Pilot randomized controlled trial of mindfulness-based relapse prevention vs cognitive behavioral therapy for smoking and alcohol use.

BACKGROUND: The combined use of cigarettes and alcohol is associated with a synergistic increase in the risk of morbidity and mortality. Continued alcohol use during a smoking quit attempt is a considerable risk factor for smoking relapse. As such, there is a need for interventions that address both behaviors concurrently. Mindfulness-based interventions hold much promise for simultaneously addressing tobacco and alcohol use. METHOD: This pilot study evaluated the feasibility and acceptability of a mindfulness-based intervention using a two-arm randomized controlled trial of Mindfulness-Based Relapse Prevention for Smoking and Alcohol (MBRP-SA) vs Cognitive Behavioral Therapy (CBT). Interventions were delivered via telehealth in a group setting; all participants received a 6-week supply of the nicotine patch. Participants (N = 69) were adults who smoked cigarettes who reported binge drinking and were motivated to both quit smoking and change their alcohol use. Primary outcomes were feasibility and acceptability of MBRP-SA compared to CBT. Changes in tobacco and alcohol use are also presented. RESULTS: Participants in MBRP-SA and CBT indicated that the treatments were highly acceptable, meeting a priori benchmarks. Feasibility was mixed with some outcomes meeting benchmarks (e.g., recruitment) and others falling below (e.g., retention). Participants in both conditions demonstrated significant reductions in tobacco and alcohol use at the end of treatment. CONCLUSIONS: In sum, MBRP-SA had comparable outcomes to CBT on all metrics measured. Future research should evaluate the efficacy of MBRP-SA on smoking abstinence and drinking reductions in a large-scale, fully powered trial. This study was registered on clinicaltrials.gov (NCT03734666).

Correction: A mindfulness-based stress management program for caregivers of allogeneic hematopoietic stem cell transplant (HCT) patients: Protocol for a randomized controlled trial.

[This corrects the article DOI: 10.1371/journal.pone.0266316.].

A mindfulness-based stress management program for caregivers of allogeneic hematopoietic stem cell transplant (HCT) patients: Protocol for a randomized controlled trial.

OBJECTIVES: Caregivers of allogeneic hematopoietic stem cell transplant (HCT) cancer patients experience high caregiver burden and carry a significant amount of responsibility. Mindfulness has the potential to lessen caregiver burden by aiding in stress management. To date, no studies have examined the efficacy of mindfulness in reducing caregiver burden in this population. Based on our pilot study demonstrating initial feasibility and acceptability of FOCUS (Focusing On mindfulness for Caregivers Under Stress), this 3-arm randomized controlled trial aims to examine the efficacy of a 6-week mindfulness-based stress management program for allogeneic HCT caregivers. Hypotheses include that the FOCUS condition will have lower post-treatment caregiver burden and that patients of these caregivers will have better patient health outcomes compared to other treatment conditions. METHOD: Eligible caregivers will be randomly assigned to one of three treatment conditions: FOCUS, Healthy Living (HL; active control), and Enhanced Care (EC; usual care). Caregivers in FOCUS and HL will participate in 6-week weekly individual treatment sessions and will be sent brief daily momentary interventions/messages. Caregivers in all conditions will complete daily diaries over the course of treatment. Patients of enrolled caregivers will be enrolled for assessments only. Participants will complete assessments at baseline, end of treatment, 2- and 6-months post-treatment. Biomarker data will be collected via hair cortisol concentrations from caregivers at baseline and 6 months post-treatment. RESULTS: Recruitment is ongoing. CONCLUSIONS: The data collected from this study will provide evidence on the efficacy of mindfulness in alleviating HCT caregiver stress and impacting patient health outcomes. TRIAL REGISTRATION: The current study is registered in clinicaltrials.gov (NCT05078229); see https://clinicaltrials.gov/ct2/show/NCT05078229?term=christine+vinci&draw=2&rank=1.

Development of a mindfulness-based treatment for smoking cessation and the modification of alcohol use: A protocol for a randomized controlled trial and pilot study findings.

The combined use of cigarettes and alcohol is associated with an increased risk of morbidity and mortality. Yet, efficacious interventions that address both behaviors concurrently are lacking. Smoking cessation and alcohol modification not only garner health benefits, but there is also value in addressing alcohol use in the context of smoking cessation to reduce the risk for smoking relapse. In this paper we describe the development of mindfulness-based relapse prevention for smoking cessation and alcohol modification (MBRP-SA) and pilot study findings (Phase 1). Next, details regarding the methods and design of an ongoing, randomized controlled trial, Project RISE (Phase 2), are described. MBRP-SA is a group-based intervention that consists of eight weekly treatment sessions. Results from the Phase 1 pilot study (N = 21 enrolled) indicated that participants planned to use the skills learned in their everyday activities and to address their smoking and alcohol goals. Based on the progression of Phase 1 cohorts, modifications were made to the inclusion/exclusion criteria and recruitment methods that will be implemented in Phase 2. Phase 2 will assess the feasibility and acceptability of MBRP-SA, delivered via live online groups, as a primary treatment option for smoking cessation and alcohol use modification.