A randomized clinical trial for Veterans age 50 years and older with chronic musculoskeletal pain in which Emotional Awareness and Expression Therapy (EAET) is compared against Cognitive Behavior Therapy (CBT) to evaluate acceptability, feasibility, and efficacy of the two treatments on pain and other outcomes, as well as potential mediators of treatment response.
Outpatient Veterans age 50 years and older at the West Los Angeles VA Medical Center who have chronic musculoskeletal pain complete baseline questionnaires and are randomized into one of two forms of psychotherapy: Emotional Awareness and Expression Therapy (EAET), which helps patients make connections between avoided or conflicted emotions and pain, or Cognitive Behavior Therapy (CBT), which teaches pain coping skills. Each treatment is delivered by an experienced therapist and includes one 90-minute individual session and eight 90-minute group sessions (in small groups of 8 Veterans). Patients in both conditions complete post-treatment and 3-month follow-up questionnaires. Outcomes of each type of psychotherapy are compared and mediators of treatment response are evaluated.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
64
Focus on emotions, writing about stress, assertiveness training, role playing new ways to handle relationships, and sharing feelings and experiences with others.
Focus on cognitive and behavioral skills, such as relaxation, increasing pleasant activities, pacing, and changing ways of thinking.
VA Greater Los Angeles Healthcare Center
Los Angeles, California, United States
Mean 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.
Time frame: Change from baseline to 8 weeks
Mean 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.
Time frame: Change from baseline to 20 weeks
Percent of Group Therapy Sessions Attended
Number of sessions each participant attends divided by 8 sessions (total number of sessions available to attend).
Time frame: 8 weeks
Satisfaction with Therapy and Therapist Scale-Revised
Satisfaction with therapy subscale is the summation of 6 items, each scored 1-5 (1 = maximum dissatisfaction; 5 = maximum satisfaction), yielding a total score between 6 and 30. Satisfaction with therapist subscale is the summation of 6 items, each scored 1-5 (1 = maximum dissatisfaction; 5 = maximum satisfaction), yielding a total score between 6 and 30. Overall satisfaction is an additional single item scored 1-5 (1 = maximum dissatisfaction; 5 = maximum satisfaction). The two subscales and the overall satisfaction item are each reported separately.
Time frame: 8 weeks
Patient Reported Outcomes Measurement Information System (PROMIS)-Pain Behavior Short Form 7a v1.1
Sum of seven self-report items assessing behaviors associated with pain over the past 7 days. Items range from 1-6 (1 = had no pain; 6 = always), yielding a total score between 7 and 42.
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Time frame: Change from baseline to 8 weeks
PROMIS-Pain Behavior Short Form 7a v1.1
Sum of seven self-report items assessing behaviors associated with pain over the past 7 days. Items range from 1-6 (1 = had no pain; 6 = always), yielding a total score between 7 and 42.
Time frame: Change from baseline to 20 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.
Time frame: Change from baseline to 8 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.
Time frame: 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.
Time frame: Change from baseline to 8 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.
Time frame: 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.
Time frame: Change from baseline to 8 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.
Time frame: Change from baseline to 20 weeks
PTSD Symptom Scale
Sum of seventeen self-report items assessing PTSD according to the frequency in which symptoms are experienced over the last two weeks. Items range from 0-3 (0 = not experiencing a symptom; 1 = once per week or less / a little bit / once in a while; 2 = 2 to 4 times per week / somewhat / half the time; 3 = 3 to 5 or more times per week / very much / almost always), yielding a total score between 0 and 51.
Time frame: Change from baseline to 8 weeks
PTSD Symptom Scale
Sum of seventeen self-report items assessing PTSD according to the frequency in which symptoms are experienced over the last two weeks. Items range from 0-3 (0 = not experiencing a symptom; 1 = once per week or less / a little bit / once in a while; 2 = 2 to 4 times per week / somewhat / half the time; 3 = 3 to 5 or more times per week / very much / almost always), yielding a total score between 0 and 51.
Time frame: Change from baseline to 20 weeks
NIH Toolbox-Positive Affect Short Form
Sum of fifteen self-report items assessing positive affect over the past 7 days. Items range from 1-5 (1 = not at all experiencing a type of positive emotion; 5 = very much feeling that emotion), yielding a total score between 15 and 75.
Time frame: Change from baseline to 8 weeks
NIH Toolbox-Positive Affect Short Form
Sum of fifteen self-report items assessing positive affect over the past 7 days. Items range from 1-5 (1 = not at all experiencing a type of positive emotion; 5 = very much feeling that emotion), yielding a total score between 15 and 75.
Time frame: Change from baseline to 20 weeks
NIH Toolbox-Purpose and Meaning Short Form
Sum of seven self-report items assessing general feelings of meaning and purpose. Items range from 1-5 (1 = no purpose and meaning; 5 = maximum purpose and meaning), yielding a total score between 7 and 35.
Time frame: Change from baseline to 8 weeks
NIH Toolbox-Purpose and Meaning Short Form
Sum of seven self-report items assessing general feelings of meaning and purpose. Items range from 1-5 (1 = no purpose and meaning; 5 = maximum purpose and meaning), yielding a total score between 7 and 35.
Time frame: 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.
Time frame: Change from baseline to 8 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.
Time frame: 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.
Time frame: Change from baseline to 8 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.
Time frame: 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.
Time frame: Change from baseline to 8 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.
Time frame: Change from baseline to 20 weeks
Multidimensional Inventory of Subjective Cognitive Impairment
Sum of ten self-report items assessing subjective cognitive impairment over the past 7 days. Items range from 1-5 (1 = no impairment; 5 = maximum impairment), yielding a total score between 10 and 50.
Time frame: Change from baseline to 8 weeks
Multidimensional Inventory of Subjective Cognitive Impairment
Sum of ten self-report items assessing subjective cognitive impairment over the past 7 days. Items range from 1-5 (1 = no impairment; 5 = maximum impairment), yielding a total score between 10 and 50.
Time frame: Change from baseline to 20 weeks
Ambivalence over Emotional Expression Questionnaire
Sum of fourteen self-report items assessing ambivalence of emotional expression. Items range from 1-5 (1 = no ambivalence; 5 = maximum ambivalence), yielding a total score between 14 and 70.
Time frame: Change from baseline to 8 weeks
Ambivalence over Emotional Expression Questionnaire
Sum of fourteen self-report items assessing ambivalence of emotional expression. Items range from 1-5 (1 = no ambivalence; 5 = maximum ambivalence), yielding a total score between 14 and 70.
Time frame: Change from baseline to 20 weeks
Emotional Approach Coping Scales
Sum of eight self-report items assessing whether the subject uses an emotional approach to coping when experiencing stress or difficulties. Items range from 1-4 (1 = I don't use this emotional coping strategy; 4 = I use this emotional coping strategy a lot), yielding a total score between 8 and 32.
Time frame: Change from baseline to 8 weeks
Emotional Approach Coping Scales
Sum of eight self-report items assessing whether the subject uses an emotional approach to coping when experiencing stress or difficulties. Items range from 1-4 (1 = I don't use this emotional coping strategy; 4 = I use this emotional coping strategy a lot), yielding a total score between 8 and 32.
Time frame: Change from baseline to 20 weeks
Pain Catastrophizing Scale
Sum of thirteen self-report items assessing the types of thoughts and feelings experienced with pain. Items range from 0-4 (0 = not experiencing a type of thought / feeling; 5 = experiencing that thought / feeling all the time), yielding a total score between 0 and 52. Higher scores indicate the subject experiences thoughts and emotions that typically catastrophizes their pain.
Time frame: Change from baseline to 8 weeks
Pain Catastrophizing Scale
Sum of thirteen self-report items assessing the types of thoughts and feelings experienced with pain. Items range from 0-4 (0 = not experiencing a type of thought / feeling; 5 = experiencing that thought / feeling all the time), yielding a total score between 0 and 52. Higher scores indicate the subject experiences thoughts and emotions that typically catastrophizes their pain.
Time frame: Change from baseline to 20 weeks
Survey of Pain Attitudes
Sum of fourteen self-report items assessing the subject's attitude towards their pain. Items range from 0-4 (0 = this attitude is very untrue for me; 4 = this attitude is very true for me), yielding a total score between 0 and 56.
Time frame: Change from baseline to 8 weeks
Survey of Pain Attitudes
Sum of fourteen self-report items assessing the subject's attitude towards their pain. Items range from 0-4, yielding a total score between 0 and 56.
Time frame: Change from baseline to 20 weeks