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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00350311
First Posted: July 10, 2006
Last Update Posted: September 26, 2008
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Australian Government Department of Health and Ageing
Information provided by:
The University of New South Wales
  Purpose
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.

Condition Intervention Phase
Psychotic Disorder Obesity Behavior, Addictive Drug: nicotine transdermal patch/lozenge Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Multicomponent Risk Factor Intervention for People With a Severe Mental Illness: a Feasibility Study

Resource links provided by NLM:


Further study details as provided by The University of New South Wales:

Primary Outcome Measures:
  • Smoking Cessation
  • Body Mass Index

Enrollment: 43
Study Start Date: February 2007
Study Completion Date: April 2008
Primary Completion Date: April 2008 (Final data collection date for primary outcome measure)
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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 40 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00350311


Locations
Australia, New South Wales
Centre for Mental Health Studies, Univeristy Of Newcastle
Newcastle, New South Wales, Australia, 2308
School of Public Health and Community Medicine, University of New South Wales
Sydney, New South Wales, Australia, 2052
Australia, Victoria
Department of Psychiatry, Monash University, The Alfred Hospital
Melbourne, Victoria, Australia, 3004
Mental Health Research Institute, University of Melbourne, Royal Melbourne Hospital
Melbourne, Victoria, Australia, 3004
Sponsors and Collaborators
The University of New South Wales
Australian Government Department of Health and Ageing
Investigators
Principal Investigator: Amanda Baker, Assoc Prof Centre for Mental Health Studies, Uni of Newcastle
  More Information

ClinicalTrials.gov Identifier: NCT00350311     History of Changes
Other Study ID Numbers: 95/05
First Submitted: July 6, 2006
First Posted: July 10, 2006
Last Update Posted: September 26, 2008
Last Verified: September 2008

Additional relevant MeSH terms:
Mental Disorders
Psychotic Disorders
Behavior, Addictive
Schizophrenia Spectrum and Other Psychotic Disorders
Compulsive Behavior
Impulsive Behavior
Nicotine
Ganglionic Stimulants
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Nicotinic Agonists
Cholinergic Agonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action