Musculoskeletal Pain
Conditions
Keywords
Chronic Pain, Psychotherapy, Musculoskeletal Disease
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.
Interventions
Focus on emotions, writing about stress, assertiveness training, role playing new ways to handle relationships, and sharing feelings and experiences with others.
BEHAVIORALCognitive Behavior Therapy
Focus on cognitive and behavioral skills, such as relaxation, increasing pleasant activities, pacing, and changing ways of thinking.
Sponsors
VA Office of Research and Development
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Two-Group Parallel Comparison Trial
Eligibility
Sex/Gender
ALL
Age
60 Years to 95 Years
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: * 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pain Severity | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Satisfaction With Therapy and Therapist Scale-Revised (Overall Satisfaction) | 10 weeks | 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. |
| PROMIS-Pain Interference Short Form 8a v1.0 | Change from baseline to 10 weeks | 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. |
| PROMIS-Depression Short Form | Change from baseline to 10 weeks | 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. |
| PROMIS-Anxiety Short Form | Change from baseline to 10 weeks | 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. |
| PTSD Checklist for DSM-5 | Change from baseline to 10 weeks | 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. |
| NIH Toolbox-Life Satisfaction Short Form | Change from baseline to 10 weeks | 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. |
| Pain Severity | Change from baseline to 20 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. |
| PROMIS-Fatigue Short Form | Change from baseline to 10 weeks | 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. |
| Patient's Global Impression of Change Scale | Change from baseline to 10 weeks | 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. |
| Percentage of Participants With at Least 30% Improvement in Pain Severity | Change from baseline to 10 weeks | 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. |
| Percentage of Participants With at Least 50% Improvement in Pain Severity | Change from baseline to 10 weeks | 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. |
| Percentage of Participants With at Least 70% Improvement in Pain Severity | Change from baseline to 10 weeks | 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. |
| PROMIS-Sleep Disturbance Short Form | Change from baseline to 10 weeks | 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. |
Countries
United States
Participant flow
Recruitment details
Participants were recruited from outpatient clinics at VA Greater Los Angeles, letter-based recruitment based on a search of data from the VA Corporate Warehouse, and self-referral from flyers. The first participants was enrolled on May 16, 2019, and the last participant was enrolled on February 1, 2023. Recruitment was paused from March 20, 2020, until February 4, 2021, due to COVID-19 related administrative holds.
Pre-assignment details
Of 126 enrolled, 126 were randomized to treatment.
Participants by arm
| Arm | Count |
|---|---|
| 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.
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. | 66 |
| 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.
Cognitive Behavior Therapy: Focus on cognitive and behavioral skills, such as relaxation, increasing pleasant activities, pacing, and changing ways of thinking. | 60 |
| Total | 126 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 12 | 10 |
Baseline characteristics
| Characteristic | Total | Cognitive Behavior Therapy | Emotional Awareness and Expression Therapy |
|---|---|---|---|
| Age, Continuous | 71.9 years STANDARD_DEVIATION 5.9 | 71.3 years STANDARD_DEVIATION 6.6 | 72.6 years STANDARD_DEVIATION 5.2 |
| Any psychiatric diagnosis No psychiatric diagnosis | 39 Participants | 17 Participants | 22 Participants |
| Any psychiatric diagnosis Psychiatric diagnosis (e.g., depression, anxiety, PTSD) | 87 Participants | 43 Participants | 44 Participants |
| Back pain Back pain | 121 Participants | 58 Participants | 63 Participants |
| Back pain No back pain | 5 Participants | 2 Participants | 3 Participants |
