None listed
Conditions
Brief summary
Tobacco smoking is one of the top causes of preventable disease worldwide. Diseases such as heart attack, stroke and cancers are associated with cigarettes. A person gets hooked to cigarettes because of nicotine in it. According to the Tobacco and E-cigarette use among Malaysian Adolescents 2016, it was reported that nearly 80% regretted smoking but finds it difficult to stop smoking due to the mental and physical effects when they don’t have nicotine in their body. The purpose of this study is to provide another alternative to help people who wants to quit smoking in a group manner.The purpose of this study is to compare two behavioral support to assist smokers to quit smoking. The objective of this study is to determine whether behavior support in group form is at least as effective as the individual therapy (standard care) to assist smokers to quit smoking. This research is necessary because it may provide a method which can be utilized by the healthcare provided to be able to treat more than one person at one time to help patients to quit smoking. A total of 120 subjects like you will be participating in this study in Malaysia. The whole study will last about 8 months and your participation will be for about 7 weeks. You will spend 60 to 90 minutes per session. You will have one session per week until you have completed the 7 weeks. Later, you will be followed up at 3 months after the quit-date
Interventions
This trial is named GRITS which is an acronym for Group vs Individual Intervention for Tobacco Smoking Cessation. This trial is designed to determine the effects of smoking cessation programmes delivered in a group format and to compare the effectiveness of group therapy with the standard care in Malaysia which is the individual therapy.The objectives are to determine whether if the group based therapy is at least as effective as the individual therapy in assisting participants to quit smoking,
This trial is named GRITS which is an acronym for Group vs Individual Intervention for Tobacco Smoking Cessation. This trial is designed to determine the effects of smoking cessation programmes delivered in a group format and to compare the effectiveness of group therapy with the standard care in Malaysia which is the individual therapy.The objectives are to determine whether if the group based therapy is at least as effective as the individual therapy in assisting participants to quit smoking, to determine whether the group based therapy plus pharmacotherapy is as effective as individual therapy in reducing the severity of the withdrawal symptoms, to determine whether the group based therapy is an acceptable method for smoking cessation and to determine whether the group based therapy is at least as cost effective as the individual therapy (Standard Care). Both arm (individual and group) will receive medication (pharmacotherapy). The medication is the standard treatment which has been approved by the Ministry of Health in Malaysia and is being provided in all hospitals and district health clinic. for patients attending quit smoking clinics. The medications are Nicotine Replacement Therapy (gum, lozanges and patch) and Varenicline. Both arm (individual and group) of the trial will receive the same behavioral intervention. The behavioral intervention includes motivation to quit smoking, explanation on health dangers related to smoking and benefits of quitting, preparing for quit date, counselling on identifying cues and craving and how to overcome those situations and how to prevent relapse. The behavioral intervention is based on the module adapted from the New Zealand Group Based Therapy for Smoking Cessation which has undergone cultural and linguistic adaptation for Malaysian population. The final version of the module is called GBT-MAL (Group Based Therapy -Malaysian version). The researcher / PI has undergone training for the New Zealand Group Based Therapy for Smoking Cessation by Inspiring in New Zealand and has received accreditation. The researcher is responsible for the delivery of the behavioral intervention based on the GBT-MAL and prescription of the medication. Any issues related to medication will be highlighted to the researcher and will be addressed accordingly. Participants will have direct contact to the researcher for any assistance required during the trial through messaging, email or whatsapp. Participants will be recruited from 3 centers in Malaysia (University of Malaya Medical Center , University of Malaya Student Health Center and Ministry of Health District Health Clinic). The total number of participants in this trial is 120. Total participants recruited in each centers is 40 in each centers. In each centers there will be 20 participants in the control arm (individual therapy) and 2 groups consisting of 10 participants in each group in the intervention arm (group therapy). In the group therapy (intervention arm), there will be 10 participants in each group who will receive the behavioral intervention by the healthcare personnel in a group form. In the individual therapy (control arm), each participant will receive the behavioral intervention by the healthcare personnel in a one-to-one session. The total duration of the intervention is 7 weeks.The sessions will be held once a week for 7 weeks for both control arm (individual therapy) and the intervention arm (group therapy) Participants will undergo each session for 60 to 90 minutes depending on the objectives and its completion for each visit, During each week of the intervention, the GBT-MAL module has different sets of objectives which the healthcare provider will follow accordingly. After completing the 7 weekly sessions, participants will be followed up again at 3 months post quit date. Participants will be reminded on the appointment dates for the sessions and adherence to medication through personal messaging and texting from the researcher.
Sponsors
UNIVERSITY OF MALAYA
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 No maximum
Healthy volunteers
No
Inclusion criteria
Participants are active smokers. Active smokers are smokers who smoke one or more cigarettes in a week.Participants who are above the age of 18 years old, able to read and understand English and Bahasa Malaysia will be eligible for this study
Exclusion criteria
Participants with polysubstance abuse, unable to read or understand English and Bahasa Malaysia will not be included
Outcome results
None listed