Ignite Creation Date:
2024-05-06 @ 11:38 AM
Last Modification Date:
2024-10-26 @ 12:48 PM
Study NCT ID:
NCT03563820
Status:
COMPLETED
Last Update Posted:
2020-01-27
First Post:
2018-06-08
Brief Title:
Resilience and Well-Being Pilot Study
Sponsor:
VA Puget Sound Health Care System
Organization:
VA Puget Sound Health Care System
Study Overview
Official Title:
Intervention to Improve Resilience and Mental Health in Veterans With Injury Illness andor Disability
Status:
COMPLETED
Status Verified Date:
2020-01
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:
It is common for Veterans with injuries illnesses or physical disabilities to experience depression post-traumatic stress disorder PTSD chronic pain and other concerns They may also have goals like becoming happier or better able to cope with challenges that life brings The purpose of this research study is to learn whether Veterans like and benefit from a 5-week group-based positive psychology program aimed at improving mental health resilience well-being and quality of life Participants will be asked to complete several assessments surveysinterviews over the course of the study that are not considered part of standard care Additionally participants will be asked to participate in a focus group at the end of the study to provide feedback about their experiences in the group
Detailed Description:
To participate in this study Veterans must first be enrolled in the Resilience and Well-Being Program a 5-week group-based positive psychology program held at VA Puget Sound as part of standard care After enrollment Veterans may choose to enroll in this research study which evaluates the effectiveness of and satisfaction with the Resilience and Well-Being Program
This research study includes two study visits at VA Puget Sound and three assessments over the phone
Informed Consent Process
This process will take place at the VA Puget Sound A research staff member will review the details of the study with the participant and answer any questions she may have to see if they are interested in participating
Assessments
1 Baseline Assessment A research staff member will ask the participant a number of standard questions The most straightforward of these questions will ask about age gender race ethnicity education level employment status marital status and military service Participants will also be asked questions about their medical and mental health treatment use and any other health problems they may experience Participants will also be asked questions about potentially stressful life experiences
2 Post-Group Satisfaction Survey This survey will happen following the completion of the 5-week group as long as a participant has attended at least one session Participants will be asked to complete this survey in-person at the end of Session 5 In this survey participants will be asked questions about how satisfying engaging and helpful they thought the program was what they thought about the program and whether they experienced any negative effects from participating in the program
3 Telephone Assessments Throughout participation in the study participants will be asked to complete three telephone assessments Within each assessment participants will be asked questions relating to
How the participant is feeling
Satisfaction with life and well-being
Positive and negative emotions
Participation and satisfaction with social activities
Problems related to very stressful experiences
Physical pain and how it is affecting the participants life
Current and past mental health treatment use
How likely the participant is to seek mental health treatment
Changes in medications psychological treatment or new major life events
How illnessinjury has impacted the participants life
Whether the participant noticed any changes in their life after the group once the group is over
The three telephone assessments will occur at the following stages of the study
Pre-Group Assessment must be completed before the first group session
Post-Group Assessment will occur at the end of the 5-week group period
5-Week Follow-Up Assessment will occur about 5 weeks after the end of the 5-week group period
Focus Group Optional
Participants will be invited to complete a focus group that will last about 60-90 minutes six to eight weeks after the completion of the group to talk about their experiences and satisfaction with the program Completing the focus group is optional but encouraged as researchers would like to receive participant feedback through open discussion to better improve this program for other Veterans The focus group leaders will use prepared questions to help guide the flow of discussion
This research study includes two study visits at VA Puget Sound and three assessments over the phone
Informed Consent Process
This process will take place at the VA Puget Sound A research staff member will review the details of the study with the participant and answer any questions she may have to see if they are interested in participating
Assessments
1 Baseline Assessment A research staff member will ask the participant a number of standard questions The most straightforward of these questions will ask about age gender race ethnicity education level employment status marital status and military service Participants will also be asked questions about their medical and mental health treatment use and any other health problems they may experience Participants will also be asked questions about potentially stressful life experiences
2 Post-Group Satisfaction Survey This survey will happen following the completion of the 5-week group as long as a participant has attended at least one session Participants will be asked to complete this survey in-person at the end of Session 5 In this survey participants will be asked questions about how satisfying engaging and helpful they thought the program was what they thought about the program and whether they experienced any negative effects from participating in the program
3 Telephone Assessments Throughout participation in the study participants will be asked to complete three telephone assessments Within each assessment participants will be asked questions relating to
How the participant is feeling
Satisfaction with life and well-being
Positive and negative emotions
Participation and satisfaction with social activities
Problems related to very stressful experiences
Physical pain and how it is affecting the participants life
Current and past mental health treatment use
How likely the participant is to seek mental health treatment
Changes in medications psychological treatment or new major life events
How illnessinjury has impacted the participants life
Whether the participant noticed any changes in their life after the group once the group is over
The three telephone assessments will occur at the following stages of the study
Pre-Group Assessment must be completed before the first group session
Post-Group Assessment will occur at the end of the 5-week group period
5-Week Follow-Up Assessment will occur about 5 weeks after the end of the 5-week group period
Focus Group Optional
Participants will be invited to complete a focus group that will last about 60-90 minutes six to eight weeks after the completion of the group to talk about their experiences and satisfaction with the program Completing the focus group is optional but encouraged as researchers would like to receive participant feedback through open discussion to better improve this program for other Veterans The focus group leaders will use prepared questions to help guide the flow of discussion
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?:
None
Is an FDA AA801 Violation?:
None