Cognitive Behavioral Therapy for Smoking Cessation in HIV/AIDS

Not currently recruiting at 2 trial locations
CM
SM
Overseen BySamantha M McKetchnie, MSW
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: Massachusetts General Hospital
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests Cognitive Behavioral Therapy (CBT) to help people with HIV quit smoking. The researchers aim to determine if this therapy can reduce anxiety and depression, which are common in people with HIV and can hinder smoking cessation. Participants will be divided into three groups: one will receive a specialized CBT called QUIT, another will receive a similar but different therapy, and the last group will receive their usual care plus nicotine patches. Individuals who smoke daily, have HIV, and wish to quit smoking may be suitable for this trial. As an unphased trial, this study offers a unique opportunity to explore new methods for improving mental health and aiding smoking cessation.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. However, if you are currently receiving smoking cessation treatment, you may not be eligible to participate.

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

Research has shown that Cognitive Behavioral Therapy (CBT) is safe and well-tolerated for helping people with HIV quit smoking. In previous studies, participants handled this therapy well, with no major safety issues reported.

Early results suggest that CBT can significantly increase the chances of quitting smoking. This therapy helps by reducing anxiety and depression, which are common among smokers with HIV.

Although CBT is not a new medication, it has been tested in various groups, including those with HIV, to help people stop smoking. This background provides some confidence in its safety.

The studies reviewed have noted no specific unwanted side effects, highlighting its general safety for participants.12345

Why are researchers excited about this trial?

Cognitive Behavioral Therapy for smoking cessation in HIV/AIDS is unique because it combines a psychological approach with smoking cessation specifically tailored for people living with HIV. Most treatments for smoking cessation, like nicotine replacement therapy or prescription medications, focus on reducing withdrawal symptoms. However, this therapy aims to enhance distress tolerance and coping skills, which are crucial for individuals with HIV who often face additional stressors. Researchers are excited because it offers a holistic method, potentially leading to higher success rates in quitting smoking by addressing both the habit and the underlying stress factors.

What evidence suggests that this trial's treatments could be effective for smoking cessation in people living with HIV?

Research has shown that Cognitive Behavioral Therapy (CBT) can help people with HIV quit smoking. In this trial, participants in the QUIT treatment arm will receive a CBT-based intervention for smoking cessation. A previous study found that individuals using the CBT approach were more successful at quitting smoking both in the short term and long term compared to those who received a brief treatment. This therapy reduces anxiety and depression, major challenges for smokers living with HIV. It addresses emotional issues such as excessive fear of anxiety, difficulty coping with emotional discomfort, and trouble experiencing pleasure. These early findings suggest that CBT could effectively help people with HIV stop smoking.13467

Who Is on the Research Team?

MZ

Michael Zvolensky, PhD

Principal Investigator

University of Houston

JS

Jasper Smits, PhD

Principal Investigator

University of Texas at Austin

Are You a Good Fit for This Trial?

This trial is for HIV-positive individuals aged 18-79 who smoke daily and are motivated to quit. They must understand English well enough to give informed consent. People using other tobacco products, undergoing current smoking cessation treatment, or with untreated/unstable psychiatric disorders can't participate.

Inclusion Criteria

HIV-positive
You are willing to stop smoking.
You smoke cigarettes every day.
See 1 more

Exclusion Criteria

I do not have untreated or unstable mental health issues.
You use tobacco products regularly, except for cigarettes.
Insufficient command of the English language
See 2 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive a 9-session, cognitive-behavioral therapy-based intervention for smoking cessation and anxiety/depression management

9 weeks
9 visits (in-person)

Short-Term Follow-up

Participants are monitored for smoking abstinence and changes in anxiety/depression at 1-month post quit day

1 month

Long-Term Follow-up

Participants are monitored for smoking abstinence and changes in anxiety/depression at 6-months post quit day

6 months

What Are the Treatments Tested in This Trial?

Interventions

  • QUIT
  • Time-Matched Control (TM)
Trial Overview The study tests a cognitive-behavioral-based intervention called QUIT against a Time-Matched Control (TM) to help smokers living with HIV quit by reducing anxiety and depression. It's a fully powered trial aiming to see if the intervention increases abstinence from smoking at 1-month and 6-month follow-ups.
How Is the Trial Designed?
3Treatment groups
Experimental Treatment
Active Control
Group I: QUIT Treatment for Smoking Cessation and Distress ToleranceExperimental Treatment1 Intervention
Group II: Time and Intensity-Match ControlActive Control1 Intervention
Group III: Standard of CareActive Control1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Massachusetts General Hospital

Lead Sponsor

Trials
3,066
Recruited
13,430,000+

Southern Methodist University

Collaborator

Trials
37
Recruited
6,000+

The Fenway Institute

Collaborator

Trials
15
Recruited
2,900+

University of Texas at Austin

Collaborator

Trials
387
Recruited
86,100+

University of Houston

Collaborator

Trials
155
Recruited
48,600+

Baylor College of Medicine

Collaborator

Trials
1,044
Recruited
6,031,000+

Citations

Smoking Cessation for People Living With HIV/AIDSPeople living with HIV/AIDS (PLWHA) are more likely to smoke cigarettes than are individuals in the general population.
NCT03904186 | Effectiveness of an Integrated Treatment to ...Participants in this intervention arm will receive a Cognitive-Behavioral therapy-based intervention for smoking cessation in people living with HIV.
Efficacy of Smoking Cessation Interventions among People ...Results ; Years since diagnosed with HIV status, mean (SD), 8.4 (6.1), 7.5 (5.7) ; Prior diagnosis of AIDS, 29 (10.2%), 6 (8.7%) ; Taking ...
Evaluation of an integrated treatment to address smoking ...AIDS Behav. (2017). D.J. Vidrine et al. Efficacy of cell phone–delivered smoking cessation counseling for persons living with HIV/AIDS: 3-month outcomes ...
Cognitive Behavioral Therapy for Smoking Cessation in ...Cognitive Behavioral Therapy for Smoking Cessation in HIV/AIDS. Recruiting at 2 trial locations. CM.
Smoking Cessation Intervention for Women Living With HIV ...This study is a pilot randomized controlled trial (RCT) testing the feasibility and acceptability of a videoconferencing smoking cessation intervention (video ...
Effect of cognitive behavior therapy on abstinence among ...The pooled analysis revealed that CBT significantly improved smoking abstinence rates, demonstrating a fourfold increase in effectiveness compared to controls ( ...
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