Phase 2
N=184
Behavioral Activation Intervention for Smoking Cessation in Smokers With Depressive Symptoms
Cigarette Smoking
Bottom Line
View on ClinicalTrials.gov: NCT01199380 ↗Enrolled (actual)
184
Serious AEs
1.6%
Results posted
Sep 2020
Primary outcome: Primary: Number of Participants Smoking-Abstinent for 7 Days, 52 Weeks Post Quit Date — 26; 19 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Standard Treatment (Behavioral); Behavioral Activation Treatment for Smoking (Behavioral); Transdermal Nicotine Patch (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- University of Maryland, College Park
- Primary completion
- May 2016
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants Smoking-Abstinent for 7 Days, 52 Weeks Post Quit Date |
26; 19 | — |
Summary
Depression related vulnerabilities are highly comorbid with smoking behavior and dramatically reduce cessation rates among both community and clinical samples. Previous research has examined the efficacy of cognitive-behavioral treatment for individuals with a history of major depressive disorder (MDD) in standard cessation treatment. A broader health impact can be achieved by targeting individuals with current elevated depressive symptoms to address their association with cessation failure. Thus the objective of the present proposal is to conduct a Stage II randomized controlled trial (RCT) comparing the behavioral activation intervention to standard treatment among a similar community sample of 200 adult smokers with elevated depressive symptoms. Participants will be followed over 52 weeks post-quit date and the larger sample size will allow for more complex analysis of cessation outcomes.
Eligibility Criteria
Inclusion Criteria
- Between 18 and 65 years of age
- A regular smoker for at least one year
- Currently smoking an average of at least 10 cigarettes per day
- Want to quit smoking
- Report current elevated depressive symptoms
Exclusion Criteria
- Current Axis I disorder
- Psychoactive substance dependence (excluding nicotine dependence) within the past 6 months
- Current use of psychotropic medication or participation in any form of psychotherapy
- A history of significant medical condition (e.g., cardiovascular , neurological, gastrointestinal), pregnancy and/or breast feeding, or other systemic illness
- Current use of any pharmacotherapy for smoking cessation not provided by the researchers during the quit attempt
Data sourced from ClinicalTrials.gov (NCT01199380). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.