Women Engaging in Quitting Smoking Together (WE QUIT) (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 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 Overview

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

• Study Type: Interventional
• Enrollment (Actual): 22
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Rhode Island
    • Providence, Rhode Island, United States, 02906
      • Butler Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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

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)
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: Health Education (HE)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Point prevalence abstinence from smoking	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).	6 months from smoking quit date

Collaborators and Investigators

• Sponsor: Butler Hospital
• Collaborators: National Institute on Drug Abuse (NIDA)
• Investigators: Principal Investigator: Erika L. Bloom, Ph.D., Butler Hospital and Rhode Island Hospital

Study record dates

Study Major Dates

• Study Start: March 1, 2014
• Primary Completion (Actual): June 1, 2015
• Study Completion (Actual): June 1, 2015

Study Registration Dates

• First Submitted: January 30, 2014
• First Submitted That Met QC Criteria: January 30, 2014
• First Posted (Estimate): January 31, 2014

Study Record Updates

• Last Update Posted (Estimate): July 31, 2015
• Last Update Submitted That Met QC Criteria: July 30, 2015
• Last Verified: July 1, 2015

More Information

Terms related to this study

• Keywords: smoking cessation; women
• Other Study ID Numbers: 1303-003; K23DA035288 (U.S. NIH Grant/Contract)