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OpenTrials
Completed

NCT Number: NCT02051803

Women Engaging in Quitting Smoking Together (WE QUIT)

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).

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Key information

Conditions

Smoking Cessation Behavior Health Behavior

Age range

18 year–65 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Butler Hospital

Providence, Rhode Island, 02906, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • female
  • 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

Exclusion criteria

  • 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

Treatment and study plan

Distress Tolerance Treatment for Weight Concern (DT-W)

Behavioral

Health Education (HE)

Behavioral

Primary outcomes

  1. Point prevalence abstinence from smoking

    Time frame: 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).

Sponsors and collaborators

Lead sponsor

Butler Hospital

Other

Collaborators

  • National Institute on Drug Abuse (NIDA)

Registry information

Official study title

Distress Tolerance Treatment for Weight Concern in Smoking Cessation Among Women

Acronym: WE QUIT

Important dates

Study start
2014
Primary completion
2015
Study completion
2015
First posted
Jan 31, 2014
Registry last updated
Jul 31, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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