- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04552860
vEAET for Older Veterans With Chronic Musculoskeletal Pain Pilot (vEAET)
April 23, 2024 updated by: VA Greater Los Angeles Healthcare System
Video Teleconference (VTC) Emotional Awareness and Expression Therapy (vEAET) for Older Veterans With Chronic Musculoskeletal Pain: An Initial, Uncontrolled Pilot Study
An uncontrolled pilot in which Veterans age 60-95 years with chronic musculoskeletal (MSK) pain will undergo Emotional Awareness and Expression Therapy (EAET) delivered over video teleconference (VTC; together vEAET).
This study aims to obtain early implementation outcomes, as well as evaluate efficacy and estimated effect sizes.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
For this pilot, vEAET will be provided to outpatient Veterans age 60-95 years with chronic MSK pain in order to obtain early implementation and clinical outcomes (i.e.
acceptability, feasibility, appropriateness, fidelity, and effectiveness).
Each Veteran will be provided a VTC capable tablet and technological support from a research coordinator as a strategy to overcome technology based obstacles and obtain feasibility data.
Veterans will receive one 90-minute individual session of vEAET plus eight 90-minute weekly group sessions of vEAET, all delivered over VTC to their homes.
Assessments will be performed at baseline, posttreatment, and 2-month follow-up remotely using OutcomeMD (Los Angeles, CA), a HIPAA-compliant, VA-approved web-based platform.
The entire study will be performed without any in-person visits.
Study Type
Interventional
Enrollment (Actual)
16
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
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California
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Los Angeles, California, United States, 90073
- VA Greater Los Angeles Healthcare Center
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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
58 years to 93 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
• Eligible Veterans are age 60-95 years old and have had at least 3 months of musculoskeletal pain, including the following conditions most likely to benefit from psychotherapy based on previous research: low back, neck, leg, or pelvic pain; temporomandibular joint disorders; fibromyalgia; tension headaches; or any combination of these disorders.
Exclusion Criteria:
- Musculoskeletal conditions likely to respond surgical or pharmacologic treatment: hip or knee osteoarthritis, leg pain greater than back pain (to exclude radiculopathy), electromyography-confirmed "tunnel" syndrome (e.g., carpal tunnel syndrome), gout, neuralgias, migraine, and cluster headaches;
- Non-musculoskeletal pain conditions: autoimmune disease that typically generates pain (e.g., rheumatoid arthritis), cancer pain, sickle cell disease, burn pain, infection associated with pain, and cauda equina syndrome;
- The following conditions or circumstances: severe psychiatric disorder such as schizophrenia or bipolar I disorder not controlled with medications, active suicide or violence risk, active severe alcohol or substance use disorder, substantial cognitive impairment based on chart review, previously completed EAET, currently enrolled in another psychological treatment for chronic pain, currently in pain-related litigation or applying for pain-related compensation or compensation increase (e.g., VA service connection for chronic pain), unable to fluently read or converse in English, no internet access.
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: N/A
- Interventional Model: Single Group 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.
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Focus on emotions, writing about stress, assertiveness training, role playing new ways to handle relationships, and sharing feelings and experiences with others.
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
The Satisfaction with Therapy and Therapist Scale-Revised
Time Frame: 8-Week Post-treatment
|
Satisfaction with therapy subscale is the summation of six 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 six 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.
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8-Week Post-treatment
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Credibility/Expectancy Questionnaire
Time Frame: Baseline
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Logical Credibility/Expectancy subscale is the average of four self report items, three of which are scored 1-9 (1 = not at all logical; 9 = very logical).
A fourth Logical Credibility/Expectancy item reflects the percentage of functioning improvement participants think will occur.
Feeling Credibility/Expectancy subscale is the average of four self report items, three of which are scored 1-9 (1 = not at all logical; 9 = very logical).
A fourth Feeling Credibility/Expectancy item reflects the percentage of functioning improvement participants feel will occur.
The two subscales are each reported separately.
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Baseline
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Functional Assessment of Currently Employed Technology Scale (FACETS)
Time Frame: Change from Baseline, 8-Week Post-treatment, 2-Month Follow Up
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The summation of ten items related to ease of use of technology, each scored 1-6 (1 = never use a technology; 5 = easy/regular use of a technology), yielding a total score between 10 and 60.
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Change from Baseline, 8-Week Post-treatment, 2-Month Follow Up
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Percent of Group Therapy Sessions Attended
Time Frame: 8 Weeks
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Number of sessions each participant attends divided by 8 sessions (total number of sessions available to attend).
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8 Weeks
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Anger Discomfort Scale
Time Frame: Change from Baseline, 8-Week Post-treatment, 2-Month Follow Up
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The summation of fifteen items related to Anger Discomfort, each scored 1-4 (1 = almost never; 5 = almost always), yielding a total score between 15 and 60.
Three items are inverted scores.
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Change from Baseline, 8-Week Post-treatment, 2-Month Follow Up
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Brief Pain Inventory (BPI)
Time Frame: Change from Baseline, 8-Week Post-treatment, 2-Month Follow Up
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Average of four 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.
