Women Engaging in Quitting Smoking Together
WE QUIT
Distress Tolerance Treatment for Weight Concern in Smoking Cessation Among Women
2 other identifiers
interventional
100
1 country
1
Brief Summary
The long-term goal of this program of research is to develop and disseminate an efficacious, group-based distress tolerance treatment for weight concern (DT-W) that will significantly increase smoking cessation rates among women. The objective of this project is to conduct a preliminary randomized controlled trial (RCT) (N = 60) comparing DT-W to a Health Education (HE) comparison intervention, in which both groups also receive standard behavioral smoking cessation treatment (ST) including counseling and transdermal nicotine patch (TNP), and examine potential mechanisms that may underlie the efficacy of DT-W in improving smoking outcomes at 1-, 3-, and 6-month follow-ups.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started May 2015
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2015
CompletedFirst Submitted
Initial submission to the registry
May 21, 2015
CompletedFirst Posted
Study publicly available on registry
May 25, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2018
CompletedMarch 28, 2019
March 1, 2019
3.6 years
May 21, 2015
March 26, 2019
Conditions
Outcome Measures
Primary Outcomes (1)
Point prevalence abstinence from smoking: percentage of participants in each treatment group who report abstinence from smoking for the 7 days prior to each follow-up assessment
The investigators 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).
6 months post-quit date
Study Arms (2)
Distress Tolerance Treatment for Weight Concern (DT-W)
EXPERIMENTALDT-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.
Health Education (HE)
ACTIVE COMPARATORHE 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.
Interventions
Eligibility Criteria
You may qualify if:
- female
- at least 18 years of age
- smoke 5 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
You may not qualify if:
- current use of other smoking cessation or weight loss therapies
- current use of other tobacco products at least weekly
- 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
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Rhode Island Hospitallead
- National Institute on Drug Abuse (NIDA)collaborator
Study Sites (1)
Rhode Island Hospital
Providence, Rhode Island, 02903, United States
Related Publications (1)
Hartmann-Boyce J, Theodoulou A, Farley A, Hajek P, Lycett D, Jones LL, Kudlek L, Heath L, Hajizadeh A, Schenkels M, Aveyard P. Interventions for preventing weight gain after smoking cessation. Cochrane Database Syst Rev. 2021 Oct 6;10(10):CD006219. doi: 10.1002/14651858.CD006219.pub4.
PMID: 34611902DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 21, 2015
First Posted
May 25, 2015
Study Start
May 1, 2015
Primary Completion
December 1, 2018
Study Completion
December 1, 2018
Last Updated
March 28, 2019
Record last verified: 2019-03