Ignite Creation Date:
2024-05-05 @ 4:57 PM
Last Modification Date:
2024-10-26 @ 9:26 AM
Study NCT ID:
NCT00350584
Status:
COMPLETED
Last Update Posted:
2011-07-29
First Post:
2006-07-10
Brief Title:
Evaluation of Telehealth Interventions for Post-Trauma Stress
Sponsor:
VA Boston Healthcare System
Organization:
VA Boston Healthcare System
Study Overview
Official Title:
Evaluation of Two Telehealth Interventions Targeting Post-Trauma Stress in Combat Veterans Comparing Mindfulness and Psychoeducation
Status:
COMPLETED
Status Verified Date:
2009-01
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:
Posttraumatic Stress Disorder PTSD is very prevalent within the veteran population and is associated with decreased quality of life and an increased risk of developing other psychiatric and physical illnesses The overarching objective of the proposed study is to evaluate the effectiveness of two telehealth treatment conditions in promoting healing within a population of veterans with full or partial PTSD In particular we are targeting newly returned veterans from the Iraq and Afghanistan conflicts Specifically we are comparing the relative efficacy of an alternative therapeutic approach a Mindfulness based treatment with a Psychoeducation treatment in reducing symptoms of PTSD and more generalized psychiatric symptoms while increasing quality of life Of note both treatment conditions will consist of two in-person sessions and six brief weekly telephone calls Participants will be 58 veterans 29 per condition recruited from the VA Boston Healthcare System Assessment will occur before and after the delivery of the intervention We hypothesize that while both treatments will result in improved outcomes the Mindfulness intervention will promote more healing than the Psychoeducation intervention Results from this project will help further our understanding of the role of mindfulness in treating PTSD particularly in those veterans who are returning from deployment
Detailed Description:
Aim To evaluate the relative feasibility and healing efficacy of two eight-week telehealth interventions for individuals with combat-related PTSD 1 Mindfulness and 2 Psychoeducation
Objectives
1 The first short-term objective is to determine whether two eight-week telehealth interventions are
1 feasible to conduct in a population of veterans with symptoms of combat-related PTSD
2 effective at promoting healing specific to combat survivors as evidenced by reductions in symptoms of PTSD
3 effective at promoting more generalized healing in combat veterans as evidenced by reductions in symptoms that are often co-morbid with PTSD eg depression anxiety and substance abuse problem severity and
4 effective at promoting healing beyond a symptom level in combat veterans as evidenced by increases in quality of life after the interventions
2 The second short-term objective of this study is to determine whether a Mindfulness intervention will be more effective at promoting healing than a Psychoeducation intervention This comparison will be made on the levels of specific PTSD symptoms more general co-morbid symptoms and global quality of life
3 The long-term objectives of this line of research are to identify mechanisms of action in a Mindfulness Telehealth Intervention that allow healing and promote increased quality of life in individuals with PTSD
4 An additional long-term objective of this project is to contribute to the development of efficacious wellness interventions that can promote healing after combat exposure in veterans returning from current military conflicts eg Iraq and Afghanistan
Hypotheses
1 It is hypothesized that both eight-week telehealth interventions Mindfulness and Psychoeducation will be feasible in a population of veterans with symptoms of combat-related PTSD Specifically satisfaction and compliance with the interventions is predicted to be high
2 It is hypothesized that both eight-week telehealth interventions Mindfulness and Psychoeducation will be effective at promoting healing and reducing symptoms of PTSD Specifically it is predicted that levels of PTSD measured post-intervention will be lower than levels measured pre-intervention
3 It is hypothesized that both eight-week telehealth interventions Mindfulness and Psychoeducation will be effective at promoting healing and reducing symptoms co-morbid with PTSD Specifically it is predicted that levels of depression anxiety and substance abuse problem severity measured post-intervention will be lower than levels measured pre-intervention
4 It is hypothesized that both eight-week telehealth interventions Mindfulness and Psychoeducation will be effective at improving quality of life Specifically it is predicted that levels of quality of life measured post-intervention will be higher than levels measured pre-intervention
5 Although it is hypothesized that both eight-week interventions will be effective at healing for veterans with PTSD symptoms the holistic Mindfulness intervention is hypothesized to be more effective at promoting healing and reducing symptoms of PTSD and co-morbid disorders and improving quality of life than the Psychoeducation intervention Specifically it is predicted that levels of PTSD depression anxiety and substance abuse problem severity will be lower post-intervention and quality of life will be higher for those individuals in the Mindfulness condition than for those in the Psychoeducation condition
Objectives
1 The first short-term objective is to determine whether two eight-week telehealth interventions are
1 feasible to conduct in a population of veterans with symptoms of combat-related PTSD
2 effective at promoting healing specific to combat survivors as evidenced by reductions in symptoms of PTSD
3 effective at promoting more generalized healing in combat veterans as evidenced by reductions in symptoms that are often co-morbid with PTSD eg depression anxiety and substance abuse problem severity and
4 effective at promoting healing beyond a symptom level in combat veterans as evidenced by increases in quality of life after the interventions
2 The second short-term objective of this study is to determine whether a Mindfulness intervention will be more effective at promoting healing than a Psychoeducation intervention This comparison will be made on the levels of specific PTSD symptoms more general co-morbid symptoms and global quality of life
3 The long-term objectives of this line of research are to identify mechanisms of action in a Mindfulness Telehealth Intervention that allow healing and promote increased quality of life in individuals with PTSD
4 An additional long-term objective of this project is to contribute to the development of efficacious wellness interventions that can promote healing after combat exposure in veterans returning from current military conflicts eg Iraq and Afghanistan
Hypotheses
1 It is hypothesized that both eight-week telehealth interventions Mindfulness and Psychoeducation will be feasible in a population of veterans with symptoms of combat-related PTSD Specifically satisfaction and compliance with the interventions is predicted to be high
2 It is hypothesized that both eight-week telehealth interventions Mindfulness and Psychoeducation will be effective at promoting healing and reducing symptoms of PTSD Specifically it is predicted that levels of PTSD measured post-intervention will be lower than levels measured pre-intervention
3 It is hypothesized that both eight-week telehealth interventions Mindfulness and Psychoeducation will be effective at promoting healing and reducing symptoms co-morbid with PTSD Specifically it is predicted that levels of depression anxiety and substance abuse problem severity measured post-intervention will be lower than levels measured pre-intervention
4 It is hypothesized that both eight-week telehealth interventions Mindfulness and Psychoeducation will be effective at improving quality of life Specifically it is predicted that levels of quality of life measured post-intervention will be higher than levels measured pre-intervention
5 Although it is hypothesized that both eight-week interventions will be effective at healing for veterans with PTSD symptoms the holistic Mindfulness intervention is hypothesized to be more effective at promoting healing and reducing symptoms of PTSD and co-morbid disorders and improving quality of life than the Psychoeducation intervention Specifically it is predicted that levels of PTSD depression anxiety and substance abuse problem severity will be lower post-intervention and quality of life will be higher for those individuals in the Mindfulness condition than for those in the Psychoeducation condition
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
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| SIIB 1 EA-0000043 | None | None | None |