Ignite Creation Date:
2024-05-06 @ 1:03 PM
Last Modification Date:
2024-10-26 @ 1:08 PM
Study NCT ID:
NCT03918642
Status:
COMPLETED
Last Update Posted:
2023-11-18
First Post:
2019-04-15
Brief Title:
Optimizing Psychotherapy for Older Veterans With Chronic Pain
Sponsor:
VA Office of Research and Development
Organization:
VA Office of Research and Development
Study Overview
Official Title:
Optimizing Psychotherapy for Older Veterans With Chronic Pain
Status:
COMPLETED
Status Verified Date:
2023-11
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:
OPOVCP
Brief Summary:
This study is being performed to compare the effects of two alternate types of psychotherapy Cognitive Behavior Therapy CBT and Emotional Awareness and Expression Therapy EAET for chronic musculoskeletal pain in older adults In addition the investigators will evaluate which patients respond better to each treatment and further investigate how each treatment works CBT which focuses on improving coping skills for pain is the standard form of psychotherapy offered at VA EAET instead focuses on understanding how life stress relationships and emotions may cause and perpetuate pain
The investigators are performing the study because pain is a large problem among Veterans Studies show that chronic pain affects as many as 50 of male Veterans and 75 of female Veterans The investigators are focusing on older adult Veterans because they have the highest rates of chronic pain at VA perhaps as high as 80 The investigators are looking at psychotherapy in this study because VA the Department of Defense and the CDC recently recommended psychosocial treatments such as psychotherapy as first treatments for chronic pain along with medications other than opioids eg oxycodone However only one form of psychotherapy CBT is currently available in clinical practice at VA and this study may provide evidence for making EAET available to Veterans as well
The investigators are performing the study because pain is a large problem among Veterans Studies show that chronic pain affects as many as 50 of male Veterans and 75 of female Veterans The investigators are focusing on older adult Veterans because they have the highest rates of chronic pain at VA perhaps as high as 80 The investigators are looking at psychotherapy in this study because VA the Department of Defense and the CDC recently recommended psychosocial treatments such as psychotherapy as first treatments for chronic pain along with medications other than opioids eg oxycodone However only one form of psychotherapy CBT is currently available in clinical practice at VA and this study may provide evidence for making EAET available to Veterans as well
Detailed Description:
The overarching goal of the proposed research is to learn how to optimize psychotherapy for those Veterans most in need and most likely to benefit from psychotherapy older Veterans with chronic musculoskeletal pain Chronic pain is a critical healthcare challenge as the condition affects 50 of all Veterans and affects older Veterans most commonly severely and persistently For years chronic pain treatment has been notoriously difficult at VA and elsewhere especially in light of the recent opioid crisis in which opioid analgesics previously a mainstay of chronic pain treatment have come under increased scrutiny In response CDC VADoD and some experts have called for enhancing and expanding psychosocial treatment options for chronic pain such as psychotherapy which are low risk for older Veterans who frequently have multiple medical comorbidities and are taking multiple medications
Yet standard VA psychotherapy approaches such as Cognitive Behavior Therapy CBT have shown modest benefits for Veterans on pain and other related outcomes such as mood anxiety and sleep In contrast a novel psychotherapy approach Emotional Awareness and Expression Therapy EAET has shown medium to large benefits for some chronic pain patients Whereas CBT improves pain and negative emotion by teaching patients cognitive and behavioral coping skills affecting brain regions that enhance cognitive control of pain EAET operates primarily through emotion regulation which is thought to influence brain regions and circuits that modulate both physical pain and emotion-a mechanism absent from existing approaches The literature and the investigators pilot data indicate that patients who express emotional distress at baseline such as high anxiety and depressive symptoms may be particularly likely to benefit from EAETs emotion regulation approach whereas patients who express less emotional distress may derive more benefit from an approach like CBT which does not require ready access to emotions
The proposed randomized clinical trial tests the hypothesis that EAET is superior to CBT on reduction in mean pain severity and other outcomes derived from IMMPACT To examine which patients are most likely to benefit this research also tests whether greater baseline emotional distress using measures of anxiety and depression predicts stronger benefits from EAET and whether lower baseline emotional distress predicts stronger benefits from CBT Finally this research explores whether the benefits of EAET are mediated by improved emotion regulation whether the benefits of CBT are mediated by improved cognitive and behavioral coping and whether the benefits of both are mediated by a stronger working alliance The investigators plan to enroll 160 multi-ethnicmulti-racial older Veterans age 60-95 years with chronic musculoskeletal pain at the West Los Angeles VA Medical Center
This research can introduce an additional potentially more effective format of psychotherapy at VA so that more Veterans with chronic pain can respond In addition this research can lead to better treatment targeting and enhance the understanding of how psychotherapy treatments work Finally this research can facilitate the development of critical skills for the PI in psychotherapy research and pain management and enhance his ability to effect positive change for older Veterans
Recruitment was resumed after the COVID-19 Administrative Hold was lifted in October 2020
Yet standard VA psychotherapy approaches such as Cognitive Behavior Therapy CBT have shown modest benefits for Veterans on pain and other related outcomes such as mood anxiety and sleep In contrast a novel psychotherapy approach Emotional Awareness and Expression Therapy EAET has shown medium to large benefits for some chronic pain patients Whereas CBT improves pain and negative emotion by teaching patients cognitive and behavioral coping skills affecting brain regions that enhance cognitive control of pain EAET operates primarily through emotion regulation which is thought to influence brain regions and circuits that modulate both physical pain and emotion-a mechanism absent from existing approaches The literature and the investigators pilot data indicate that patients who express emotional distress at baseline such as high anxiety and depressive symptoms may be particularly likely to benefit from EAETs emotion regulation approach whereas patients who express less emotional distress may derive more benefit from an approach like CBT which does not require ready access to emotions
The proposed randomized clinical trial tests the hypothesis that EAET is superior to CBT on reduction in mean pain severity and other outcomes derived from IMMPACT To examine which patients are most likely to benefit this research also tests whether greater baseline emotional distress using measures of anxiety and depression predicts stronger benefits from EAET and whether lower baseline emotional distress predicts stronger benefits from CBT Finally this research explores whether the benefits of EAET are mediated by improved emotion regulation whether the benefits of CBT are mediated by improved cognitive and behavioral coping and whether the benefits of both are mediated by a stronger working alliance The investigators plan to enroll 160 multi-ethnicmulti-racial older Veterans age 60-95 years with chronic musculoskeletal pain at the West Los Angeles VA Medical Center
This research can introduce an additional potentially more effective format of psychotherapy at VA so that more Veterans with chronic pain can respond In addition this research can lead to better treatment targeting and enhance the understanding of how psychotherapy treatments work Finally this research can facilitate the development of critical skills for the PI in psychotherapy research and pain management and enhance his ability to effect positive change for older Veterans
Recruitment was resumed after the COVID-19 Administrative Hold was lifted in October 2020
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 |
|---|---|---|---|
| 1K2CX001884-01A1 | OTHER_GRANT | VA CSRD | None |