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Trial registered on ANZCTR


Registration number
ACTRN12613000452796
Ethics application status
Approved
Date submitted
19/03/2013
Date registered
19/04/2013
Date last updated
19/04/2013
Type of registration
Retrospectively registered

Titles & IDs
Public title
Improving cardiovascular health among smokers with and without mental health problems: The iHeLP (healthy lifestyles) pilot trial
Scientific title
In current smokers (with depression, psychosis or neither conditions), will an internet-delivered healthy lifestyles treatment (the iHeLP program) be associated with improvements in tobacco use, physical activity and diet?
Secondary ID [1] 282151 0
Nil
Universal Trial Number (UTN)
U1111-1140-7668
Trial acronym
iHeLP pilot
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Tobacco Use 288654 0
Depression 288655 0
Psychosis 288656 0
Condition category
Condition code
Mental Health 288995 288995 0 0
Addiction
Mental Health 288996 288996 0 0
Depression
Mental Health 288997 288997 0 0
Psychosis and personality disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
In this study, we will pilot test an internet-delivered intervention (iHeLP) designed to reduce tobacco use, and improve cardiovascular and mental health among 3 groups of smokers: people with psychosis, people with depression, or people without a diagnosis of psychosis or depression.

Participants smoking 10 or more cigarettes a day with or without elevated depressive symptoms or psychosis will have access to five sessions of cognitive-behavioural therapy delivered via an internet-based healthy lifestyles-focused program (iHeLP). The sessions take approximately 30 minutes to complete and participants will be asked to complete the five sessions within a ten week period. The order of presentation of sessions will be randomised such that following completion of an initial “Setting the Scene” module participants will have access to the modules in one of four sequences:
1) Setting the Scene then open access to the iHeLP program;
2) Setting the Scene then sequential access to Smoking Cessation (2 modules), Healthy Eating (1 module) and then Physical Activity (1 module) modules;
3) Setting the Scene then sequential access to Healthy Eating, Physical Activity and then Smoking Cessation modules;
4) Setting the Scene then sequential access to Physical Activity, Healthy Eating and then Smoking Cessation modules.
Intervention code [1] 286757 0
Behaviour
Intervention code [2] 286874 0
Treatment: Other
Intervention code [3] 286875 0
Lifestyle
Comparator / control treatment
All participants receive the iHeLP intervention, but in four different sequences. We will compare treatment process and outcomes for participants completing the four different sequences of treatment.
Control group
Active

Outcomes
Primary outcome [1] 289111 0
Changes in tobacco use, as measured by the Opiate Treatment Index - Smoking subscale (quantity/frequency measure of tobacco use).
Timepoint [1] 289111 0
Baseline-6 months post-baseline
Primary outcome [2] 289112 0
Changes in nicotine dependence (Fagerstrom Test for Nicotine Dependence)
Timepoint [2] 289112 0
Baseline-6-months post-baseline
Primary outcome [3] 289113 0
Standardised Residualised Change in cardiovascular risk behaviours This will include scores on the Food Frequency Questionnaire (fruit and vegetable intake), International Physical Activity Questionnaire (physical activity), Opiate Treatment Index - smoking scale (tobacco use), Depression Anxiety Stress Scale (depression), Sitting Behaviour Questionnaire (sedentary behaviours)
Timepoint [3] 289113 0
6-months post-baseline
Secondary outcome [1] 301837 0
Change in depressive symptoms (DASS-21 - depression scale)
Timepoint [1] 301837 0
Baseline, 15-weeks post-baseline, 6-months post-baseline
Secondary outcome [2] 301838 0
Changes in alcohol/other drug use (as measured by the Opiate Treatment Index for alcohol, cannabis, amphetamine, heroin, cocaine, trnaquilisers, barbiturates, hallucinogens, and inhalants)
Timepoint [2] 301838 0
Baseline-6-months post-baseline
Secondary outcome [3] 301839 0
Changes in caffeine consumption (as measured by the Opiate Treatment Index created to monitor energy drink consumption)
Timepoint [3] 301839 0
Baseline-6-months post-baseline
Secondary outcome [4] 301840 0
Perceptions of internet-delivered treatments (as measured through the Internet Credibility/Expectancy Questionnaire)
Timepoint [4] 301840 0
Screening-Baseline-15 weeks post-baseline
Secondary outcome [5] 301841 0
Changes in self-rated quality of life (as measured by the WHO-8 EUROHIS Quality of LIfe scale)
Timepoint [5] 301841 0
Baseline-6-months post-baseline
Secondary outcome [6] 301842 0
Website utilisation as measured by tracking data recorded by the iHeLP program
Timepoint [6] 301842 0
Throughout the 10-week treatment period
Secondary outcome [7] 301843 0
Self vs. Clinician-Administered ratings of major depressive disorder (online vs. clinician-administered SCID)
Timepoint [7] 301843 0
Baseline and 6-months post-baseline

