Trial registered on ANZCTR


Trial ID
ACTRN12609001039279
Ethics application status
Approved
Date submitted
17/07/2009
Date registered
4/12/2009
Type of registration
Retrospectively registered

Titles & IDs
Public title
Healthy lifestyle intervention for cardiovascular disease risk reduction among smokers with psychotic disorders
Scientific title
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?
Secondary ID [1] 928 0
N/A
Universal Trial Number (UTN)
Trial acronym
N/A
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Cardiovascular disease risk behaviours (in people with psychosis) 237272 0
Smoking (in people with psychosis) 237283 0
Condition category
Condition code
Mental Health 239594 239594 0 0
Psychosis and personality disorders

Intervention/exposure
Study type
Interventional
Description 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.
Intervention code [1] 236952 0
Treatment: Other
Intervention code [2] 236953 0
Lifestyle
Intervention code [3] 236954 0
Behaviour
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.
Control group
Active

Outcomes
Primary outcome [1] 238383 0
Primary Outcome 1: Overall CVD risk index
Timepoint [1] 238383 0
Timepoint: Measured at 15-weeks, 12-, 18-, 24-, 30- and 36-months following the initial assessment
Primary outcome [2] 238384 0
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
Timepoint [2] 238384 0
Timepoint: Measured at 15-weeks, 12-, 18-, 24-, 30- and 36-months following the initial assessment
Secondary outcome [1] 244836 0
Secondary Outcome 1: Weight [Kg, Body mass index (BMI), waist/hip ratio, waist circumference)
Timepoint [1] 244836 0
Timepoint: Measured at 15-weeks, 12-, 18-, 24-, 30- and 36-months following the initial assessment
Secondary outcome [2] 244837 0
Secondary Outcome 2: Physical activity (International Physical Activity Questionnaire-IPAQ which measure the frequency and intensity of physical activity via a self report questionnaire)
Timepoint [2] 244837 0
Timepoint: Measured at 15-weeks, 12-, 18-, 24-, 30- and 36-months following the initial assessment
Secondary outcome [3] 244838 0
Secondary Outcome 3: Unhealthy eating as measured by client's self reported dietary intake .
Timepoint [3] 244838 0
Timepoint: Measured at 15-weeks, 12-, 18-, 24-, 30- and 36-months following the initial assessment
Secondary outcome [4] 244839 0
Secondary Outcome 4: Substance use (alcohol and cannabis use as measured by the Opiate Treatment Index Drug Use Scale items)
Timepoint [4] 244839 0
Timepoint: Measured at 15-weeks, 12-, 18-, 24-, 30- and 36-months following the initial assessment
Secondary outcome [5] 244840 0
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)]
Timepoint [5] 244840 0
Timepoint: Measured at 15-weeks, 12-, 18-, 24-, 30- and 36-months following the initial assessment
Secondary outcome [6] 244841 0
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.
Timepoint [6] 244841 0
Timepoint: Measured at Session 1, 4 and 8 of treatment and at the 15 week assessment.
Secondary outcome [7] 244842 0
Secondary outcome 7: Service utilisation as measured by client's self reported access of health professionals and health facilities including hospitals
Timepoint [7] 244842 0
Timepoint: Measured at 15-weeks, 12-, 18-, 24-, 30- and 36-months following the initial assessment
Secondary outcome [8] 244843 0
Secondary outcome 8: General functioning and quality of life [Global Assessment of Functioning (GAF)]
Timepoint [8] 244843 0
Timepoint: Measured at 15-weeks, 12-, 18-, 24-, 30- and 36-months following the initial assessment

Eligibility
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
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
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.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
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.
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)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
N/A
Phase
Not Applicable
Type of endpoint(s)
Efficacy

Recruitment
Anticipated date of first participant enrolment
27/07/2009
Actual date of first participant enrolment
Anticipated date last participant enrolled
Actual date last participant enrolled
Anticipated date of last data collection
Actual date of last data collection
Target sample size
250
Actual sample size
Recruitment status
Recruiting
Recruitment in Australia
Recruitment state(s)
Recruitment postcode(s) [1] 1941 0
2052
Recruitment postcode(s) [2] 1942 0
2077
Recruitment postcode(s) [3] 1943 0
2153
Recruitment postcode(s) [4] 1944 0
2010
Recruitment postcode(s) [5] 1945 0
2112
Recruitment postcode(s) [6] 1946 0
2256
Recruitment postcode(s) [7] 1947 0
2259
Recruitment postcode(s) [8] 1948 0
2250
Recruitment postcode(s) [9] 1949 0
3181
Recruitment postcode(s) [10] 1950 0
2300

