Smoking Cessation for Depressed Smokers (NCT00494728) | Clinical Trial Compass
Active — Not RecruitingPhase 1/2
Smoking Cessation for Depressed Smokers
United States91 participantsStarted 2007-06-28
Plain-language 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.
Who can participate
Age range16 Years
SexALL
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Inclusion criteria
✓. 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
Exclusion criteria
✕. History of psychotic or bipolar disorder
✕. Current psychotherapy
What they're measuring
1
Abstinence Rates
Timeframe: Approximately each 12 weeks following end of treatment (about 6 weeks)
✕. 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