Musculoskeletal PainOPOVCPNCT03918642
Optimizing Psychotherapy for Older Veterans With Chronic Pain
A study testing Emotional Awareness and Expression Therapy and Cognitive Behavior Therapy in people with Musculoskeletal Pain, run by VA Office of Research and Development at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 60 to 95 years
- Conditions the study is for
- Musculoskeletal Pain
- What is being tested?
- Emotional Awareness and Expression Therapy and Cognitive Behavior Therapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 126 participants
- Where
- 1 siteUnited States
- Study dates
- 16 May 2019to 14 Sep 2023
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 to 95 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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;
Show all 12Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
VA Greater Los Angeles Healthcare System, West Los Angeles, CA
West Los Angeles, California, 90073-1003
About this study
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.
Read the 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.
- Conditions
- Musculoskeletal Pain
- Being tested
- Emotional Awareness and Expression Therapy, Cognitive Behavior Therapy
- Keywords
- Chronic Pain, Psychotherapy, Musculoskeletal Disease
- Medical subject headings
- Musculoskeletal Pain, Chronic Pain, Musculoskeletal Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Emotional Awareness and Expression TherapyBehavioural
Also called EAET
Focus on emotions, writing about stress, assertiveness training, role playing new ways to handle relationships, and sharing feelings and experiences with others.
Cognitive Behavior TherapyBehavioural
Also called CBT
Focus on cognitive and behavioral skills, such as relaxation, increasing pleasant activities, pacing, and changing ways of thinking.
| Study group | Role | What they receive |
|---|---|---|
| Emotional Awareness and Expression Therapy | Experimental | 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. Receives: Behavioral: Emotional Awareness and Expression Therapy |
| Cognitive Behavior Therapy | Active comparator | 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. Receives: Behavioral: Cognitive Behavior Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain Severity
Average of 4 self report items: current pain, worst pain over the last 7 days, least pain over the last 7 days, and average pain over the last 7 days. Each item is scored 0-10 (0 = no pain; 10 = pain as bad as can be), yielding a total score between 0 and 10 with higher scores indicating a worse outcome.
Measured: Change from baseline to 10 weeks
Secondary outcomes (24)
Pain Severity
Average of 4 self report items: current pain, worst pain over the last 7 days, least pain over the last 7 days, and average pain over the last 7 days. Each item is scored 0-10 (0 = no pain; 10 = pain as bad as can be), yielding a total score between 0 and 10 with higher scores indicating a worse outcome.
Measured: Change from baseline to 20 weeks
Satisfaction With Therapy and Therapist Scale-Revised (Overall Satisfaction)
Overall satisfaction is a single item on the Satisfaction with Therapy and Therapist Scale-Revised scored 1-5 (1 = maximum dissatisfaction; 5 = maximum satisfaction) with higher scores indicating a better outcome.
Measured: 10 weeks
PROMIS-Pain Interference Short Form 8a v1.0
Sum of eight self-report items assessing interference of pain with daily activities over the past 7 days. Items range from 1-5 (1 = no interference; 5 = maximum interference), yielding a total score between 8 and 40 with higher scores indicating a worse outcome.
Measured: Change from baseline to 10 weeks
PROMIS-Pain Interference Short Form 8a v1.0
Sum of eight self-report items assessing interference of pain with daily activities over the past 7 days. Items range from 1-5 (1 = no interference; 5 = maximum interference), yielding a total score between 8 and 40 with higher scores indicating a worse outcome.
Measured: Change from baseline to 20 weeks
PROMIS-Depression Short Form
Sum of eight self-report items assessing depression and emotional distress over the past 7 days. Items range from 1-5 (1 = never feeling a type of distressing emotion; 5 = always feeling that emotion), yielding a total score between 8 and 40 with higher scores indicating a worse outcome.
Measured: Change from baseline to 10 weeks
PROMIS-Depression Short Form
Sum of eight self-report items assessing depression and emotional distress over the past 7 days. Items range from 1-5 (1 = never feeling a type of distressing emotion; 5 = always feeling that emotion), yielding a total score between 8 and 40 with higher scores indicating a worse outcome.
Measured: Change from baseline to 20 weeks
PROMIS-Anxiety Short Form
Sum of seven self-report items assessing anxiety over the past 7 days. Items range from 1-5 (1 = never experiencing a type of distressing emotion; 5 = always feeling that emotion), yielding a total score between 7 and 35 with higher scores indicating a worse outcome.
