Women Engaging in Quitting Smoking Together

Not Applicable

Completed

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

• Registration Number: NCT02453659
• Lead Sponsor: Rhode Island Hospital

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2015-05
• Study First Submitted: 2015-05-21
• Study First Submitted QC: 2015-05-22
• Study First Posted: 2015-05-25
• Primary Completion: 2018-12
• Study Completion: 2018-12
• Status Verified: 2019-03
• Last Update Submitted: 2019-03-26
• Last Update Posted: 2019-03-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 100

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Distress Tolerance Treatment for Weight Concern (DT-W)	Transdermal Nicotine Patch	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.
Health Education (HE)	Transdermal Nicotine Patch	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.
Distress Tolerance Treatment for Weight Concern (DT-W)	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.
Health Education (HE)	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.
Health Education (HE)	Smoking Cessation counseling	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.
Distress Tolerance Treatment for Weight Concern (DT-W)	Smoking Cessation counseling	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.

Primary Outcome Measures

Name	Time	Method
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	6 months post-quit date	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).

Trial Locations

Locations (1)

Rhode Island Hospital; 🇺🇸 Providence, Rhode Island, United States