NCT Number: NCT06004804
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.
Interested in participating?
Request Info60 year–95 year
All sexes
Interventional
Not applicable
VA Greater Los Angeles Healthcare System, West Los Angeles, CA, West Los Angeles, California, United States
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Eligible individuals are
Exclusion criteria
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.
Other names: EAET
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.
Other names: MM
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.
Other names: CBT
Time frame: Change from baseline to 8 weeks
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.
Time frame: Change from baseline to 20 weeks
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.
Time frame: Change from baseline to 8 weeks
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.
Time frame: Change from baseline to 20 weeks
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.
Time frame: Change from baseline to 8 weeks
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.
Time frame: Change from baseline to 20 weeks
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.
Time frame: Change from baseline to 8 weeks
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.
Time frame: Change from baseline to 20 weeks
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.
Time frame: Change from baseline to 8 weeks
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.
Time frame: Change from baseline to 20 weeks
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.
Time frame: 8 weeks
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).
Time frame: 20 weeks
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).
Time frame: Change from baseline to 4 weeks
Sum of four self-report items assessing whether the subject uses an emotional approach to coping when experiencing stress or difficulties. Items range from 1-4 (1 = I don't use this emotional coping strategy; 4 = I use this emotional coping strategy a lot), yielding a total score between 4 and 16.
Time frame: Change from baseline to 8 weeks
Sum of four self-report items assessing whether the subject uses an emotional approach to coping when experiencing stress or difficulties. Items range from 1-4 (1 = I don't use this emotional coping strategy; 4 = I use this emotional coping strategy a lot), yielding a total score between 4 and 16.
Time frame: Change from baseline to 20 weeks
Sum of four self-report items assessing whether the subject uses an emotional approach to coping when experiencing stress or difficulties. Items range from 1-4 (1 = I don't use this emotional coping strategy; 4 = I use this emotional coping strategy a lot), yielding a total score between 4 and 16.
Time frame: Change from baseline to 4 weeks
Sum of five self-report items assessing whether the subject beliefs about whether pain is related to stress, brain changes, or emotions. Items range from 0-4 (0 = strongly disagree; 4 = strongly agree) for a total score between 0 and 20.
Time frame: Change from baseline to 8 weeks
Sum of five self-report items assessing whether the subject beliefs about whether pain is related to stress, brain changes, or emotions. Items range from 0-4 (0 = strongly disagree; 4 = strongly agree) for a total score between 0 and 20.
Time frame: Change from baseline to 20 weeks
Sum of five self-report items assessing whether the subject beliefs about whether pain is related to stress, brain changes, or emotions. Items range from 0-4 (0 = strongly disagree; 4 = strongly agree) for a total score between 0 and 20.
Time frame: Change from baseline to 4 weeks
Sum of six self-report items assessing the subject's use of coping strategies. Items range 0-6 (0 = never use this strategy; 6 = always use this strategy). Two-item subscales (catastrophizing, increased behavioral activities, cognitive coping) are scored separately, yielding total scores between 0 and 12.
Time frame: Change from baseline to 8 weeks
Sum of six self-report items assessing the subject's use of coping strategies. Items range 0-6 (0 = never use this strategy; 6 = always use this strategy). Two-item subscales (catastrophizing, increased behavioral activities, cognitive coping) are scored separately, yielding total scores between 0 and 12.
Time frame: Change from baseline to 20 weeks
Sum of six self-report items assessing the subject's use of coping strategies. Items range 0-6 (0 = never use this strategy; 6 = always use this strategy). Two-item subscales (catastrophizing, increased behavioral activities, cognitive coping) are scored separately, yielding total scores between 0 and 12.
Time frame: Change from baseline to 4 weeks
Sum of two self report items assessing the subject's acceptance of chronic pain. Items range from 0-6 (0 = never true; 6 = always true), yielding a total score between 0 and 12.
Time frame: Change from baseline to 8 weeks
Sum of two self report items assessing the subject's acceptance of chronic pain. Items range from 0-6 (0 = never true; 6 = always true), yielding a total score between 0 and 12.
Time frame: Change from baseline to 20 weeks
Sum of two self report items assessing the subject's acceptance of chronic pain. Items range from 0-6 (0 = never true; 6 = always true), yielding a total score between 0 and 12.
Time frame: Change from baseline to 4 weeks
Sum of twelve self report items assessing the subject's feelings of self-compassion. Items range from 1-5 (1 = almost never; 6 = almost always), yielding a total score between 12 and 60.
Time frame: Change from baseline to 8 weeks
Sum of twelve self report items assessing the subject's feelings of self-compassion. Items range from 1-5 (1 = almost never; 6 = almost always), yielding a total score between 12 and 60.
Time frame: Change from baseline to 20 weeks
Sum of twelve self report items assessing the subject's feelings of self-compassion. Items range from 1-5 (1 = almost never; 6 = almost always), yielding a total score between 12 and 60.
Time frame: Change from baseline to 4 weeks
Sum of three self-report items assessing the subject's thoughts and feelings on their therapist. Items range 1-7 (1 = never; 4 = sometimes; 7 = always), yielding a total score between 3 and 21.
Time frame: Change from baseline to 8 weeks
Sum of three self-report items assessing the subject's thoughts and feelings on their therapist. Items range 1-7 (1 = never; 4 = sometimes; 7 = always), yielding a total score between 3 and 21.
Time frame: Change from baseline to 20 weeks
Sum of three self-report items assessing the subject's thoughts and feelings on their therapist. Items range 1-7 (1 = never; 4 = sometimes; 7 = always), yielding a total score between 3 and 21.
Time frame: Change from baseline to 4 weeks
Sum of two self-report items assessing the subject's confidence in performing activities of daily living despite pain. Items range 0-6 (0 = not at all confident; 6 = completely confident), yielding a total score between 0 and 12.
Time frame: Change from baseline to 8 weeks
Sum of two self-report items assessing the subject's confidence in performing activities of daily living despite pain. Items range 0-6 (0 = not at all confident; 6 = completely confident), yielding a total score between 0 and 12.
Time frame: Change from baseline to 20 weeks
Sum of two self-report items assessing the subject's confidence in performing activities of daily living despite pain. Items range 0-6 (0 = not at all confident; 6 = completely confident), yielding a total score between 0 and 12.
Time frame: Baseline
Self report checklist on whether 17 potentially traumatic and life threatening events occurred (yes/no) in the subject's life.
Contact information is provided by the study sponsor or research team.
Brandon C Yarns, MD MS BME
CONTACT
(310) 478-3711 ext. 42764
Karin C Liu, MPH
CONTACT
(310) 478-3711 ext. 40515
VA Office of Research and Development
Fed
Evaluating Group-Based Psychological Treatments Over Home Video Teleconference for Older Veterans With Chronic Pain
Acronym: GPTVTCOVCP
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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