Trial Summary
What is the purpose of this trial?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.
Eligibility Criteria
This trial is for smokers aged 16 or older who are also dealing with depression, including major depressive disorder (recurrent or single episode lasting over 2 years) or dysthymia. Participants must smoke at least 5 cigarettes daily, score ≥8 on the PHQ depression scale, be willing to quit within six weeks and attend all sessions. Exclusions include current psychotherapy, severe medical conditions, use of nicotine patches if contraindicated, pregnancy/lactation, high suicide risk, psychotic/bipolar disorders.Inclusion Criteria
I have been diagnosed with a long-term or recurring major depressive disorder.
Exclusion Criteria
Currently at severe or extreme risk of suicide or moderate risk with resolved plans and preparation
History of psychotic or bipolar disorder
Involvement in any smoking cessation activities
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Participant Groups
The study tests whether a combination of cognitive behavioral analysis system of psychotherapy (CBASP) and standard smoking cessation treatment improves quitting success and reduces depressive symptoms compared to Health Education combined with smoking cessation treatment. It will also explore how brain responses to emotional/smoking cues relate to quitting success.
2Treatment groups
Experimental Treatment
Group I: STExperimental Treatment2 Interventions
Smoking Cessation Treatment (ST)
Group II: CBASP + STExperimental Treatment3 Interventions
Cognitive Behavioral Analysis System of Psychotherapy (CBASP) + Smoking Cessation Treatment (ST)
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
University of Texas MD Anderson Cancer CenterHouston, TX
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Who Is Running the Clinical Trial?
M.D. Anderson Cancer CenterLead Sponsor
National Institute of Mental Health (NIMH)Collaborator