Measured: Change from baseline to 10 weeks
PROMIS-Anxiety Short Form
Sum of seven self-report items assessing anxiety over the past 7 days. Items range from 1-5 (1 = never experiencing a type of distressing emotion; 5 = always feeling that emotion), yielding a total score between 7 and 35 with higher scores indicating a worse outcome.
Measured: Change from baseline to 20 weeks
PTSD Checklist for DSM-5
Sum of twenty self-report items assessing PTSD according to the frequency in which symptoms are experienced over the past month. Items range from 0-4 (0 = not at all; 1 = a little bit; 2 = moderately; 3 = quite a bit; 4 = extremely), yielding a total score between 0 and 80 with higher scores indicating a worse outcome.
Measured: Change from baseline to 10 weeks
PTSD Checklist for DSM-5
Sum of twenty self-report items assessing PTSD according to the frequency in which symptoms are experienced over the past month. Items range from 0-4 (0 = not at all; 1 = a little bit; 2 = moderately; 3 = quite a bit; 4 = extremely), yielding a total score between 0 and 80 with higher scores indicating a worse outcome.
Measured: Change from baseline to 20 weeks
NIH Toolbox-Life Satisfaction Short Form
Sum of five self-report items assessing general life satisfaction. Items range from 1-5 (1 = no satisfaction; 5 = maximum satisfaction), yielding a total score between 5 and 25 with higher scores indicating a better outcome.
Measured: Change from baseline to 10 weeks
NIH Toolbox-Life Satisfaction Short Form
Sum of five self-report items assessing general life satisfaction. Items range from 1-5 (1 = no satisfaction; 5 = maximum satisfaction), yielding a total score between 5 and 25 with higher scores indicating a better outcome.
Measured: Change from baseline to 20 weeks
PROMIS-Sleep Disturbance Short Form
Sum of eight self-report items assessing sleep disturbance over the past 7 days. Items range from 1-5 (1 = no sleep disturbance; 5 = maximum sleep disturbance), yielding a total score between 8 and 40 with higher scores indicating a worse outcome.
Measured: Change from baseline to 10 weeks
PROMIS-Sleep Disturbance Short Form
Sum of eight self-report items assessing sleep disturbance over the past 7 days. Items range from 1-5 (1 = no sleep disturbance; 5 = maximum sleep disturbance), yielding a total score between 8 and 40 with higher scores indicating a worse outcome.
Measured: Change from baseline to 20 weeks
PROMIS-Fatigue Short Form
Sum of seven self-report items assessing fatigue over the past 7 days. Items range from 1-5 (1 = no fatigue; 5 = maximum fatigue), yielding a total score between 7 and 35 with higher scores indicating a worse outcome.
Measured: Change from baseline to 10 weeks
PROMIS-Fatigue Short Form
Sum of seven self-report items assessing fatigue over the past 7 days. Items range from 1-5 (1 = no fatigue; 5 = maximum fatigue), yielding a total score between 7 and 35 with higher scores indicating a worse outcome.
Measured: Change from baseline to 20 weeks
Patient's Global Impression of Change Scale
Patient rates on a single item with a scale of 1-7 the change (if any) they've experienced since beginning treatment in the study (1 = no change or condition has worsened; 7 = a great deal better and a considerable improvement that has made all the difference) with higher scores indicating a better outcome.
Measured: Change from baseline to 10 weeks
Patient's Global Impression of Change Scale
Patient rates on a single item with a scale of 1-7 the change (if any) they've experienced since beginning treatment in the study (1 = no change or condition has worsened; 7 = a great deal better and a considerable improvement that has made all the difference) with higher scores indicating a better outcome.
Measured: Change from baseline to 20 weeks
Percentage of Participants With at Least 30% Improvement in Pain Severity
Mean pain severity is calculated from an average of 4 self report items: current pain, worst pain over the last 7 days, least pain over the last 7 days, and average pain over the last 7 days. Each item is scored 0-10 (0 = no pain; 10 = pain as bad as can be), yielding a total score between 0 and 10 . Mean pain severity is calculated at baseline and 10 weeks, and the two scores are compared to see if mean pain severity at 10 weeks is 30% lower than at baseline.
