Multicomponent Risk Factor Intervention for People With a Severe Mental Illness: a Feasibility Study

Phase 2

Completed

• Conditions: Psychotic Disorder; Obesity; Behavior, Addictive

• Registration Number: NCT00350311
• Lead Sponsor: The University of New South Wales

Brief Summary

This study is a feasibility study of a multi-component intervention to enhance healthy living among young people with psychotic disorders, specifically targeting smoking and weight.

Detailed Description

We propose a feasibility study of a multi-component intervention to enhance healthy living among young people (18 to 40 years) with psychotic disorders, specifically targeting smoking and weight. Smoking is very common amongst people with psychotic disorders (around 70% of males, and over 50% of females) and this adds to the overall cardiovascular risk for this group. Obesity is also a common problem for people with psychosis, with an estimated 40-60% being obese or overweight. Obesity in this population may contribute to adverse medical and psychological consequences. For many obese people, targeted pharmacotherapy in addition to diet and increased physical activity can assist in both weight reduction and the maintenance of gains. Similarly, smoking cessation is enhanced by use of adjunctive medications such as nicotine replacement; such strategies continue to produce abstinence rates for up to 10 years.

The proposed study will assess the feasibility of a multi-component behavioural intervention focussing on smoking cessation/diet/physical activity.

The primary outcome measures from the feasibility study are smoking cessation and reduction in body mass index (BMI). Secondary outcomes will include tolerability and safety, as well as the impact the package has on other cardiovascular risk factors including serum lipids, blood sugar levels and depression in young people with psychosis. We will also establish whether smoking cessation and reduction in obesity is correlated with gains in terms of body image, quality and enjoyment of life and reduction in depression. Based on published data, behavioural interventions for smoking cessation and diet and physical activity lead smoking cessation in 20% of people at 12 months and to modest weight loss (around 5%).

Study Timeline

• Study First Submitted: 2006-07-06
• Study First Submitted QC: 2006-07-06
• Study First Posted: 2006-07-10
• Study Start: 2007-02
• Primary Completion: 2008-04
• Study Completion: 2008-04
• Status Verified: 2008-09
• Last Update Submitted: 2008-09-25
• Last Update Posted: 2008-09-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 43

Inclusion Criteria

• 18-40 yrs
• DSM-IV diagnosis of non-organic psychotic illness
• Obesity (BMI > 30 or 27 if co-morbidities such as diabetes, hypertension or dyslipidaemia are present
• Current smoker ( > 15 cigarettes per day) if also smoking cannabis regularly, they will still be able to participate

Exclusion Criteria

• Medical contraindication to exercise or use of the nicotine patch
• Intellectual disability that would significantly impair ability to participate in the program
• Inability to give informed consent (acutely psychotic potential participants will be reassessed one month post screening

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Smoking Cessation
Body Mass Index

Trial Locations

Locations (4)

Mental Health Research Institute, University of Melbourne, Royal Melbourne Hospital; 🇦🇺 Melbourne, Victoria, Australia

Centre for Mental Health Studies, Univeristy Of Newcastle; 🇦🇺 Newcastle, New South Wales, Australia

School of Public Health and Community Medicine, University of New South Wales; 🇦🇺 Sydney, New South Wales, Australia

Department of Psychiatry, Monash University, The Alfred Hospital; 🇦🇺 Melbourne, Victoria, Australia