- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03844880
Emotional Awareness and Expression Therapy (EAET) or Cognitive Behavior Therapy (CBT) for Older Veterans With Chronic Musculoskeletal Pain
September 2, 2020 updated by: VA Greater Los Angeles Healthcare System
Emotional Awareness and Expression Therapy (EAET) or Cognitive Behavior Therapy (CBT) for the Treatment of Chronic Musculoskeletal Pain in Older Veterans: A Pilot Randomized Clinical Trial
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
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
Enrollment (Actual)
64
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
California
-
Los Angeles, California, United States, 90073
- VA Greater Los Angeles Healthcare Center
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
50 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Veteran;
- Age 50 years and older;
- 3 months of musculoskeletal pain including low back pain and other regional pain syndromes (e.g. neck, leg, pelvic pain and temporomandibular joint disorders), whiplash, widespread pain (e.g. fibromyalgia), or tension headaches.
Exclusion Criteria:
- Leg pain greater than back pain (to exclude radiculopathy in isolation);
- Electromyography (EMG)-confirmed "tunnel" syndromes (e.g. carpal or tarsal tunnel syndrome) without any other pain complaints;
- Autoimmune disease that typically generates pain (e.g. systemic lupus erythematosus, rheumatoid arthritis, inflammatory bowel disease, ankylosing spondylitis);
- Confirmed hip or knee osteoarthritis without any other pain complaints;
- Cancer pain, sickle cell disease, neuralgias (e.g. trigeminal neuralgia), burn pain, infection associated with pain (e.g. vertebral infection), cauda equina syndrome, gout as the only pain complaint, migraine or cluster headaches only;
- Uncontrolled severe psychiatric disorder including current psychotic disorder (e.g. schizophrenia or bipolar I disorder not controlled with medications), dissociative identity disorder, or active suicide/violence risk in the past 6 months;
- Moderate to severe cognitive impairment or dementia (Mini-Mental State Exam score ≤ 25);
- Active severe alcohol or substance use disorder that inhibits the participant's ability to attend sessions or participate in homework;
- Currently with pain-related litigation or applying for compensation or compensation increase (e.g. applying for VA service connection or applying for VA service connection increase for pain);
- Unable to fluently read/converse in English;
- Planning to move from the area in the next 6 months.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: 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.
|
Focus on emotions, writing about stress, assertiveness training, role playing new ways to handle relationships, and sharing feelings and experiences with others.
|
Active Comparator: 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.
|
Focus on cognitive and behavioral skills, such as relaxation, increasing pleasant activities, pacing, and changing ways of thinking.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Mean Pain Severity
Time Frame: Change from baseline to 8 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.
|
Change from baseline to 8 weeks
|
Mean Pain Severity
Time Frame: 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.
|
Change from baseline to 20 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Percent of Group Therapy Sessions Attended
Time Frame: 8 weeks
|
Number of sessions each participant attends divided by 8 sessions (total number of sessions available to attend).
|
8 weeks
|
Satisfaction with Therapy and Therapist Scale-Revised
Time Frame: 8 weeks
|
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.
|
8 weeks
|
PROMIS-Pain Behavior Short Form 7a v1.1
Time Frame: Change from baseline to 20 weeks
|
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.
|
Change from baseline to 20 weeks
|
PROMIS-Pain Interference Short Form 8a v1.0
Time Frame: Change from baseline to 8 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.
|
Change from baseline to 8 weeks
|
PROMIS-Pain Interference Short Form 8a v1.0
Time Frame: Change from baseline to 20 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.
|
Change from baseline to 20 weeks
|
PROMIS-Depression Short Form
Time Frame: Change from baseline to 8 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.
|
Change from baseline to 8 weeks
|
PROMIS-Depression Short Form
Time Frame: Change from baseline to 20 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.
|
Change from baseline to 20 weeks
|
PROMIS-Anxiety Short Form
Time Frame: Change from baseline to 8 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.
|
Change from baseline to 8 weeks
|
PROMIS-Anxiety Short Form
Time Frame: Change from baseline to 20 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.
