Clinical trial NCT04130698: Comparing Two Treatments That Both Target Smoking Cessation and Weight Loss at the Same Time.
Official title: Biobehavioral Regulation to Extinguish Smoking While Treating Another Health Risk
Conditions: Smoking Cessation
Weight Loss
Summary: The study has two phases. In Phase 1, the investigators will revise and pilot the distress tolerance (DT) protocol that was originally developed and piloted in a previous study (2P20 GM103430, Spas, PI). Despite the 4-week post-intervention treatment outcomes demonstrating the DT protocol's association with smoking cessation and weight loss, several revisions to the DT protocol are important to improve the intervention. First, the investigators will include the overweight/obese smokers' group-level feedback that the investigators collected during the 7-week intervention and at the 4-week post-intervention individual interviews to tailor the DT protocol to meet the unique needs of smokers with excess weight. Subjects from the previous study revealed factors that led to current and/or previous successful smoking cessation and weight loss efforts, barriers to sustaining current and/or previous successful smoking cessation and weight loss efforts, and general feedback about DT intervention for both health risks. The investigators believe revising the DT protocol to include overweight/obese smokers' unique experience with the novel intervention and their acumen about these key factors will improve the intervention and its generalizability to smokers with excess weight. Additional revisions are described elsewhere. After the investigators pilot the revised DT protocol, the investigators will revise the active health control protocol comprised of standard treatment for smoking cessation and weight loss to ensure both protocols equate for intervention contact time. Although both protocols will have some similar content, to avoid any threats to internal validity, no DT-specific material will be included in the control. In Phase 2, the investigators will conduct a two-armed, preliminary randomized controlled trial (RCT) to compare the revised DT protocol's efficacy to the active health control protocol.
Interventions:
description: The group-level intervention is comprised of one 2-hour weekly group sessions with overweight smokers to learn skills and strategies consistent with distress tolerance intervention to quit smoking and lose weight.
name: Distress Tolerance
type: Behavioral
description: Participants will use the patch for 8 weeks as outlined by the recommended usage for steps 1-3 going from 21mg for 4 weeks, 14mg for 1 week, and 7mg for 1 week.
name: transdermal nicotine patch
other_name: the "patch"
type: Drug
description: The group-level intervention is comprised of one 2-hour weekly group sessions with overweight smokers to learn skills and strategies consistent with psychoeducation intervention to quit smoking and lose weight.
name: Active Health Control
other_name: Psychoeducation
type: Behavioral
Study arms:
design_group_description: Treatment rationale: RAs will explain that there are 3 (not 2 as in the control) key factors that maintain smoking behavior and excess weight: 1) learned habits, 2) the addictive properties of smoking and food, and 3) a way to manage distress. Therefore, to be effective, an intervention designed to simultaneously treat smoking cessation and weight loss must address all 3 key factors. This condition includes both key factors in the control but introduces the third key factor distress tolerance (DT). Toward that end, modules will include: a values discussion; experiential avoidance; distress tolerance; and mindfulness-based ways to manage distress.<br/>Module 1: Orientation & ACT; Module 2: Avoidance; Module 3: Cognitive Fusion vs. Defusion; Module 4: Self-As-Context; Module 5: Present-Moment-Awareness; and Module 6: Values and Committed Action.
design_group_title: Distress Tolerance
design_group_type: Experimental
design_group_description: Treatment rationale: RAs will explain that there are 2 key factors that maintain smoking behavior and excess weight: 1) learned habits and 2) the addictive properties of smoking and food. Therefore, to be effective, an intervention designed to simultaneously treat smoking cessation and weight loss must address both key factors. Toward that end, modules will include standard treatment on: the dangers of smoking, excess weight, unhealthy diets and sedentariness; the importance of healthy behaviors; and relaxation exercises to manage stress. These are all key aspects of standard treatment for smoking cessation and weight loss.<br/>Module 1: Orientation and Health; Module 2: Game Plan; Module 3: Stress and Coping Strategies; Module 4: Physical Activity; Module 5: Changes in Activities, Habits and Lifestyle; and Module 6: Long-Term Rewards.
design_group_title: Active Health Control
design_group_type: Active Comparator
Sponsor: Rhode Island College
Collaborators: National Institute on Drug Abuse
Drug name mappings:
name: 尼古丁
lang: CN
name: Nicotine
lang: EN