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Chronic Musculoskeletal PainGPTVTCOVCPNCT06004804

Group-Based Psychological Treatments Over Video Conference for Older Veterans With Chronic Pain

A study testing Emotional Awareness and Expression Therapy, Mindfulness Meditation and Cognitive Behavioral Therapy in people with Chronic Musculoskeletal Pain, run by VA Office of Research and Development at 2 sites in United States.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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. Read more about this study

Who is it for?
Ages 60 to 95 years
Conditions the study is for
Chronic Musculoskeletal Pain
What is being tested?
Emotional Awareness and Expression Therapy, Mindfulness Meditation and Cognitive Behavioral Therapy
Could I receive a placebo?
No, everyone receives an active treatment
How many people
216 participants
Where
2 sitesUnited States
Study dates
1 Oct 2023to 30 Sep 2027
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 60 to 95 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Eligible individuals are
  • Veterans
  • 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
  • have an average daily pain intensity of at least 4 on a 0 to 10 scale

Who cannot join

  • 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
  • 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

Trial locations and contacts

2 sites in 1 country. Contact the study team or a site near you to ask about taking part.

United States2 sites, 2 recruiting
  • VA Connecticut Healthcare System West Haven Campus, West Haven, CT

    West Haven, Connecticut, 06516-2770

    Mary Driscoll, PhD, (203) 932-5744 ext. 3631, Mary.Driscoll3@va.gov

    Elizabeth A Galliford, MPH BS, (646) 833-8369, elizabeth.galliford@va.gov

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

    West Los Angeles, California, 90073-1003

    Deborah M Delevan, MEd, (310) 478-3711 ext. 36101, deborah.delevan@va.gov

    Angela B Cohen, MPH, (818) 891-7711 ext. 36004, Angela.Cohen2@va.gov

    Recruiting

Other trials in United States

About this study

Official title: Evaluating Group-Based Psychological Treatments Over Home Video Teleconference for Older Veterans With Chronic Pain

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.

Read the 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.

Being tested
Emotional Awareness and Expression Therapy, Mindfulness Meditation, Cognitive Behavioral Therapy
Keywords
Chronic pain, Psychological intervention, Musculoskeletal disease, Telehealth
Medical subject headings
Chronic Pain, Musculoskeletal Diseases

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Emotional Awareness and Expression TherapyBehavioural

    Also called EAET

    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.

  • Mindfulness MeditationBehavioural

    Also called MM

    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.

  • Cognitive Behavioral TherapyBehavioural

    Also called CBT

    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.

Study groups in NCT06004804
Study groupRoleWhat they receive
Emotional Awareness and Expression TherapyExperimentalSeeks 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.
Receives: Behavioral: Emotional Awareness and Expression Therapy
Mindfulness MeditationExperimentalSeeks 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.
Receives: Behavioral: Mindfulness Meditation
Cognitive Behavioral TherapyActive 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.
Receives: Behavioral: Cognitive Behavioral Therapy

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: Change from baseline to 8 weeks

  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.

    Measured: Change from baseline to 20 weeks

Secondary outcomes (10)
  1. Brief Pain Inventory: Pain Interference

    Average of 7 self report items on interference of pain with daily activities over the last 7 days: general activity, walking, work, mood, enjoyment of life, relations with others, and sleep. Each item is scored 0-10 (0 = does not interfere; 10 = completely interferes), yielding a total score between 0 and 10.

    Measured: Change from baseline to 8 weeks

  2. Brief Pain Inventory: Pain Interference

    Average of 7 self report items on interference of pain with daily activities over the last 7 days: general activity, walking, work, mood, enjoyment of life, relations with others, and sleep. Each item is scored 0-10 (0 = does not interfere; 10 = completely interferes), yielding a total score between 0 and 10.

    Measured: Change from baseline to 20 weeks

  3. Patient Health Questionnaire-8

    Sum of 8 self report items assessing depression and emotional distress over the last 2 weeks. Items range from 0-3 (0 = not at all; 3 = nearly every day) for a total score between 0 and 24.

    Measured: Change from baseline to 8 weeks

  4. Patient Health Questionnaire-8

    Sum of 8 self report items assessing depression and emotional distress over the last 2 weeks. Items range from 0-3 (0 = not at all; 3 = nearly every day) for a total score between 0 and 24.

    Measured: Change from baseline to 20 weeks

  5. Generalized Anxiety Disorder 7-item

    Sum of 7 self report items assessing anxiety and worrying over the last 2 weeks. Items range from 0-3 (0 = not at all; 3 = nearly every day) for a total score between 0 and 21.

    Measured: Change from baseline to 8 weeks

  6. Generalized Anxiety Disorder 7-item

    Sum of 7 self report items assessing anxiety and worrying over the last 2 weeks. Items range from 0-3 (0 = not at all; 3 = nearly every day) for a total score between 0 and 21.

    Measured: Change from baseline to 20 weeks

  7. PTSD Checklist for DSM-5

    Sum of 20 self report items assessing post-traumatic stress disorder symptoms over the last month. Items range from 0-4 (0 = not at all; 3 = extremely) for a total score between 0 and 80.

    Measured: Change from baseline to 8 weeks

  8. PTSD Checklist for DSM-5

    Sum of 20 self report items assessing post-traumatic stress disorder symptoms over the last month. Items range from 0-4 (0 = not at all; 3 = extremely) for a total score between 0 and 80.

    Measured: Change from baseline to 20 weeks

  9. Patient's Global Impression of Change

    Patient rates on a single item with a scale of 1-7 the change (if any) they've experienced since beginning treatment in the study (1 = no change or condition has worsened; 7 = a great deal better and a considerable improvement that has made all the difference).

    Measured: 8 weeks

  10. Patient's Global Impression of Change

    Patient rates on a single item with a scale of 1-7 the change (if any) they've experienced since beginning treatment in the study (1 = no change or condition has worsened; 7 = a great deal better and a considerable improvement that has made all the difference).

    Measured: 20 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted22 Aug 2023
  2. Study start1 Oct 2023
  3. Primary completion30 Sep 2027 (estimated)
  4. Study completion30 Sep 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
Three-Group Parallel Comparison Trial
Masking
Double blind
Who is masked
Investigator, Outcomes assessor
Enrolment
216 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06004804
Sponsor's protocol ID
IIR 21-207
Other IDs
I01HX003494-01A2
Acronym
GPTVTCOVCP
Status last verified
Aug 2026
First submitted
16 Aug 2023
Last updated
28 Aug 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: 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.

Questions about this trial

What is this clinical trial studying?

A study testing Emotional Awareness and Expression Therapy, Mindfulness Meditation and Cognitive Behavioral Therapy in people with Chronic Musculoskeletal Pain, run by VA Office of Research and Development at 2 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 28 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Karin C Liu, MPH ((310) 478-3711 ext. 40515, karin.liu@va.gov), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Brief Pain Inventory: Mean Pain Severity (time frame: Change from baseline to 8 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Aug 2026.

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