Clinical trial NCT04552860: vEAET for Older Veterans With Chronic Musculoskeletal Pain Pilot
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
Overall status: COMPLETED
Phase: NA
Conditions: Musculoskeletal Pain
Keywords: Chronic Pain
Psychotherapy
Musculoskeletal Disease
Video Teleconference Delivered Therapy
Lead sponsor: VA Greater Los Angeles Healthcare System
Sponsor class: FED
First posted: 2020-09-17
Enrollment: 16
Sex: ALL
Minimum age (years): 60
Maximum age (years): 95
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Video teleconference delivered Emotional Awareness and Expression Therapy
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: The Satisfaction with Therapy and Therapist Scale-Revised
timeFrame: 8-Week Post-treatment
measure: Credibility/Expectancy Questionnaire
timeFrame: Baseline
measure: Functional Assessment of Currently Employed Technology Scale (FACETS)
timeFrame: Change from Baseline, 8-Week Post-treatment, 2-Month Follow Up
measure: Percent of Group Therapy Sessions Attended
timeFrame: 8 Weeks
Secondary outcomes:
measure: Anger Discomfort Scale
timeFrame: Change from Baseline, 8-Week Post-treatment, 2-Month Follow Up
measure: Brief Pain Inventory (BPI)
timeFrame: Change from Baseline, 8-Week Post-treatment, 2-Month Follow Up
measure: Coping Strategies Questionnaire (CSQ)
timeFrame: Change from Baseline, 8-Week Post-treatment, 2-Month Follow Up
measure: Patient Reported Outcomes Measurement Information System (PROMIS)-Anxiety Short Form 7a
timeFrame: Change from Baseline, 8-Week Post-treatment, 2-Month Follow Up
measure: PROMIS-Depression Short Form 8a
timeFrame: Change from Baseline, 8-Week Post-treatment, 2-Month Follow Up
measure: PROMIS-Global Health
timeFrame: Change from Baseline, 8-Week Post-treatment, 2-Month Follow Up
measure: PROMIS-Pain Interference Short Form 8a
timeFrame: Change from Baseline, 8-Week Post-treatment, 2-Month Follow Up
measure: Property Association Task
timeFrame: Change from Baseline, 8-Week Post-treatment, 2-Month Follow Up
measure: PANAS Emotion Differentiation
timeFrame: Change from Baseline, 8-Week Post-treatment, 2-Month Follow Up
measure: Patient Global Impression of Change (PGIC)
timeFrame: 8-Week Post-treatment
measure: Social Connectedness Scale-Revised
timeFrame: Change from Baseline, 8-Week Post-treatment, 2-Month Follow Up
measure: Survey of Pain Attitudes (SOPA)
timeFrame: Change from Baseline, 8-Week Post-treatment, 2-Month Follow Up
measure: Test of Self-Conscious Affect 3-Short Version (TOSCA-3)
timeFrame: Change from Baseline, 8-Week Post-treatment, 2-Month Follow Up
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: VA Greater Los Angeles Healthcare Center
state: California
Study officials:
References: