Ignite Creation Date:
2024-10-25 @ 8:04 PM
Last Modification Date:
2024-10-26 @ 3:37 PM
Study NCT ID:
NCT06544057
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-07-12
Brief Title:
Real-time eCounselling for Nicotine Addiction
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Real-time eCounselling for Nicotine Addiction a Feasibility Study and Pilot RCT
Status:
RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The goal of this clinical trial is to pilot an eHealth intervention real-time telecounselling in nicotine addiction The main questions it aims to answer are
Is the intervention likely to be efficacious in preventing an increase in Abstinence Is the intervention likely to be efficacious in preventing an increase in nicotine consumption Is the intervention likely to be efficacious in influencing Readiness to quit nicotine How feasible is the intervention for developing a larger-scale trial
Researchers will compare a range of outcome measures between the active and control arms to see if a pilot eHealth intervention can successfully treat nicotine addiction
Is the intervention likely to be efficacious in preventing an increase in Abstinence Is the intervention likely to be efficacious in preventing an increase in nicotine consumption Is the intervention likely to be efficacious in influencing Readiness to quit nicotine How feasible is the intervention for developing a larger-scale trial
Researchers will compare a range of outcome measures between the active and control arms to see if a pilot eHealth intervention can successfully treat nicotine addiction
Detailed Description:
The goal of this clinical trial is to pilot an eHealth intervention in nicotine addiction real-time telecounselling It will also attempt to better understand the psychology of nicotine addiction and craving regarding consumption behaviour The main questions it aims to answer are
Is the intervention likely to be efficacious in preventing an increase in Abstinence Is the intervention likely to be efficacious in preventing an increase in nicotine consumption Is the intervention likely to be efficacious in influencing Readiness to quit nicotine How feasible is the intervention for developing a larger-scale trial
Researchers will compare outcomes pre and post intervention in the active arm and also between active and control arms to ascertain the treatment effect of the intervention on primary nicotine consumption abstinence and secondary self-efficacy readiness to quit decisional balance measures in tests of efficacy
Following randomisation participants will be allocated to either the active arm or the control arm In the active arm participants will undergo six weekly sessions of real-time CBT-MI Cognitive Behavioural Therapy with Motivational Interviewing with each session lasting approximately 45 to 60 minutes In the control arm A Wait List Control Group WLCG will denote the comparator who will undergo screening and assessment only
Is the intervention likely to be efficacious in preventing an increase in Abstinence Is the intervention likely to be efficacious in preventing an increase in nicotine consumption Is the intervention likely to be efficacious in influencing Readiness to quit nicotine How feasible is the intervention for developing a larger-scale trial
Researchers will compare outcomes pre and post intervention in the active arm and also between active and control arms to ascertain the treatment effect of the intervention on primary nicotine consumption abstinence and secondary self-efficacy readiness to quit decisional balance measures in tests of efficacy
Following randomisation participants will be allocated to either the active arm or the control arm In the active arm participants will undergo six weekly sessions of real-time CBT-MI Cognitive Behavioural Therapy with Motivational Interviewing with each session lasting approximately 45 to 60 minutes In the control arm A Wait List Control Group WLCG will denote the comparator who will undergo screening and assessment only
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None