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Clinical Trials/NCT02051803
NCT02051803CompletedNot Applicable

Distress Tolerance Treatment for Weight Concern in Smoking Cessation Among Women

Butler Hospital2 sites in 1 country22 target enrollmentStarted: March 2014Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
22
Locations
2
Primary Endpoint
Point prevalence abstinence from smoking

Study Overview

Brief Summary

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).

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
None

Eligibility Criteria

Ages
18 Years to 65 Years (Adult, Older Adult)
Sex
Female
Accepts Healthy Volunteers
No

Inclusion Criteria

  • 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

Outcomes

Primary Outcomes

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).

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (2)

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