Ignite Creation Date:
2024-05-06 @ 1:51 PM
Last Modification Date:
2024-10-26 @ 1:21 PM
Study NCT ID:
NCT04143243
Status:
COMPLETED
Last Update Posted:
2024-01-30
First Post:
2019-10-25
Brief Title:
One-day Life Skills Workshop for Veterans With TBI Pain and Psychopathology Evaluating Efficacy and Mechanism of Change
Sponsor:
VA Office of Research and Development
Organization:
VA Office of Research and Development
Study Overview
Official Title:
One-day Life Skills Workshop for Veterans With TBI Pain and Psychopathology Evaluating Efficacy and Mechanism of Change
Status:
COMPLETED
Status Verified Date:
2024-08
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:
Mild traumatic brain injury mTBI is the signature wound of Veterans returning from the operations in Iraq and Afghanistan ie OIFOEFOND with up to 20 percent experiencing persistent post-concussive symptoms Among Veterans with mTBI the majority also experience stress-based psychopathology eg depression post-traumatic stress disorder andor generalized anxiety disorder and chronic pain To cope with distress pain and other difficulties Veterans often turn to maladaptive avoidant coping strategies which offer short term relief but exacerbatemaintain mental health problems and have detrimental long-term effects on social occupational and community reintegration Unfortunately Veterans face important barriers to seeking mental health treatment including stigma and logistical issues This proposal aims to examine 1 the impact of a Veteran-centered non-stigmatizing 1-day life skills group workshop on overall distress and reintegration and 2 the mechanisms by which this treatment might work as well as possible influences on treatment efficacy
Detailed Description:
Traumatic brain injury TBI is the signature wound of Veterans returning from Operations Iraqi Freedom Operation Enduring Freedom and Operation New Dawn OIFOEFOND with up to 20 percent exposed to a mild TBI mTBI and experiencing persistent post-concussive symptoms Among those with a mTBI diagnosis the majority also suffers from stress-based psychopathology eg depression post-traumatic stress disorder generalized anxiety disorder as well as chronic pain To cope with distress pain and other difficulties Veterans often turn to maladaptive avoidant coping strategies which offer short term relief but exacerbatemaintain mental health problems and have detrimental long-term effects on social occupational and community reintegration Unfortunately Veterans face significant barriers to engaging in mental health treatment including stigma the belief that one should overcome psychological difficulties on hisher own and concern that receiving such care would negatively impact their careers Practical barriers including time constraints distance from a treatment facility and competing priorities eg work and family demands are also barriers to care Even among Veterans who start mental health treatment only a small minority complete a recommended course of evidence-based therapy
Acceptance and Commitment Therapy ACT is a trans-diagnostic treatment model that helps patients to overcome avoidance by promoting acceptance-based coping and engagement in meaningful life activities In this context Veterans are asked to think about their new missions after leaving the military and the importance of engaging in actions that fulfill their mission even when it may be difficult ACT has established efficacy in the treatment of depression anxiety and chronic pain and has been effectively implemented in various treatment-delivery formats including 1-day group workshops A 1-day ACT workshop addresses specific needs of Veterans with mTBI stress-based psychopathology and chronic pain polytrauma triad and important barriers to treatment It 1 is trans-diagnostic ie applies to more than one condition 2 targets avoidance-based coping 3 cultivates acceptance-based coping and builds on Veterans values and goals to motivate them to make difficult decisions 4 is delivered efficiently and thus more accessible 5 is less stigmatizing and thus acceptable and 6 address problems with treatment adherence and completion
With the support of an RRD SPiRE pilot grant the PIs developed a 1-day ACT on Life workshop tailored specifically for the needs of Veterans with mTBI stress-based psychopathology and chronic pain Veterans with this polytrauma were then randomly assigned to the ACT on Life workshop N20 or to Treatment as Usual TAU N12 All Veterans attending the 1-day ACT workshop completed it and relative to TAU exhibited greater improvements in distress and reintegration at the 3-month follow-up effect sizes 68 and 47 respectively Building on these promising preliminary findings the investigators now propose to conduct a more rigorous randomized controlled trial with 212 Veterans to compare the efficacy of the 1-day ACT workshop to an active treatment comparison Education Resources and Support ERS on symptoms of distress and social occupational and community reintegration The investigators will also examine mediators and moderators of treatment response to identify which ACT components are directly responsible for treatment effectiveness and whether treatment benefits are constrained by various personal factors
Establishing the efficacy of a 1-day ACT workshop for OEFOEFOND Veterans with mTBI and multiple coexistent conditions addresses key priorities of VHA RRD 1 developing interventions which will improve the psychological health status of Veterans who have specific needs and 2 enhancing the community social and occupational reintegration and functioning of post-deployment Veterans so that they may function more fully in society
Acceptance and Commitment Therapy ACT is a trans-diagnostic treatment model that helps patients to overcome avoidance by promoting acceptance-based coping and engagement in meaningful life activities In this context Veterans are asked to think about their new missions after leaving the military and the importance of engaging in actions that fulfill their mission even when it may be difficult ACT has established efficacy in the treatment of depression anxiety and chronic pain and has been effectively implemented in various treatment-delivery formats including 1-day group workshops A 1-day ACT workshop addresses specific needs of Veterans with mTBI stress-based psychopathology and chronic pain polytrauma triad and important barriers to treatment It 1 is trans-diagnostic ie applies to more than one condition 2 targets avoidance-based coping 3 cultivates acceptance-based coping and builds on Veterans values and goals to motivate them to make difficult decisions 4 is delivered efficiently and thus more accessible 5 is less stigmatizing and thus acceptable and 6 address problems with treatment adherence and completion
With the support of an RRD SPiRE pilot grant the PIs developed a 1-day ACT on Life workshop tailored specifically for the needs of Veterans with mTBI stress-based psychopathology and chronic pain Veterans with this polytrauma were then randomly assigned to the ACT on Life workshop N20 or to Treatment as Usual TAU N12 All Veterans attending the 1-day ACT workshop completed it and relative to TAU exhibited greater improvements in distress and reintegration at the 3-month follow-up effect sizes 68 and 47 respectively Building on these promising preliminary findings the investigators now propose to conduct a more rigorous randomized controlled trial with 212 Veterans to compare the efficacy of the 1-day ACT workshop to an active treatment comparison Education Resources and Support ERS on symptoms of distress and social occupational and community reintegration The investigators will also examine mediators and moderators of treatment response to identify which ACT components are directly responsible for treatment effectiveness and whether treatment benefits are constrained by various personal factors
Establishing the efficacy of a 1-day ACT workshop for OEFOEFOND Veterans with mTBI and multiple coexistent conditions addresses key priorities of VHA RRD 1 developing interventions which will improve the psychological health status of Veterans who have specific needs and 2 enhancing the community social and occupational reintegration and functioning of post-deployment Veterans so that they may function more fully in society
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