Ignite Creation Date:
2024-05-06 @ 7:38 AM
Last Modification Date:
2024-10-26 @ 11:51 AM
Study NCT ID:
NCT02576899
Status:
COMPLETED
Last Update Posted:
2020-04-10
First Post:
2015-10-06
Brief Title:
Improving Functional Outcomes of Veterans With PTSD and Tobacco Dependence
Sponsor:
VA Office of Research and Development
Organization:
VA Office of Research and Development
Study Overview
Official Title:
Improving Functional Outcomes of Veterans With PTSD and Tobacco Dependence
Status:
COMPLETED
Status Verified Date:
2020-03
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:
ACT-PT
Brief Summary:
Veterans with PTSD have high rates of smoking 34-86 vs 18 in the general population and have substantial difficulties with quitting tobacco Despite the significant morbidity and mortality associated with smoking no smoking cessation treatments exist that intensively target PTSD symptoms as an obstacle to quit smoking although this is a significant barrier to quitting for many Veterans In addition no smoking cessation treatments have a large emphasis on improving the functioning of Veterans with PTSD and tobacco dependence although both PTSD and tobacco use negatively affect functioning across physical mental health and social domains
The goal of this SPiRE project is to evaluate Acceptance and Commitment Therapy for Veterans with PTSD and Tobacco Use ACT-PT which is an acceptance and mindfulness-based smoking cessation treatment for Veterans with PTSD and tobacco dependence ACT-PT specifically targets smoking cravings related to PTSD symptoms and memories of trauma in addition to difficulties managing PTSD symptoms negative affect and nicotine withdrawal symptoms during quit attempts ACT-PT includes structured intervention components that guide Veterans to replace smoking as a coping strategy for PTSD symptoms and memories with alternative coping strategies eg mindfulness acceptance And healthy living activities eg engaging in work expanding social networks engaging in physical exercise that are consistent with Veterans values
This project involves a small randomized clinical trial study of Veteran smokers with PTSD and tobacco dependence randomized to one of two different types of psychosocial treatment ACT-PT versus the American Lung Associations Freedom From Smoking Program FFS This study has two primary aims 1 evaluate the relative feasibility and acceptability of the two interventions including ease of recruitment randomization proportion staff and Veteran acceptance of the treatment retention rates treatment adherence fidelity ease of the assessment process and 2 evaluate the preliminary efficacy of ACT-PT vs FFS with the primary outcomes of tobacco use PTSD symptoms health-related quality of life and functional impairment
The goal of this SPiRE project is to evaluate Acceptance and Commitment Therapy for Veterans with PTSD and Tobacco Use ACT-PT which is an acceptance and mindfulness-based smoking cessation treatment for Veterans with PTSD and tobacco dependence ACT-PT specifically targets smoking cravings related to PTSD symptoms and memories of trauma in addition to difficulties managing PTSD symptoms negative affect and nicotine withdrawal symptoms during quit attempts ACT-PT includes structured intervention components that guide Veterans to replace smoking as a coping strategy for PTSD symptoms and memories with alternative coping strategies eg mindfulness acceptance And healthy living activities eg engaging in work expanding social networks engaging in physical exercise that are consistent with Veterans values
This project involves a small randomized clinical trial study of Veteran smokers with PTSD and tobacco dependence randomized to one of two different types of psychosocial treatment ACT-PT versus the American Lung Associations Freedom From Smoking Program FFS This study has two primary aims 1 evaluate the relative feasibility and acceptability of the two interventions including ease of recruitment randomization proportion staff and Veteran acceptance of the treatment retention rates treatment adherence fidelity ease of the assessment process and 2 evaluate the preliminary efficacy of ACT-PT vs FFS with the primary outcomes of tobacco use PTSD symptoms health-related quality of life and functional impairment
Detailed Description:
Veterans with PTSD have high rates of smoking 34-86 vs 18 in the general population and have substantial difficulties with quitting tobacco Only 23 of individuals with PTSD quit smoking compared to 50 of the general population As a result Veterans with PTSD are at high risk of developing severe health problems and poor physical functioning Fifty percent of these long-term smokers will die of a smoking-related cause and on average will lose 25 years of their life compared to non-smokers Despite the significant morbidity and mortality associated with smoking no smoking cessation treatments exist that intensively target PTSD symptoms as an obstacle to quit smoking although this is a significant barrier to quitting for many Veterans In addition no smoking cessation treatments have a large emphasis on improving the functioning of Veterans with PTSD and tobacco dependence although both PTSD and tobacco use negatively affect functioning across physical mental health and social domains
The goal of this SPiRE project is to evaluate Acceptance and Commitment Therapy for Veterans with PTSD and Tobacco Use ACT-PT which is an acceptance and mindfulness-based smoking cessation treatment for Veterans with PTSD and tobacco dependence ACT-PT specifically targets smoking cravings related to PTSD symptoms and memories of trauma in addition to difficulties managing PTSD symptoms negative affect and nicotine withdrawal symptoms during quit attempts ACT-PT includes structured intervention components that guide Veterans to replace smoking as a coping strategy for PTSD symptoms and memories with alternative coping strategies eg mindfulness acceptance And healthy living activities eg engaging in work expanding social networks engaging in physical exercise that are consistent with Veterans values This emphasis on substantially improving health-related quality of life and functioning across several areas makes ACT-PT particularly innovative and different from existing treatments However research is needed on the relative feasibility acceptability and efficacy of ACT-PT compared to standard smoking cessation treatments
This project involves a randomized clinical trial study of Veteran smokers with PTSD and tobacco dependence randomized to one of two different types of psychosocial treatment ACT-PT versus the American Lung Associations Freedom From Smoking Program FFS with all participants This study has two primary aims 1 evaluate the relative feasibility and acceptability of the two interventions including ease of recruitment randomization proportion staff and Veteran acceptance of the treatment retention rates treatment adherence fidelity ease of the assessment process and 2 evaluate the preliminary efficacy of ACT-PT vs FFS with the primary outcomes of tobacco use PTSD symptoms health-related quality of life and functional impairment
The goal of this SPiRE project is to evaluate Acceptance and Commitment Therapy for Veterans with PTSD and Tobacco Use ACT-PT which is an acceptance and mindfulness-based smoking cessation treatment for Veterans with PTSD and tobacco dependence ACT-PT specifically targets smoking cravings related to PTSD symptoms and memories of trauma in addition to difficulties managing PTSD symptoms negative affect and nicotine withdrawal symptoms during quit attempts ACT-PT includes structured intervention components that guide Veterans to replace smoking as a coping strategy for PTSD symptoms and memories with alternative coping strategies eg mindfulness acceptance And healthy living activities eg engaging in work expanding social networks engaging in physical exercise that are consistent with Veterans values This emphasis on substantially improving health-related quality of life and functioning across several areas makes ACT-PT particularly innovative and different from existing treatments However research is needed on the relative feasibility acceptability and efficacy of ACT-PT compared to standard smoking cessation treatments
This project involves a randomized clinical trial study of Veteran smokers with PTSD and tobacco dependence randomized to one of two different types of psychosocial treatment ACT-PT versus the American Lung Associations Freedom From Smoking Program FFS with all participants This study has two primary aims 1 evaluate the relative feasibility and acceptability of the two interventions including ease of recruitment randomization proportion staff and Veteran acceptance of the treatment retention rates treatment adherence fidelity ease of the assessment process and 2 evaluate the preliminary efficacy of ACT-PT vs FFS with the primary outcomes of tobacco use PTSD symptoms health-related quality of life and functional impairment
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 121RX-001756-01A1 | OTHER_GRANT | VA RRD | None |