Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12609001039279
Ethics application status
Approved
Date submitted
17/07/2009
Date registered
4/12/2009
Date last updated
26/11/2018
Date data sharing statement initially provided
26/11/2018
Date results provided
26/11/2018
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
Sex
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
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
27/07/2009
Actual
4/08/2009
Date of last participant enrolment
Anticipated
Actual
30/04/2011
Date of last data collection
Anticipated
Actual
30/04/2014
Sample size
Target
250
Accrual to date
Final
235
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)
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
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
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
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
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
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 29911 0
Prof Amanda Baker
Address 29911 0
Centre for Translational Neuroscience and Mental Health; University of Newcastle, The McAuley Centre - Mater Hospital, Edith Street Waratah NSW 2298
Country 29911 0
Australia
Phone 29911 0
+61240335690
Fax 29911 0
+61240335692
Email 29911 0
[email protected]
Contact person for public queries
Name 13158 0
Amanda Baker
Address 13158 0
Centre for Translational Neuroscience and Mental Health; University of Newcastle, The McAuley Centre - Mater Hospital, Edith Street Waratah NSW 2298
Country 13158 0
Australia
Phone 13158 0
+61 2 40335690
Fax 13158 0
+61 2 40335692
Email 13158 0
[email protected]
Contact person for scientific queries
Name 4086 0
Amanda Baker
Address 4086 0
Centre for Translational Neuroscience and Mental Health; University of Newcastle, The McAuley Centre - Mater Hospital, Edith Street Waratah NSW 2298
Country 4086 0
Australia
Phone 4086 0
+61 2 40335690
Fax 4086 0
+61 2 40335692
Email 4086 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
Trial participants are ensured confidentiality and only group de-identified data will be shared


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
SourceTitleYear of PublicationDOI
EmbaseStudy protocol: a randomised controlled trial investigating the effect of a healthy lifestyle intervention for people with severe mental disorders.2011https://dx.doi.org/10.1186/1471-2458-11-10
EmbaseEarly therapeutic alliance, treatment retention, and 12-month outcomes in a healthy lifestyles intervention for people with psychotic disorders.2016https://dx.doi.org/10.1097/NMD.0000000000000585
EmbaseReducing smoking reduces suicidality among individuals with psychosis: Complementary outcomes from a Healthy Lifestyles intervention study.2016https://dx.doi.org/10.1016/j.psychres.2016.07.006
EmbaseRandomised controlled trial of a healthy lifestyle intervention among smokers with psychotic disorders: Outcomes to 36 months.2018https://dx.doi.org/10.1177/0004867417714336
EmbaseSmoking cessation for improving mental health.2021https://dx.doi.org/10.1002/14651858.CD013522.pub2
EmbaseWorking with people experiencing psychotic disorders and co-occurring nicotine dependence: Attitudes and reflections from psychologists on the healthy lifestyles research trial.2021https://dx.doi.org/10.1521/BUMC.2021.85.2.204
N.B. These documents automatically identified may not have been verified by the study sponsor.