| Education level College graduate or more | 40 Participants | 20 Participants | 20 Participants |
| Education level High school or less | 24 Participants | 14 Participants | 10 Participants |
| Education level Some college | 62 Participants | 26 Participants | 36 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 8 Participants | 2 Participants | 6 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 118 Participants | 58 Participants | 60 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Marital status Divorced or separated | 50 Participants | 25 Participants | 25 Participants |
| Marital status Married or partnered | 42 Participants | 19 Participants | 23 Participants |
| Marital status Never married or other | 34 Participants | 16 Participants | 18 Participants |
| Mini-Mental State Examination Scores | 28.6 units on a scale STANDARD_DEVIATION 1.4 | 28.4 units on a scale STANDARD_DEVIATION 1.6 | 28.9 units on a scale STANDARD_DEVIATION 1.1 |
| No. non-pain chronic medical conditions | 5.0 conditions STANDARD_DEVIATION 2.4 | 4.9 conditions STANDARD_DEVIATION 2.7 | 5.0 conditions STANDARD_DEVIATION 2.2 |
| No. prescribed opioids at baseline No opioids | 112 Participants | 54 Participants | 58 Participants |
| No. prescribed opioids at baseline Opioids | 14 Participants | 6 Participants | 8 Participants |
| No. prescription medications | 9.6 medications STANDARD_DEVIATION 4.8 | 9.4 medications STANDARD_DEVIATION 4.3 | 9.9 medications STANDARD_DEVIATION 5.2 |
| Pain duration | 23.3 years STANDARD_DEVIATION 17.7 | 24.4 years STANDARD_DEVIATION 17.3 | 22.5 years STANDARD_DEVIATION 18.2 |
| Race (NIH/OMB) American Indian or Alaska Native | 1 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 69 Participants | 37 Participants | 32 Participants |
| Race (NIH/OMB) More than one race | 9 Participants | 4 Participants | 5 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 8 Participants | 2 Participants | 6 Participants |
| Race (NIH/OMB) White | 39 Participants | 17 Participants | 22 Participants |
| Sex: Female, Male Female | 10 Participants | 3 Participants | 7 Participants |
| Sex: Female, Male Male | 116 Participants | 57 Participants | 59 Participants |
| VA service-connected for PTSD Not VA service-connected for PTSD | 79 Participants | 38 Participants | 41 Participants |
| VA service-connected for PTSD VA service-connected for PTSD | 47 Participants | 22 Participants | 25 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 1 / 66 | 1 / 60 |
| other Total, other adverse events | 10 / 66 | 5 / 60 |
| serious Total, serious adverse events | 2 / 66 | 1 / 60 |
Outcome results
Primary
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.
Time frame: Change from baseline to 10 weeks
Population: Intent to Treat Population (all participants assigned to Emotional Awareness and Expression Therapy or Cognitive Behavior Therapy)
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Emotional Awareness and Expression Therapy | Pain Severity | -2.18 score on a scale |
| Cognitive Behavior Therapy | Pain Severity | -0.60 score on a scale |
p-value: <0.00195% CI: [-2.35, -0.83]Mixed Models Analysis
Secondary
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.
Time frame: Change from baseline to 10 weeks
Population: Intent to Treat Population (all participants assigned to Emotional Awareness and Expression Therapy or Cognitive Behavior Therapy)
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Emotional Awareness and Expression Therapy | NIH Toolbox-Life Satisfaction Short Form | 1.68 score on a scale |
| Cognitive Behavior Therapy | NIH Toolbox-Life Satisfaction Short Form | 0.45 score on a scale |
p-value: 0.00595% CI: [0.36, 2.1]Mixed Models Analysis
Secondary
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.
Time frame: Change from baseline to 20 weeks
Population: Intent to Treat Population (all participants assigned to Emotional Awareness and Expression Therapy or Cognitive Behavior Therapy)
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Emotional Awareness and Expression Therapy | NIH Toolbox-Life Satisfaction Short Form | 1.15 score on a scale |
| Cognitive Behavior Therapy | NIH Toolbox-Life Satisfaction Short Form | 0.21 score on a scale |
p-value: 0.1795% CI: [-0.4, 2.29]Mixed Models Analysis
Secondary
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.
