Back to resultsvEAET for Older Veterans With Chronic Musculoskeletal Pain Pilot (vEAET)
Primary Purpose
Musculoskeletal Pain
Status
Unknown status
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Emotional Awareness and Expression Therapy
Sponsored by
About this trial
This is an interventional treatment trial for Musculoskeletal Pain focused on measuring Chronic Pain, Psychotherapy, Musculoskeletal Disease, Video Teleconference Delivered Therapy
Eligibility Criteria
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.
Sites / Locations
- VA Greater Los Angeles Healthcare CenterRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Emotional Awareness and Expression Therapy
Arm Description
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.
Outcomes
Primary Outcome Measures
The Satisfaction with Therapy and Therapist Scale-Revised
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.
Credibility/Expectancy Questionnaire
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.
Functional Assessment of Currently Employed Technology Scale (FACETS)
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.
Percent of Group Therapy Sessions Attended
Number of sessions each participant attends divided by 8 sessions (total number of sessions available to attend).
Secondary Outcome Measures
Anger Discomfort Scale
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.
Brief Pain Inventory (BPI)
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.
Coping Strategies Questionnaire (CSQ)
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.
Patient Reported Outcomes Measurement Information System (PROMIS)-Anxiety Short Form 7a
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.
PROMIS-Depression Short Form 8a
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.
PROMIS-Global Health
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.
PROMIS-Pain Interference Short Form 8a
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.
Property Association Task
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.
PANAS Emotion Differentiation
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).
Patient Global Impression of Change (PGIC)
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).
Social Connectedness Scale-Revised
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.
Survey of Pain Attitudes (SOPA)
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.
Test of Self-Conscious Affect 3-Short Version (TOSCA-3)
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.
Full Information
NCT ID
NCT04552860
First Posted
September 2, 2020
Last Updated
September 10, 2020
Sponsor
VA Greater Los Angeles Healthcare System
1. Study Identification
Unique Protocol Identification Number
NCT04552860
Brief Title
vEAET for Older Veterans With Chronic Musculoskeletal Pain Pilot
Acronym
vEAET
Official Title
Video Teleconference (VTC) Emotional Awareness and Expression Therapy (vEAET) for Older Veterans With Chronic Musculoskeletal Pain: An Initial, Uncontrolled Pilot Study
Study Type
Interventional
2. Study Status
Record Verification Date
September 2020
Overall Recruitment Status
Unknown status
Study Start Date
August 15, 2020 (Actual)
Primary Completion Date
June 2021 (Anticipated)
Study Completion Date
September 2021 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
VA Greater Los Angeles Healthcare System
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Musculoskeletal Pain
Keywords
Chronic Pain, Psychotherapy, Musculoskeletal Disease, Video Teleconference Delivered Therapy
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
Video teleconference delivered Emotional Awareness and Expression Therapy
Masking
None (Open Label)
Allocation
N/A
Enrollment
18 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Emotional Awareness and Expression Therapy
Arm Type
Experimental
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Emotional Awareness and Expression Therapy
Other Intervention Name(s)
EAET
Intervention Description
Focus on emotions, writing about stress, assertiveness training, role playing new ways to handle relationships, and sharing feelings and experiences with others.
Primary Outcome Measure Information:
Title
The Satisfaction with Therapy and Therapist Scale-Revised
Description
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.
Time Frame
8-Week Post-treatment
Title
Credibility/Expectancy Questionnaire
Description
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.
Time Frame
Baseline
Title
Functional Assessment of Currently Employed Technology Scale (FACETS)
Description
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.
Time Frame
Change from Baseline, 8-Week Post-treatment, 2-Month Follow Up
Title
Percent of Group Therapy Sessions Attended
Description
Number of sessions each participant attends divided by 8 sessions (total number of sessions available to attend).
Time Frame
8 Weeks
Secondary Outcome Measure Information:
Title
Anger Discomfort Scale
Description
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.
Time Frame
Change from Baseline, 8-Week Post-treatment, 2-Month Follow Up
Title
Brief Pain Inventory (BPI)
Description
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.
Time Frame
Change from Baseline, 8-Week Post-treatment, 2-Month Follow Up
Title
Coping Strategies Questionnaire (CSQ)
Description
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.
Time Frame
Change from Baseline, 8-Week Post-treatment, 2-Month Follow Up
Title
Patient Reported Outcomes Measurement Information System (PROMIS)-Anxiety Short Form 7a
Description
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, 8-Week Post-treatment, 2-Month Follow Up
Title
PROMIS-Depression Short Form 8a
Description
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, 8-Week Post-treatment, 2-Month Follow Up
Title
PROMIS-Global Health
Description
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.
Time Frame
Change from Baseline, 8-Week Post-treatment, 2-Month Follow Up
Title
PROMIS-Pain Interference Short Form 8a
Description
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, 8-Week Post-treatment, 2-Month Follow Up
Title
Property Association Task
Description
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.
Time Frame
Change from Baseline, 8-Week Post-treatment, 2-Month Follow Up
Title
PANAS Emotion Differentiation
Description
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).
Time Frame
Change from Baseline, 8-Week Post-treatment, 2-Month Follow Up
Title
Patient Global Impression of Change (PGIC)
Description
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).
Time Frame
8-Week Post-treatment
Title
Social Connectedness Scale-Revised
Description
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.
Time Frame
Change from Baseline, 8-Week Post-treatment, 2-Month Follow Up
Title
Survey of Pain Attitudes (SOPA)
Description
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, 8-Week Post-treatment, 2-Month Follow Up
Title
Test of Self-Conscious Affect 3-Short Version (TOSCA-3)
Description
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.
Time Frame
Change from Baseline, 8-Week Post-treatment, 2-Month Follow Up
10. Eligibility
Sex
All
Minimum Age & Unit of Time
60 Years
Maximum Age & Unit of Time
95 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Brandon C Yarns, MD, MS
Phone
310.478.3711
Email
brandon.yarns@va.gov
Facility Information:
Facility Name
VA Greater Los Angeles Healthcare Center
City
Los Angeles
State/Province
California
ZIP/Postal Code
90073
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Brandon C Yarns, MD, MS
12. IPD Sharing Statement
Plan to Share IPD
Undecided
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vEAET for Older Veterans With Chronic Musculoskeletal Pain Pilot
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