Mood Management Phone Counseling in Smoking Cessation

NCT ID: NCT00500877

Last Updated: 2016-07-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

53 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-02-28

Study Completion Date

2008-06-30

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Cigarette Smoking

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Mood Management Phone counseling

Mood management phone counseling for smoking cessation

Group Type ACTIVE_COMPARATOR

Mood Management Phone Counseling for Smoking Cessation

Intervention Type BEHAVIORAL

Phone counseling addressed mood management and smoking cessation

Phone Counseling Standard

Phone counseling standard

Group Type PLACEBO_COMPARATOR

Mood Management Phone Counseling for Smoking Cessation

Intervention Type BEHAVIORAL

Phone counseling addressed mood management and smoking cessation

Interventions

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Mood Management Phone Counseling for Smoking Cessation

Phone counseling addressed mood management and smoking cessation

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Institute on Drug Abuse (NIDA)

NIH

Sponsor Role collaborator

Butler Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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David Strong, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

Butler Hospital

Locations

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Butler Hospital

Providence, Rhode Island, United States

Site Status

Countries

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United States

Other Identifiers

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R01DA017947

Identifier Type: NIH

Identifier Source: secondary_id

View Link

1R01DA017947

Identifier Type: NIH

Identifier Source: org_study_id

View Link

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