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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up approximately each 12 weeks following end of treatment (about 6 weeks)
Awards & highlights

Study 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.Check my eligibility
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.See study design
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 below
Select...
I have been diagnosed with a long-term or recurring major depressive disorder.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~approximately each 12 weeks following end of treatment (about 6 weeks)
This trial's timeline: 3 weeks for screening, Varies for treatment, and approximately each 12 weeks following end of treatment (about 6 weeks) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Abstinence Rates

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
Nicotine Replacement Therapy
2019
Completed Phase 4
~9020
CBASP
2011
Completed Phase 4
~780

Find a Location

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
2,974 Previous Clinical Trials
1,789,383 Total Patients Enrolled
14 Trials studying Smoking
4,304 Patients Enrolled for Smoking
National Institute of Mental Health (NIMH)NIH
2,786 Previous Clinical Trials
2,689,618 Total Patients Enrolled
Jan Blalock, PhDPrincipal InvestigatorM.D. Anderson Cancer Center
1 Previous Clinical Trials
51 Total Patients Enrolled

Media Library

CBASP (Behavioral Intervention) Clinical Trial Eligibility Overview. Trial Name: NCT00494728 — Phase 1 & 2
Smoking Research Study Groups: CBASP + ST, ST
Smoking Clinical Trial 2023: CBASP Highlights & Side Effects. Trial Name: NCT00494728 — Phase 1 & 2
CBASP (Behavioral Intervention) 2023 Treatment Timeline for Medical Study. Trial Name: NCT00494728 — Phase 1 & 2
Smoking Patient Testimony for trial: Trial Name: NCT00494728 — Phase 1 & 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there any available positions in this research project for participants?

"This particular study has stopped looking for new candidates, however, there are 1235 other trials for depression that are still enrolling patients. Additionally, there are 74 studies for this treatment that are still actively recruiting participants."

Answered by AI

Are there similar therapies that have been explored in the past?

"As of right now, 74 clinical trials are still running that study this particular treatment. Out of these, 5 are in Phase 3. Most of the research is based in Oconto Falls, Wisconsin, but 208 medical centres across America are running these trials."

Answered by AI

Who else is applying?

What state do they live in?
Texas
How old are they?
18 - 65
What site did they apply to?
University of Texas MD Anderson Cancer Center
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
How many prior treatments have patients received?
1
2
0

What questions have other patients asked about this trial?

How long are each of CBA/psych sessions on average, and how much will we be compensated?
PatientReceived 2+ prior treatments

Why did patients apply to this trial?

I’m tired smoking. Try to quit smoking. I smoke 5 or more cigarettes a day.
PatientReceived 1 prior treatment
I would like to stay healthy in my life. Anything, almost anything that would help me ease the depression, sounds good.
PatientReceived no prior treatments
~1 spots leftby Jun 2024