N/A
Completed N=126
Optimizing Psychotherapy for Older Veterans With Chronic Pain
Source: ClinicalTrials.gov NCT03918642 ↗Enrolled (actual)
126
Serious AEs
2.4%
Results posted
Nov 2024
Primary outcomePrimary: Pain Severity — -2.18; -0.60 score on a scale — p=<0.001
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Pain Severity |
-1.26; -0.25 | 0.01 sig |
| SECONDARY Pain Severity |
-1.26; -0.25 | 0.01 sig |
| SECONDARY Satisfaction With Therapy and Therapist Scale-Revised (Overall Satisfaction) |
4.30; 4.01 | <0.001 sig |
| SECONDARY PROMIS-Pain Interference Short Form 8a v1.0 |
-2.87; -3.08 | 0.85 |
| SECONDARY PROMIS-Depression Short Form |
-3.48; -1.09 | 0.02 sig |
| SECONDARY PROMIS-Anxiety Short Form |
-3.17; -1.22 | 0.11 |
| SECONDARY PTSD Checklist for DSM-5 |
-4.07; -0.31 | 0.07 |
| SECONDARY NIH Toolbox-Life Satisfaction Short Form |
1.15; 0.21 | 0.17 |
| SECONDARY PROMIS-Sleep Disturbance Short Form |
-2.73; -0.16 | 0.11 |
| SECONDARY PROMIS-Fatigue Short Form |
-1.47; -1.17 | 0.69 |
| SECONDARY Patient's Global Impression of Change Scale |
4.01; 2.77 | <0.001 sig |
| SECONDARY Percentage of Participants With at Least 30% Improvement in Pain Severity |
40.3; 14.2 | 0.006 sig |
| SECONDARY Percentage of Participants With at Least 50% Improvement in Pain Severity |
16.6; 3.9 | 0.05 |
| SECONDARY Percentage of Participants With at Least 70% Improvement in Pain Severity |
7.5; 2.1 | 0.22 |
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.
Data sourced from ClinicalTrials.gov (NCT03918642). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.