Measured: Change from baseline to 10 weeks
Percentage of Participants With at Least 30% Improvement in Pain Severity
Mean pain severity is calculated from an average of 4 self report items: current pain, worst pain over the last 7 days, least pain over the last 7 days, and average pain over the last 7 days. Each item is scored 0-10 (0 = no pain; 10 = pain as bad as can be), yielding a total score between 0 and 10. Mean pain severity is calculated at baseline and 20 weeks, and the two scores are compared to see if mean pain severity at 20 weeks is at least 30% lower than at baseline.
Measured: Change from baseline to 20 weeks
Percentage of Participants With at Least 50% Improvement in Pain Severity
Mean pain severity is calculated from an average of 4 self report items: current pain, worst pain over the last 7 days, least pain over the last 7 days, and average pain over the last 7 days. Each item is scored 0-10 (0 = no pain; 10 = pain as bad as can be), yielding a total score between 0 and 10. Mean pain severity is calculated at baseline and 10 weeks, and the two scores are compared to see if mean pain severity at 10 weeks is at least 50% lower than at baseline.
Measured: Change from baseline to 10 weeks
Percentage of Participants With at Least 50% Improvement in Pain Severity
Mean pain severity is calculated from an average of 4 self report items: current pain, worst pain over the last 7 days, least pain over the last 7 days, and average pain over the last 7 days. Each item is scored 0-10 (0 = no pain; 10 = pain as bad as can be), yielding a total score between 0 and 10. Mean pain severity is calculated at baseline and 20 weeks, and the two scores are compared to see if mean pain severity at 20 weeks is at least 50% lower than at baseline.
Measured: Change from baseline to 20 weeks
Percentage of Participants With at Least 70% Improvement in Pain Severity
Mean pain severity is calculated from an average of 4 self report items: current pain, worst pain over the last 7 days, least pain over the last 7 days, and average pain over the last 7 days. Each item is scored 0-10 (0 = no pain; 10 = pain as bad as can be), yielding a total score between 0 and 10. Mean pain severity is calculated at baseline and 10 weeks, and the two scores are compared to see if mean pain severity at 10 weeks is at least 70% lower than at baseline.
Measured: Change from baseline to 10 weeks
Percentage of Participants With at Least 70% Improvement in Pain Severity
Mean pain severity is calculated from an average of 4 self report items: current pain, worst pain over the last 7 days, least pain over the last 7 days, and average pain over the last 7 days. Each item is scored 0-10 (0 = no pain; 10 = pain as bad as can be), yielding a total score between 0 and 10. Mean pain severity is calculated at baseline and 20 weeks, and the two scores are compared to see if mean pain severity at 20 weeks is at least 70% lower than at baseline.
Measured: Change from baseline to 20 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Apr 2019
- Study start16 May 2019
- Primary completion14 Sep 2023
- Study completion14 Sep 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Musculoskeletal PainStudies of the same condition, open and under way.
- More trials run by VA Office of Research and DevelopmentThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Two-Group Parallel Comparison Trial
- Masking
- None (open label)
- Enrolment
- 126 participants (actual)
Sponsor and investigators
- Lead sponsor
- VA Office of Research and Development
- Sponsor type
- US federal agency
- Responsible party
- Sponsor
- Investigators
- Brandon C Yarns, MD MS BME, Principal investigator, VA Greater Los Angeles Healthcare System, West Los Angeles, CA
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03918642
- Sponsor's protocol ID
- NURA-013-18F
- Other IDs
- 1K2CX001884-01A1
- Acronym
- OPOVCP
- Status last verified
- Oct 2024
- First submitted
- 15 Apr 2019
- Last updated
- 4 Nov 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 38869899
Study at a glance
From the registry record, last updated by the sponsor on 4 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Optimizing Psychotherapy for Older Veterans With Chronic Pain
- ClinicalTrials.gov ID
- NCT03918642
- Acronym / sponsor ID
- OPOVCP / NURA-013-18F
- Conditions
- Musculoskeletal Pain
- Keywords
- Chronic Pain, Psychotherapy, Musculoskeletal Disease
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 126 participants (actual)
- Lead sponsor
- VA Office of Research and DevelopmentUS federal agency
- Study start
- 16 May 2019 (actual)
- Primary completion
- 14 Sep 2023 (actual)
- Study completion
- 14 Sep 2023 (actual)
- First posted
- 17 Apr 2019 (actual)
- Results
- Posted 4 Nov 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Two-Group Parallel Comparison Trial
| Arm | Type | Receives |
|---|---|---|
| Emotional Awareness and Expression Therapy | Experimental | Behavioral: Emotional Awareness and Expression TherapySeeks 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. |
| Cognitive Behavior Therapy | Active comparator | Behavioral: Cognitive Behavior TherapySeeks 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. |
Who may qualify
- Ages
- 60 to 95 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (12 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Emotional Awareness and Expression TherapyAlso: EAETFocus on emotions, writing about stress, assertiveness training, role playing new ways to handle relationships, and sharing feelings and experiences with others. | Behavioural | Emotional Awareness and Expression Therapy |
| Cognitive Behavior TherapyAlso: CBTFocus on cognitive and behavioral skills, such as relaxation, increasing pleasant activities, pacing, and changing ways of thinking. | Behavioural | Cognitive Behavior Therapy |
Primary outcome
Pain Severity
Time frame: Change from baseline to 10 weeks
Average of 4 self report items: current pain, worst pain over the last 7 days, least pain over the last 7 days, and average pain over the last 7 days. Each item is scored 0-10 (0 = no pain; 10 = pain as bad as can be), yielding a total score between 0 and 10 with higher scores indicating a worse outcome.
