Clinical trial NCT00350311: Multicomponent Risk Factor Intervention for People With a Severe Mental Illness: a Feasibility Study
Official title: Multicomponent Risk Factor Intervention for People With a Severe Mental Illness: a Feasibility Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Psychotic Disorder
Obesity
Behavior, Addictive
Lead sponsor: The University of New South Wales
Sponsor class: OTHER
Collaborators: name: Australian Government Department of Health and Ageing
First posted: 2006-07-10
Enrollment: 43
Sex: ALL
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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%).

Eligibility criteria: 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

Primary outcomes:
measure: Smoking Cessation
measure: Body Mass Index
Secondary outcomes:
Other outcomes:
Locations:
city: Newcastle
country: Australia
facility: Centre for Mental Health Studies, Univeristy Of Newcastle
state: New South Wales
city: Sydney
country: Australia
facility: School of Public Health and Community Medicine, University of New South Wales
state: New South Wales
city: Melbourne
country: Australia
facility: Department of Psychiatry, Monash University, The Alfred Hospital
state: Victoria
city: Melbourne
country: Australia
facility: Mental Health Research Institute, University of Melbourne, Royal Melbourne Hospital
state: Victoria
Study officials:
affiliation: Centre for Mental Health Studies, Uni of Newcastle
name: Amanda Baker, Assoc Prof
role: PRINCIPAL_INVESTIGATOR
References: