Trial from ANZCTR


Trial ID ACTRN12609001039279
Trial Status: Registered
Date Submitted: 17/07/2009
Date Registered: 4/12/2009
Retrospectively registered

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Public title Healthy lifestyle intervention for cardiovascular disease risk reduction among smokers with psychotic disorders
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Study title in 'Participant- Intervention- Comparator- Outcome (PICO)' format In smokers with psychotic disorders, is an intervention consisting of nicotine replacement therapy (NRT) and motivational interviewing and cognitive-behaviour therapy (MICBT) and contingency management (CM) as or more effective as a one-session intervention followed by NRT plus brief contact for reduction of cardiovascular disease (CVD) risk and smoking cessation?
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Secondary ID [1] 928 0
N/A
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UTN
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Trial acronym N/A
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Health condition(s) or problem(s) studied:
Cardiovascular disease risk behaviours (in people with psychosis) 237272 0
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Smoking (in people with psychosis) 237283 0
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Condition category: Condition code:
Mental Health Psychosis and personality disorders
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239594 239594 0 0

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Descriptions of intervention(s) / exposure 1) Experimental (treatment) condition: One 2 hour session of feedback which includes a summary of initial assessment findings, identification of a problem list and goal setting around smoking and lifestyle issues presented in face to face format by a therapist. Following the feedback session the participant will then attend 7 individual once weekly sessions of MICBT + CM and will be provided with a supply of NRT for daily use. Weekly sessions will be followed by 3 fortnightly sessions of MICBT + CM, followed by 6 monthly sessions of MICBT + CM. The particpants' supply of NRT will be provided in batches at regular intervals between 2-4 weeks for a maximum of 6 months. NRT will be tapered during the last month it is provided. Participants will then attend their final treatment session at Session 17. Sessions target smoking and CVD risk behaviours such as poor dietary habits and lack of exercise and CVD risk factors such as depression and social support.

(2) Control condition: One 2 hour session of feedback which includes a summary of initial assessment findings, identification of a problem list and goal setting around smoking and lifestyle issues presented in face to face format by a therapist with provision of NRT followed by 2 brief weekly telephone check-ins to monitor withdrawal symptoms and side-effects from medication. At week 4 participants will attend a brief face to face session to provide further NRT followed by 3 brief weekly telephone check-ins. At Week 8 participants will then attend a brief face to face session to provide further NRT followed by 3 fortnightly telephone check-ins, and 6 monthly brief telephone check-ins. The particpants' supply of NRT will be provided in batches at regular intervals between 2-4 weeks for a maximum of 6 months. NRT will be tapered during the last month it is provided.

Cognitive Behavior Therapy (CBT) refers to a therapy approach that helps people to change unhelpful thinking habits, feelings and behaviours. Motivational Interviewing (MI) is a directive, client-centered counselling style to bring about behavior change by helping clients to explore and resolve ambivalence. Therapy sessions have a typical duration of 1 hour and are provided as one to one sessions with a Psychologist.
The duration of sessions for both the intervention and control session is approximately 9 months.
Nicotine Replacement Therapy (NRT) is the use of alternate forms of nicotine delivery ( e.g. transdermal patch and lozenges)intended to replace the nicotine obtained from smoking. NRT will be provided daily for up to 6 months in total. Commencing from the date of the participant's quit attempt they will be provided with NRT for up to 6 months, as long as they remain in treatment. For participants smoking less than 30 cigarettes per day they will be provided with NRT in the form of transdermal patches and lozenges (up to 45mg nicotine daily) for up 5 months. NRT will then be tapered during the final month of treatment. For participants smoking more than 30 cigarettes daily, they will be given the opportunity to use two transdermal patches daily and lozenges (up to 66mg nicotine daily) for the first three months reducing to 45mg Nicotine daily for up to 2 months.NRT will then be tapered during the final month of treatment.
All participants will have their use of NRT, Nicotine withdrawal symptoms and adverse symptoms related to medication usage monitored at every contact (either face to face or telephone). The overall duration of treatment for the intervention condition is 9 months.
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Intervention Code:
Treatment: Other 236952 0
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Intervention Code:
Lifestyle 236953 0
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Intervention Code:
Behaviour 236954 0
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Comparator / control treatment Control condition: One 2 hour session of feedback which includes a summary of initial assessment findings, identification of a problem list and goal setting around smoking and lifestyle issues presented in face to face format by a therapist with provision of NRT followed by 2 brief weekly telephone check-ins to monitor withdrawal symptoms and side-effects from medication. At week 4 participants will attend a brief face to face session to provide further NRT followed by 3 brief weekly telephone check-ins. At Week 8 participants will then attend a brief face to face session to provide further NRT followed by 3 fortnightly telephone check-ins, and 6 monthly brief telephone check-ins. The particpants' supply of NRT will be provided in batches at regular intervals between 2-4 weeks for a maximum of 6 months. NRT will be tapered during the last month it is provided.

