Group Counseling for Smoking Cessation | NCT00104481

Studies
Group Counseling for Smoking Cessation

NCT00104481

Sponsor

American University

Status

Completed

Last Update Posted

Dec 8, 2011Estimated

Enrollment

240

Phase

Phase 1Phase 2

Conditions

Smoking

Interventions

cognitive behavior therapy

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
2R15CA077732-02A1	U.S. NIH Grant/Contract		View source

Status Module

Record Verification Date

Mar 2007

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 2005

Primary Completion Date

Not provided

Completion Date

Aug 2007

First Submitted Date

Mar 1, 2005

First Submission Date that Met QC Criteria

Mar 1, 2005

First Posted Date

Mar 2, 2005Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Dec 7, 2011

Last Update Posted Date

Dec 8, 2011Estimated

Description Module

Brief Summary

The purpose of this study is to evaluate the effectiveness of group therapy for cigarette smoking cessation. The group meets for 8 sessions and includes education and group discussion about the effects of smoking and ways to cope with withdrawal symptoms and other challenges to maintaining abstinence. In one condition, the groups also learn techniques based on cognitive therapy, to help cope with negative feelings.

Detailed Description

The comparison condition is the same length as the cognitive behavior therapy condition but omits the cognitive restructuring component. In both conditions, smokers prepare for a quit date by using scheduled reduced smoking, which involves smoking on a set schedule that gradually reduces the number of cigarettes smoked. Post-treatment assessments occur one week after the end of treatment, and at 3-month followup.

Pre- and post-treatment assessments include measures of coping skills and emotional acceptance, as well as smoking rate.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 1Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

240

Name	Type	Description	Arm Group Labels	Other Names
cognitive behavior therapy	Behavioral

Measure	Description	Time Frame
cigarette smoking abstinence

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Regular daily smokers interested in quitting

Exclusion Criteria:

Significant suicidal ideation

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
David A Haaga, Ph.D.	American University	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
American University		Washington D.C.	District of Columbia	20016-8062	United States

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
15236811	Background	Haaga DA, Thorndike FP, Friedman-Wheeler DG, Pearlman MY, Wernicke RA. Cognitive coping skills and depression vulnerability among cigarette smokers. Addict Behav. 2004 Aug;29(6):1109-22. doi: 10.1016/j.addbeh.2004.03.026.

ID	Term
D001519	Behavior
D015438	Health Behavior

ID	Term
D001521	Behavior Therapy
D011613	Psychotherapy
D004191	Behavioral Disciplines and Activities