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Mood Management Phone Counseling in Smoking Cessation

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00500877
First Posted: July 13, 2007
Last Update Posted: July 20, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
National Institute on Drug Abuse (NIDA)
Information provided by (Responsible Party):
Butler Hospital
  Purpose
Information obtained from this study will help us to have a better idea of how phone counseling may facilitate the process of quitting smoking for individuals with a history of recurrent depression.

Condition Intervention Phase
Cigarette Smoking Behavioral: Mood Management Phone Counseling for Smoking Cessation Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Mood Management Phone Counseling in Smoking Cessation

Resource links provided by NLM:


Further study details as provided by Butler Hospital:

Primary Outcome Measures:
  • Smoking Abstinence [ Time Frame: 6 months ]

Enrollment: 53
Study Start Date: February 2007
Study Completion Date: June 2008
Primary Completion Date: June 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Mood Management Phone counseling
Mood management phone counseling for smoking cessation
Behavioral: Mood Management Phone Counseling for Smoking Cessation
Phone counseling addressed mood management and smoking cessation
Placebo Comparator: Phone Counseling Standard
Phone counseling standard
Behavioral: Mood Management Phone Counseling for Smoking Cessation
Phone counseling addressed mood management and smoking cessation

Detailed Description:
Adult smokers with a history of recurrent major depression (MDD) report higher levels of depressive symptoms when presenting for smoking cessation treatment and have poor smoking outcomes relative to other smokers. Carefully conducted clinical trials have supported the efficacy of cognitive-behavioral mood management treatment for depression in improving smoking cessation outcomes in this high-risk group. Although efficacious, these intensive group treatments require significant resources and thus may have limited impact outside of specialized smoking cessation programs. In the present study we will develop and obtain preliminary data on the efficacy of proactive telephone counseling for smoking cessation that integrates cognitive-behavioral mood management skills training for depression (MM). Smokers with a history of recurrent MDD will be randomly assigned to the proactive telephone counseling for smoking cessation with mood management (MM) or a standard proactive telephone counseling (ST) comparison condition. We expect that this program of research will result in the development of a specialized, efficacious treatment with broad reach into a significant subpopulation of smokers at greatest risk for difficulties quitting, and will therefore have important clinical and public health significance in decreasing the overall prevalence of cigarette smoking.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • history of two or more past episodes of depression
  • regular cigarette smoker for at least one year
  • currently smoking 10 or more cigarettes each day
  • want to quit smoking

Exclusion Criteria:

  • Current Depressive Episode
  • Current Alcohol of Substance abuse
  • Pregnant, planning to become pregnant
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00500877


Locations
United States, Rhode Island
Butler Hospital
Providence, Rhode Island, United States, 02906
Sponsors and Collaborators
Butler Hospital
National Institute on Drug Abuse (NIDA)
Investigators
Principal Investigator: David Strong, Ph.D. Butler Hospital
  More Information

Responsible Party: Butler Hospital
ClinicalTrials.gov Identifier: NCT00500877     History of Changes
Other Study ID Numbers: 1R01DA017947 ( U.S. NIH Grant/Contract )
R01DA017947 ( U.S. NIH Grant/Contract )
First Submitted: July 11, 2007
First Posted: July 13, 2007
Last Update Posted: July 20, 2016
Last Verified: July 2016

Keywords provided by Butler Hospital:
Smoking cessation
Phone Counseling