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 range
16 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This trial is in Phase 1 and 2, which means it's still in relatively early stages — what does that tell us about how much is known so far about the safety and effectiveness of this approach for people with both depression and a smoking habit?
2Since the trial is 'active but not recruiting,' does that mean it's too late for me to join, and if so, are there similar studies or programs specifically designed for smokers dealing with depression that I could still be considered for?
3The trial is specifically looking at abstinence rates in people who have depression — given my own mental health history, how might quitting smoking affect my depression symptoms, and would I need extra monitoring or support?
4Are there standard treatments already available — like certain medications or counseling programs — that are already proven for smokers with depression, and how would those compare to what this trial is testing?
5If I were able to participate in a study like this, how would the demands of the trial — such as check-ins, tracking my smoking, or any treatment changes — realistically fit into my current mental health care routine?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Abstinence Rates
Timeframe: Approximately each 12 weeks following end of treatment (about 6 weeks)
. Willing to provide informed consent and agree to all assessments and study procedures
Exclusion criteria
. 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