The overall duration of treatment for the control condition is 9 months.
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Control group Active
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Primary Outcome: Primary Outcome 1: Overall CVD risk index 238383 0
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Timepoint: Timepoint: Measured at 15-weeks, 12-, 18-, 24-, 30- and 36-months following the initial assessment 238383 0
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Primary Outcome: Primary Outcome 2: Smoking status- continuous and point prevalence abstinence [confirmed by expired carbon monoxide level (CO)] and self reported number of cigarettes per day 238384 0
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Timepoint: Timepoint: Measured at 15-weeks, 12-, 18-, 24-, 30- and 36-months following the initial assessment 238384 0
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Secondary Outcome: Secondary Outcome 1: Weight [Kg, Body mass index (BMI), waist/hip ratio, waist circumference) 244836 0
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Timepoint: Timepoint: Measured at 15-weeks, 12-, 18-, 24-, 30- and 36-months following the initial assessment 244836 0
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Secondary Outcome: Secondary Outcome 2: Physical activity (International Physical Activity Questionnaire-IPAQ which measure the frequency and intensity of physical activity via a self report questionnaire) 244837 0
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Timepoint: Timepoint: Measured at 15-weeks, 12-, 18-, 24-, 30- and 36-months following the initial assessment 244837 0
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Secondary Outcome: Secondary Outcome 3: Unhealthy eating as measured by client's self reported dietary intake . 244838 0
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Timepoint: Timepoint: Measured at 15-weeks, 12-, 18-, 24-, 30- and 36-months following the initial assessment 244838 0
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Secondary Outcome: Secondary Outcome 4: Substance use (alcohol and cannabis use as measured by the Opiate Treatment Index Drug Use Scale items) 244839 0
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Timepoint: Timepoint: Measured at 15-weeks, 12-, 18-, 24-, 30- and 36-months following the initial assessment 244839 0
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Secondary Outcome: Secondary outcome 5: Psychiatric Symptomatology [MINI Neuropsychiatric interview for Schizophrenia and Psychotic Disorders for diagnosis (MINI); The Brief Psychiatric Rating Scale (BPRS) and the Beck Depression Inventory II( BDI-II)] 244840 0
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Timepoint: Timepoint: Measured at 15-weeks, 12-, 18-, 24-, 30- and 36-months following the initial assessment 244840 0
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Secondary Outcome: Secondary outcome 6: treatment retention and treatment alliance (Agnew Davies relationship measure- Therapist and client version). Number of sessions of treatment completed will also be measured. 244841 0
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Timepoint: Timepoint: Measured at Session 1, 4 and 8 of treatment and at the 15 week assessment. 244841 0
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Secondary Outcome: Secondary outcome 7: Service utilisation as measured by client's self reported access of health professionals and health facilities including hospitals 244842 0
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Timepoint: Timepoint: Measured at 15-weeks, 12-, 18-, 24-, 30- and 36-months following the initial assessment 244842 0
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Secondary Outcome: Secondary outcome 8: General functioning and quality of life [Global Assessment of Functioning (GAF)] 244843 0
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Timepoint: Timepoint: Measured at 15-weeks, 12-, 18-, 24-, 30- and 36-months following the initial assessment 244843 0
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Key inclusion criteria Diagnosis of a psychotic disorder or Bipolar Disorder
Current smoker ( at least 15 cigarettes per day)
Taking anti-psychotic medication as prescribed for a period of at least 2 months, with intention to continue for the duration of the study
English speaker
No organic/acquired brain damage
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Minimum age 18 Years
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Maximum age No limit
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Gender Both males and females
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Healthy volunteers? No
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Key exclusion criteria Smoke less than 15 cigarettes daily, non english speaking, organic brain damage,
medical condition that would preclude NRT,
actively suidical or acutely unwell.
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Study type Interventional
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Purpose of the study Treatment
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Allocation to intervention Randomised controlled trial
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Describe the procedure for enrolling a subject and allocating the treatment (allocation concealment procedures) A simple stratified randomised list generated by the research manager using a randomisation table by a computer software will be linked to a unique participation identification code. Treatment allocations (intervention or control) are transferred from this list by an administrative assistant and concealed in individual envelopes labelled with the relevant participant code. Neither the research manager no the administrative assistant are involved with the assessment or treatment phases of the study. Prior to the initial feedback session for each participant, the research clinicians are issued with a new randomisation envelope, according to the stratification of the subject (see below) by the administrative assistant, which displays the participant number on the outside of the envelope, with the treatment allocation sealed on the inside. This envelope is opened by the research participant at the conclusion of the feedback session.
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Describe the methods used to generate the sequence in which subjects will be randomised (sequence generation) A simple stratified randomisation list developed by using a randomisation table created by computer software will be generated independently for each site and linked to a unique participation identification code (1-100). Stratification will be made by site, BMI category (normal, overweight, obese) and type of antipsychotic medication (typical, atypical)
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Masking / blinding Blinded (masking used)
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Who is / are masked / blinded (choose all that apply)


