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Cognitive Behavioral Therapy for Smoking Cessation in HIV/AIDS
N/A
Waitlist Available
Led By Jasper Smits, PhD
Research Sponsored by Massachusetts General Hospital
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
18-79 years old
Be older than 18 years old
Must not have
Cognitive behavioral therapy for anxiety within the past year
Untreated or unstable psychiatric disorders
Timeline
Screening 3 weeks
Treatment Varies
Follow Up time frame: 6-month follow-up (approximately 6-months post quit date)
Awards & highlights
No Placebo-Only Group
Summary
This trial is testing a cognitive-behavioral-based intervention to help smokers living with HIV quit smoking by reducing anxiety and depression.
Who is the study for?
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.
What is being tested?
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.
What are the potential side effects?
While specific side effects are not listed for this behavioral intervention, participants may experience discomfort discussing personal issues or stress related to quitting smoking during the sessions.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am between 18 and 79 years old.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I have undergone cognitive behavioral therapy for anxiety in the last year.
Select...
I do not have untreated or unstable mental health issues.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ time frame: 6-month follow-up (approximately 6-months post quit date)
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~time frame: 6-month follow-up (approximately 6-months post quit date)
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Long-Term Point Prevalence Smoking Abstinence
Short-Term Point Prevalence Smoking Abstinence
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
3Treatment groups
Experimental Treatment
Active Control
Group I: QUIT Treatment for Smoking Cessation and Distress ToleranceExperimental Treatment1 Intervention
Participants in this intervention arm will receive a Cognitive-Behavioral therapy-based intervention for smoking cessation in people living with HIV.
Group II: Time and Intensity-Match ControlActive Control1 Intervention
Participants in this control arm will receive an intervention matched in time and intensity with the experimental arm.
Group III: Standard of CareActive Control1 Intervention
At each clinic, routine assessment of smoking status occurs at least annually for patients receiving care, but prescription for pharmacotherapy for smoking cessation and referral for behavioral smoking cessation services are rare. Patients will receive the standard of care at the clinic they attend. SOC patients will also attend the first session that participants in the other sessions receive (pre-randomization), will come to the clinic for assessment only during the weeks lining up with sessions 6-10 for the other conditions, and receive the transdermal nicotine patch for 8 weeks.
Find a Location
Who is running the clinical trial?
Southern Methodist UniversityOTHER
36 Previous Clinical Trials
5,636 Total Patients Enrolled
1 Trials studying Smoking
150 Patients Enrolled for Smoking
Massachusetts General HospitalLead Sponsor
3,023 Previous Clinical Trials
13,317,585 Total Patients Enrolled
6 Trials studying Smoking
2,004 Patients Enrolled for Smoking
The Fenway InstituteOTHER
14 Previous Clinical Trials
2,501 Total Patients Enrolled
University of Texas at AustinOTHER
377 Previous Clinical Trials
86,214 Total Patients Enrolled
1 Trials studying Smoking
261 Patients Enrolled for Smoking
University of HoustonOTHER
150 Previous Clinical Trials
47,565 Total Patients Enrolled
5 Trials studying Smoking
204 Patients Enrolled for Smoking
Baylor College of MedicineOTHER
1,025 Previous Clinical Trials
6,029,419 Total Patients Enrolled
Jasper Smits, PhDPrincipal InvestigatorUniversity of Texas at Austin
6 Previous Clinical Trials
998 Total Patients Enrolled
1 Trials studying Smoking
150 Patients Enrolled for Smoking
Michael Zvolensky, PhDPrincipal InvestigatorUniversity of Houston
1 Previous Clinical Trials
150 Total Patients Enrolled
1 Trials studying Smoking
150 Patients Enrolled for Smoking
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I do not have untreated or unstable mental health issues.You use tobacco products regularly, except for cigarettes.I am between 18 and 79 years old.You are willing to stop smoking.You smoke cigarettes every day.You are currently receiving treatment to quit smoking.I am willing and able to sign a consent form.I have undergone cognitive behavioral therapy for anxiety in the last year.
Research Study Groups:
This trial has the following groups:- Group 1: Time and Intensity-Match Control
- Group 2: QUIT Treatment for Smoking Cessation and Distress Tolerance
- Group 3: Standard of Care
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.
Smoking Patient Testimony for trial: Trial Name: NCT03904186 — N/A