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临床试验/NCT02051803
NCT02051803已完成不适用

Distress Tolerance Treatment for Weight Concern in Smoking Cessation Among Women

Butler Hospital1 个研究点 分布在 1 个国家目标入组 22 人开始时间: 2014年3月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
22
试验地点
1
主要终点
Point prevalence abstinence from smoking

研究概览

简要总结

The long-term goal of this program of research is to develop and disseminate an efficacious intervention for weight concern that will significantly increase smoking cessation rates among women. The overall objective of this project is to develop this intervention and modify it based on piloting and feedback to ensure its feasibility and acceptability. These objectives will be accomplished by pursuing the following specific aim: 1) develop a group-based distress tolerance treatment for weight concern (DT-W) in female smokers and a comparison health education (HE) program and pilot both treatments with three groups of 10 (total N = 30) female weight-concerned smokers (2 DT-W groups, 1 HE group).

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

年龄范围
18 Years 至 65 Years(Adult, Older Adult)
性别
Female
接受健康志愿者
否

入选标准

  • •18 to 65 years of age
  • •smoke 10 or more cigarettes per day
  • •daily smoker for at least the past year
  • •report motivation to quit smoking in the next month of at least 5 on a 10 point scale
  • •report concern of at least 50 on at least one of two 100 point scales assessing weight concern
  • •able to travel to study location for study appointments

排除标准

  • •current use of other smoking cessation or weight loss therapies
  • •current use of other tobacco products at least weekly
  • •current diagnosis of depression
  • •diagnosis or treatment for non-nicotine substance use disorder with substance use during the past 6 months
  • •lifetime diagnosis or treatment of eating disorder, bipolar disorder, schizophrenia, or schizoaffective disorder
  • •current use of psychotropic medication except antidepressants
  • •score above established cut-offs on self-report screening measures of depressive symptomology, eating disorder symptomology, alcohol use disorder, or drug use disorder
  • •current suicidality or homicidality
  • •medical condition that is a contraindication for the use of transdermal nicotine patch
  • •lives at same address as current or past participant

研究组 & 干预措施

Distress Tolerance Treatment for Weight Concern (DT-W)

Experimental

DT-W is delivered over a 9 week period with 1 1-hr individual session during week 1, 8 weekly 1.5-hr group counseling sessions during weeks 2-9, and 1 20-minute individual telephone session during week 4. Session content includes distress tolerance intervention for weight concern plus standard behavioral smoking cessation treatment. Participants also receive 8 weeks of nicotine patch.

干预措施: Distress Tolerance Treatment for Weight Concern (DT-W) (Behavioral)

Health Education (HE)

Active Comparator

HE is delivered over a 9 week period with 1 1-hr individual session during week 1, 8 weekly 1.5-hr group counseling sessions during weeks 2-9, and 1 20-minute individual telephone session during week 4. Session content includes smoking health education program plus standard behavioral smoking cessation treatment. Participants also receive 8 weeks of nicotine patch.

干预措施: Health Education (HE) (Behavioral)

结局指标

主要结局

Point prevalence abstinence from smoking

时间窗: 6 months from smoking quit date

We will compare the percentage of participants in each treatment group who report abstinence from smoking for the 7 days prior to each follow-up assessment (1-, 3-, and 6-months post-quit date).

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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