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Study protocol: a randomised controlled trial investigating the effect of a healthy lifestyle intervention for people
Amanda Baker1, Frances J Kay-Lambkin, Robyn Richmond
1Centre for Brain and Mental Health Research, Faculty of Health, University of Newcastle, Callaghan, NSW 2308, Australia. amanda.baker@newcastle.edu.au
Insights
This study investigates a healthy lifestyle intervention for individuals with severe mental disorders to reduce smoking and cardiovascular disease (CVD) risk. Findings will inform clinical practice for this high-risk population.
Area of Science:
- Psychiatry
- Public Health
- Cardiology
Background:
- Cardiovascular disease (CVD) is the leading cause of mortality in individuals with severe mental disorders.
- High rates of smoking and overweight conditions in schizophrenia and bipolar disorder populations significantly elevate CVD risk.
- Health risk behavior interventions are often under-prioritized in severe mental disorder treatment.
Purpose of the Study:
- To assess the effectiveness of a healthy lifestyle intervention program.
- To evaluate the intervention's impact on smoking cessation and cardiovascular disease (CVD) risk reduction.
- To examine associated health behavior changes in individuals with severe mental disorders.
Main Methods:
- A randomized controlled trial involving 250 smokers with severe mental disorders.
- Comparison of a multi-component healthy lifestyle intervention against a minimal telephone-based intervention.
- Stratified randomization by site, BMI, and antipsychotic medication type; long-term follow-up to 36 months.
Main Results:
- Data collection ongoing to determine intervention effectiveness.
- Comprehensive assessment of smoking cessation and CVD risk factors.
- Evaluation of changes in associated health behaviors.
Conclusions:
- The study will provide crucial data on a healthy lifestyle intervention's efficacy for severe mental disorders.
- Successful outcomes could lead to widespread clinical adoption of the intervention.
- The intervention aims to improve long-term health outcomes and reduce mortality in this population.
Background:
The largest single cause of death among people with severe mental disorders is cardiovascular disease (CVD). The majority of people with schizophrenia and bipolar disorder smoke and many are also overweight, considerably increasing their risk of CVD. Treatment for smoking and other health risk behaviours is often not prioritized among people with severe mental disorders. This protocol describes a study in which we will assess the effectiveness of a healthy lifestyle intervention on smoking and CVD risk and associated health behaviours among people with severe mental disorders.
Methods/Design:
250 smokers with a severe mental disorder will be recruited. After completion of a baseline assessment and an initial face-to-face intervention session, participants will be randomly assigned to either a multi-component intervention for smoking cessation and CVD risk reduction or a telephone-based minimal intervention focusing on smoking cessation. Randomisation will be stratified by site (Newcastle, Sydney, Melbourne, Australia), Body Mass Index (BMI) category (normal, overweight, obese) and type of antipsychotic medication (typical, atypical). Participants will receive 8 weekly, 3 fortnightly and 6 monthly sessions delivered face to face (typically 1 hour) or by telephone (typically 10 minutes). Assessments will be conducted by research staff blind to treatment allocation at baseline, 15 weeks, and 12-, 18-, 24-, 30- and 36-months.
Discussion:
This study will provide comprehensive data on the effect of a healthy lifestyle intervention on smoking and CVD risk among people with severe mental disorders. If shown to be effective, this intervention can be disseminated to treating clinicians using the treatment manuals.
Trial Registration:
Australian New Zealand Clinical Trials Registry (ANZCTR) identifier: ACTRN12609001039279.