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Assignment Parallel
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Other design features N/A
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Type of endpoint(s) Efficacy
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Statistical Methods/Analysis
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Phase Not Applicable
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Anticipated date of first participant enrolment 27/07/2009
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Date of first participant enrolment
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Anticipated date last participant recruited/enrolled
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Actual date last participant recruited/enrolled
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Target sample size 250
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Recruitment status Recruiting
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Recruitment in Australia

Recruitment state(s)
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Postcode: 2052 1941 0
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Postcode: 2077 1942 0
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Postcode: 2153 1943 0
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Postcode: 2010 1944 0
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Postcode: 2112 1945 0
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Postcode: 2256 1946 0
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Postcode: 2259 1947 0
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Postcode: 2250 1948 0
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Postcode: 3181 1949 0
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Postcode: 2300 1950 0
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Recruitment outside Australia

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Funding Source: Government body 237341 0
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Name: National Health and Medical Research Council (NHMRC) 237341 0
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Address: National Health and Medical Research Council
GPO Box 1421
Canberra ACT 2601
Australia
237341 0
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Country: Australia 237341 0
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Primary Sponsor University
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Name: University of Newcastle
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Address: University of Newcastle
University Drive
Callaghan NSW 2308
Australia
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Country: Australia
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Secondary Sponsor: University 236828 0
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Name: University of NSW 236828 0
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Address: University of NSW
Kensington Campus
Sydney NSW 2052
Australia
236828 0
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Country: Australia 236828 0
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Secondary Sponsor: Hospital 236829 0
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Name: Alfred Psychiatry Research Centre 236829 0
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Address: Alfred Psychiatry Research Centre
The Alfred / Monash University
Level 1 - Old Baker Building
PO Box 315 Prahran 3181
Commercial Road Melbourne
Victoria 3004
Australia
236829 0
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Country: Australia 236829 0
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Secondary Sponsor: Hospital 236830 0
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Name: St Vincents Hospital, Melbourne 236830 0
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Address: St Vincents Hospital, Melbourne
59-61 Victoria Pde
Fitzroy
Melbourne VIC 3065
Australia
236830 0
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Country: Australia 236830 0
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Other Collaborator: Other Collaborative groups 764 0
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Name: Baker Heart Research Institute- Dr Melinda Carrington 764 0
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Address: Baker IDI Heart and Diabetes Institute
PO Box 6492, St Kilda Road Central
Victoria 8008, Australia
764 0
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Country: Australia 764 0
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Has the study received approval from at least one Ethics Committee? Yes
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Ethics Committee name: Hunter New England Area Health Human Research Ethics Committee 239469 0
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Address: Locked Bag 1
New Lambton NSW 2305
239469 0
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Country: Australia 239469 0
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Approval Date: 04/02/2009 239469 0
