Effectiveness of a Smoking Cessation Quit Line for Mental Health Patients

NCT03230955 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 300

Last updated 2021-10-11

No results posted yet for this study

Summary

Pragmatic randomized clinical trial, single-blind, with allocation 2:1 \[Intervention Group (IG) and control group (CG)\] in 5 acute hospitals. The IG will receive telephone assistance to quit smoking (including psychological and psycho-educational support and pharmacological treatment advice, if required) proactively for 12 months, and the CG only brief counselling after discharge.

To assess the effectiveness of a multicomponent and motivational intensive telephone-based intervention to stop smoking ("quit line") addressed to smokers with mental disorders discharged from hospitals.

Conditions

  • Mental Disorder
  • Smoking Cessation
  • Motivation

Interventions

BEHAVIORAL

Psychological and psycho-educational support by phone

The intervention is based on cognitive-behavioural therapy (CBT). The intervention, in order to achieve behavioural changes, will include components based in Bandura's social learning theory and social cognitive theory (Bandura, 1986) and the transtheorical model of change (Prochaska, 1992). It has been shown that expectations and self-efficacy are behavioural predictors and that they are an effective framework for the assistance to quit smoking. This theory allows evaluating patient motivation phase and adapting the interventions according to each phase (Fiore, 2011)

OTHER

Brief counselling session

Brief counselling session

Sponsors & Collaborators

  • Hospital Universitari de Bellvitge

    collaborator OTHER
  • Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau

    collaborator OTHER
  • Hospital Clinic of Barcelona

    collaborator OTHER
  • Hospital Vall d'Hebron

    collaborator OTHER
  • Hestia Alliance

    collaborator OTHER
  • Institut Català d'Oncologia

    lead OTHER

Principal Investigators

  • Cristina Martínez, RN,BA, PhD · Institut Català d'Oncologia

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
76 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2017-05-02
Primary Completion
2020-05-31
Completion
2020-12-31

Countries

  • Spain

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03230955 on ClinicalTrials.gov