Smoking Cessation Intervention for Smokers With Depression Receiving Outpatient Psychiatric Treatment

Smoking Cessation Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02742610
• Other study ID #: 1R34DA037364-01A1
• Status: Completed
• Phase: N/A
• Start date: November 2015
• Est. completion date: December 2018

Study information

• Verified date: January 2019
• Source: Fordham University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: December 2018
• Est. primary completion date: December 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Smoking Cessation

Intervention

Behavioral:
• Mindfulness with Contingency Management

• Active Control

Locations

Country	Name	City	State
United States	Montefiore Medical Center	Bronx	New York

Sponsors (4)

Lead Sponsor	Collaborator
Fordham University	Albert Einstein College of Medicine, Inc., University of Texas at Austin, William Marsh Rice University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Smoking Status	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.	2-week, 4-week, and 3-month post-target quit date assessment visit