Smoking Cessation Intervention for Smokers With Depression Receiving Outpatient Psychiatric Treatment



Status:Completed
Conditions:Smoking Cessation
Therapuetic Areas:Pulmonary / Respiratory Diseases
Healthy:No
Age Range:18 - Any
Updated:1/17/2019
Start Date:November 2015
End Date:December 2018

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Brief Mindfulness Cessation Training With EMA for Post-hospital Depressed Smokers

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.

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.

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
We found this trial at
1
site
3550 Jerome Avenue
Bronx, New York 10467
(718) 920-4321
Montefiore Medical Center As the academic medical center and University Hospital for Albert Einstein College...
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mi
from
Bronx, NY
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