Funding & Sponsors
Funding source category [1] 237341 0
Government body
Name [1] 237341 0
National Health and Medical Research Council (NHMRC)
Address [1] 237341 0
National Health and Medical Research Council
GPO Box 1421
Canberra ACT 2601
Australia
Country [1] 237341 0
Australia
Primary sponsor type
University
Name
University of Newcastle
Address
University of Newcastle
University Drive
Callaghan NSW 2308
Australia
Country
Australia
Secondary sponsor category [1] 236828 0
University
Name [1] 236828 0
University of NSW
Address [1] 236828 0
University of NSW
Kensington Campus
Sydney NSW 2052
Australia
Country [1] 236828 0
Australia
Secondary sponsor category [2] 236829 0
Hospital
Name [2] 236829 0
Alfred Psychiatry Research Centre
Address [2] 236829 0
Alfred Psychiatry Research Centre
The Alfred / Monash University
Level 1 - Old Baker Building
PO Box 315 Prahran 3181
Commercial Road Melbourne
Victoria 3004
Australia
Country [2] 236829 0
Australia
Secondary sponsor category [3] 236830 0
Hospital
Name [3] 236830 0
St Vincents Hospital, Melbourne
Address [3] 236830 0
St Vincents Hospital, Melbourne
59-61 Victoria Pde
Fitzroy
Melbourne VIC 3065
Australia
Country [3] 236830 0
Australia
Other collaborator category [1] 764 0
Other Collaborative groups
Name [1] 764 0
Baker Heart Research Institute- Dr Melinda Carrington
Address [1] 764 0
Baker IDI Heart and Diabetes Institute
PO Box 6492, St Kilda Road Central
Victoria 8008, Australia
Country [1] 764 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 239469 0
Hunter New England Area Health Human Research Ethics Committee
Ethics committee address [1] 239469 0
Locked Bag 1
New Lambton NSW 2305
Ethics committee country [1] 239469 0
Australia
Date submitted for ethics approval [1] 239469 0
Approval date [1] 239469 0
04/02/2009
Ethics approval number [1] 239469 0
08/12/17/5.10
Ethics committee name [2] 239470 0
University of Newcastle Human Research Ethics Committee
Ethics committee address [2] 239470 0
University of Newcastle
University Drive
Callaghan NSW 2308
Ethics committee country [2] 239470 0
Australia
Date submitted for ethics approval [2] 239470 0
Approval date [2] 239470 0
10/03/2009
Ethics approval number [2] 239470 0
H-2009-0052
Ethics committee name [3] 239471 0
Northern Sydney Central Coast Area Health Service Human Reserach Ethics Committee
Ethics committee address [3] 239471 0
Level 2, Building 51
Royal North Shore Hospital
Pacific Highway
St Leonards NSW 2065
Ethics committee country [3] 239471 0
Australia
Date submitted for ethics approval [3] 239471 0
Approval date [3] 239471 0
01/05/2009
Ethics approval number [3] 239471 0
0905-092M 0906-112M 0906-113M 0906-114M
Ethics committee name [4] 239472 0
The Alfred Ethics Committee
Ethics committee address [4] 239472 0
Level 1, The Old Baker Building
The Alfred
Commercial Road
Melbourne VIC 3004
Ethics committee country [4] 239472 0
Australia
Date submitted for ethics approval [4] 239472 0
Approval date [4] 239472 0
14/04/2009
Ethics approval number [4] 239472 0
77/09

Summary
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.
Trial website
None
Trial related presentations / publications
N/A
Public notes

Contacts
Principal investigator
Name 29911 0
Address 29911 0
Country 29911 0
Phone 29911 0
Fax 29911 0
Email 29911 0
Contact person for public queries
Name 13158 0
Professor Amanda Baker
Address 13158 0
Centre for Brain and Mental Health Research
University of Newcastle
The McAuley Centre
The Mater
Edith Street
WARATAH NSW 2298
Country 13158 0
Australia
Phone 13158 0
+61 2 40335690
Fax 13158 0
+61 2 40335692
Email 13158 0
amanda.baker@newcastle.edu.au
Contact person for scientific queries
Name 4086 0
Professor Amanda Baker
Address 4086 0
Centre for Brain and Mental Health Research
University of Newcastle
The McAuley Centre
The Mater
Edith Street
WARATAH NSW 2298
Country 4086 0
Australia
Phone 4086 0
+61 2 40335690
Fax 4086 0
+61 2 40335692
Email 4086 0
amanda.baker@newcastle.edu.au