Time frame: Change from baseline to 20 weeks
Population: Intent to Treat Population (all participants assigned to Emotional Awareness and Expression Therapy or Cognitive Behavior Therapy)
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Emotional Awareness and Expression Therapy | Pain Severity | -1.26 score on a scale |
| Cognitive Behavior Therapy | Pain Severity | -0.25 score on a scale |
p-value: 0.0195% CI: [-1.78, -0.24]Mixed Models Analysis
Secondary
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.
Time frame: Change from baseline to 10 weeks
Population: Intent to Treat Population (all participants assigned to Emotional Awareness and Expression Therapy or Cognitive Behavior Therapy)
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Emotional Awareness and Expression Therapy | Patient's Global Impression of Change Scale | 4.67 score on a scale |
| Cognitive Behavior Therapy | Patient's Global Impression of Change Scale | 3.20 score on a scale |
p-value: <0.00195% CI: [0.77, 2.15]Mixed Models Analysis
Secondary
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.
Time frame: Change from baseline to 20 weeks
Population: Intent to Treat Population (all participants assigned to Emotional Awareness and Expression Therapy or Cognitive Behavior Therapy)
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Emotional Awareness and Expression Therapy | Patient's Global Impression of Change Scale | 4.01 score on a scale |
| Cognitive Behavior Therapy | Patient's Global Impression of Change Scale | 2.77 score on a scale |
p-value: <0.00195% CI: [0.62, 1.86]Mixed Models Analysis
Secondary
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.
Time frame: Change from baseline to 10 weeks
Population: Intent to Treat Population (all participants assigned to Emotional Awareness and Expression Therapy or Cognitive Behavior Therapy)
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Emotional Awareness and Expression Therapy | Percentage of Participants With at Least 30% Improvement in Pain Severity | 63.5 percentage of participants |
| Cognitive Behavior Therapy | Percentage of Participants With at Least 30% Improvement in Pain Severity | 17.1 percentage of participants |
p-value: <0.00195% CI: [4.66, 99.56]Mixed Models Analysis
Secondary
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.
Time frame: Change from baseline to 20 weeks
Population: Intent to Treat Population (all participants assigned to Emotional Awareness and Expression Therapy or Cognitive Behavior Therapy)
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Emotional Awareness and Expression Therapy | Percentage of Participants With at Least 30% Improvement in Pain Severity | 40.3 percentage of participants |
| Cognitive Behavior Therapy | Percentage of Participants With at Least 30% Improvement in Pain Severity | 14.2 percentage of participants |
p-value: 0.00695% CI: [1.74, 30.06]Mixed Models Analysis
Secondary
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.
Time frame: Change from baseline to 10 weeks
Population: Intent to Treat Population (all participants assigned to Emotional Awareness and Expression Therapy or Cognitive Behavior Therapy)
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Emotional Awareness and Expression Therapy | Percentage of Participants With at Least 50% Improvement in Pain Severity | 35.7 percentage of participants |
| Cognitive Behavior Therapy | Percentage of Participants With at Least 50% Improvement in Pain Severity | 7.4 percentage of participants |
p-value: 0.00295% CI: [2.38, 58.25]Mixed Models Analysis
Secondary
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.
Time frame: Change from baseline to 20 weeks
Population: Intent to Treat Population (all participants assigned to Emotional Awareness and Expression Therapy or Cognitive Behavior Therapy)
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Emotional Awareness and Expression Therapy | Percentage of Participants With at Least 50% Improvement in Pain Severity | 16.6 percentage of participants |
| Cognitive Behavior Therapy | Percentage of Participants With at Least 50% Improvement in Pain Severity | 3.9 percentage of participants |
p-value: 0.0595% CI: [0.99, 43.67]Mixed Models Analysis
Secondary
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.
Time frame: Change from baseline to 20 weeks
Population: Intent to Treat Population (all participants assigned to Emotional Awareness and Expression Therapy or Cognitive Behavior Therapy)
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Emotional Awareness and Expression Therapy | Percentage of Participants With at Least 70% Improvement in Pain Severity | 7.5 percentage of participants |
| Cognitive Behavior Therapy | Percentage of Participants With at Least 70% Improvement in Pain Severity | 2.1 percentage of participants |
p-value: 0.2295% CI: [0.35, 89.3]Mixed Models Analysis
Secondary
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.
Time frame: Change from baseline to 10 weeks
Population: Intent to Treat Population (all participants assigned to Emotional Awareness and Expression Therapy or Cognitive Behavior Therapy)
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Emotional Awareness and Expression Therapy | Percentage of Participants With at Least 70% Improvement in Pain Severity | 12.8 percentage of participants |
| Cognitive Behavior Therapy | Percentage of Participants With at Least 70% Improvement in Pain Severity | 1.9 percentage of participants |
p-value: 0.0695% CI: [0.86, 225.44]Mixed Models Analysis
Secondary
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.
Time frame: Change from baseline to 20 weeks
Population: Intent to Treat Population (all participants assigned to Emotional Awareness and Expression Therapy or Cognitive Behavior Therapy)
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Emotional Awareness and Expression Therapy | PROMIS-Anxiety Short Form | -3.17 score on a scale |
| Cognitive Behavior Therapy | PROMIS-Anxiety Short Form | -1.22 score on a scale |
p-value: 0.1195% CI: [-4.34, 0.45]Mixed Models Analysis
Secondary
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.
Time frame: Change from baseline to 10 weeks
Population: Intent to Treat Population (all participants assigned to Emotional Awareness and Expression Therapy or Cognitive Behavior Therapy)
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Emotional Awareness and Expression Therapy | PROMIS-Anxiety Short Form | -3.13 score on a scale |
| Cognitive Behavior Therapy | PROMIS-Anxiety Short Form | -0.64 score on a scale |
p-value: 0.00695% CI: [-4.3, -0.68]Mixed Models Analysis
Secondary
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.
Time frame: Change from baseline to 20 weeks
Population: Intent to Treat Population (all participants assigned to Emotional Awareness and Expression Therapy or Cognitive Behavior Therapy)
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Emotional Awareness and Expression Therapy | PROMIS-Depression Short Form | -3.48 score on a scale |
| Cognitive Behavior Therapy | PROMIS-Depression Short Form | -1.09 score on a scale |
p-value: 0.0295% CI: [-4.33, -0.45]Mixed Models Analysis
Secondary
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.
Time frame: Change from baseline to 10 weeks
Population: Intent to Treat Population (all participants assigned to Emotional Awareness and Expression Therapy or Cognitive Behavior Therapy)
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Emotional Awareness and Expression Therapy | PROMIS-Depression Short Form | -5.12 score on a scale |
| Cognitive Behavior Therapy | PROMIS-Depression Short Form | -2.06 score on a scale |
p-value: 0.0395% CI: [-5.88, -0.25]Mixed Models Analysis
Secondary
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.
Time frame: Change from baseline to 10 weeks
Population: Intent to Treat Population (all participants assigned to Emotional Awareness and Expression Therapy or Cognitive Behavior Therapy)
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Emotional Awareness and Expression Therapy | PROMIS-Fatigue Short Form | -1.97 score on a scale |
| Cognitive Behavior Therapy | PROMIS-Fatigue Short Form | -1.19 score on a scale |
p-value: 0.3395% CI: [-2.33, 0.78]Mixed Models Analysis
Secondary
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.
Time frame: Change from baseline to 20 weeks
Population: Intent to Treat Population (all participants assigned to Emotional Awareness and Expression Therapy or Cognitive Behavior Therapy)
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Emotional Awareness and Expression Therapy | PROMIS-Fatigue Short Form | -1.47 score on a scale |
| Cognitive Behavior Therapy | PROMIS-Fatigue Short Form | -1.17 score on a scale |
p-value: 0.6995% CI: [-1.74, 1.14]Mixed Models Analysis
Secondary
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.
Time frame: Change from baseline to 20 weeks
Population: Intent to Treat Population (all participants assigned to Emotional Awareness and Expression Therapy or Cognitive Behavior Therapy)
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Emotional Awareness and Expression Therapy | PROMIS-Pain Interference Short Form 8a v1.0 | -2.87 score on a scale |
| Cognitive Behavior Therapy | PROMIS-Pain Interference Short Form 8a v1.0 | -3.08 score on a scale |
p-value: 0.8595% CI: [-1.99, 2.42]Mixed Models Analysis
Secondary
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.
Time frame: Change from baseline to 10 weeks
Population: Intent to Treat Population (all participants assigned to Emotional Awareness and Expression Therapy or Cognitive Behavior Therapy)
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Emotional Awareness and Expression Therapy | PROMIS-Pain Interference Short Form 8a v1.0 | -5.41 score on a scale |
| Cognitive Behavior Therapy | PROMIS-Pain Interference Short Form 8a v1.0 | -3.99 score on a scale |
p-value: 0.1495% CI: [-3.3, 0.46]Mixed Models Analysis
Secondary
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.
Time frame: Change from baseline to 10 weeks
Population: Intent to Treat Population (all participants assigned to Emotional Awareness and Expression Therapy or Cognitive Behavior Therapy)
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Emotional Awareness and Expression Therapy | PROMIS-Sleep Disturbance Short Form | -2.69 score on a scale |
| Cognitive Behavior Therapy | PROMIS-Sleep Disturbance Short Form | -0.84 score on a scale |
p-value: 0.1195% CI: [-4.14, 0.44]Mixed Models Analysis
Secondary
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.
Time frame: Change from baseline to 20 weeks
Population: Intent to Treat Population (all participants assigned to Emotional Awareness and Expression Therapy or Cognitive Behavior Therapy)
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Emotional Awareness and Expression Therapy | PROMIS-Sleep Disturbance Short Form | -2.73 score on a scale |
| Cognitive Behavior Therapy | PROMIS-Sleep Disturbance Short Form | -0.16 score on a scale |
p-value: 0.1195% CI: [-5.73, 0.6]Mixed Models Analysis
Secondary
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.
Time frame: Change from baseline to 20 weeks
Population: Intent to Treat Population (all participants assigned to Emotional Awareness and Expression Therapy or Cognitive Behavior Therapy when PTSD symptoms were assessed; groups 3-10)
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Emotional Awareness and Expression Therapy | PTSD Checklist for DSM-5 | -4.07 score on a scale |
| Cognitive Behavior Therapy | PTSD Checklist for DSM-5 | -0.31 score on a scale |
p-value: 0.0795% CI: [-7.83, 0.32]Mixed Models Analysis
Secondary
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.
Time frame: Change from baseline to 10 weeks
Population: Intent to Treat Population (all participants assigned to Emotional Awareness and Expression Therapy or Cognitive Behavior Therapy when PTSD symptoms were assessed; groups 3-10)
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Emotional Awareness and Expression Therapy | PTSD Checklist for DSM-5 | -4.45 score on a scale |
| Cognitive Behavior Therapy | PTSD Checklist for DSM-5 | -0.06 score on a scale |
p-value: 0.0395% CI: [-8.44, -0.34]Mixed Models Analysis
Secondary
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.
Time frame: 10 weeks
Population: Intent to Treat Population (all participants assigned to Emotional Awareness and Expression Therapy or Cognitive Behavior Therapy)
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Emotional Awareness and Expression Therapy | Satisfaction With Therapy and Therapist Scale-Revised (Overall Satisfaction) | 4.30 score on a scale |
| Cognitive Behavior Therapy | Satisfaction With Therapy and Therapist Scale-Revised (Overall Satisfaction) | 4.01 score on a scale |
p-value: <0.00195% CI: [0.12, 0.45]Mixed Models Analysis