Eligibility
Key inclusion criteria
Participants will be respondents to an online Facebook advertisement who reside in Australia.

Potential eligibility will be met by those with:
- Consumption of 10 or more cigarettes per day (indicated by self report);
- Group 1 (n=40) will have current elevated depressive symptoms (as indicated by a DASS-21, with a score greater than or equal to 14) and a lifetime diagnosis of a Major Depressive Disorder (as confirmed by a clinician administered SCID);
- Group 2 (n=40) will have a self-reported DSM diagnosis of psychosis or bipolar disorder and currently be enrolled in treatment for psychosis;
- Group 3 (n=40) will not have current elevated depressive symptoms (as indicated by a DASS-21, with a score lower than or equal to 9) with or without a lifetime diagnosis of a Major Depressive Disorder (as confirmed by a clinician administered SCID), and will not have current/previous symptoms or a diagnosis of a psychotic or bipolar disorder; and
- Access to the internet
Minimum age
18 Years
Maximum age
94 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
(a) people who are not smoking more than 10 cigarettes per day;
(b) any participant who does have access to the internet;
(c) people under 18 years of age;
(d) people who screen positive for psychosis but are not receiving treatment for psychosis;
(e) people who score greater than 2 on the SCOFF screening questionnaire for Eating Disorders.

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)
Participants will be recruited via Facebook to participate in a screening assessment for the eligibility criteria for the study. Screening assessments are completed online via Survey Monkey, with participants providing consent for screening data to be retained for later analysis according to CONSORT guidelines. Those providing consent and completing the screening assessment will then be deemed eligible/ineligible for the main study. Those participants who are ineligible will be advised of this outcome and provided with options for referral to other services/online programs addressing healthy lifestyle issues. Eligible participants will also receive an email advising of this outcome, with referral options provided as per the ineligible participants, which will also provide the Participant Information Statement and Consent Form in electronic format and advice regarding a time/day at which an iHeLP assessor will contact them to discuss consent and baseline assessment options. Consent to participate in the study will be obtained verbally over the telephone and digitally recorded. All eligible participants who provide consent will complete a baseline assessment (part online and part via telephone) covering the main primary and secondary outcomes for the pilot trial. At the conclusion of this baseline assessment process, participants will be provided with an email that contains login details for iHeLP, instructions on how to access the modules, and advice of their randomised sequence in which to complete the modules.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
All participants will receive the iHeLP intervention, but will be randomised to complete the individual modules in either a set sequence or as an open access program. The randomisation sequence associated with this phase will be generated by an independent researcher not associated with the pilot study. Each participant will be assigned a unique study number according to a computer-generated randomisation schedule (using IBM Statistics Program Version 21), using permuted blocks of varying sizes (multiples of 4) to reduce potential for guessing. Separate randomisation lists will be used for each of the Groups 1-3.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis
The effect of the treatment conditions (Sequential vs. Open; Groups 1 vs. 2 vs 3) on the primary outcome measures will be assessed using a baseline vs. 6-months post-baseline by treatment group interaction in a repeated measures random effects regression model. Secondary outcomes will be analysed in the same way (family-wise error rate set a 0.01). All tests will be two-sided. A post-hoc multi-leve mixed effects model will be used to determine whether treatment groups differ in their trajectory on each outcome measure over the follow-up period.

