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

Part of paid clinical trials in West Los Angeles, California.

Sponsor
VA Office of Research and Development
Study ID
NCT06004804
Status
Recruiting

Conditions

  • Chronic Musculoskeletal Pain

Eligibility Criteria

Sex
ALL
Age
60 Years - 95 Years
Healthy Volunteers
Not accepted

Interventions

  • Emotional Awareness and Expression Therapy — BEHAVIORAL
    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 Meditation — BEHAVIORAL
    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 Therapy — BEHAVIORAL
    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 Details

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.

Key Dates

Start date
Oct 1, 2023
Status verified
Sep 2025
Primary completion
Sep 30, 2027
Completion
Sep 30, 2027

Study Design

Enrollment
216 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: 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.
  • Experimental: 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.
  • Active Comparator: 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.

Primary Outcome Measure

Brief Pain Inventory: Mean Pain Severity [ Time Frame: Change from baseline to 8 weeks ]

Central Contacts

Locations (2)

FacilityCityStateZIPSite coordinators
VA Greater Los Angeles Healthcare System, West Los Angeles, CAWest Los AngelesCalifornia90073-1003
Deborah M Delevan, MEd
(310) 478-3711
Angela B Cohen, MPH
(818) 891-7711
Brandon C Yarns, MD MS BME (PRINCIPAL_INVESTIGATOR)
David Avram Ganz, MD PhD MPH (SUB_INVESTIGATOR)
VA Connecticut Healthcare System West Haven Campus, West Haven, CTWest HavenConnecticut06516-2770
Mary Driscoll, PhD
203-932-5744
Elizabeth A Galliford, MPH BS
(646) 833-8369
Mary Driscoll, PhD (SUB_INVESTIGATOR)

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