Behavioral Activation Intervention, Reward Processing, and Youth Smoking Cessation
Recruitment status was Recruiting
Evidence suggests a significant percentage of adolescent regular smokers are interested in trying to quit smoking and frequently make attempts to quit, yet are unsuccessful in maintaining abstinence on their own. Despite a genuine desire to quit on the part of many adolescents, there is an increasing incidence of smoking among older adolescents that runs counter to the overall trends of smoking reduction seen in the general population. Unfortunately, psychosocial and pharmacological smoking interventions have yet to indicate clear effectiveness with youth. Moreover, depression-related vulnerabilities, particularly currently elevated depressive symptoms, are highly comorbid with smoking behavior and dramatically reduce cessation rates. As a result, new approaches to smoking cessation are needed for adolescent smokers with currently elevated depressive symptoms. Thus the objective of the present study is to develop a specialized behavioral activation treatment for smoking in youths ages 18-21 with elevated depressive symptoms. In the first phase we utilize focus groups and pilot testing with 15 youths to develop the behavioral activation smoking treatment for youth (BATSY). In Phase II, we will conduct an open-label trial of BATSY plus nicotine replacement therapy with 30 youths who will also take part in a neuroimaging protocol examining reward sensitivity. Participants will be followed over 26 weeks post-quit date.
|Study Design:||Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Behavioral Activation Intervention, Reward Processing, and Youth Smoking Cessation|
- Smoking abstinence based on expired carbon monoxide tests, urinary cotinine tests, and self report [ Time Frame: 12 months post quit date ] [ Designated as safety issue: No ]
|Study Start Date:||April 2010|
|Estimated Study Completion Date:||April 2013|
|Estimated Primary Completion Date:||March 2013 (Final data collection date for primary outcome measure)|
Experimental: Behavioral Activation Treatment for Smoking
BATSY includes standard smoking cessation strategies and identifying life areas, values, and daily activities to help manage mood. Participants will complete between group exercises and will also monitor and plan daily activities in line with their values. Treatment will be delivered in 8, 60-minute group sessions over an 8-week period.
Drug: Transdermal Nicotine Patch
8 weeks of the Transdermal Nicotine Patch Nicoderm CQ at 24 hour doses of 21, 14, and 7 mg respectively depending on participant's initial level of nicotine use. Nicotine patch dose will decrease at 2 or 4 week increments also specific to participant's initial nicotine level.
This will be a Open-label trial to examine the efficacy of behavioral activation treatment for smoking-youths (BATSY). After completing a focus group phase and pilot study phase of BATSY with 15 youths, we will recruit 30 adolescent smokers with elevated depressive symptoms between the ages of 18-21 into the open-label trial of the the BATSY treatment. All participants in the open-label trial will receive 8 weeks of transdermal nicotine patch in addition to the BATSY intervention. Participants will also undergo an fMRI session including a behavioral task assessing reward sensitivity prior to commencement of the BATSY intervention. We intend to examine both abstinence and relapse outcomes. In addition we will examine to what extent depressive symptoms and reward sensitivity prior to quit date will correspond with improved smoking cessation outcomes over time.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01351766
|Contact: Laura MacPherson, PhDfirstname.lastname@example.org|
|United States, Maryland|
|University of Maryland, College Park||Recruiting|
|College Park, Maryland, United States, 20742|
|Contact: Laura MacPherson, PhD 301-405-7895 email@example.com|
|Principal Investigator:||Laura MacPherson, PhD||University of Maryland|