Trial of Integrated Smoking Cessation, Exercise, and Weight Management in SMI
SMI 综合戒烟、运动和体重管理试验
基本信息
- 批准号:8764228
- 负责人:
- 金额:$ 74.1万
- 依托单位:
- 依托单位国家:美国
- 项目类别:
- 财政年份:2014
- 资助国家:美国
- 起止时间:2014-08-11 至 2019-06-30
- 项目状态:已结题
- 来源:
- 关键词:AbstinenceAcuteAdoptedAdultAffectAmerican Heart AssociationBehavior TherapyBody Weight decreasedBody mass indexBupropionCardiovascular DiseasesCaringCessation of lifeClinicClinical TrialsCombination Drug TherapyCommunitiesCounselingDietDropsEnrollmentEpidemicEventExerciseFutureGeneral PopulationGuidelinesHealthHealth StatusHealth behavior changeHigh PrevalenceHospitalizationIndividualInterdisciplinary StudyInterventionJointsMarylandMediator of activation proteinMental HealthModelingNicotine DependenceNicotine WithdrawalObesityOutcomeParticipantPatient Self-ReportPatientsPersonsPharmacotherapyPhysical FitnessPhysical activityPopulationPremature MortalityPrevalenceProbabilityPsychiatric DiagnosisQualifyingQuality of lifeRandomizedReadinessReportingResearchResearch PersonnelRiskRisk BehaviorsRisk FactorsSF-12SamplingSmokeSmokerSmokingSmoking Cessation InterventionSubgroupSymptomsTechnologyTestingTextTimeTobaccoTobacco smokingVisitVulnerable PopulationsWalkingWeightWeight GainWeight maintenance regimenWithdrawal SymptomWithholding Treatmentarmbasebehavior changecardiovascular disorder riskcardiovascular risk factorcommunity settingcostcost effectivenessdesignexperiencegood diethealth disparityhigh riskimprovedinnovationinterestmental health organizationmortalitynicotine replacementprematureprimary outcomeprogramspublic health relevancequitlinerandomized trialsecondary outcomesevere mental illnesssmoking cessationsmoking prevalencesuccessful interventiontreatment as usualtwo-arm studyvareniclineweight maintenance
项目摘要
DESCRIPTION (provided by applicant): Persons with serious mental illness (SMI) have three times higher mortality rates than those without SMI, primarily due to cardiovascular disease (CVD). Tobacco smoking is the single largest contributor to CVD in SMI. Even while nationally smoking rates are dropping, nicotine addiction is an entrenched problem for at least half of SMI adults, and rates of guideline-concordant cessation treatment are minimal. The vast majority with SMI state they would like to quit. Combination pharmacotherapy and behavioral treatment increases abstinence rates in trials in SMI, but has not been tested or widely used in community settings. Moreover, weight gain has been observed with smoking abstinence, and obesity is already widespread in SMI. Exercise may improve nicotine withdrawal symptoms and reduce weight gain during a quit attempt, but no studies of exercise added to smoking cessation treatment have been done in SMI. With extraordinarily high burden of all the CVD risk behaviors: smoking; physical inactivity; unhealthy diet; and obesity, combined health behavior change interventions are urgently needed in this vulnerable population, especially in those who smoke. The objective of this R-01 application is to develop and test an innovative, scalable intervention that could be widely adopted to promote long-term smoking abstinence, improved physical activity and weight control in SMI. Our multidisciplinary research team is uniquely qualified in health behavior change in persons with SMI, combining leading experts in smoking cessation, weight loss and exercise interventions and knowledgeable in testing text messaging technology to sustain and support behavior change. We propose the TRIUMPH Trial, a community mental health organization-based, two-arm trial that will test the hypothesis that an 18-month comprehensive, practical tobacco smoking cessation program integrating exercise and weight counseling will be superior to a treatment as usual (TAU) control in achieving prolonged smoking abstinence, physical fitness and weight maintenance. We will enroll 220 adults with SMI attending one of two community mental health organizations in Maryland, who are current smokers expressing interest in quitting. We will stratify by readiness to set a quit date within 1 or 6 months and randomly assign participants to receive: 1) TAU with referral to a quit line or 2) the 18-month intervention that will include: i) group and individual smoking cessation and weight counseling by a health coach and tailored to participants' readiness to quit; ii) pharmacotherapy with either varenicline, or bupropion + nicotine replacement therapy, prescribed in the community clinic; iii) group exercise and gym access; and iv) text messaging supporting health behavior change. The primary outcome will be 7-day point- prevalence smoking abstinence at 18 months; secondary outcomes will include weight, 6-minute walk test, diet and 10-year risk of CVD events. Improving all CVD risk behaviors is critical to decrease premature mortality in SMI, and will require innovative, integrated interventions in community settings. The TRIUMPH Trial will test such an approach that reaches a broad range of smokers with SMI and is practical to implement.
