Cognitive and Emotional Skills to Aid Smoking Cessation

NCT03148652 | Withdrawn

• 1 other identifier: 4417E
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

Cigarette smoking is a leading cause of morbidity and mortality in the United States. Among individuals who engage in smoking cessation treatment, attrition rates remain high. Many smokers experience difficulties in regulating their emotions, which reduces their ability to benefit from standard interventions and leads to increased smoking behaviors. In addition, cognitive deficits (e.g., reduced working memory capacity) may prevent smokers from applying information from interventions, making smart choices about the benefits and risks of smoking, and resisting smoking advertisements. This study will test whether adding a working memory training and motivational enhancement component to a standard, evidence-based cognitive behavioral therapy-based smoking cessation program (SCP) can improve treatment adherence and successful quit rates. This study will compare 5 sessions of SCP with an additional wellness-focused component (control intervention) to SCP incorporating motivational enhancement and working memory training ("enhanced" intervention). Participants will be adult smokers recruited from the greater Boston community who are interested in quitting smoking. This study will determine the efficacy, acceptability, and feasibility of the enhanced intervention.

Conditions

Cigarette Smoking

Outcome Measures

Primary Outcomes (2)

• Smoking Status

  Smoking status will be assessed at baseline and each of the follow-up assessments using point-prevalence abstinence (PPA) measures verified with carbon monoxide and saliva cotinine.

  9 weeks.

• Prolonged abstinence (PA)

  Prolonged abstinence is defined as 7 or more consecutive days of smoking or smoking at least 1 cigarette over the 2 consecutive weeks prior to the assessment.

  As informed by assessments from endpoint to final follow-up.

Secondary Outcomes (17)

• Carbon monoxide (CO) testing

  Assessed at baseline, weeks 1-5, 1-week, 2-week, and 1-month follow-up assessments

• Behavioral/emotional markers preceding smoking behavior

  Assessed for the first week of study participation

• Demographic Questionnaire

  Assessed at baseline

• Center for Epidemiological Study - Depression Scale (CES-D)

  Assessed at baseline

• Pittsburgh Sleep Quality Index (PSQI)

  Assessed at baseline

Study Arms (2)

Enhanced Intervention (CBT+working memory training)

EXPERIMENTAL

A standard, manualized cognitive behavioral therapy-based intervention for individuals interested in quitting smoking plus computerized working memory training

Other: Enhanced Intervention Condition

Control Intervention Condition

PLACEBO COMPARATOR

Participants will receive a manualized cognitive behavioral therapy-based intervention

Other: Enhanced Intervention Condition

Interventions

Enhanced Intervention Condition OTHER

The intervention incorporates 1) a standard, evidence-based cognitive behavioral therapy-based smoking cessation program, 2) working memory training, and 3) a motivational enhancement component. Working memory training will be administered via the computerized program Cogmed QM. Investigators will be able to monitor participants' progress throughout the study, using the data that the program gathers.

Control Intervention Condition; Enhanced Intervention (CBT+working memory training)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• adults aged 18 or older, current smoker interested in participating in smoking cessation treatment

You may not qualify if:

• Non-English speaking (operationalized as the inability to read and understand the consent form and converse in spoken English), pregnancy

Sponsors & Collaborators

• Boston University Charles River Campus: lead

Study Sites (1)

Boston University Charles River Campus

Boston, Massachusetts, 02215, United States

Location

Related Publications (1)

• Otto MW, Gorlin EI, Rosenfield D, Patten EA, Bickel WK, Zvolensky MJ, Doan SN. Rescuing cognitive and emotional regulatory skills to aid smoking prevention in at-risk youth: A randomized trial. Contemp Clin Trials. 2018 Jul;70:1-7. doi: 10.1016/j.cct.2018.04.005. Epub 2018 Apr 12.

  PMID: 29655859 DERIVED

MeSH Terms

Conditions

Cigarette Smoking

Condition Hierarchy (Ancestors)

Tobacco Smoking; Smoking; Behavior; Tobacco Use

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Investigator

Study Record Dates

• First Submitted: May 3, 2017
• First Posted: May 11, 2017
• Study Start: October 1, 2018
• Primary Completion: September 1, 2020
• Study Completion: September 1, 2020
• Last Updated: July 10, 2019

Record last verified: 2019-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)