Clinical trial NCT06004804: Group-Based Psychological Treatments Over Video Conference for Older Veterans With Chronic Pain
Official title: Evaluating Group-Based Psychological Treatments Over Home Video Teleconference for Older Veterans With Chronic Pain
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Chronic Musculoskeletal Pain
Keywords: Chronic pain
Psychological intervention
Musculoskeletal disease
Telehealth
Lead sponsor: VA Office of Research and Development
Sponsor class: FED
First posted: 2023-08-22
Enrollment: 216
Sex: ALL
Minimum age (years): 60
Maximum age (years): 95
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Three-Group Parallel Comparison Trial
Primary purpose: TREATMENT

Brief summary: This study is being performed to compare the effects of three types of group-based psychological treatments delivered over video telehealth for chronic musculoskeletal pain in older U.S. military Veterans. The three types of psychological treatments are: Cognitive-Behavioral Therapy (CBT), Emotional Awareness and Expression Therapy (EAET), and Mindfulness Meditation (MM). In addition, the investigators will evaluate which patients respond best to each treatment and how each treatment works.

The investigators are performing the study because chronic pain is a big problem among Veterans. Older Veterans are the focus because they have the highest rates of chronic pain, perhaps as high has 80%. The investigators are looking at psychological treatments because they are less risky than medications or procedures for older Veterans. Telehealth is an important aspect of the proposal, as delivery over telehealth could improve access to treatments. CBT is endorsed nationally by VA, but no standardized MM is available through VA, and only a few VA sites use EAET, which is a newer treatment focusing on how stress and emotions affect pain. The project aims to evaluate a standardized form of MM and the newer treatment, EAET, compared to the standard CBT used widely in VA.

Detailed description: The overarching goal of the proposed research is to learn how to optimize group-based psychological treatments for chronic pain delivered over video telehealth to the homes of older Veterans. Chronic pain is a critical healthcare challenge for VA, because the condition affects 50% of Veterans and is notoriously difficult to treat. Older Veterans are affected with chronic pain even more commonly and severely than younger Veterans, and older Veterans are more susceptible to side effects from pain medications and invasive procedures. Psychological chronic pain treatments do not usually have severe side effects, but tend to produce only modest benefits. To increase the effectiveness of psychological treatments, VA experts have recommended testing standardized treatments with larger and more durable benefits, testing group and video telehealth delivered treatments to improve access, identifying mechanisms of response so that the most powerful mechanisms may be targeted, and determining what Veteran characteristics may predict response to the various treatment options. The proposed randomized clinical trial will address all the recommendation of VA experts. First, the project will evaluate the effects of standardized formats of Mindfulness Meditation (MM) and Emotional Awareness and Expression Therapy (EAET) compared to the VA standard psychological chronic pain treatment, Cognitive Behavioral Therapy (CBT). Many Veterans are interested in MM, but a standardized protocol so far has not been established. EAET is a newer treatment that addresses painful stress and emotions to reduce or eliminate chronic pain. These two approaches are hypothesized to have larger benefits than CBT. Second, the project will deliver all treatments in groups and over video telehealth to the homes of Veterans to enhance access. Third, the project will test shared and specific (unique) mechanisms of response for each treatment. Fourth, the project will evaluate a set of demographic and clinical characteristics (e.g., trauma history) to see whether Veterans with certain characteristics are more likely to respond to one treatment or another. The Investigators plan to enroll up to 216 multi-ethnic/multi-racial older Veterans (age 60-95 years) with chronic musculoskeletal pain at VA Greater Los Angeles Healthcare System and VA Connecticut Healthcare System.

Eligibility criteria: Inclusion Criteria:

Eligible individuals are

* Veterans;
* age 60-95 years;
* have at least 3 months of musculoskeletal pain, including the following conditions: back, neck, leg, or pelvic pain; temporomandibular joint disorders; fibromyalgia; tension headaches; or any combination of these disorders; and
* have an average daily pain intensity of at least 4 on a 0 to 10 scale.

