search
Back to results

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

Primary Purpose

Psychotic Disorder, Obesity, Behavior, Addictive

Status
Completed
Phase
Phase 2
Locations
Australia
Study Type
Interventional
Intervention
nicotine transdermal patch/lozenge
Sponsored by
The University of New South Wales
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Psychotic Disorder

Eligibility Criteria

18 Years - 40 Years (Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Centre for Mental Health Studies, Univeristy Of Newcastle
  • School of Public Health and Community Medicine, University of New South Wales
  • Department of Psychiatry, Monash University, The Alfred Hospital
  • Mental Health Research Institute, University of Melbourne, Royal Melbourne Hospital

Outcomes

Primary Outcome Measures

Smoking Cessation
Body Mass Index

Secondary Outcome Measures

Full Information

First Posted
July 6, 2006
Last Updated
September 25, 2008
Sponsor
The University of New South Wales
Collaborators
Australian Government Department of Health and Ageing
search

1. Study Identification

Unique Protocol Identification Number
NCT00350311
Brief Title
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

2. Study Status

Record Verification Date
September 2008
Overall Recruitment Status
Completed
Study Start Date
February 2007 (undefined)
Primary Completion Date
April 2008 (Actual)
Study Completion Date
April 2008 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
The University of New South Wales
Collaborators
Australian Government Department of Health and Ageing

4. Oversight

5. Study Description

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%).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Psychotic Disorder, Obesity, Behavior, Addictive

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
43 (Actual)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
nicotine transdermal patch/lozenge
Primary Outcome Measure Information:
Title
Smoking Cessation
Title
Body Mass Index

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Amanda Baker, Assoc Prof
Organizational Affiliation
Centre for Mental Health Studies, Uni of Newcastle
Official's Role
Principal Investigator
Facility Information:
Facility Name
Centre for Mental Health Studies, Univeristy Of Newcastle
City
Newcastle
State/Province
New South Wales
ZIP/Postal Code
2308
Country
Australia
Facility Name
School of Public Health and Community Medicine, University of New South Wales
City
Sydney
State/Province
New South Wales
ZIP/Postal Code
2052
Country
Australia
Facility Name
Department of Psychiatry, Monash University, The Alfred Hospital
City
Melbourne
State/Province
Victoria
ZIP/Postal Code
3004
Country
Australia
Facility Name
Mental Health Research Institute, University of Melbourne, Royal Melbourne Hospital
City
Melbourne
State/Province
Victoria
ZIP/Postal Code
3004
Country
Australia

12. IPD Sharing Statement

Learn more about this trial

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

We'll reach out to this number within 24 hrs