Ignite Creation Date:
2024-05-05 @ 10:00 AM
Last Modification Date:
2024-10-26 @ 9:05 AM
Study NCT ID:
NCT00005687
Status:
COMPLETED
Last Update Posted:
2016-02-29
First Post:
2000-05-25
Brief Title:
Recycling Attempters and Relapsers in Smoking Cessation
Sponsor:
National Heart Lung and Blood Institute NHLBI
Organization:
National Heart Lung and Blood Institute NHLBI
Study Overview
Official Title:
None
Status:
COMPLETED
Status Verified Date:
2000-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
To study the process of recycling failed smoking cessation attempts and relapses
Detailed Description:
BACKGROUND
Depending on the type of treatment between 25 percent and 80 percent of smokers fail to quit with a program and of those who initially quit as many as 80 percent may relapse within a year Thus we need to understand more about the consequences of these failures on subsequent cessation attempts and success and to develop more effective treatment programs to recycle these smokers into sustained abstinence
DESIGN NARRATIVE
The study focused on two subsets of smokers frequently ignored by researchers and intervention programs subjects who failed to quit with a cessation program and subjects who relapsed after achieving abstinence The primary aim was to develop and evaluate the efficacy of an intervention tailored to stage of change still smoking abstinent relapsed that used extended contact motivation and efficacy building strategies to 1 increase the percentage of subjects who achieved subsequent abstinence after failing to quit with a core group treatment 2 decrease relapse rates and 3 increase the rate of sustained recycling ie maintained abstinence following a relapse The investigators also tested the extent to which the effects on abstinence were explained by the mediating variables of motivation and self- efficacy Secondary aims included 1 examining the role of several psychosocial variables in the maintenance relapse and cessation processes 2 describing and examining longitudinal changes following smoking cessation and 3 examining the long-term beyond two years effects of the studys intervention
The design of the study comprised two conditions 1 Control Condition N 452 and 2 Enhanced Treatment Condition N 452 the two treatment conditions had a common core seven-week cessation and relapse prevention group program Following the group program the two conditions differed in both format and content of treatment Subjects in the Control Condition received seven counselor-initiated phone calls over a three month period The content of the phone calls represented the most effective components of the study and varied depending on whether the subjects were smoking or abstinent Treatment in the Enhanced Condition was tailored to three groups of subjects smokers abstainers and relapsers Subjects who were smoking at the end of the core program received three more weekly group meetings followed by three phone calls and then six monthly calls The content of their treatment was based on the factors that the study found most related to failure to quit negative affect low motivation low efficacy Subjects who were abstinent at the end of the core program received seven phone cells over a three month period and then six monthly calls The content of their treatment included efficacy and motivation building exercises as well as the continued contact for six more months than in the Control condition Follow-up data were collected every three months for 15 months beyond the core cessation program The hypothesis was that the Enhanced Treatment compared with the Control would improve rates of recycling after a failure to quit decrease relapse rates and increase sustained recycling following a relapse
The study completion date listed in this record was obtained from the End Date entered in the Protocol Registration and Results System PRS record
Depending on the type of treatment between 25 percent and 80 percent of smokers fail to quit with a program and of those who initially quit as many as 80 percent may relapse within a year Thus we need to understand more about the consequences of these failures on subsequent cessation attempts and success and to develop more effective treatment programs to recycle these smokers into sustained abstinence
DESIGN NARRATIVE
The study focused on two subsets of smokers frequently ignored by researchers and intervention programs subjects who failed to quit with a cessation program and subjects who relapsed after achieving abstinence The primary aim was to develop and evaluate the efficacy of an intervention tailored to stage of change still smoking abstinent relapsed that used extended contact motivation and efficacy building strategies to 1 increase the percentage of subjects who achieved subsequent abstinence after failing to quit with a core group treatment 2 decrease relapse rates and 3 increase the rate of sustained recycling ie maintained abstinence following a relapse The investigators also tested the extent to which the effects on abstinence were explained by the mediating variables of motivation and self- efficacy Secondary aims included 1 examining the role of several psychosocial variables in the maintenance relapse and cessation processes 2 describing and examining longitudinal changes following smoking cessation and 3 examining the long-term beyond two years effects of the studys intervention
The design of the study comprised two conditions 1 Control Condition N 452 and 2 Enhanced Treatment Condition N 452 the two treatment conditions had a common core seven-week cessation and relapse prevention group program Following the group program the two conditions differed in both format and content of treatment Subjects in the Control Condition received seven counselor-initiated phone calls over a three month period The content of the phone calls represented the most effective components of the study and varied depending on whether the subjects were smoking or abstinent Treatment in the Enhanced Condition was tailored to three groups of subjects smokers abstainers and relapsers Subjects who were smoking at the end of the core program received three more weekly group meetings followed by three phone calls and then six monthly calls The content of their treatment was based on the factors that the study found most related to failure to quit negative affect low motivation low efficacy Subjects who were abstinent at the end of the core program received seven phone cells over a three month period and then six monthly calls The content of their treatment included efficacy and motivation building exercises as well as the continued contact for six more months than in the Control condition Follow-up data were collected every three months for 15 months beyond the core cessation program The hypothesis was that the Enhanced Treatment compared with the Control would improve rates of recycling after a failure to quit decrease relapse rates and increase sustained recycling following a relapse
The study completion date listed in this record was obtained from the End Date entered in the Protocol Registration and Results System PRS record
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?:
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| R01HL042485 | NIH | None | httpsreporternihgovquickSearchR01HL042485 |