Clinical trial NCT03148652: Cognitive and Emotional Skills to Aid Smoking Cessation
Official title: Cognitive and Emotional Skills to Aid Smoking Cessation
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Cigarette Smoking
Lead sponsor: Boston University Charles River Campus
Sponsor class: OTHER
First posted: 2017-05-11
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Detailed description: This study is targeting adult smokers in the greater Boston community who are interested in entering smoking cessation treatment. This study will employ a block randomization of 74 smoking participants to one of two intervention conditions: (1) a control condition offering the 5-session standard, smoking cessation program (SCP) plus a wellness component, (2) a treatment condition offering the 5-session SCP, a motivational enhancement component, and working memory training.

Research assessments will consist of participant self-reports of smoking behavior and proximal smoking measures (e.g., cravings) as well as self-report of personality characteristics (e.g., sensation seeking) associated with risk behaviors. CO exhalations will also be evaluated to confirm non-smoking status. Subjects will wear a wrist worn wearable sensor to monitor their physiological data and physical activity. The sensors will measure heart rate, inter-beat interval, electrodermal activity, skin temperature and acceleration signal arising from body movement. Once the data is collected, it will be statistically analyzed and machine learning techniques used to determine if specific physiological and behavioral markers precede smoking behavior (ex fidgeting). In addition, each participant's intervention session attendance and engagement will be recorded by the therapist. Participants in both conditions will make their quit attempt prior to the 5th and final intervention session, and will be invited to return for a follow-up visit at 1 week, 2 weeks, and 1 month after completing the final session, at which time their smoking status and related outcomes will be re-assessed.

Participants who miss more than 50% of intervention sessions will be considered off-protocol, but will remain in the study.

Participants will be randomly assigned to 1 of 2 study conditions. Each intervention is to be delivered over five consecutive weeks. Interventions will be led by Master's- or Doctoral-level study clinicians with ongoing supervision from Dr. Otto. For the working memory training component of the enhanced treatment condition, a computerized training program will be utilized.

All interventions will be delivered in groups with variable group size (1-8 members). Each of the study interventions is to be delivered once per week over five consecutive weeks. Therapy components of the sessions will be 60 minutes in length. Sessions may last, in total, up to 2.5 hours. Between intervention sessions, participants will also be asked to complete homework to practice skills learned during each session.

The first half of each intervention session (across randomized conditions) will consist of material adapted from the Smoking Cessation Program (SCP)-a standard, manualized cognitive behavioral therapy-based intervention for individuals interested in quitting smoking. The program, administered by a trained interventionist, combines empirically validated smoking and relapse prevention techniques. Specific goals of the sessions include targeting barriers to smoking cessation, enhancing self-confidence/preparedness for quitting smoking, and positive lifestyle changes.

Enhanced Intervention Condition

During the second half of each intervention session, participants in the Enhanced Intervention condition will complete 45 minutes of computerized working memory training, adapted from the Cogmed QM program. Participants in this condition will also be asked to use the program a few times a week for 25-35 minutes between sessions,remotely on a home computer or at a computer provided at the BU Translational Research Program lab (to ensure all participants have adequate access to the program). The CogMed QM program has been shown to produce higher effect sizes than other programs including noncommercial programs developed by researchers for the purposes of their studies. It resembles a video game, and comprises several different "games" that require visuo-spatial working memory (remembering the position of objects) and a combination of verbal and visual working memory (remembering phonemes, letters, and digits). The program adapts to the user's performance. If the trainee is doing well, the to-be-remembered list will increase by one item. If the trainee is struggling, the to-be-remembered list will decrease by one item. Accordingly, trainees are able to perform at the limit of their ability, stimulating WM capacity adaptation.

Before and after completing their weekly CogMed QM working memory training task, participants will be asked to reflect on their long-term goals for quitting smoking, using guided imagery about future smoking/non-smoking life status as well as open-ended exploration of the perceived advantages and disadvantages of smoking versus quitting. Participants will be informed of the hypothesized role of working memory training as an exercise to help them keep their long-term goals in mind when cravings and temptations arise, and will be encouraged to use the skills they are practicing during the working memory exercise to help them resist temptations to smoke.

Control Intervention Condition

This control informational intervention has been used in the primary investigator's and other's previous studies. In the current application, it will match the session time of the working memory training and motivational enhancement components in the Enhanced Intervention Condition, and will consist of discussions of a variety of healthy lifestyle topics, such as healthy eating, stress/time management, and recommended health screenings (excluding discussion of smoking, which will be addressed during the SCP component that is common to both intervention conditions).

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

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

Primary outcomes:
measure: Smoking Status
timeFrame: 9 weeks.
measure: Prolonged abstinence (PA)
timeFrame: As informed by assessments from endpoint to final follow-up.
Secondary outcomes:
measure: Carbon monoxide (CO) testing
timeFrame: Assessed at baseline, weeks 1-5, 1-week, 2-week, and 1-month follow-up assessments
measure: Behavioral/emotional markers preceding smoking behavior
timeFrame: Assessed for the first week of study participation
measure: Demographic Questionnaire
timeFrame: Assessed at baseline
measure: Center for Epidemiological Study - Depression Scale (CES-D)
timeFrame: Assessed at baseline
measure: Pittsburgh Sleep Quality Index (PSQI)
timeFrame: Assessed at baseline
measure: Perceived Locus of Causality
timeFrame: Assessed at baseline
measure: Delay Discounting
timeFrame: Assessed at baseline and post-quit week 1
measure: Working Memory Capacity
timeFrame: Assessed at baseline, week 4/study visit 4, and week 2 follow-up/study visit 7
measure: Positive and Negative Affect Schedule
timeFrame: Assessed at baseline, week 4/study visit 4, and week 2 follow-up/study visit 7
measure: Distress Tolerance--Perceived
timeFrame: Assessed at baseline, week 4/study visit 4, and week 2 follow-up/study visit 7)
measure: Distress Tolerance--Behavioral
timeFrame: Assessed at baseline, week 4/study visit 4, and week 2 follow-up/study visit 7)
measure: Satisfaction
timeFrame: Assessed at baseline, week 4/study visit 4, and week 2 follow-up/study visit 7
measure: Readiness to Change
timeFrame: Assessed at baseline, week 4/study visit 4, and week 2 follow-up/study visit 7
measure: Self-efficacy
timeFrame: Assessed at baseline, week 4/study visit 4, and week 2 follow-up/study visit 7)
measure: Treatment Adherence
timeFrame: 9 weeks (throughout study completion).
measure: Executive Function
timeFrame: Assessed at baseline, week 4/study visit 4, and week 2 follow-up/study visit 7
measure: Treatment Acceptability
timeFrame: 9 weeks (throughout study completion).
Other outcomes:
Locations:
city: Boston
country: United States
facility: Boston University Charles River Campus
state: Massachusetts
Study officials:
References:
citation: 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.