- ICH GCP
- Registre américain des essais cliniques
- Essai clinique NCT00075972
Mood and Smoking: A Comparison of Smoking Cessation Treatments
CSP #725 - Mood and Smoking: A Comparison of Smoking Cessation Treatments
Objectives:
The long term objectives of this research program are:
- 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.
- To expand upon our knowledge of the feasibility and effectiveness of commonly-used treatments for nicotine dependence.
- 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:
- 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.
- To inform equivocal findings in the literature regarding the role of mood as trigger for smoking behavior.
- To explore selected mood, coping, and individual difference variable that may be predictive of successful abstinence from cigarettes among veterans.
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Description détaillée
Objectives:
The short-term objectives of this project are:
- 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.
- 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:
- 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.
- 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.
- To evaluate effectiveness of common treatments for ND.
- 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.
Type d'étude
Inscription
Phase
- N'est pas applicable
Contacts et emplacements
Lieux d'étude
-
-
Massachusetts
-
Boston, Massachusetts, États-Unis, 02103
- Boston VA Healthcare System
-
-
Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
- Enfant
- Adulte
- Adulte plus âgé
Accepte les volontaires sains
Sexes éligibles pour l'étude
La description
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Répartition: Randomisé
- Modèle interventionnel: Affectation à un seul groupe
- Masquage: Seul
Collaborateurs et enquêteurs
Parrainer
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude
Achèvement de l'étude
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Estimation)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Estimation)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- 725
Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .
Essais cliniques sur Mood Tolearance
-
HucircadianPusan National University Hospital; Korea University Guro Hospital; Korea University... et autres collaborateursRecrutementTrouble dépressif majeur | Trouble bipolaire 1 | Trouble bipolaire IICorée, République de
-
University of MichiganRecrutementLa dépression | Troubles de l'humeur | Stresser | Anxiété | Santé mentale Bien-être 1États-Unis
-
Neurovalens Ltd.NRI Institute of Medical SciencesRecrutement
-
Chenland Nutritionals Inc.KGK Science Inc.Complété
-
Silver Cloud HealthUniversity of Dublin, Trinity College; Berkshire Healthcare NHS Foundation...ComplétéLa dépressionRoyaume-Uni
-
Emory UniversitySusan G. Komen Breast Cancer FoundationRetiréCancer du seinÉtats-Unis