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Improving cardiovascular health among smokers with and without mental health problems: The iHeLP (healthy lifestyles) pilot trial

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?

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12613000452796
Acronym
iHeLP pilot
Enrollment
120
Registered
2013-04-19
Start date
2013-03-25
Completion date
2013-05-31
Last updated
2020-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

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.

Interventions

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 healt

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.

Sponsors

Frances Kay-Lambkin
Lead SponsorIndividual

Study design

Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Open (masking not used)

Eligibility

Sex/Gender
All
Age
18 Years to 94 Years
Healthy volunteers
No

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

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.

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026