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Mood and Smoking: A Comparison of Smoking Cessation Treatments

25 juni 2015 bijgewerkt door: US Department of Veterans Affairs

CSP #725 - Mood and Smoking: A Comparison of Smoking Cessation Treatments

Objectives:

The long term objectives of this research program are:

  1. To advance the mission of the VHA Boston Healthcare System to deliver comprehensive quality healthcare that meets the needs of patients (in this case, who have been unresponsive to standard smoking cessation treatment) through research and clinical care.
  2. To expand upon our knowledge of the feasibility and effectiveness of commonly-used treatments for nicotine dependence.
  3. To further explore variables related to mood and coping that may contribute to or prevent successful reduction and cessation of smoking behavior among veterans.

The short-term objectives of this project are:

  1. To evaluate the feasibility and effectiveness of two adjunctive treatments (a mood-focused exposure-based treatment, Mood Tolerance, with Nicotine Replacement Therapy [MTNRT] and mood-focused affect-management treatment, Mood Management, with Nicotine Replacement Therapy [MMNRT]) aimed at reduction and cessation of smoking behavior among veterans who were previously non-responders to smoking cessation treatment in the VA.
  2. To inform equivocal findings in the literature regarding the role of mood as trigger for smoking behavior.
  3. To explore selected mood, coping, and individual difference variable that may be predictive of successful abstinence from cigarettes among veterans.

Studie Overzicht

Gedetailleerde beschrijving

Objectives:

The short-term objectives of this project are:

  1. To evaluate the effectiveness of two adjunctive treatments (mood-focused exposure-based treatment, Mood Tolerance, with Nicotine Replacement Therapy [MT-NRT] and mood-focused affect-management treatment, Mood Management, with NRT [MM-NRT] aimed at reduction and cessation of smoking behavior among veterans who were previously non-responders to smoking cessation treatment.
  2. To examine specific variables that may serve as mechanisms of action for successful treatment (i.e., mood and coping variables).

The long-term objectives of this research program are:

  1. To advance the mission of the VA to deliver comprehensive quality healthcare that meets the needs of patients who have been unresponsive to standard smoking cessation treatment, through research and clinical care.
  2. To reduce the exorbitant healthcare costs of nicotine dependence (ND) to the VA, and to improve veterans' physical and psychological well-being, healthcare utilization, and mortality rates.
  3. To evaluate effectiveness of common treatments for ND.
  4. To explore mechanisms of action related to efficacy of treatment for ND among veterans (i.e., changes in mood and coping.)

Research Design:

This is a two-cell, single-blind, randomized, treatment outcome study.

Methodology:

One hundred and twenty-eight smoking outpatients who have previously participated in standard group smoking cessation treatment (treatment non-responders, with NRT) will be recruited through the VA Boston Outpatient Health Psychology Clinic. Advertising flyers posted throughout the Boston VA Medical Center and Outpatient Clinic will be used to supplement this recruitment.

Baseline Assessment:

Interested and eligible patients will sign an informed consent form, which will be thoroughly reviewed with each participant and co-signed by the investigators. Baseline evaluation of the participants will take approximately 90 minutes. This evaluation will include assessment of smoking-related variables, moods, and affect-regulation and coping strategies, as well as carbon monoxide (CO) levels in expired breath.

Treatment:

Participants will be randomly assigned to one of the two treatments. This will involve meeting with a pharmacist, primary care physician, psychiatrist, or nurse practitioner to be screened for use of nicotine replacement therapy (NRT; transdermal patch) and to initiate NRT use. A member of the research team will continue to monitor the participant's physical health during the course of the treatment. In addition, the participant will attend treatment groups once a week for 15 weeks. These treatment groups will be conducted by a member of the research team or clinical students supervised by the PI. Each of these groups will last 90 minutes.

Follow-Up:

The first follow-up appointment will take place in the week after completion of the treatment. Additional follow-up assessments will take place at 3-, 6-, 9-, and 12-months subsequent to the first follow-up appointment. These assessments will be almost identical to the baseline assessment, and will last approximately 90 minutes.

Findings:

Thirty-four participants have been enrolled in this study; 12 of whom are currently actively involved in the protocol. No data have been analyzed or presented yet.

Studietype

Ingrijpend

Inschrijving

128

Fase

  • Niet toepasbaar

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studie Locaties

    • Massachusetts
      • Boston, Massachusetts, Verenigde Staten, 02103
        • Boston VA Healthcare System

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

  • Kind
  • Volwassen
  • Oudere volwassene

Accepteert gezonde vrijwilligers

Ja

Geslachten die in aanmerking komen voor studie

Allemaal

Beschrijving

Outpatient veteran smokers who have previously failed a smoking cessation treatment program with nicotine replacement therapy

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

  • Toewijzing: Gerandomiseerd
  • Interventioneel model: Opdracht voor een enkele groep
  • Masker: Enkel

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start

1 maart 2003

Studie voltooiing

1 maart 2006

Studieregistratiedata

Eerst ingediend

12 januari 2004

Eerst ingediend dat voldeed aan de QC-criteria

13 januari 2004

Eerst geplaatst (Schatting)

14 januari 2004

Updates van studierecords

Laatste update geplaatst (Schatting)

26 juni 2015

Laatste update ingediend die voldeed aan QC-criteria

25 juni 2015

Laatst geverifieerd

1 juni 2015

Meer informatie

Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .

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