Recruitment
Recruitment status
Active, not recruiting
Date of first participant enrolment
Anticipated
25/03/2013
Actual
Date of last participant enrolment
Anticipated
31/05/2013
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
120
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
ACT,NSW,NT,QLD,SA,TAS,WA,VIC

Funding & Sponsors
Funding source category [1] 286918 0
Government body
Name [1] 286918 0
Tobacco, Drug Prevention & Youth Policy section
Commonwealth Department of Health and Ageing
Country [1] 286918 0
Australia
Funding source category [2] 286919 0
University
Name [2] 286919 0
University of NSW Goldstar Funding
Country [2] 286919 0
Australia
Primary sponsor type
Individual
Name
Frances Kay-Lambkin
Address
National Drug and Alcohol Research Centre
University of NSW
Sydney 2052
Country
Australia
Secondary sponsor category [1] 285706 0
Individual
Name [1] 285706 0
Professor Amanda Baker
Address [1] 285706 0
University of Newcastle
University Drive
Callaghan NSW 2308
Country [1] 285706 0
Australia
Secondary sponsor category [2] 285707 0
Individual
Name [2] 285707 0
Professor Robyn Richmond
Address [2] 285707 0
School of Public Health and Community Medicine
University of NSW
Sydney 2052
Country [2] 285707 0
Australia
Other collaborator category [1] 277324 0
Individual
Name [1] 277324 0
Professor Bonnie Spring
Address [1] 277324 0
Preventive Medicine, Psychiatry and Behavioral Sciences
Northwestern University
633 Clark Street
Evanston IL 60611
Country [1] 277324 0
United States of America

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 288976 0
University of NSW Human Research Ethics Committee
Ethics committee address [1] 288976 0
Ethics Secretariat
UNSW Grants Management Office
Rupert Myers Building, Level 3, South Wing
The University of New South Wales
SYDNEY NSW 2052
Ethics committee country [1] 288976 0
Australia
Date submitted for ethics approval [1] 288976 0
Approval date [1] 288976 0
06/02/2013
Ethics approval number [1] 288976 0
HC12547

Summary
Brief summary
This project aims to increase the accessibility of an innovative, evidence-based psychological treatment (Healthy Lifestyles Treatment) for reducing tobacco use, improving cardiovascular and mental health among tobacco smokers with depression, psychosis, or neither of these conditions, by translating it to internet-based delivery (iHeLP) and running a small-scale pilot study of the efficacy of this mode of delivery of treatment.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 38606 0
Dr Frances Kay-Lambkin
Address 38606 0
National Drug and Alcohol Research Centre
University of NSW
Sydney 2052
Country 38606 0
Australia
Phone 38606 0
+61 2 4033 5690
Fax 38606 0
Email 38606 0
[email protected]
Contact person for public queries
Name 38607 0
Frances Kay-Lambkin
Address 38607 0
National Drug and Alcohol Research Centre
University of NSW
Sydney 2052
Country 38607 0
Australia
Phone 38607 0
+61 2 4033 5690
Fax 38607 0
Email 38607 0
[email protected]
Contact person for scientific queries
Name 38608 0
Frances Kay-Lambkin
Address 38608 0
National Drug and Alcohol Research Centre
University of NSW
Sydney 2052
Country 38608 0
Australia
Phone 38608 0
+61 2 4033 5690
Fax 38608 0
Email 38608 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

Current supporting documents:


Updated to:
Doc. No.TypeCitationLinkEmailOther DetailsAttachment
23263Informed consent form-999999  
23264Ethical approval-999999  

Results publications and other study-related documents

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