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Behavioral Intervention
CBASP + Smoking Cessation for Depressed Smokers
Phase 1 & 2
Waitlist Available
Led By Jan Blalock, PhD
Research Sponsored by M.D. Anderson Cancer Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
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
Must not have
Current psychotherapy
Current use of antidepressant
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights
No Placebo-Only Group
Summary
This trial is testing whether combining cognitive behavioral analysis system of psychotherapy with standard smoking cessation treatment is more effective than just standard smoking cessation treatment in helping smokers with major depressive disorder quit smoking.
Who is the study for?
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.
What is being tested?
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.
What are the potential side effects?
Potential side effects may include skin irritation from nicotine patches and mood changes due to withdrawal or psychological therapy. Emotional discomfort could arise during CBASP as participants work through personal issues related to their depression.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have been diagnosed with a long-term or recurring major depressive disorder.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I am currently undergoing psychotherapy.
Select...
I am currently taking antidepressants.
Select...
I am currently using nicotine replacement therapy.
Select...
I am experiencing severe depression or symptoms that could harm me.
Select...
I cannot use nicotine patches due to heart issues, allergies to them, or because I am pregnant/breastfeeding.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 5 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
Treatment Details
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
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)
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Smoking Cessation Treatment
2021
N/A
~60
Nicotine Replacement Therapy
2019
Completed Phase 4
~8830
CBASP
2016
Completed Phase 4
~790
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Logistics
Participation is compensated
You will be compensated for participating in this trial.
Who is running the clinical trial?
M.D. Anderson Cancer CenterLead Sponsor
3,066 Previous Clinical Trials
1,802,154 Total Patients Enrolled
11 Trials studying Depression
701,283 Patients Enrolled for Depression
National Institute of Mental Health (NIMH)NIH
2,918 Previous Clinical Trials
2,739,874 Total Patients Enrolled
701 Trials studying Depression
261,060 Patients Enrolled for Depression
Jan Blalock, PhDPrincipal InvestigatorM.D. Anderson Cancer Center
1 Previous Clinical Trials
51 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am currently undergoing psychotherapy.I am currently taking antidepressants.I am currently using nicotine replacement therapy.I am experiencing severe depression or symptoms that could harm me.I have been diagnosed with a long-term or recurring major depressive disorder.I cannot use nicotine patches due to heart issues, allergies to them, or because I am pregnant/breastfeeding.I speak English and have access to a telephone.I am 16 years old or older.You smoke at least 5 cigarettes per day.You have a score of 8 or more on the Patient Health Questionnaire (PHQ) at the beginning of the study.I have been diagnosed with long-term or recurring depression.
Research Study Groups:
This trial has the following groups:- Group 1: CBASP + ST
- Group 2: ST
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Depression Patient Testimony for trial: Trial Name: NCT00494728 — Phase 1 & 2
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