描述(由申请人提供):患有严重精神疾病(SMI)的人的死亡率比没有SMI的人高三倍,主要是由于心血管疾病(CVD)。吸烟是导致重度精神病患者心血管疾病的最大因素。尽管全国吸烟率正在下降,但尼古丁成瘾对至少一半的重度精神病患者来说是一个根深蒂固的问题,与指南一致的戒烟治疗率很低。绝大多数患有SMI的人表示他们想辞职。药物治疗和行为治疗的组合增加了SMI试验中的戒断率,但尚未在社区环境中进行测试或广泛使用。此外,在戒烟的情况下观察到体重增加,肥胖在SMI中已经很普遍。运动可以改善尼古丁戒断症状,并减少戒烟过程中的体重增加,但在SMI中没有关于戒烟治疗中增加运动的研究。由于所有CVD风险行为的负担非常高:吸烟;缺乏身体活动;不健康的饮食;和肥胖,迫切需要在这个脆弱的人群中,特别是在那些吸烟的人群中,联合健康行为改变干预措施。这项R-01应用的目的是开发和测试一种创新的、可扩展的干预措施,这种干预措施可以被广泛采用,以促进SMI患者的长期戒烟、改善体力活动和体重控制。我们的多学科研究团队在SMI患者的健康行为改变方面具有独特的资格,结合了戒烟,减肥和运动干预方面的领先专家,并在测试短信技术方面具有丰富的知识,以维持和支持行为改变。我们提出了TRIUMPH试验,这是一项以社区精神卫生组织为基础的双臂试验,将检验一个假设,即一个为期18个月的综合性、实用的戒烟计划,结合运动和体重咨询,在实现长期戒烟、身体健康和体重维持方面上级常规治疗(TAU)对照。我们将招募220名患有SMI的成年人,他们参加马里兰州的两个社区精神卫生组织之一,他们目前是吸烟者,表示有兴趣戒烟。我们将根据是否准备好在1个月或6个月内设定戒烟日期进行分层,并随机分配参与者接受:1)TAU,并转介到戒烟热线或2)18个月的干预,包括:i)健康教练根据参与者的戒烟准备程度提供的团体和个人戒烟和体重咨询; ii)在社区诊所处方的伐尼克兰或安非他酮+尼古丁替代疗法的药物治疗; iii)团体锻炼和健身房访问;以及iv)支持健康行为改变的短信。主要结果将是18个月时的7天点吸烟率戒烟率;次要结果将包括体重、6分钟步行试验、饮食和10年CVD事件风险。改善所有CVD风险行为对于降低重度精神病患者的过早死亡率至关重要,需要在社区环境中进行创新的综合干预。TRIUMPH试验将测试这样一种方法,该方法可以接触到广泛的SMI吸烟者,并且可以实际实施。
项目成果
期刊论文数量(0)
专著数量(0)
科研奖励数量(0)
会议论文数量(0)
专利数量(0)
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Gail L. Daumit其他文献
Chronic pain and narcotics
- DOI:
10.1046/j.1525-1497.2002.20109.x - 发表时间:
2002-03-01 - 期刊:
- 影响因子:4.200
- 作者:
Yngvild Olsen;Gail L. Daumit - 通讯作者:
Gail L. Daumit
Technologic and Nontechnologic Barriers to Implementing Behavioral Health Homes in Community Mental Health Settings During the COVID-19 Pandemic.