Exclusion Criteria:

* pain conditions likely to respond pharmacologic or surgical treatment only when they are the primary or sole complaint: hip or knee osteoarthritis, leg pain greater than back pain (to exclude radiculopathy), electromyography-confirmed "tunnel" syndromes (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; and
* these 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 or dementia (assessed using telephone Mini-Mental State Examination (tMMSE) score \<19), previously completed EAET, CBT-CP, or MM/MBSR, currently enrolled in another psychological pain treatment, currently in pain-related litigation or applying for pain-related compensation or compensation increase, unable to fluently read or converse in English, no home internet access.

Primary outcomes:
measure: Brief Pain Inventory: Mean Pain Severity
timeFrame: Change from baseline to 8 weeks
measure: Brief Pain Inventory: Mean Pain Severity
timeFrame: Change from baseline to 20 weeks
Secondary outcomes:
measure: Brief Pain Inventory: Pain Interference
timeFrame: Change from baseline to 8 weeks
measure: Brief Pain Inventory: Pain Interference
timeFrame: Change from baseline to 20 weeks
measure: Patient Health Questionnaire-8
timeFrame: Change from baseline to 8 weeks
measure: Patient Health Questionnaire-8
timeFrame: Change from baseline to 20 weeks
measure: Generalized Anxiety Disorder 7-item
timeFrame: Change from baseline to 8 weeks
measure: Generalized Anxiety Disorder 7-item
timeFrame: Change from baseline to 20 weeks
measure: PTSD Checklist for DSM-5
timeFrame: Change from baseline to 8 weeks
measure: PTSD Checklist for DSM-5
timeFrame: Change from baseline to 20 weeks
measure: Patient's Global Impression of Change
timeFrame: 8 weeks
measure: Patient's Global Impression of Change
timeFrame: 20 weeks
Other outcomes:
measure: Emotional Approach Coping Scales
timeFrame: Change from baseline to 4 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/Brain Attributions Scale
timeFrame: Change from baseline to 4 weeks
measure: Pain/Brain Attributions Scale
timeFrame: Change from baseline to 8 weeks
measure: Pain/Brain Attributions Scale
timeFrame: Change from baseline to 20 weeks
measure: Coping Strategies Questionnaire
timeFrame: Change from baseline to 4 weeks
measure: Coping Strategies Questionnaire
timeFrame: Change from baseline to 8 weeks
measure: Coping Strategies Questionnaire
timeFrame: Change from baseline to 20 weeks
measure: Chronic Pain Acceptance Questionnaire-2 Item
timeFrame: Change from baseline to 4 weeks
measure: Chronic Pain Acceptance Questionnaire-2 Item
timeFrame: Change from baseline to 8 weeks
measure: Chronic Pain Acceptance Questionnaire-2 Item
timeFrame: Change from baseline to 20 weeks
measure: Self-Compassion Scale-Short Form
timeFrame: Change from baseline to 4 weeks
measure: Self-Compassion Scale-Short Form
timeFrame: Change from baseline to 8 weeks
measure: Self-Compassion Scale-Short Form
timeFrame: Change from baseline to 20 weeks
measure: Working Alliance Inventory
timeFrame: Change from baseline to 4 weeks
measure: Working Alliance Inventory
timeFrame: Change from baseline to 8 weeks
measure: Working Alliance Inventory
timeFrame: Change from baseline to 20 weeks
measure: Pain Self-Efficacy Questionnaire-2 item
timeFrame: Change from baseline to 4 weeks
measure: Pain Self-Efficacy Questionnaire-2 item
timeFrame: Change from baseline to 8 weeks
measure: Pain Self-Efficacy Questionnaire
timeFrame: Change from baseline to 20 weeks
measure: Life Events Checklist for DSM-5
timeFrame: Baseline
Locations:
city: West Los Angeles
country: United States
facility: VA Greater Los Angeles Healthcare System, West Los Angeles, CA
state: California
city: West Haven
country: United States
facility: VA Connecticut Healthcare System West Haven Campus, West Haven, CT
state: Connecticut
Study officials:
affiliation: VA Greater Los Angeles Healthcare System, West Los Angeles, CA
name: Brandon C Yarns, MD MS BME
role: PRINCIPAL_INVESTIGATOR
References: