Testing the Combination of Behavioral Activation and Problem Solving as a Novel Behavioral Smoking Cessation Intervention for Smokers With HIV in Botswana

Status: Recruiting
Location: See location...
Intervention Type: Behavioral
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

The main purpose of this research study is to compare traditional behavioral smoking cessation therapy with a different type of behavioral therapy-known as behavioral activation problem solving (BAPS)-for smoking cessation. Standard smoking cessation counseling (SC) focuses on self-monitoring, identifying smoking triggers and how to manage them, relaxation and social support for non-smoking, and relapse prevention. BAPS focuses on recognizing he feelings you are having that lead to smoking and how to overcome those feelings and focus on activities that discourage you from smoking and avoid activities that encourage you to smoke. Both counseling types include gathering information about your personal smoking patterns, your likes, dislikes, and other personal characteristics about your lifestyle. Half of participants who enroll in the study will receive standard smoking cessation counseling (SC) and half will receive BAPS counseling. We will compare the rates of quitting smoking across the two groups at the end of treatment (study week 10), and 12 weeks after the end of treatment (study week 26)

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• \>18 years old

• Smoking cigarettes daily for the past 30 days

• HIV+ with HIV viral load of \<1000 copies/mL, obtained within the 6 months prior to enrollment

• Receiving HIV care at Infectious Diseases Care Clinics (IDCCs) in and around Gaborone

• Able to communicate in English OR Setswana and provide written informed consent

• Planning on residing in the geographic area for at least the next 7 months

Locations
Other Locations
Botswana
University of Botswana
RECRUITING
Gaborone
Contact Information
Primary
Robert Gross, MD
grossr@pennmedicine.upenn.edu
215-898-2437
Backup
Robert Schnoll, PhD
schnoll@pennmedicine.upenn.edu
215-746-7143
Time Frame
Start Date: 2021-05-06
Estimated Completion Date: 2025-12-01
Participants
Target number of participants: 650
Treatments
Placebo_comparator: Standard
Eligible patients will be randomized to one of the treatment arms, which will involve 5 phone-delivered counseling sessions over a 9 week treatment phase. SC will be based on the 2008 PHS Clinical Practice Guideline (Fiore et al., 2008) and on SC in our ongoing two-site trials (R01DA025078; R01CA165001) This intervention arm will begin with a pre-quit session designed to help participants prepare for their Target Quit Day (TDQ). The TQD session will occur at week 1. The SC arm will focus on self-monitoring, identifying smoking triggers and alternative trigger management strategies, relaxation, social support for non-smoking, relapse prevention, and homework. The pre-quit session prepares participants for their TQD by reviewing their experience with quitting, beliefs about smoking/quitting, perceived barriers to cessation, and creating a quit plan to identify smoking triggers and implement alternative strategies to manage those triggers without smoking.
Experimental: BAPS
Key components of BAPS include activity monitoring and rewarding activity scheduling, assessment of personal goals and values, assessment and altering of avoidance behavior and other maladaptive coping strategies, and contingency management. BAPS focuses on reducing stress pile-up and loss of pleasure that accompanies the cessation process and on identifying and establishing environmental/social changes to promote abstinence. BAPS addresses smoking as a behavior that prevents and restricts opportunities for contact with healthy rewarding behaviors. These changes are achieved through altering daily routines previously associated with smoking in ways that increase pleasure and mastery across life domains, reducing rumination, and increasing behavioral skills to prevent return to smoking as a means of avoiding stressors.
Related Therapeutic Areas
Sponsors
Collaborators: National Institute on Drug Abuse (NIDA), University of Botswana
Leads: University of Pennsylvania

This content was sourced from clinicaltrials.gov