NCT Number: NCT00350311
Multicomponent Risk Factor Intervention for People With a Severe Mental Illness: a Feasibility Study
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.
Looking for future studies?
Notify MeKey information
Conditions
Age range
18 year–40 year
Sex eligibility
All sexes
Study type
Interventional
Phase
Phase 2
Primary location
Centre for Mental Health Studies, Univeristy Of Newcastle, Newcastle, New South Wales, Australia
About this study
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%).
Who can participate
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
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
Treatment and study plan
Primary outcomes
-
Smoking Cessation
-
Body Mass Index
Sponsors and collaborators
Lead sponsor
The University of New South Wales
Other
Collaborators
- Australian Government Department of Health and Ageing
Registry information
Important dates
- Study start
- 2007
- Primary completion
- 2008
- Study completion
- 2008
- First posted
- Jul 10, 2006
- Registry last updated
- Sep 26, 2008
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Related clinical trials
Published trials that share one or more normalized conditions with this study.
Three Year Follow up of a Randomised Controlled Trial (RCT) of an Intervention for Tobacco Dependence Among Those With a Psychotic Illness
NCT00350493
Behavior, Behavior, Addictive
Newcastle, New South Wales, Australia
View Trial DetailsImplementing Effective, Collaborative Care for Schizophrenia (EQUIP-2)
NCT00137280
Behavior, Body Weight
Long Beach, California, United States
View Trial DetailsArts-based Social Prescribing for Mental Health
NCT07137572
Adjustment Disorder, Adjustment Disorders
Athens, Greece
View Trial DetailsThe Effectiveness of Forest Therapy on Psychotic Patients: Focusing on Changes in Inflammatory Pathways and The Psychotic Condition of Patients
NCT07436481
Mental Disorders, Psychotic Disorder
Semarang, Central Java, Indonesia
View Trial Details