|
Change from baseline to 20 weeks
|
PTSD Symptom Scale
Time Frame: Change from baseline to 8 weeks
|
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.
|
Change from baseline to 8 weeks
|
PTSD Symptom Scale
Time Frame: Change from baseline to 20 weeks
|
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.
|
Change from baseline to 20 weeks
|
NIH Toolbox-Positive Affect Short Form
Time Frame: Change from baseline to 8 weeks
|
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.
|
Change from baseline to 8 weeks
|
NIH Toolbox-Positive Affect Short Form
Time Frame: Change from baseline to 20 weeks
|
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.
|
Change from baseline to 20 weeks
|
NIH Toolbox-Purpose and Meaning Short Form
Time Frame: Change from baseline to 8 weeks
|
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.
|
Change from baseline to 8 weeks
|
NIH Toolbox-Purpose and Meaning Short Form
Time Frame: Change from baseline to 20 weeks
|
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.
|
Change from baseline to 20 weeks
|
NIH Toolbox-Life Satisfaction Short Form
Time Frame: Change from baseline to 8 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.
|
Change from baseline to 8 weeks
|
NIH Toolbox-Life Satisfaction Short Form
Time Frame: Change from baseline to 20 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.
|
Change from baseline to 20 weeks
|
PROMIS-Sleep Disturbance Short Form
Time Frame: Change from baseline to 8 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.
|
Change from baseline to 8 weeks
|
PROMIS-Sleep Disturbance Short Form
Time Frame: Change from baseline to 20 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.
|
Change from baseline to 20 weeks
|
PROMIS-Fatigue Short Form
Time Frame: Change from baseline to 8 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.
|
Change from baseline to 8 weeks
|
PROMIS-Fatigue Short Form
Time Frame: Change from baseline to 20 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.
|
Change from baseline to 20 weeks
|
Ambivalence over Emotional Expression Questionnaire
Time Frame: Change from baseline to 8 weeks
|
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.
|
Change from baseline to 8 weeks
|
Ambivalence over Emotional Expression Questionnaire
Time Frame: Change from baseline to 20 weeks
|
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.
|
Change from baseline to 20 weeks
|
Emotional Approach Coping Scales
Time Frame: Change from baseline to 8 weeks
|
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.
|
Change from baseline to 8 weeks
|
Emotional Approach Coping Scales
Time Frame: Change from baseline to 20 weeks
|
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.
|
Change from baseline to 20 weeks
|
Pain Catastrophizing Scale
Time Frame: Change from baseline to 8 weeks
|
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.
|
Change from baseline to 8 weeks
|
Pain Catastrophizing Scale
Time Frame: Change from baseline to 20 weeks
|
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.
|
Change from baseline to 20 weeks
|
Survey of Pain Attitudes
Time Frame: Change from baseline to 8 weeks
|
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.
|
Change from baseline to 8 weeks
|
Patient Reported Outcomes Measurement Information System (PROMIS)-Pain Behavior Short Form 7a v1.1
Time Frame: Change from baseline to 8 weeks
|
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.
|
Change from baseline to 8 weeks
|
Multidimensional Inventory of Subjective Cognitive Impairment
Time Frame: Change from baseline to 8 weeks
|
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.
|
Change from baseline to 8 weeks
|
Multidimensional Inventory of Subjective Cognitive Impairment
Time Frame: Change from baseline to 20 weeks
|
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.
|
Change from baseline to 20 weeks
|
Survey of Pain Attitudes
Time Frame: Change from baseline to 20 weeks
|
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.
|
Change from baseline to 20 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
October 19, 2017
Primary Completion (Actual)
August 28, 2019
Study Completion (Actual)
August 28, 2019
Study Registration Dates
First Submitted
December 19, 2018
First Submitted That Met QC Criteria
February 13, 2019
First Posted (Actual)
February 19, 2019
Study Record Updates
Last Update Posted (Actual)
September 7, 2020
Last Update Submitted That Met QC Criteria
September 2, 2020
Last Verified
September 1, 2020
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 0001 (Cancer Research Institute)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
UNDECIDED
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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