Ignite Creation Date:
2024-05-05 @ 11:00 PM
Last Modification Date:
2024-10-26 @ 10:27 AM
Study NCT ID:
NCT01231711
Status:
COMPLETED
Last Update Posted:
2010-11-01
First Post:
2010-10-28
Brief Title:
Improving Quality-of-life and Depressive Symptoms of Combat Veterans Via Internet-based Intervention
Sponsor:
Prevail Health Solutions LLC
Organization:
Prevail Health Solutions LLC
Study Overview
Official Title:
Improving Quality-of-life and Depressive Symptoms for OEFOIF Combat Veterans Assessing the Benefits of Interactive Internet-based Psychotherapy and Peer-to-peer Support
Status:
COMPLETED
Status Verified Date:
2010-10
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:
Background Current military involvement in Afghanistan Operation Enduring Freedom - OEF and Iraq Operation Iraqi Freedom - OIF has created unforeseen burdens on the mental health and well-being of US service women and men Although OEFOIF service members and veterans are at high risk of developing sub-threshold combat stress and depressive symptoms or full disorders in the post-deployment period only a small fraction ever receive care The VETS PREVAIL Intervention which combines Cognitive-Behavioral-Therapy-based CBT-based coping skills training with peer-to-peer support and counseling was specifically designed to offer the returning OEFOIF service member or veteran an accessible and confidential first step to care
Evaluation Study RISE Consulting lead by Dr Benjamin W Van Voorhees MD MPH was contracted to supervise a pilot study of potential benefit feasibility and safety of the VETS PREVAIL Intervention The study would consist of a single group prepost comparison study of N50 recent OEFOIF veterans in the frame work of a phase 1 clinical trial phase 1 Feasibility adherence and satisfaction evidence of clinical benefit would be evaluated through changes in the following clinical self-report measures i symptoms of depressed mood Center for Epidemiologic Studies Depression Scale CES-D ii post traumatic stress disorder Post Traumatic Stress Disorder Checklist-Military PCL-M and iii functional status Short Form 12 SF-12 as well as changes in key attitudes toward mental health care seeking intent to seek treatment mental health self-efficacy and stigma
Evaluation Study RISE Consulting lead by Dr Benjamin W Van Voorhees MD MPH was contracted to supervise a pilot study of potential benefit feasibility and safety of the VETS PREVAIL Intervention The study would consist of a single group prepost comparison study of N50 recent OEFOIF veterans in the frame work of a phase 1 clinical trial phase 1 Feasibility adherence and satisfaction evidence of clinical benefit would be evaluated through changes in the following clinical self-report measures i symptoms of depressed mood Center for Epidemiologic Studies Depression Scale CES-D ii post traumatic stress disorder Post Traumatic Stress Disorder Checklist-Military PCL-M and iii functional status Short Form 12 SF-12 as well as changes in key attitudes toward mental health care seeking intent to seek treatment mental health self-efficacy and stigma
Detailed Description:
Intervention overview content and design
The intervention VETS PREVAIL will empower the user to gain control over life problems through enhancement of coping strategies self-care social support and a repertoire of problems solving skills in an interactive internet intervention This intervention will have two components internet delivery of the intervention and brief person-to-person electronic contact structured around ensuring effective motivation engagement and completion The coaching model for the person-to-person contact will be based on motivational interviewing with masters level social workers as well as contact with peers who have completed the Vet-to-Vet certificate program offered by the Depression and Bipolar Support Alliance DBSA The internet component is focused on combat stress self-assessment coping strategies problem solving and social support
Trainer Role
During the 6 weeks of Vets Prevail a trainer a masters level social worker will engage with subjects through one online chat per week post lesson approximately 15 minute time blocks duration will vary per subject The total amount of person-to-person contact time with a trainer is an estimated 90 minutes throughout the 6 week program contact time may vary per subject The trainer will use motivational interviewing to clarify concepts within each weeks lesson In addition the trainer will be responsible for making referrals and follow ups when needed
Masters level social work education trains people to use evidence-based knowledge derived from research practice evaluation and theories of human development and behavior and social systems to analyze complex situations between individuals and their environment in addition to facilitating individual organizational social and cultural changes
Peer Role
During the 6 weeks of Vets Prevail a peer a DBSA certified veteran will engage with subject through one online chat per week pre lesson approximately 15 minute time blocks duration will vary per subject The total amount of person-to-person contact time with a peer is an estimated 60 minutes throughout the 6 week program contact time my vary per subject The purpose of the peer engagement is to motivate the subject to complete the activities they schedule for themselves during the week and to apply the lessons from each session into their lives
