Optimizing Psychotherapy for Older Veterans With Chronic Pain

NCT03918642 | Completed Results DMC

• 2 other identifiers: NURA-013-18F1K2CX001884-01A1
• Study Type: interventional
• Target: 126
• Locations: 1 country
• Sites: 1

Brief Summary

This study is being performed to compare the effects of two alternate types of psychotherapy, Cognitive Behavior Therapy (CBT) and Emotional Awareness and Expression Therapy (EAET), for chronic musculoskeletal pain in older adults. In addition, the investigators will evaluate which patients respond better to each treatment and further investigate how each treatment works. CBT, which focuses on improving coping skills for pain, is the standard form of psychotherapy offered at VA. EAET instead focuses on understanding how life stress, relationships, and emotions may cause and perpetuate pain. The investigators are performing the study because pain is a large problem among Veterans. Studies show that chronic pain affects as many as 50% of male Veterans and 75% of female Veterans. The investigators are focusing on older adult Veterans because they have the highest rates of chronic pain at VA, perhaps as high as 80%. The investigators are looking at psychotherapy in this study because VA, the Department of Defense, and the CDC recently recommended psychosocial treatments, such as psychotherapy, as first treatments for chronic pain, along with medications other than opioids (e.g., oxycodone). However, only one form of psychotherapy, CBT, is currently available in clinical practice at VA, and this study may provide evidence for making EAET available to Veterans as well.

Conditions

Musculoskeletal Pain

Keywords

Chronic Pain; Psychotherapy; Musculoskeletal Disease

Outcome Measures

Primary Outcomes (1)

• 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 with higher scores indicating a worse outcome.

  Change from baseline to 10 weeks

Secondary Outcomes (24)

• Pain Severity

  Change from baseline to 20 weeks

• Satisfaction With Therapy and Therapist Scale-Revised (Overall Satisfaction)

  10 weeks

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

  Change from baseline to 10 weeks

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

  Change from baseline to 20 weeks

• PROMIS-Depression Short Form

  Change from baseline to 10 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.

Also known as: EAET

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.

Also known as: CBT

Cognitive Behavior 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 to 95 years old and have had at least 3 months of musculoskeletal pain, including the following conditions most likely to benefit from psychosocial intervention based on previous research:
• regional pain syndromes (e.g., low back, neck, leg, or pelvic pain, or temporomandibular joint disorders);
• widespread pain syndromes (e.g., fibromyalgia);
• whiplash;
• tension headaches; or
• any combination of these disorders.

You may not qualify if:

• Confirmed hip or knee osteoarthritis without other musculoskeletal pain complaints;
• Leg pain greater than back pain only without other musculoskeletal pain complaints (to exclude radiculopathy in isolation);
• EMG-confirmed "tunnel" syndromes (e.g., carpal or tarsal tunnel syndrome) only without other musculoskeletal pain complaints;
• Autoimmune disease that typically generates pain (e.g., systemic lupus erythematosus, rheumatoid arthritis, inflammatory bowel disease, ankylosing spondylitis);
• Cancer pain, sickle cell disease, neuralgias (e.g., trigeminal neuralgia), burn pain, infection associated with pain (e.g., vertebral infection), cauda equina syndrome, gout, migraine or cluster headaches without additional musculoskeletal pain complaints;
• Uncontrolled severe psychiatric disorder including current psychotic disorder or severe mood disorder not controlled with medications (e.g., schizophrenia or bipolar I disorder), dissociative identity disorder, or active suicide/violence risk in the past 6 months;
• Substantial cognitive impairment or dementia (Mini-Mental State Exam (78) score 24);
• Active severe alcohol or substance use disorder that inhibits the participant's ability to attend session or participate in homework;
• Currently with pain-related litigation or applying for pain-related compensation or compensation increase, or undergoing compensation re-evaluation (e.g., applying for VA service connection or service connection increase for pain);
• Patients who have undergone CBT for pain within the last 3 months of enrollment or who are currently receiving CBT or EAET psychotherapy treatment for pain;
• Unable to fluently read/converse in English;
• Planning to move from the area in the next 6 months.

Sponsors & Collaborators

• VA Office of Research and Development: lead

Study Sites (1)

VA Greater Los Angeles Healthcare System, West Los Angeles, CA

West Los Angeles, California, 90073-1003, United States

Location

Related Publications (1)

• Yarns BC, Jackson NJ, Alas A, Melrose RJ, Lumley MA, Sultzer DL. Emotional Awareness and Expression Therapy vs Cognitive Behavioral Therapy for Chronic Pain in Older Veterans: A Randomized Clinical Trial. JAMA Netw Open. 2024 Jun 3;7(6):e2415842. doi: 10.1001/jamanetworkopen.2024.15842.

  PMID: 38869899 RESULT

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

Results Point of Contact

• Title: Brandon C. Yarns
• Organization: VA Greater Los Angeles Healthcare System

brandon.yarns@va.gov

310-478-3711

Study Officials

• Brandon C Yarns, MD MS BME

  VA Greater Los Angeles Healthcare System, West Los Angeles, CA

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

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

Model Details: Two-Group Parallel Comparison Trial

Study Record Dates

• First Submitted: April 15, 2019
• First Posted: April 17, 2019
• Study Start: May 16, 2019
• Primary Completion: September 14, 2023
• Study Completion: September 14, 2023
• Last Updated: November 4, 2024
• Results First Posted: November 4, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)