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
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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