vEAET for Older Veterans With Chronic Musculoskeletal Pain Pilot

NCT04552860 | Completed

• 1 other identifier: 2020-000142
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

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.

Conditions

Musculoskeletal Pain

Keywords

Chronic Pain; Psychotherapy; Musculoskeletal Disease; Video Teleconference Delivered Therapy

Outcome Measures

Primary Outcomes (4)

• 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.

  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.

  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.

  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).

  8 Weeks

Secondary Outcomes (13)

• Anger Discomfort Scale

  Change from Baseline, 8-Week Post-treatment, 2-Month Follow Up

• Brief Pain Inventory (BPI)

  Change from Baseline, 8-Week Post-treatment, 2-Month Follow Up

• Coping Strategies Questionnaire (CSQ)

  Change from Baseline, 8-Week Post-treatment, 2-Month Follow Up

• Patient Reported Outcomes Measurement Information System (PROMIS)-Anxiety Short Form 7a

  Change from Baseline, 8-Week Post-treatment, 2-Month Follow Up

• PROMIS-Depression Short Form 8a

  Change from Baseline, 8-Week Post-treatment, 2-Month Follow Up

Study Arms (1)

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.

Behavioral: Emotional Awareness and Expression Therapy

Interventions

Emotional Awareness and Expression Therapy BEHAVIORAL

Focus on emotions, writing about stress, assertiveness training, role playing new ways to handle relationships, and sharing feelings and experiences with others.

Also known as: EAET

Emotional Awareness and Expression Therapy

Eligibility Criteria

• Age: 60 Years - 95 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• VA Greater Los Angeles Healthcare System: lead

Study Sites (1)

VA Greater Los Angeles Healthcare Center

Los Angeles, California, 90073, United States

Location

MeSH Terms

Conditions

Musculoskeletal Pain; Chronic Pain; Musculoskeletal Diseases

Condition Hierarchy (Ancestors)

Muscular Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: FED
• Responsible Party: SPONSOR

Model Details: Video teleconference delivered Emotional Awareness and Expression Therapy

Study Record Dates

• First Submitted: September 2, 2020
• First Posted: September 17, 2020
• Study Start: August 15, 2020
• Primary Completion: August 16, 2021
• Study Completion: August 16, 2021
• Last Updated: April 26, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)