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Change from Baseline, 8-Week Post-treatment, 2-Month Follow Up
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Coping Strategies Questionnaire (CSQ)
Time Frame: Change from Baseline, 8-Week Post-treatment, 2-Month Follow Up
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The summation of fourteen items related to Coping Strategies, each scored 0-6 (0 = never do; 6 = always do), yielding a total score between 0 and 84.
Two items are inverted scores.
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Change from Baseline, 8-Week Post-treatment, 2-Month Follow Up
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Patient Reported Outcomes Measurement Information System (PROMIS)-Anxiety Short Form 7a
Time Frame: Change from Baseline, 8-Week Post-treatment, 2-Month Follow Up
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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.
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Change from Baseline, 8-Week Post-treatment, 2-Month Follow Up
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PROMIS-Depression Short Form 8a
Time Frame: Change from Baseline, 8-Week Post-treatment, 2-Month Follow Up
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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.
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Change from Baseline, 8-Week Post-treatment, 2-Month Follow Up
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PROMIS-Global Health
Time Frame: Change from Baseline, 8-Week Post-treatment, 2-Month Follow Up
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Global Physical health subscale is the summation of two items, each scored 1-5 (1 = excellent; 5 = poor), yielding a total score between 2 and 10.
Global Mental health subscale is the summation of two items, each scored 1-5 (1 = excellent; 5 = poor), yielding a total score between 2 and 10.
Health Perception & Social Roles subscale is the summation of two items, each scored 1-5 (1 = excellent; 5 = poor), yielding a total score between 2 and 10.
The three subscales are each reported separately.
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Change from Baseline, 8-Week Post-treatment, 2-Month Follow Up
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PROMIS-Pain Interference Short Form 8a
Time Frame: Change from Baseline, 8-Week Post-treatment, 2-Month Follow Up
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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.
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Change from Baseline, 8-Week Post-treatment, 2-Month Follow Up
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Property Association Task
Time Frame: Change from Baseline, 8-Week Post-treatment, 2-Month Follow Up
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One-hundred-thirty property-emotion pairs (e.g.
frown-sadness) are assessed for the level of association between them on a scale of 0-6 (0 = not at all; 6 = extremely).
Each pair represents a way of associating emotions to either interoception, behaviors, or situations (40 pairs each; 10 false pairs as controls).
The three different association scores are summed up independently on a scale between 0 and 240.
Answer reaction times are also collected.
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Change from Baseline, 8-Week Post-treatment, 2-Month Follow Up
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PANAS Emotion Differentiation
Time Frame: Change from Baseline, 8-Week Post-treatment, 2-Month Follow Up
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The average of five self-report items assessing how much they current experience a certain emotional state.
Items range from 0-100 (0 = Very slightly or not at all; 100 = Extremely).
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Change from Baseline, 8-Week Post-treatment, 2-Month Follow Up
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Patient Global Impression of Change (PGIC)
Time Frame: 8-Week Post-treatment
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A single self report item assessing the Patient Global Impression of Change as a result of treatment.
Items range from 1-7 (1 = No change (or condition has gotten worse); 7 = A great deal better and a considerable improvement that has made all the difference).
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8-Week Post-treatment
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Social Connectedness Scale-Revised
Time Frame: Change from Baseline, 8-Week Post-treatment, 2-Month Follow Up
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Sum of eight self-report items assessing feelings of Social Connectedness.
Items range from 1-6 (1 = strongly agree/low connectedness; 5 = strongly disagree/high connectedness), yielding a total score between 8 and 48.
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Change from Baseline, 8-Week Post-treatment, 2-Month Follow Up
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Survey of Pain Attitudes (SOPA)
Time Frame: Change from Baseline, 8-Week Post-treatment, 2-Month Follow Up
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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.
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Change from Baseline, 8-Week Post-treatment, 2-Month Follow Up
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Test of Self-Conscious Affect 3-Short Version (TOSCA-3)
Time Frame: Change from Baseline, 8-Week Post-treatment, 2-Month Follow Up
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Forty-four self report items assess the likelihood of orientation towards feeling shame, detachment, guilt and externalization as reactions to eleven different scenarios.
Items range from 1-5 (1 = not likely/low likelihood of reaction style; 5 = very likely/high likelihood of reaction style) and the four different reaction style scores are summed up independently on a scale between 11 and 55.
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Change from Baseline, 8-Week Post-treatment, 2-Month Follow Up
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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)
August 15, 2020
Primary Completion (Actual)
August 16, 2021
Study Completion (Actual)
August 16, 2021
Study Registration Dates
First Submitted
September 2, 2020
First Submitted That Met QC Criteria
September 10, 2020
First Posted (Actual)
September 17, 2020
Study Record Updates
Last Update Posted (Actual)
April 26, 2024
Last Update Submitted That Met QC Criteria
April 23, 2024
Last Verified
April 1, 2024
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2020-000142
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
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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