Emotional Awareness and Expression Therapy (EAET) or Cognitive Behavior Therapy (CBT) for Older Veterans With Chronic Musculoskeletal Pain

NCT03844880 | Completed

• 1 other identifier: 0001
• Study Type: interventional
• Target: 64
• Locations: 1 country
• Sites: 1

Brief Summary

A randomized clinical trial for Veterans age 50 years and older with chronic musculoskeletal pain in which Emotional Awareness and Expression Therapy (EAET) is compared against Cognitive Behavior Therapy (CBT) to evaluate acceptability, feasibility, and efficacy of the two treatments on pain and other outcomes, as well as potential mediators of treatment response.

Conditions

Musculoskeletal Pain

Keywords

Chronic Pain; Psychotherapy; Musculoskeletal Disease

Outcome Measures

Primary Outcomes (2)

• Mean Pain Severity

  Average of 4 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.

  Change from baseline to 8 weeks

• Mean Pain Severity

  Average of 4 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.

  Change from baseline to 20 weeks

Secondary Outcomes (32)

• Percent of Group Therapy Sessions Attended

  8 weeks

• Satisfaction with Therapy and Therapist Scale-Revised

  8 weeks

• Patient Reported Outcomes Measurement Information System (PROMIS)-Pain Behavior Short Form 7a v1.1

  Change from baseline to 8 weeks

• PROMIS-Pain Behavior Short Form 7a v1.1

  Change from baseline to 20 weeks

• PROMIS-Pain Interference Short Form 8a v1.0

  Change from baseline to 8 weeks

Study Arms (2)

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

Cognitive Behavior Therapy

ACTIVE COMPARATOR

Seeks to help individuals function better and improve symptoms by teaching various cognitive and behavioral skills to manage symptoms. It will use techniques such as relaxation training, engaging in pleasant activities, pacing yourself, and changing unhelpful ways of thinking.

Behavioral: Cognitive Behavior 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.

Emotional Awareness and Expression Therapy

Cognitive Behavior Therapy BEHAVIORAL

Focus on cognitive and behavioral skills, such as relaxation, increasing pleasant activities, pacing, and changing ways of thinking.

Cognitive Behavior Therapy

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Veteran;
• Age 50 years and older;
• months of musculoskeletal pain including low back pain and other regional pain syndromes (e.g. neck, leg, pelvic pain and temporomandibular joint disorders), whiplash, widespread pain (e.g. fibromyalgia), or tension headaches.

You may not qualify if:

• Leg pain greater than back pain (to exclude radiculopathy in isolation);
• Electromyography (EMG)-confirmed "tunnel" syndromes (e.g. carpal or tarsal tunnel syndrome) without any other pain complaints;
• Autoimmune disease that typically generates pain (e.g. systemic lupus erythematosus, rheumatoid arthritis, inflammatory bowel disease, ankylosing spondylitis);
• Confirmed hip or knee osteoarthritis without any other pain complaints;
• Cancer pain, sickle cell disease, neuralgias (e.g. trigeminal neuralgia), burn pain, infection associated with pain (e.g. vertebral infection), cauda equina syndrome, gout as the only pain complaint, migraine or cluster headaches only;
• Uncontrolled severe psychiatric disorder including current psychotic disorder (e.g. schizophrenia or bipolar I disorder not controlled with medications), dissociative identity disorder, or active suicide/violence risk in the past 6 months;
• Moderate to severe cognitive impairment or dementia (Mini-Mental State Exam score ≤ 25);
• Active severe alcohol or substance use disorder that inhibits the participant's ability to attend sessions or participate in homework;
• Currently with pain-related litigation or applying for compensation or compensation increase (e.g. applying for VA service connection or applying for VA service connection increase for pain);
• Unable to fluently read/converse in English;
• Planning to move from the area in the next 6 months.

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

Interventions

Cognitive Behavioral Therapy

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities

Study Design

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

Study Record Dates

• First Submitted: December 19, 2018
• First Posted: February 19, 2019
• Study Start: October 19, 2017
• Primary Completion: August 28, 2019
• Study Completion: August 28, 2019
• Last Updated: September 7, 2020

Record last verified: 2020-09

Locations

US (1)