NCT06004804

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

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

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 216 (estimated)
• Sponsor: VA Office of Research and Development · Federal
• Sex: All
• Age: 60 Years – 95 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Chronic Musculoskeletal Pain

Interventions

Type	Name	Description
BEHAVIORAL	Emotional Awareness and Expression Therapy	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	Mindfulness Meditation	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.
BEHAVIORAL	Cognitive Behavioral Therapy	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.

Timeline

• Start date: 2023-10-01
• Primary completion: 2027-09-30
• Completion: 2027-09-30
• First posted: 2023-08-22
• Last updated: 2025-09-22

Locations

2 sites across 1 country: United States