NCT02051803

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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
22

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Mar 2014

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 30, 2014

Completed
1 day until next milestone

First Posted

Study publicly available on registry

January 31, 2014

Completed
29 days until next milestone

Study Start

First participant enrolled

March 1, 2014

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2015

Completed
Last Updated

July 31, 2015

Status Verified

July 1, 2015

Enrollment Period

1.3 years

First QC Date

January 30, 2014

Last Update Submit

July 30, 2015

Conditions

Smoking Cessation

Keywords

smoking cessationwomen

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (2)

Distress Tolerance Treatment for Weight Concern (DT-W)

EXPERIMENTAL

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)

Health Education (HE)

ACTIVE COMPARATOR

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)

Interventions

Distress Tolerance Treatment for Weight Concern (DT-W)BEHAVIORAL
Distress Tolerance Treatment for Weight Concern (DT-W)
Health Education (HE)BEHAVIORAL
Health Education (HE)

Eligibility Criteria

Age18 Years - 65 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • female
  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Butler Hospital

Providence, Rhode Island, 02906, United States

Location

MeSH Terms

Conditions

Smoking Cessation

Condition Hierarchy (Ancestors)

Health BehaviorBehavior

Study Officials

  • Erika L. Bloom, Ph.D.

    Butler Hospital and Rhode Island Hospital

    PRINCIPAL INVESTIGATOR

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

January 30, 2014

First Posted

January 31, 2014

Study Start

March 1, 2014

Primary Completion

June 1, 2015

Study Completion

June 1, 2015

Last Updated

July 31, 2015

Record last verified: 2015-07

Locations

US(1)