CBASP + Smoking Cessation for Depressed Smokers

Age: Any Age

Sex: Any

Trial Phase: Phase 1 & 2

Sponsor: M.D. Anderson Cancer Center

Must not be taking: Antidepressants, Nicotine replacement

Disqualifiers: Psychotic, Bipolar, Severe depression, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 9

Duration: 5 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to assist people who smoke and suffer from depression. It tests whether combining a special therapy called CBASP (a structured talk therapy) with standard Nicotine Replacement Therapy (NRT) is more effective than NRT alone. The trial also examines if this approach can reduce depression symptoms and improve daily life. Eligible participants should have experienced depression for some time and smoke at least five cigarettes daily. They must be ready to set a quit date within six weeks and commit to attending all sessions. As a Phase 1, Phase 2 trial, this research seeks to understand how the treatment works in people and measure its effectiveness in an initial, smaller group, offering participants a chance to contribute to groundbreaking treatment development.

Will I have to stop taking my current medications?

Yes, you will need to stop taking any current antidepressants to participate in this trial.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that CBASP, or Cognitive Behavioral Analysis System of Psychotherapy, is generally well-tolerated by patients, including those with ongoing depression. It has also been applied to individuals with alcohol use issues. This therapy combines depression treatment with strategies to help quit smoking, benefiting smokers who also face depression.

Studies have found therapies like CBASP to be safe and effective for treating depression, with no major reports of serious side effects in these contexts.

While specific safety data for the smoking cessation component is lacking, these treatments are typically designed to be safe. Overall, both CBASP and smoking cessation treatments are known to be well-tolerated, with research supporting CBASP for depression treatment. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about the treatments in this trial because they combine smoking cessation techniques with Cognitive Behavioral Analysis System of Psychotherapy (CBASP) to help depressed smokers quit. Unlike standard smoking cessation programs that might only address nicotine addiction, this approach also targets the underlying depression, which can be a significant barrier to quitting smoking. By integrating mental health treatment with smoking cessation, this method could potentially improve both mood and success rates in quitting. This dual approach could offer a more comprehensive solution for individuals struggling with both depression and smoking.

What evidence suggests that this trial's treatments could be effective for depressed smokers?

Research has shown that the Cognitive Behavioral Analysis System of Psychotherapy (CBASP) can help treat long-term depression. In one study, 85% of patients who completed CBASP therapy with medication saw improvements in their depression symptoms. Another study found that patients receiving CBASP experienced a greater reduction in depression symptoms after 52 weeks compared to other treatments. Additionally, CBASP has been linked to better social and personal functioning, which could assist smokers dealing with depression. In this trial, one group of participants will receive CBASP combined with Smoking Cessation Treatment (ST), while another group will receive only Smoking Cessation Treatment. These findings suggest that CBASP might be effective when combined with treatments to help people quit smoking. ^{1 2 4 5 6}

Who Is on the Research Team?

Jan Blalock

Principal Investigator

M.D. Anderson Cancer Center

Are You a Good Fit for This Trial?

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

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

1 visit (in-person)

Treatment

Participants receive counseling sessions and nicotine patches to aid smoking cessation

5 weeks

6 visits (in-person)

Follow-up

Participants are monitored for abstinence, mood, and smoking behavior at 3 and 6 months post-treatment

6 months

2 visits (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• CBASP
• Nicotine Replacement Therapy
• Smoking Cessation Treatment

Trial Overview 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.

How Is the Trial Designed?

Group I: ST Experimental Treatment 2 Interventions

Smoking Cessation Treatment (ST)

Group II: CBASP + ST Experimental Treatment 3 Interventions

Cognitive Behavioral Analysis System of Psychotherapy (CBASP) + Smoking Cessation Treatment (ST)

Who Is Running the Clinical Trial?