DBSA training trains people to use their experiences to work with others Training features a nationally-developed recovery philosophy curriculum to enhance wellness and treatment strategies through peer delivery services
Internet based component
The current intervention will have four major sections The first section will relate stress in the context of depressive symptoms with direct tactics that can be immediately implemented to reduce symptoms and guide users towards their individual goals The second section will demonstrate how to recognize treatment obstacles and organizing implementation of the tactics from section one The third section addresses overcoming treatment obstacles along with reinforcing reduction of symptoms and goal-directed action The fourth section provides instruction and application of personal problem-solving taking goal-directed action to full implementation The intervention concludes with a review a reinforcement of personally-relevant treatment applications and an evaluation of techniques The internet component will also require active engagement of the individual with interactive activities to improve learningskill building along with other activities designed to identify how they would manage specific behavioral symptoms skill development The internet component will consist of 6 individual sessions with approximately one week between sessions The electronic chat with the peer will occur directly before the subjects view this content and the chat with the trainer occurs immediately afterwards so the trainer can answer any questions about the content the subject might have
The intervention VETS PREVAIL will empower the user to gain control over life problems through enhancement of coping strategies self-care social support and a repertoire of problems solving skills in an interactive internet intervention This intervention will have two components internet delivery of the intervention and brief person-to-person electronic contact structured around ensuring effective motivation engagement and completion The coaching model for the person-to-person contact will be based on motivational interviewing with masters level social workers as well as contact with peers who have completed the Vet-to-Vet certificate program offered by the Depression and Bipolar Support Alliance DBSA The internet component is focused on combat stress self-assessment coping strategies problem solving and social support
Trainer Role
During the 6 weeks of Vets Prevail a trainer a masters level social worker will engage with subjects through one online chat per week post lesson approximately 15 minute time blocks duration will vary per subject The total amount of person-to-person contact time with a trainer is an estimated 90 minutes throughout the 6 week program contact time may vary per subject The trainer will use motivational interviewing to clarify concepts within each weeks lesson In addition the trainer will be responsible for making referrals and follow ups when needed
Masters level social work education trains people to use evidence-based knowledge derived from research practice evaluation and theories of human development and behavior and social systems to analyze complex situations between individuals and their environment in addition to facilitating individual organizational social and cultural changes
Peer Role
During the 6 weeks of Vets Prevail a peer a DBSA certified veteran will engage with subject through one online chat per week pre lesson approximately 15 minute time blocks duration will vary per subject The total amount of person-to-person contact time with a peer is an estimated 60 minutes throughout the 6 week program contact time my vary per subject The purpose of the peer engagement is to motivate the subject to complete the activities they schedule for themselves during the week and to apply the lessons from each session into their lives
DBSA training trains people to use their experiences to work with others Training features a nationally-developed recovery philosophy curriculum to enhance wellness and treatment strategies through peer delivery services
Internet based component
The current intervention will have four major sections The first section will relate stress in the context of depressive symptoms with direct tactics that can be immediately implemented to reduce symptoms and guide users towards their individual goals The second section will demonstrate how to recognize treatment obstacles and organizing implementation of the tactics from section one The third section addresses overcoming treatment obstacles along with reinforcing reduction of symptoms and goal-directed action The fourth section provides instruction and application of personal problem-solving taking goal-directed action to full implementation The intervention concludes with a review a reinforcement of personally-relevant treatment applications and an evaluation of techniques The internet component will also require active engagement of the individual with interactive activities to improve learningskill building along with other activities designed to identify how they would manage specific behavioral symptoms skill development The internet component will consist of 6 individual sessions with approximately one week between sessions The electronic chat with the peer will occur directly before the subjects view this content and the chat with the trainer occurs immediately afterwards so the trainer can answer any questions about the content the subject might have
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