Group-Based Psychological Treatments Over Video Conference for Older Veterans With Chronic Pain
GPTVTCOVCP
Evaluating Group-Based Psychological Treatments Over Home Video Teleconference for Older Veterans With Chronic Pain
2 other identifiers
interventional
216
1 country
2
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Oct 2023
Longer than P75 for not_applicable
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 16, 2023
CompletedFirst Posted
Study publicly available on registry
August 22, 2023
CompletedStudy Start
First participant enrolled
October 1, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 30, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
September 30, 2027
September 22, 2025
September 1, 2025
4 years
August 16, 2023
September 19, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Brief Pain Inventory: 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
Brief Pain Inventory: 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 (10)
Brief Pain Inventory: Pain Interference
Change from baseline to 8 weeks
Brief Pain Inventory: Pain Interference
Change from baseline to 20 weeks
Patient Health Questionnaire-8
Change from baseline to 8 weeks
Patient Health Questionnaire-8
Change from baseline to 20 weeks
Generalized Anxiety Disorder 7-item
Change from baseline to 8 weeks
- +5 more secondary outcomes
Other Outcomes (22)
Emotional Approach Coping Scales
Change from baseline to 4 weeks
Emotional Approach Coping Scales
Change from baseline to 8 weeks
Emotional Approach Coping Scales
Change from baseline to 20 weeks
- +19 more other outcomes
Study Arms (3)
Emotional Awareness and Expression Therapy
EXPERIMENTALSeeks 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.
Mindfulness Meditation
EXPERIMENTALSeeks to help individuals achieve present moment awareness, self-compassion, and acceptance of chronic pain. It will use techniques such as the body scan, grounding, mindful breathing, mindful walking, loving kindness, and compassionate breathing.
Cognitive Behavioral Therapy
ACTIVE COMPARATORSeeks 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.
Interventions
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.
Seeks to help individuals achieve present moment awareness, self-compassion, and acceptance of chronic pain. It will use techniques such as the body scan, grounding, mindful breathing, mindful walking, loving kindness, and compassionate breathing.
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.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
VA Greater Los Angeles Healthcare System, West Los Angeles, CA
West Los Angeles, California, 90073-1003, United States
VA Connecticut Healthcare System West Haven Campus, West Haven, CT
West Haven, Connecticut, 06516-2770, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Brandon C Yarns, MD MS BME
VA Greater Los Angeles Healthcare System, West Los Angeles, CA
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- INVESTIGATOR, OUTCOMES ASSESSOR
- Masking Details
- The study will rely on a blinded outcomes assessor who will be blind to condition assignment. Investigators will be blind to outcomes until the conclusion of the trial.
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- FED
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 16, 2023
First Posted
August 22, 2023
Study Start
October 1, 2023
Primary Completion (Estimated)
September 30, 2027
Study Completion (Estimated)
September 30, 2027
Last Updated
September 22, 2025
Record last verified: 2025-09
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, ICF, ANALYTIC CODE
- Time Frame
- Datasets that meet VA standards for disclosure to the public will be made available within 1 year of publication. The analytical datasets and statistical code used in publications will be retained for 6 years, in accordance with VA record retention policy.
- Access Criteria
- Datasets that meet VA standards for disclosure to the public will be made available within 1 year of publication. The analytical datasets and statistical code used in publications will be retained for 6 years, in accordance with VA record retention policy.
Datasets that meet VA standards for disclosure to the public will be made available within 1 year of publication. Prior to their distribution, a local privacy officer will certify that all datasets contain no PHI. Final datasets will be maintained locally until enterprise-level resources become available for long-term storage and access. Guidance on request and distribution processes will be provided by ORD. Those requesting datasets will be asked to sign a Letter of Agreement.