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 (e.g., 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.
Condition or disease | Intervention/treatment | Phase |
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Musculoskeletal Pain | Behavioral: Emotional Awareness and Expression Therapy Behavioral: Cognitive Behavior Therapy | Not Applicable |
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, VA/DoD, 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 EAET's 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-ethnic/multi-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 Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 160 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Intervention Model Description: | Two-Group Parallel Comparison Trial |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | Optimizing Psychotherapy for Older Veterans With Chronic Pain |
Actual Study Start Date : | April 1, 2019 |
Estimated Primary Completion Date : | March 29, 2024 |
Estimated Study Completion Date : | March 29, 2024 |
Arm | Intervention/treatment |
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Experimental: Emotional Awareness and Expression Therapy
Seeks to reduce physical (e.g., pain) and emotional (e.g., depression, anxiety) symptoms by helping individuals become aware of their emotions, express them, and resolve emotional conflicts. It will use techniques such as writing about stress, role playing how to handle difficult relationships, recognizing and expressing anger and other feelings, and being more open with others.
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Behavioral: Emotional Awareness and Expression Therapy
Focus on emotions, writing about stress, assertiveness training, role playing new ways to handle relationships, and sharing feelings and experiences with others.
Other Name: EAET
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Active Comparator: Cognitive Behavior Therapy
Seeks to help individuals function better and improve symptoms by teaching various cognitive and behavioral skills to manage symptoms. It will use techniques such as relaxation training, engaging in pleasant activities, pacing yourself, and changing unhelpful ways of thinking.
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Behavioral: Cognitive Behavior Therapy
Focus on cognitive and behavioral skills, such as relaxation, increasing pleasant activities, pacing, and changing ways of thinking.
Other Name: CBT
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Eight self-report items assessing the subject's beliefs and perceptions about their pain.
Items range -2 to 2 (-2 = strongly disagree; 2 = strongly agree). Scored with four two-item scales, each yielding a total score between -4 and 4.
Eight self-report items assessing the subject's beliefs and perceptions about their pain.
Items range -2 to 2 (-2 = strongly disagree; 2 = strongly agree). Scored with four two-item scales, each yielding a total score between -4 and 4.
Ages Eligible for Study: | 60 Years to 95 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Eligible Veterans are age 60 to 95 years old and have had at least 3 months of musculoskeletal pain, including the following conditions most likely to benefit from psychosocial intervention based on previous research:
Exclusion Criteria:
Contact: Brandon C Yarns, MD MS BME | (310) 478-3711 ext 42764 | Brandon.Yarns@va.gov |
United States, California | |
VA Greater Los Angeles Healthcare System, West Los Angeles, CA | Recruiting |
West Los Angeles, California, United States, 90073 | |
Contact: Brandon C Yarns, MD MS BME 310-478-3711 ext 42764 Brandon.Yarns@va.gov | |
Principal Investigator: Brandon C Yarns, MD MS BME |
Principal Investigator: | Brandon C Yarns, MD MS BME | VA Greater Los Angeles Healthcare System, West Los Angeles, CA |
Tracking Information | |||||||
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First Submitted Date ICMJE | April 15, 2019 | ||||||
First Posted Date ICMJE | April 17, 2019 | ||||||
Last Update Posted Date | January 29, 2021 | ||||||
Actual Study Start Date ICMJE | April 1, 2019 | ||||||
Estimated Primary Completion Date | March 29, 2024 (Final data collection date for primary outcome measure) | ||||||
Current Primary Outcome Measures ICMJE |
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Original Primary Outcome Measures ICMJE | Same as current | ||||||
Change History | |||||||
Current Secondary Outcome Measures ICMJE |
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Original Secondary Outcome Measures ICMJE | Same as current | ||||||
Current Other Pre-specified Outcome Measures | Not Provided | ||||||
Original Other Pre-specified Outcome Measures | Not Provided | ||||||
Descriptive Information | |||||||
Brief Title ICMJE | Optimizing Psychotherapy for Older Veterans With Chronic Pain | ||||||
Official Title ICMJE | Optimizing Psychotherapy for Older Veterans With Chronic Pain | ||||||
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 (e.g., 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. |
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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, VA/DoD, 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 EAET's 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-ethnic/multi-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. |
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Study Type ICMJE | Interventional | ||||||
Study Phase ICMJE | Not Applicable | ||||||
Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Intervention Model Description: Two-Group Parallel Comparison Trial Masking: None (Open Label)Primary Purpose: Treatment |
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Condition ICMJE | Musculoskeletal Pain | ||||||
Intervention ICMJE |
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Study Arms ICMJE |
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Publications * | Not Provided | ||||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||||
Recruitment Status ICMJE | Recruiting | ||||||
Estimated Enrollment ICMJE |
160 | ||||||
Original Estimated Enrollment ICMJE | Same as current | ||||||
Estimated Study Completion Date ICMJE | March 29, 2024 | ||||||
Estimated Primary Completion Date | March 29, 2024 (Final data collection date for primary outcome measure) | ||||||
Eligibility Criteria ICMJE |
Inclusion Criteria: Eligible Veterans are age 60 to 95 years old and have had at least 3 months of musculoskeletal pain, including the following conditions most likely to benefit from psychosocial intervention based on previous research:
Exclusion Criteria:
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Sex/Gender ICMJE |
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Ages ICMJE | 60 Years to 95 Years (Adult, Older Adult) | ||||||
Accepts Healthy Volunteers ICMJE | No | ||||||
Contacts ICMJE |
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Listed Location Countries ICMJE | United States | ||||||
Removed Location Countries | |||||||
Administrative Information | |||||||
NCT Number ICMJE | NCT03918642 | ||||||
Other Study ID Numbers ICMJE | NURA-013-18F 1K2CX001884-01A1 ( Other Grant/Funding Number: VA CSR&D ) |
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Has Data Monitoring Committee | Yes | ||||||
U.S. FDA-regulated Product |
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IPD Sharing Statement ICMJE |
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Responsible Party | VA Office of Research and Development | ||||||
Study Sponsor ICMJE | VA Office of Research and Development | ||||||
Collaborators ICMJE | Not Provided | ||||||
Investigators ICMJE |
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PRS Account | VA Office of Research and Development | ||||||
Verification Date | January 2021 | ||||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |