Clinical trial NCT03918642: Optimizing Psychotherapy for Older Veterans With Chronic Pain
Official title: Optimizing Psychotherapy for Older Veterans With Chronic Pain
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Musculoskeletal Pain
Keywords: Chronic Pain
Psychotherapy
Musculoskeletal Disease
Lead sponsor: VA Office of Research and Development
Sponsor class: FED
First posted: 2019-04-17
Enrollment: 126
Sex: ALL
Minimum age (years): 60
Maximum age (years): 95
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Two-Group Parallel Comparison Trial
Primary purpose: TREATMENT

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.

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. These mediators (e.g., Survey of Pain Attitudes, Working Alliance Inventory) were originally listed as outcomes in the trial registration, but they have been removed. 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.

Eligibility criteria: 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:

* regional pain syndromes (e.g., low back, neck, leg, or pelvic pain, or temporomandibular joint disorders);
* widespread pain syndromes (e.g., fibromyalgia);
* whiplash;
* tension headaches; or
* any combination of these disorders.

Exclusion Criteria:

* Confirmed hip or knee osteoarthritis without other musculoskeletal pain complaints;
* Leg pain greater than back pain only without other musculoskeletal pain complaints (to exclude radiculopathy in isolation);
* EMG-confirmed "tunnel" syndromes (e.g., carpal or tarsal tunnel syndrome) only without other musculoskeletal pain complaints;
* Autoimmune disease that typically generates pain (e.g., systemic lupus erythematosus, rheumatoid arthritis, inflammatory bowel disease, ankylosing spondylitis);
* Cancer pain, sickle cell disease, neuralgias (e.g., trigeminal neuralgia), burn pain, infection associated with pain (e.g., vertebral infection), cauda equina syndrome, gout, migraine or cluster headaches without additional musculoskeletal pain complaints;
* Uncontrolled severe psychiatric disorder including current psychotic disorder or severe mood disorder not controlled with medications (e.g., schizophrenia or bipolar I disorder), dissociative identity disorder, or active suicide/violence risk in the past 6 months;
* Substantial cognitive impairment or dementia (Mini-Mental State Exam (78) score 24);
* Active severe alcohol or substance use disorder that inhibits the participant's ability to attend session or participate in homework;
* Currently with pain-related litigation or applying for pain-related compensation or compensation increase, or undergoing compensation re-evaluation (e.g., applying for VA service connection or service connection increase for pain);
* Patients who have undergone CBT for pain within the last 3 months of enrollment or who are currently receiving CBT or EAET psychotherapy treatment for pain;
* Unable to fluently read/converse in English;
* Planning to move from the area in the next 6 months.

Primary outcomes:
measure: Pain Severity
timeFrame: Change from baseline to 10 weeks
Secondary outcomes:
measure: Pain Severity
timeFrame: Change from baseline to 20 weeks
measure: Satisfaction With Therapy and Therapist Scale-Revised (Overall Satisfaction)
timeFrame: 10 weeks
measure: PROMIS-Pain Interference Short Form 8a v1.0
timeFrame: Change from baseline to 10 weeks
measure: PROMIS-Pain Interference Short Form 8a v1.0
timeFrame: Change from baseline to 20 weeks
measure: PROMIS-Depression Short Form
timeFrame: Change from baseline to 10 weeks
measure: PROMIS-Depression Short Form
timeFrame: Change from baseline to 20 weeks
measure: PROMIS-Anxiety Short Form
timeFrame: Change from baseline to 10 weeks
measure: PROMIS-Anxiety Short Form
timeFrame: Change from baseline to 20 weeks
measure: PTSD Checklist for DSM-5
timeFrame: Change from baseline to 10 weeks
measure: PTSD Checklist for DSM-5
timeFrame: Change from baseline to 20 weeks
measure: NIH Toolbox-Life Satisfaction Short Form
timeFrame: Change from baseline to 10 weeks
measure: NIH Toolbox-Life Satisfaction Short Form
timeFrame: Change from baseline to 20 weeks
measure: PROMIS-Sleep Disturbance Short Form
timeFrame: Change from baseline to 10 weeks
measure: PROMIS-Sleep Disturbance Short Form
timeFrame: Change from baseline to 20 weeks
measure: PROMIS-Fatigue Short Form
timeFrame: Change from baseline to 10 weeks
measure: PROMIS-Fatigue Short Form
timeFrame: Change from baseline to 20 weeks
measure: Patient's Global Impression of Change Scale
timeFrame: Change from baseline to 10 weeks
measure: Patient's Global Impression of Change Scale
timeFrame: Change from baseline to 20 weeks
measure: Percentage of Participants With at Least 30% Improvement in Pain Severity
timeFrame: Change from baseline to 10 weeks
measure: Percentage of Participants With at Least 30% Improvement in Pain Severity
timeFrame: Change from baseline to 20 weeks
measure: Percentage of Participants With at Least 50% Improvement in Pain Severity
timeFrame: Change from baseline to 10 weeks
measure: Percentage of Participants With at Least 50% Improvement in Pain Severity
timeFrame: Change from baseline to 20 weeks
measure: Percentage of Participants With at Least 70% Improvement in Pain Severity
timeFrame: Change from baseline to 10 weeks
measure: Percentage of Participants With at Least 70% Improvement in Pain Severity
timeFrame: Change from baseline to 20 weeks
Other outcomes:
Locations:
city: West Los Angeles
country: United States
facility: VA Greater Los Angeles Healthcare System, West Los Angeles, CA
state: California
Study officials:
affiliation: VA Greater Los Angeles Healthcare System, West Los Angeles, CA
name: Brandon C Yarns, MD MS BME
role: PRINCIPAL_INVESTIGATOR
References:
citation: Yarns BC, Jackson NJ, Alas A, Melrose RJ, Lumley MA, Sultzer DL. Emotional Awareness and Expression Therapy vs Cognitive Behavioral Therapy for Chronic Pain in Older Veterans: A Randomized Clinical Trial. JAMA Netw Open. 2024 Jun 3;7(6):e2415842. doi: 10.1001/jamanetworkopen.2024.15842.