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Completed

NCT Number: NCT02742610

Smoking Cessation Intervention for Smokers With Depression Receiving Outpatient Psychiatric Treatment

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Montefiore Medical Center

The Bronx, New York, 10467, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Mindfulness with Contingency Management

Behavioral

Active Control

Behavioral

Primary outcomes

  1. Smoking Status

    Time frame: 2-week, 4-week, and 3-month post-target quit date assessment visit

    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.

Sponsors and collaborators

Lead sponsor

Fordham University

Other

Collaborators

  • Albert Einstein College of Medicine
  • University of Texas at Austin
  • William Marsh Rice University

Registry information

Official study title

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

Important dates

Study start
2015
Primary completion
2018
Study completion
2018
First posted
Apr 19, 2016
Registry last updated
Jan 15, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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