None listed
Conditions
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.
Interventions
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.
Sponsors
Study design
Eligibility
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
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.