transdermal nicotine patches
* pregnant, breastfeeding, or planning to become pregnant within 6 months
* significant history of cardiovascular disease (a standard contraindication for nicotine patch use),
* patient does not have a stable home address where the research team could reliably reach patient, or
* regular (3 or more times in the past month) use of other tobacco products (i.e., cigars, cigarillos, chewing tobacco) or marijuana
Inclusion Criteria
Inclusion Criteria:
* be 18 years of age
* be current daily smokers (i.e., at least 5 cigarettes for the past 6 months)
* English-speaking
* motivated to quit smoking (i.e., "intent to quit in the next 3 months")
* have a diagnosis of depressive or bipolar disorders
* engaged in outpatient psychiatric treatment (i.e., has been receiving outpatient psychiatric treatment for at least 3 months AND has received counseling from social worker at outpatient psychiatric treatment clinic at least 3 times in the past 3 months)
* be 18 years of age
* be current daily smokers (i.e., at least 5 cigarettes for the past 6 months)
* English-speaking
* motivated to quit smoking (i.e., "intent to quit in the next 3 months")
* have a diagnosis of depressive or bipolar disorders
* engaged in outpatient psychiatric treatment (i.e., has been receiving outpatient psychiatric treatment for at least 3 months AND has received counseling from social worker at outpatient psychiatric treatment clinic at least 3 times in the past 3 months)
Gender
All
Gender Based
false
Healthy Volunteers
No
Last Update Post Date
Last Update Post Date Type
Actual
Last Update Submit Date
Minimum Age
18 Years
NCT Id
NCT02742610
Org Class
Other
Org Full Name
Fordham University
Org Study Id
1R34DA037364-01A1
Overall Status
Completed
Phases
Not Applicable
Primary Completion Date
Primary Completion Date Type
Actual
Official Title
Brief Mindfulness Cessation Training With EMA for Post-hospital Depressed Smokers
Primary Outcomes
Outcome Description
Self-reports of smoking status and verification via CO will be collected at 2-week, 4-week, and 3-month (cotinine level) post-target quit date assessment. The main outcome analyses are based upon 7-day point prevalence abstinence (PPA). As a secondary approach, we will use the timeline followback (TLFB) procedure for assessing the longitudinal course of smoking outcomes. Our approach permits us to follow the standard NCI and NHLBI guidelines for measurement. Biochemical Verification. Self-reported abstinence will be verified by carbon monoxide (CO) analysis of breath samples (6 ppm cutoff) for abstinence of 24 hours to one week for 3-month follow-up. Values above the cutoff will be considered indicative of smoking.
Outcome Measure
Smoking Status
Outcome Time Frame
2-week, 4-week, and 3-month post-target quit date assessment visit
Start Date
Status Verified Date
First Post Date
First Post Date Type
Estimated
First Submit Date
First Submit QC Date
Std Ages
Adult
Older Adult
Maximum Age Number (converted to Years and rounded down)
999
Minimum Age Number (converted to Years and rounded down)
18
Investigators
Investigator Type
Principal Investigator
Investigator Name
Shadi Nahvi
Investigator Email
snahvi@montefiore.org
Investigator Phone