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Submitted Date: 239469 0
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HREC: 08/12/17/5.10 239469 0
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Ethics Committee name: University of Newcastle Human Research Ethics Committee 239470 0
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Address: University of Newcastle
University Drive
Callaghan NSW 2308
239470 0
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Country: Australia 239470 0
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Approval Date: 10/03/2009 239470 0
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Submitted Date: 239470 0
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HREC: H-2009-0052 239470 0
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Ethics Committee name: Northern Sydney Central Coast Area Health Service Human Reserach Ethics Committee 239471 0
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Address: Level 2, Building 51
Royal North Shore Hospital
Pacific Highway
St Leonards NSW 2065
239471 0
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Country: Australia 239471 0
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Approval Date: 01/05/2009 239471 0
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Submitted Date: 239471 0
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HREC: 0905-092M 0906-112M 0906-113M 0906-114M 239471 0
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Ethics Committee name: The Alfred Ethics Committee 239472 0
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Address: Level 1, The Old Baker Building
The Alfred
Commercial Road
Melbourne VIC 3004
239472 0
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Country: Australia 239472 0
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Approval Date: 14/04/2009 239472 0
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Submitted Date: 239472 0
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HREC: 77/09 239472 0
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Brief summary This study will be a multi-site randomised control (RCT) of treatment to enhance healthy living among people with psychotic disorders, specifically targeting smoking, diet and physical activity. These issues are highly prevalent, associated with premature death and reduced quality of life amongst this group.
It is expected that the present study will result in the development if an effective treatment program for people with psychotic disorders who have a range of CVD risk factors. We further hypothesise that the Healthy Lifestyles intervention offered to participants in the study will produce greater, more sustainable improvements on CVD risk and smoking status relative to the controls at follow up. The results will better inform the treatment choices of clinicians and will potentially improve the match between treatment and client, improving the health and wellbeing of the group.
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Trial website None
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Trial related presentations / publications N/A
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Public Notes
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Principal Investigator
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Contact person for public queries
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Name: Professor Amanda Baker
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Address: Centre for Brain and Mental Health Research University of Newcastle The McAuley Centre The Mater Edith Street WARATAH NSW 2298
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Country: Australia
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Tel: +61 2 40335690
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Fax: +61 2 40335692
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Email: amanda.baker@newcastle.edu.au
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Contact person for scientific queries
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Name: Professor Amanda Baker
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Address: Centre for Brain and Mental Health Research University of Newcastle The McAuley Centre The Mater Edith Street WARATAH NSW 2298
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Contact person responsible for updating information
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Name: Jenny Geddes
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Address: Centre for Brain and Mental Health Research University of Newcastle The McAuley Centre The Mater Edith Street WARATAH NSW 2298
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Country: Australia
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Email: jenny.geddes@newcastle.edu.au
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Addition Cancer fields
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