Musculoskeletal PainvEAETNCT04552860
vEAET for Older Veterans With Chronic Musculoskeletal Pain Pilot
A study testing Emotional Awareness and Expression Therapy in people with Musculoskeletal Pain, run by VA Greater Los Angeles Healthcare System at 1 site in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 60 to 95 years
- Conditions the study is for
- Musculoskeletal Pain
- What is being tested?
- Emotional Awareness and Expression Therapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Aug 2020to 16 Aug 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 to 95 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
VA Greater Los Angeles Healthcare Center
Los Angeles, California, 90073
About this study
Official title: 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.
Read the 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.
- Conditions
- Musculoskeletal Pain
- Being tested
- Emotional Awareness and Expression Therapy
- Keywords
- Chronic Pain, Psychotherapy, Musculoskeletal Disease, Video Teleconference Delivered Therapy
- Medical subject headings
- Musculoskeletal Pain, Chronic Pain, Musculoskeletal Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Emotional Awareness and Expression TherapyBehavioural
Also called EAET
Focus on emotions, writing about stress, assertiveness training, role playing new ways to handle relationships, and sharing feelings and experiences with others.
| Study group | Role | What they receive |
|---|---|---|
| Emotional Awareness and Expression Therapy | Experimental | 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. Receives: Behavioral: Emotional Awareness and Expression Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 8-Week Post-treatment
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.
Measured: Baseline
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.
Measured: Change from Baseline, 8-Week Post-treatment, 2-Month Follow Up
Percent of Group Therapy Sessions Attended
Number of sessions each participant attends divided by 8 sessions (total number of sessions available to attend).
Measured: 8 Weeks
Secondary outcomes (13)
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.
Measured: Change from Baseline, 8-Week Post-treatment, 2-Month Follow Up
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.
Measured: Change from Baseline, 8-Week Post-treatment, 2-Month Follow Up
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.
Measured: Change from Baseline, 8-Week Post-treatment, 2-Month Follow Up
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.
Measured: Change from Baseline, 8-Week Post-treatment, 2-Month Follow Up
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.
Measured: Change from Baseline, 8-Week Post-treatment, 2-Month Follow Up
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.
Measured: Change from Baseline, 8-Week Post-treatment, 2-Month Follow Up
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.
Measured: Change from Baseline, 8-Week Post-treatment, 2-Month Follow Up
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.
Measured: Change from Baseline, 8-Week Post-treatment, 2-Month Follow Up
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).
Measured: Change from Baseline, 8-Week Post-treatment, 2-Month Follow Up
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).
Measured: 8-Week Post-treatment
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.
Measured: Change from Baseline, 8-Week Post-treatment, 2-Month Follow Up
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.
Measured: Change from Baseline, 8-Week Post-treatment, 2-Month Follow Up
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.
Measured: Change from Baseline, 8-Week Post-treatment, 2-Month Follow Up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Sep 2020
- Study start15 Aug 2020
- Primary completion16 Aug 2021
- Study completion16 Aug 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Musculoskeletal PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Video teleconference delivered Emotional Awareness and Expression Therapy
- Masking
- None (open label)
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- VA Greater Los Angeles Healthcare System
- Sponsor type
- US federal agency
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04552860
- Sponsor's protocol ID
- 2020-000142
- Acronym
- vEAET
- Status last verified
- Apr 2024
- First submitted
- 2 Sep 2020
- Last updated
- 26 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Video Teleconference (VTC) Emotional Awareness and Expression Therapy (vEAET) for Older Veterans With Chronic Musculoskeletal Pain: An Initial, Uncontrolled Pilot Study
- ClinicalTrials.gov ID
- NCT04552860
- Acronym / sponsor ID
- vEAET / 2020-000142
- Conditions
- Musculoskeletal Pain
- Keywords
- Chronic Pain, Psychotherapy, Musculoskeletal Disease, Video Teleconference Delivered Therapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- VA Greater Los Angeles Healthcare SystemUS federal agency
- Study start
- 15 Aug 2020 (actual)
- Primary completion
- 16 Aug 2021 (actual)
- Study completion
- 16 Aug 2021 (actual)
- First posted
- 17 Sep 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Video teleconference delivered Emotional Awareness and Expression Therapy
| Arm | Type | Receives |
|---|---|---|
| Emotional Awareness and Expression Therapy | Experimental | Behavioral: Emotional Awareness and Expression TherapySeeks 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. |
Who may qualify
- Ages
- 60 to 95 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Emotional Awareness and Expression TherapyAlso: EAETFocus on emotions, writing about stress, assertiveness training, role playing new ways to handle relationships, and sharing feelings and experiences with others. | Behavioural | Emotional Awareness and Expression Therapy |
Primary outcome
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.
Credibility/Expectancy Questionnaire
Time frame: Baseline
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)
Time frame: Change from Baseline, 8-Week Post-treatment, 2-Month Follow Up
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
Time frame: 8 Weeks
Number of sessions each participant attends divided by 8 sessions (total number of sessions available to attend).
13 secondary outcomes
Anger Discomfort Scale
Time frame: Change from Baseline, 8-Week Post-treatment, 2-Month Follow Up
Brief Pain Inventory (BPI)
Time frame: Change from Baseline, 8-Week Post-treatment, 2-Month Follow Up
Coping Strategies Questionnaire (CSQ)
Time frame: Change from Baseline, 8-Week Post-treatment, 2-Month Follow Up
Patient Reported Outcomes Measurement Information System (PROMIS)-Anxiety Short Form 7a
Time frame: Change from Baseline, 8-Week Post-treatment, 2-Month Follow Up
PROMIS-Depression Short Form 8a
Time frame: Change from Baseline, 8-Week Post-treatment, 2-Month Follow Up
PROMIS-Global Health
Time frame: Change from Baseline, 8-Week Post-treatment, 2-Month Follow Up
PROMIS-Pain Interference Short Form 8a
Time frame: Change from Baseline, 8-Week Post-treatment, 2-Month Follow Up
Property Association Task
Time frame: Change from Baseline, 8-Week Post-treatment, 2-Month Follow Up
PANAS Emotion Differentiation
Time frame: Change from Baseline, 8-Week Post-treatment, 2-Month Follow Up
Patient Global Impression of Change (PGIC)
Time frame: 8-Week Post-treatment
Social Connectedness Scale-Revised
Time frame: Change from Baseline, 8-Week Post-treatment, 2-Month Follow Up
Survey of Pain Attitudes (SOPA)
Time frame: Change from Baseline, 8-Week Post-treatment, 2-Month Follow Up
Test of Self-Conscious Affect 3-Short Version (TOSCA-3)
Time frame: Change from Baseline, 8-Week Post-treatment, 2-Month Follow Up
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Apr 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Emotional Awareness and Expression Therapy in people with Musculoskeletal Pain, run by VA Greater Los Angeles Healthcare System at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The Satisfaction with Therapy and Therapist Scale-Revised (time frame: 8-Week Post-treatment). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Apr 2024.