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

Not Applicable

Active, not recruiting

• Conditions: Tobacco Use; Depression; Psychosis; Mental Health - Addiction; Mental Health - Depression; Mental Health - Psychosis and personality disorders

• Registration Number: ACTRN12613000452796
• Lead Sponsor: Frances Kay-Lambkin

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2013-04-19
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Active, not recruiting
• Sex: All
• Target Recruitment: 120

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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Changes in tobacco use, as measured by the Opiate Treatment Index - Smoking subscale (quantity/frequency measure of tobacco use).[Baseline-6 months post-baseline];Changes in nicotine dependence (Fagerstrom Test for Nicotine Dependence)[Baseline-6-months post-baseline];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)[6-months post-baseline]