Smoking Cessation for Depressed Smokers
Smoking Cessation Intervention for Depressed Smokers: Treatment Development
4 other identifiers
interventional
91
1 country
1
Brief Summary
Objectives: Primary Aim: To conduct a preliminary randomized trial in smokers with current recurrent major depressive disorder (MDD), current MDD with a single episode of 2 years or more, and current dysthymia comparing combined cognitive behavioral analysis system of psychotherapy (CBASP) and standard smoking cessation treatment (ST) (CBASP/ST) to combined Health Education and ST treatment (HE/ST) to: 1\. Examine the effects of CBASP/ST on both short and long-term point prevalence abstinence Secondary Aims:
- 1.To test the hypothesis that depressed smokers in the CBASP/ST treatment will experience greater decreases in depressive symptoms from baseline to each of our follow-up assessment points, compared to depressed smokers in the HE/ST treatment, and;
- 2.That depressed smokers in the CBASP/ST treatment will experience greater improvements in psychosocial functioning from baseline to follow-up assessment points, compared to depressed smokers in the ST treatment.
- 3.To evaluate between subject neurophysiological predictors of abstinence at 3 and 6 months, and:
- 4.To evaluate within-subject changes in neurophysiological responses to emotional and smoking-related stimuli across treatment sessions, and the relation of these changes to abstinence and depressive symptoms at end of treatment, and 3- and 6-months.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1
Started Jun 2007
Longer than P75 for phase_1
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 28, 2007
CompletedStudy Start
First participant enrolled
June 28, 2007
CompletedFirst Posted
Study publicly available on registry
July 2, 2007
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 30, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
June 30, 2026
April 16, 2026
April 1, 2026
19 years
June 28, 2007
April 13, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Abstinence Rates
Approximately each 12 weeks following end of treatment (about 6 weeks)
Study Arms (2)
CBASP + ST
OTHERCognitive Behavioral Analysis System of Psychotherapy (CBASP) + Smoking Cessation Treatment (ST)
ST
OTHERSmoking Cessation Treatment (ST)
Interventions
12 60-minute individual sessions of standard smoking cessation treatment.
21 mg patch for 4 weeks; 14 mg patch for 2 weeks; 7 mg patch for 2 weeks.
Individual counseling sessions where taught/develop interpersonal and behavioral coping skills to help decrease depression and negative moods, and to increase ability to quit smoking.
Eligibility Criteria
You may qualify if:
- Currently meeting DSM-IV criteria for major depressive disorder, recurrent; or major depressive disorder, recurrent, in partial remission; or major depressive disorder, single episode with a duration of 2 years or more; or; dysthymic disorder.
- Score greater than or equal to 8 on the PHQ at baseline
- Age greater than or equal to 16
- Smoking greater than or equal to 5 cigarettes per day
- Willing to set a quit date within 6 weeks of baseline
- English speaking and have a telephone
- Willing to attend all sessions
- Willing to provide informed consent and agree to all assessments and study procedures
You may not qualify if:
- History of psychotic or bipolar disorder
- Current psychotherapy
- Current use of antidepressant
- Current principal DSM-IV Axis I disorder other than unipolar depression or nicotine dependence
- Involvement in any smoking cessation activities
- Current use of nicotine replacement therapy
- Known health or other complications that would adversely affect attendance
- Severe levels of depressive symptoms, vegetative symptoms, and/or symptoms related to secondary psychiatric disorders that place participant at risk for harm or require immediate treatment
- Currently at severe or extreme risk of suicide or moderate risk with resolved plans and preparation
- Medical contraindications for use of nicotine patch, including uncontrolled heart disease, history of severe hypersensitivity to nicotine replacement products, or currently pregnant or lactating
- \) History of current medical condition, or any other factor that, in the judgment of the principal investigator, would likely preclude completion of study requirements.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University of Texas MD Anderson Cancer Center
Houston, Texas, 77030, United States
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Jan Blalock, PhD
M.D. Anderson Cancer Center
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 28, 2007
First Posted
July 2, 2007
Study Start
June 28, 2007
Primary Completion (Estimated)
June 30, 2026
Study Completion (Estimated)
June 30, 2026
Last Updated
April 16, 2026
Record last verified: 2026-04