M.D. Anderson Cancer Center

Lead Sponsor

Trials

3,107

Recruited

1,813,000+

National Institute of Mental Health (NIMH)

Collaborator

Trials

3,007

Recruited

2,852,000+

Published Research Related to This Trial

Varenicline is the most effective first-line pharmacotherapy for smoking cessation, showing a significant effect compared to placebo with an odds ratio of 2.27, followed by bupropion (1.69) and nicotine replacement therapy (1.60).

Despite some safety concerns, regulatory agencies deem bupropion and varenicline to have a favorable benefit/risk profile, but healthcare providers should monitor patients for potential neuropsychiatric symptoms, especially in those with psychiatric comorbidities.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pharmacotherapy for smoking cessation: pharmacological principles and clinical practice. Aubin, HJ., Luquiens, A., Berlin, I.[2022]

In a study involving 179 cigarette smokers with a history of major depressive disorder, both standard smoking cessation treatment and a combined treatment for depression showed high abstinence rates after one year, with 24.7% for standard treatment and 32.5% for the combined treatment.

Smokers with recurrent major depressive disorder and those who smoked heavily (25 or more cigarettes a day) had significantly higher abstinence rates when receiving cognitive-behavioral treatment for depression alongside smoking cessation, indicating that this combined approach may be particularly beneficial for these groups.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cognitive-behavioral treatment for depression in smoking cessation. Brown, RA., Kahler, CW., Niaura, R., et al.[2019]

This case report highlights the first fatal instance of hepatotoxicity linked to bupropion, occurring in a 55-year-old man who developed severe liver injury after 6 months of treatment for smoking cessation.

The patient exhibited autoimmune features alongside liver injury, suggesting that bupropion can cause significant liver damage, and physicians should be cautious and consider it as a potential cause in patients with unexplained liver issues.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A fatal case of bupropion (Zyban) hepatotoxicity with autoimmune features: Case report. Humayun, F., Shehab, TM., Tworek, JA., et al.[2018]

In a study of 222 smokers who did not significantly reduce their smoking with nicotine patches, the combination of varenicline and bupropion led to a higher abstinence rate (39.8%) compared to varenicline plus placebo (25.9%).

The combination treatment was particularly effective for male smokers and those with high nicotine dependence, suggesting it may be a better option for these groups when initial nicotine patch treatment fails.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Combination treatment with varenicline and bupropion in an adaptive smoking cessation paradigm. Rose, JE., Behm, FM.[2022]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC2881321/

Effects of an Intensive Depression-Focused Intervention for ... The results showed that at 6-months posttreatment, women with higher levels of baseline depressive symptoms treated with CBASP had a higher probability of ...

2. sciencedirect.com sciencedirect.com/science/article/pii/S0165032725012339

Cognitive behavioral therapies are evidence-based – ... Within CBTs for depression specifically, a systematic review and meta-analysis showed that lower age, higher initial depression severity, individual treatment ...

3. withpower.com withpower.com/trial/cbasp-smoking-cessation-for-depressed-smokers-0ed32

CBASP + Smoking Cessation for Depressed Smokers That depressed smokers in the CBASP/ST treatment will experience greater improvements in psychosocial functioning from baseline to follow-up assessment points, ...

4. cbaspsociety.org cbaspsociety.org/

Cognitive Behavioral Analysis System of Psychotherapy ... When combined with medication, CBASP therapy has been shown to be 85 percent effective in treating chronic depression for patients who complete treatment.A ...

5. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/25116461/

The effectiveness of the cognitive behavioral analysis ... Results: At week 52, patients assigned to CBASP had a greater reduction of depressive symptoms compared to patients assigned to CAU (t = -2.00, p = 0.05).

6. formative.jmir.org formative.jmir.org/2022/8/e35482

Adding an App-Based Intervention to the Cognitive Behavioral ... Background: The Cognitive Behavioral Analysis System of Psychotherapy (CBASP) is an empirically supported psychotherapeutic treatment developed ...