COVID-19 大流行期间在社区心理健康环境中实施行为健康之家的技术和非技术障碍。
- DOI:
10.18865/ed.decipher.105 - 发表时间:
2023 - 期刊:
- 影响因子:3.2
- 作者:
Emily M. Woltmann;Brianna Osorio;Christina T. Yuan;Gail L. Daumit;Amy M Kilbourne - 通讯作者:
Amy M Kilbourne
A Community-Engaged Process for Adapting a Cardiovascular Health Intervention for Persons with Serious Mental Illness.
针对严重精神疾病患者调整心血管健康干预措施的社区参与过程。
- DOI:
10.18865/ed.decipher.27 - 发表时间:
2023 - 期刊:
- 影响因子:3.2
- 作者:
Christina T. Yuan;Gail L. Daumit;Lisa A. Cooper;Courtney Cook;Casey Corches;A. Dalcin;Benjamin Eidman;Tyler Fink;Joseph Gennusa;Stacy Goldsholl;Celeste Liebrecht;Eva Minahan;Brianna Osorio;Shawna N. Smith;Nae;Emily M. Woltmann;Amy M Kilbourne - 通讯作者:
Amy M Kilbourne
Gail L. Daumit的其他文献
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{{ truncateString('Gail L. Daumit', 18)}}的其他基金
Achieving Cardiovascular Health Equity in Community Mental Health: Optimizing Implementation Strategies
实现社区心理健康中的心血管健康公平:优化实施策略
- 批准号:
10254410 - 财政年份:2020
- 资助金额:
$ 74.1万 - 项目类别:
Achieving Cardiovascular Health Equity in Community Mental Health: Optimizing Implementation Strategies
实现社区心理健康中的心血管健康公平:优化实施策略
- 批准号:
10723250 - 财政年份:2020
- 资助金额:
$ 74.1万 - 项目类别:
Achieving Cardiovascular Health Equity in Community Mental Health: Optimizing Implementation Strategies
实现社区心理健康中的心血管健康公平:优化实施策略
- 批准号:
10064406 - 财政年份:2020
- 资助金额:
$ 74.1万 - 项目类别:
Center to Accelerate Translation of Interventions to Decrease Premature Mortality in SMI
加速转化干预措施以降低 SMI 过早死亡率的中心
- 批准号:
9762194 - 财政年份:2018
- 资助金额:
$ 74.1万 - 项目类别:
Promoting evidenced-based tobacco smoking cessation treatment in community mental health clinics
在社区心理健康诊所推广循证戒烟治疗
- 批准号:
10188640 - 财政年份:2018
- 资助金额:
$ 74.1万 - 项目类别:
Center to Accelerate Translation of Interventions to Decrease Premature Mortality in SMI
加速转化干预措施以降低 SMI 过早死亡率的中心
- 批准号:
10188636 - 财政年份:2018
- 资助金额:
$ 74.1万 - 项目类别:
Randomized Trial of a Healthy Weight Intervention for Youth with Serious Emotional Disturbance
对患有严重情绪障碍的青少年进行健康体重干预的随机试验
- 批准号:
9469564 - 财政年份:2016
- 资助金额:
$ 74.1万 - 项目类别:
Randomized Trial of a Healthy Weight Intervention for Youth with Serious Emotional Disturbance
对患有严重情绪障碍的青少年进行健康体重干预的随机试验
- 批准号:
9177934 - 财政年份:2016
- 资助金额:
$ 74.1万 - 项目类别:
Trial of Integrated Smoking Cessation, Exercise, and Weight Management in SMI
SMI 综合戒烟、运动和体重管理试验
- 批准号:
8910790 - 财政年份:2014
- 资助金额:
$ 74.1万 - 项目类别:
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