24 secondary outcomes
Pain Severity
Time frame: Change from baseline to 20 weeks
Satisfaction With Therapy and Therapist Scale-Revised (Overall Satisfaction)
Time frame: 10 weeks
PROMIS-Pain Interference Short Form 8a v1.0
Time frame: Change from baseline to 10 weeks
PROMIS-Pain Interference Short Form 8a v1.0
Time frame: Change from baseline to 20 weeks
PROMIS-Depression Short Form
Time frame: Change from baseline to 10 weeks
PROMIS-Depression Short Form
Time frame: Change from baseline to 20 weeks
PROMIS-Anxiety Short Form
Time frame: Change from baseline to 10 weeks
PROMIS-Anxiety Short Form
Time frame: Change from baseline to 20 weeks
PTSD Checklist for DSM-5
Time frame: Change from baseline to 10 weeks
PTSD Checklist for DSM-5
Time frame: Change from baseline to 20 weeks
NIH Toolbox-Life Satisfaction Short Form
Time frame: Change from baseline to 10 weeks
NIH Toolbox-Life Satisfaction Short Form
Time frame: Change from baseline to 20 weeks
PROMIS-Sleep Disturbance Short Form
Time frame: Change from baseline to 10 weeks
PROMIS-Sleep Disturbance Short Form
Time frame: Change from baseline to 20 weeks
PROMIS-Fatigue Short Form
Time frame: Change from baseline to 10 weeks
PROMIS-Fatigue Short Form
Time frame: Change from baseline to 20 weeks
Patient's Global Impression of Change Scale
Time frame: Change from baseline to 10 weeks
Patient's Global Impression of Change Scale
Time frame: Change from baseline to 20 weeks
Percentage of Participants With at Least 30% Improvement in Pain Severity
Time frame: Change from baseline to 10 weeks
Percentage of Participants With at Least 30% Improvement in Pain Severity
Time frame: Change from baseline to 20 weeks
Percentage of Participants With at Least 50% Improvement in Pain Severity
Time frame: Change from baseline to 10 weeks
Percentage of Participants With at Least 50% Improvement in Pain Severity
Time frame: Change from baseline to 20 weeks
Percentage of Participants With at Least 70% Improvement in Pain Severity
Time frame: Change from baseline to 10 weeks
Percentage of Participants With at Least 70% Improvement in Pain Severity
Time frame: Change from baseline to 20 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Nov 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 38869899Yarns 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.
- Individual participant dataSharing planned: No
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Rheumatic Arthritis
Active, not recruiting
ASCEND: A Clinical Trial to Evaluate the Safety and Effectiveness of VIA Disc NP, a Supplement for Degenerated Intervertebral Discs
Degenerative Disc Disease, Disc Degeneration
Active, not recruitingPhase 4
Intraarticular Steroids, Saline and Occupational Therapy in People With CMC1 Osteoarthritis
Osteoarthritis Thumb
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Brandon C Yarns, MD MS BME principal investigator
VA Greater Los Angeles Healthcare System, West Los Angeles, CA
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Emotional Awareness and Expression Therapy and Cognitive Behavior Therapy in people with Musculoskeletal Pain, run by VA Office of Research and Development at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 4 Nov 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain Severity (time frame: Change from baseline to 10 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03918642, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Nov 2024.