Women Engaging in Quitting Smoking Together (WE QUIT)

Distress Tolerance Treatment for Weight Concern in Smoking Cessation Among Women

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.

Study Overview

• Status: Completed
• Conditions: Smoking Cessation
• Intervention / Treatment: Behavioral: Distress Tolerance Treatment for Weight Concern (DT-W); Behavioral: Smoking Cessation counseling; Drug: Transdermal Nicotine Patch; Behavioral: Health Education (HE)

• Study Type: Interventional
• Enrollment (Actual): 100
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Rhode Island
    • Providence, Rhode Island, United States, 02903
      • Rhode Island Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

Inclusion Criteria:

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

Exclusion Criteria:

• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Distress Tolerance Treatment for Weight Concern (DT-W); 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.	Behavioral: Distress Tolerance Treatment for Weight Concern (DT-W); Behavioral: Smoking Cessation counseling; Drug: Transdermal Nicotine Patch
Active Comparator: Health Education (HE); 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.	Behavioral: Smoking Cessation counseling; Drug: Transdermal Nicotine Patch; Behavioral: Health Education (HE)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Rhode Island Hospital
• Collaborators: National Institute on Drug Abuse (NIDA)

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): May 1, 2015
• Primary Completion (Actual): December 1, 2018
• Study Completion (Actual): December 1, 2018

Study Registration Dates

• First Submitted: May 21, 2015
• First Submitted That Met QC Criteria: May 22, 2015
• First Posted (Estimate): May 25, 2015

Study Record Updates

• Last Update Posted (Actual): March 28, 2019
• Last Update Submitted That Met QC Criteria: March 26, 2019
• Last Verified: March 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Autonomic Agents; Peripheral Nervous System Agents; Cholinergic Agents; Ganglionic Stimulants; Nicotinic Agonists; Cholinergic Agonists; Nicotine
• Other Study ID Numbers: 215114; K23DA035288 (U.S. NIH Grant/Contract)