Clinical trial NCT03844880: Emotional Awareness and Expression Therapy (EAET) or Cognitive Behavior Therapy (CBT) for Older Veterans With Chronic Musculoskeletal Pain
Official title: Emotional Awareness and Expression Therapy (EAET) or Cognitive Behavior Therapy (CBT) for the Treatment of Chronic Musculoskeletal Pain in Older Veterans: A Pilot Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Musculoskeletal Pain
Keywords: Chronic Pain
Psychotherapy
Musculoskeletal Disease
Lead sponsor: VA Greater Los Angeles Healthcare System
Sponsor class: FED
First posted: 2019-02-19
Enrollment: 64
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Detailed description: Outpatient Veterans age 50 years and older at the West Los Angeles VA Medical Center who have chronic musculoskeletal pain complete baseline questionnaires and are randomized into one of two forms of psychotherapy: Emotional Awareness and Expression Therapy (EAET), which helps patients make connections between avoided or conflicted emotions and pain, or Cognitive Behavior Therapy (CBT), which teaches pain coping skills. Each treatment is delivered by an experienced therapist and includes one 90-minute individual session and eight 90-minute group sessions (in small groups of 8 Veterans). Patients in both conditions complete post-treatment and 3-month follow-up questionnaires. Outcomes of each type of psychotherapy are compared and mediators of treatment response are evaluated.

Eligibility criteria: Inclusion Criteria:

* Veteran;
* Age 50 years and older;
* 3 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.

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Mean Pain Severity
timeFrame: Change from baseline to 8 weeks
measure: Mean Pain Severity
timeFrame: Change from baseline to 20 weeks
Secondary outcomes:
measure: Percent of Group Therapy Sessions Attended
timeFrame: 8 weeks
measure: Satisfaction with Therapy and Therapist Scale-Revised
timeFrame: 8 weeks
measure: Patient Reported Outcomes Measurement Information System (PROMIS)-Pain Behavior Short Form 7a v1.1
timeFrame: Change from baseline to 8 weeks
measure: PROMIS-Pain Behavior Short Form 7a v1.1
timeFrame: Change from baseline to 20 weeks
measure: PROMIS-Pain Interference Short Form 8a v1.0
timeFrame: Change from baseline to 8 weeks
measure: PROMIS-Pain Interference Short Form 8a v1.0
timeFrame: Change from baseline to 20 weeks
measure: PROMIS-Depression Short Form
timeFrame: Change from baseline to 8 weeks
measure: PROMIS-Depression Short Form
timeFrame: Change from baseline to 20 weeks
measure: PROMIS-Anxiety Short Form
timeFrame: Change from baseline to 8 weeks
measure: PROMIS-Anxiety Short Form
timeFrame: Change from baseline to 20 weeks
measure: PTSD Symptom Scale
timeFrame: Change from baseline to 8 weeks
measure: PTSD Symptom Scale
timeFrame: Change from baseline to 20 weeks
measure: NIH Toolbox-Positive Affect Short Form
timeFrame: Change from baseline to 8 weeks
measure: NIH Toolbox-Positive Affect Short Form
timeFrame: Change from baseline to 20 weeks
measure: NIH Toolbox-Purpose and Meaning Short Form
timeFrame: Change from baseline to 8 weeks
measure: NIH Toolbox-Purpose and Meaning Short Form
timeFrame: Change from baseline to 20 weeks
measure: NIH Toolbox-Life Satisfaction Short Form
timeFrame: Change from baseline to 8 weeks
measure: NIH Toolbox-Life Satisfaction Short Form
timeFrame: Change from baseline to 20 weeks
measure: PROMIS-Sleep Disturbance Short Form
timeFrame: Change from baseline to 8 weeks
measure: PROMIS-Sleep Disturbance Short Form
timeFrame: Change from baseline to 20 weeks
measure: PROMIS-Fatigue Short Form
timeFrame: Change from baseline to 8 weeks
measure: PROMIS-Fatigue Short Form
timeFrame: Change from baseline to 20 weeks
measure: Multidimensional Inventory of Subjective Cognitive Impairment
timeFrame: Change from baseline to 8 weeks
measure: Multidimensional Inventory of Subjective Cognitive Impairment
timeFrame: Change from baseline to 20 weeks
measure: Ambivalence over Emotional Expression Questionnaire
timeFrame: Change from baseline to 8 weeks
measure: Ambivalence over Emotional Expression Questionnaire
timeFrame: Change from baseline to 20 weeks
measure: Emotional Approach Coping Scales
timeFrame: Change from baseline to 8 weeks
measure: Emotional Approach Coping Scales
timeFrame: Change from baseline to 20 weeks
measure: Pain Catastrophizing Scale
timeFrame: Change from baseline to 8 weeks
measure: Pain Catastrophizing Scale
timeFrame: Change from baseline to 20 weeks
measure: Survey of Pain Attitudes
timeFrame: Change from baseline to 8 weeks
measure: Survey of Pain Attitudes
timeFrame: Change from baseline to 20 weeks
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: VA Greater Los Angeles Healthcare Center
state: California
Study officials:
References: