xml: <clinical_study>
    <!-- This xml conforms to an XML Schema at:
      https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
    <required_header>
      <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
      <link_text>Link to the current ClinicalTrials.gov record.</link_text>
      <url>https://clinicaltrials.gov/ct2/show/NCT06004804</url>
    </required_header>
    <id_info>
      <org_study_id>IIR 21-207</org_study_id>
      <secondary_id>I01HX003494-01A2</secondary_id>
      <nct_id>NCT06004804</nct_id>
    </id_info>
    <brief_title>Group-Based Psychological Treatments Over Video Conference for Older Veterans With Chronic Pain</brief_title>
    <acronym>GPTVTCOVCP</acronym>
    <official_title>Evaluating Group-Based Psychological Treatments Over Home Video Teleconference for Older Veterans With Chronic Pain</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>VA Office of Research and Development</agency>
        <agency_class>U.S. Fed</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>VA Office of Research and Development</source>
    <oversight_info>
      <has_dmc>Yes</has_dmc>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
      <is_us_export>No</is_us_export>
    </oversight_info>
    <brief_summary>
      <textblock>
        This study is being performed to compare the effects of three types of group-based&#xD;
        psychological treatments delivered over video telehealth for chronic musculoskeletal pain in&#xD;
        older U.S. military Veterans. The three types of psychological treatments are:&#xD;
        Cognitive-Behavioral Therapy (CBT), Emotional Awareness and Expression Therapy (EAET), and&#xD;
        Mindfulness Meditation (MM). In addition, the investigators will evaluate which patients&#xD;
        respond best to each treatment and how each treatment works.&#xD;
  &#xD;
        The investigators are performing the study because chronic pain is a big problem among&#xD;
        Veterans. Older Veterans are the focus because they have the highest rates of chronic pain,&#xD;
        perhaps as high has 80%. The investigators are looking at psychological treatments because&#xD;
        they are less risky than medications or procedures for older Veterans. Telehealth is an&#xD;
        important aspect of the proposal, as delivery over telehealth could improve access to&#xD;
        treatments. CBT is endorsed nationally by VA, but no standardized MM is available through VA,&#xD;
        and only a few VA sites use EAET, which is a newer treatment focusing on how stress and&#xD;
        emotions affect pain. The project aims to evaluate a standardized form of MM and the newer&#xD;
        treatment, EAET, compared to the standard CBT used widely in VA.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        The overarching goal of the proposed research is to learn how to optimize group-based&#xD;
        psychological treatments for chronic pain delivered over video telehealth to the homes of&#xD;
        older Veterans. Chronic pain is a critical healthcare challenge for VA, because the condition&#xD;
        affects 50% of Veterans and is notoriously difficult to treat. Older Veterans are affected&#xD;
        with chronic pain even more commonly and severely than younger Veterans, and older Veterans&#xD;
        are more susceptible to side effects from pain medications and invasive procedures.&#xD;
        Psychological chronic pain treatments do not usually have severe side effects, but tend to&#xD;
        produce only modest benefits. To increase the effectiveness of psychological treatments, VA&#xD;
        experts have recommended testing standardized treatments with larger and more durable&#xD;
        benefits, testing group and video telehealth delivered treatments to improve access,&#xD;
        identifying mechanisms of response so that the most powerful mechanisms may be targeted, and&#xD;
        determining what Veteran characteristics may predict response to the various treatment&#xD;
        options. The proposed randomized clinical trial will address all the recommendation of VA&#xD;
        experts. First, the project will evaluate the effects of standardized formats of Mindfulness&#xD;
        Meditation (MM) and Emotional Awareness and Expression Therapy (EAET) compared to the VA&#xD;
        standard psychological chronic pain treatment, Cognitive Behavioral Therapy (CBT). Many&#xD;
        Veterans are interested in MM, but a standardized protocol so far has not been established.&#xD;
        EAET is a newer treatment that addresses painful stress and emotions to reduce or eliminate&#xD;
        chronic pain. These two approaches are hypothesized to have larger benefits than CBT. Second,&#xD;
        the project will deliver all treatments in groups and over video telehealth to the homes of&#xD;
        Veterans to enhance access. Third, the project will test shared and specific (unique)&#xD;
        mechanisms of response for each treatment. Fourth, the project will evaluate a set of&#xD;
        demographic and clinical characteristics (e.g., trauma history) to see whether Veterans with&#xD;
        certain characteristics are more likely to respond to one treatment or another. The&#xD;
        Investigators plan to enroll up to 216 multi-ethnic/multi-racial older Veterans (age 60-95&#xD;
        years) with chronic musculoskeletal pain at VA Greater Los Angeles Healthcare System and VA&#xD;
        Connecticut Healthcare System.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">October 1, 2023</start_date>
    <completion_date type="Anticipated">September 30, 2027</completion_date>
    <primary_completion_date type="Anticipated">September 30, 2027</primary_completion_date>
    <phase>N/A</phase>
    <study_type>Interventional</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <allocation>Randomized</allocation>
      <intervention_model>Parallel Assignment</intervention_model>
      <intervention_model_description>Three-Group Parallel Comparison Trial</intervention_model_description>
      <primary_purpose>Treatment</primary_purpose>
      <masking>Double (Investigator, Outcomes Assessor)</masking>
      <masking_description>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.</masking_description>
    </study_design_info>
    <primary_outcome>
      <measure>Brief Pain Inventory: Mean Pain Severity</measure>
      <time_frame>Change from baseline to 8 weeks</time_frame>
      <description>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.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Brief Pain Inventory: Mean Pain Severity</measure>
      <time_frame>Change from baseline to 20 weeks</time_frame>
      <description>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.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Brief Pain Inventory: Pain Interference</measure>
      <time_frame>Change from baseline to 8 weeks</time_frame>
      <description>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.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Brief Pain Inventory: Pain Interference</measure>
      <time_frame>Change from baseline to 20 weeks</time_frame>
      <description>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.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Patient Health Questionnaire-8</measure>
      <time_frame>Change from baseline to 8 weeks</time_frame>
      <description>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.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Patient Health Questionnaire-8</measure>
      <time_frame>Change from baseline to 20 weeks</time_frame>
      <description>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.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Generalized Anxiety Disorder 2-item</measure>
      <time_frame>Change from baseline to 8 weeks</time_frame>
      <description>Sum of 2 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 6.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Generalized Anxiety Disorder 2-item</measure>
      <time_frame>Change from baseline to 20 weeks</time_frame>
      <description>Sum of 2 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 6.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>PTSD Checklist for DSM-5</measure>
      <time_frame>Change from baseline to 8 weeks</time_frame>
      <description>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.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>PTSD Checklist for DSM-5</measure>
      <time_frame>Change from baseline to 20 weeks</time_frame>
      <description>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.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>The Veterans RAND 12 Item Health Survey</measure>
      <time_frame>Change from baseline to 8 weeks</time_frame>
      <description>Includes 12 self report items assessing mental and physical health quality of life. Scores range from 0 to 100 with 50 being an average score and higher scores representing better health related quality of life.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>The Veterans RAND 12 Item Health Survey</measure>
      <time_frame>Change from baseline to 20 weeks</time_frame>
      <description>Includes 12 self report items assessing mental and physical health quality of life. Scores range from 0 to 100 with 50 being an average score and higher scores representing better health related quality of life.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Satisfaction with Therapy and Therapist Scale-Revised</measure>
      <time_frame>8 weeks</time_frame>
      <description>Satisfaction with therapy subscale is the summation of 6 items, each scored 1-5 (1 = maximum dissatisfaction; 5 = maximum satisfaction), yielding a total score between 6 and 30. Satisfaction with therapist subscale is the summation of 6 items, each scored 1-5 (1 = maximum dissatisfaction; 5 = maximum satisfaction), yielding a total score between 6 and 30. Overall satisfaction is an additional single item scored 1-5 (1 = maximum dissatisfaction; 5 = maximum satisfaction). The two subscales and the overall satisfaction item are each reported separately.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Patient's Global Impression of Change</measure>
      <time_frame>8 weeks</time_frame>
      <description>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).</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Patient's Global Impression of Change</measure>
      <time_frame>20 weeks</time_frame>
      <description>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).</description>
    </secondary_outcome>
    <other_outcome>
      <measure>Emotional Approach Coping Scales</measure>
      <time_frame>Change from baseline to 4 weeks</time_frame>
      <description>Sum of eight 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 8 and 32.</description>
    </other_outcome>
    <other_outcome>
      <measure>Emotional Approach Coping Scales</measure>
      <time_frame>Change from baseline to 8 weeks</time_frame>
      <description>Sum of eight 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 8 and 32.</description>
    </other_outcome>
    <other_outcome>
      <measure>Emotional Approach Coping Scales</measure>
      <time_frame>Change from baseline to 20 weeks</time_frame>
      <description>Sum of eight 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 8 and 32.</description>
    </other_outcome>
    <other_outcome>
      <measure>Pain/Brain Attributions Scale</measure>
      <time_frame>Change from baseline to 4 weeks</time_frame>
      <description>Sum of seven 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 28.</description>
    </other_outcome>
    <other_outcome>
      <measure>Pain/Brain Attributions Scale</measure>
      <time_frame>Change from baseline to 8 weeks</time_frame>
      <description>Sum of seven 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 28.</description>
    </other_outcome>
    <other_outcome>
      <measure>Pain/Brain Attributions Scale</measure>
      <time_frame>Change from baseline to 20 weeks</time_frame>
      <description>Sum of seven 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 28.</description>
    </other_outcome>
    <other_outcome>
      <measure>Survey of Pain Attitudes</measure>
      <time_frame>Change from baseline to 4 weeks</time_frame>
      <description>Sum of fourteen self-report items assessing the subject's attitude towards their pain. Items range from 0-4 (0 = this attitude is very untrue for me; 4 = this attitude is very true for me), yielding a total score between 0 and 56.</description>
    </other_outcome>
    <other_outcome>
      <measure>Survey of Pain Attitudes</measure>
      <time_frame>Change from baseline to 8 weeks</time_frame>
      <description>Sum of fourteen self-report items assessing the subject's attitude towards their pain. Items range from 0-4 (0 = this attitude is very untrue for me; 4 = this attitude is very true for me), yielding a total score between 0 and 56.</description>
    </other_outcome>
    <other_outcome>
      <measure>Survey of Pain Attitudes</measure>
      <time_frame>Change from baseline to 20 weeks</time_frame>
      <description>Sum of fourteen self-report items assessing the subject's attitude towards their pain. Items range from 0-4 (0 = this attitude is very untrue for me; 4 = this attitude is very true for me), yielding a total score between 0 and 56.</description>
    </other_outcome>
    <other_outcome>
      <measure>Coping Strategies Questionnaire</measure>
      <time_frame>Change from baseline to 4 weeks</time_frame>
      <description>Sum of fourteen 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), yielding a total score between 0 and 84.</description>
    </other_outcome>
    <other_outcome>
      <measure>Coping Strategies Questionnaire</measure>
      <time_frame>Change from baseline to 8 weeks</time_frame>
      <description>Sum of fourteen 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), yielding a total score between 0 and 84.</description>
    </other_outcome>
    <other_outcome>
      <measure>Coping Strategies Questionnaire</measure>
      <time_frame>Change from baseline to 20 weeks</time_frame>
      <description>Sum of fourteen 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), yielding a total score between 0 and 84.</description>
    </other_outcome>
    <other_outcome>
      <measure>Chronic Pain Acceptance Questionnaire-2 Item</measure>
      <time_frame>Change from baseline to 4 weeks</time_frame>
      <description>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.</description>
    </other_outcome>
    <other_outcome>
      <measure>Chronic Pain Acceptance Questionnaire-2 Item</measure>
      <time_frame>Change from baseline to 8 weeks</time_frame>
      <description>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.</description>
    </other_outcome>
    <other_outcome>
      <measure>Chronic Pain Acceptance Questionnaire-2 Item</measure>
      <time_frame>Change from baseline to 20 weeks</time_frame>
      <description>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.</description>
    </other_outcome>
    <other_outcome>
      <measure>Self-Compassion Scale-Short Form</measure>
      <time_frame>Change from baseline to 4 weeks</time_frame>
      <description>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.</description>
    </other_outcome>
    <other_outcome>
      <measure>Self-Compassion Scale-Short Form</measure>
      <time_frame>Change from baseline to 8 weeks</time_frame>
      <description>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.</description>
    </other_outcome>
    <other_outcome>
      <measure>Self-Compassion Scale-Short Form</measure>
      <time_frame>Change from baseline to 20 weeks</time_frame>
      <description>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.</description>
    </other_outcome>
    <other_outcome>
      <measure>Working Alliance Inventory</measure>
      <time_frame>Change from baseline to 4 weeks</time_frame>
      <description>Sum of twelve 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 12 and 84.</description>
    </other_outcome>
    <other_outcome>
      <measure>Working Alliance Inventory</measure>
      <time_frame>Change from baseline to 8 weeks</time_frame>
      <description>Sum of twelve 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 12 and 84.</description>
    </other_outcome>
    <other_outcome>
      <measure>Working Alliance Inventory</measure>
      <time_frame>Change from baseline to 20 weeks</time_frame>
      <description>Sum of twelve 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 12 and 84.</description>
    </other_outcome>
    <other_outcome>
      <measure>Pain Self-Efficacy Questionnaire</measure>
      <time_frame>Change from baseline to 4 weeks</time_frame>
      <description>Sum of ten 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 60.</description>
    </other_outcome>
    <other_outcome>
      <measure>Pain Self-Efficacy Questionnaire</measure>
      <time_frame>Change from baseline to 8 weeks</time_frame>
      <description>Sum of ten 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 60.</description>
    </other_outcome>
    <other_outcome>
      <measure>Pain Self-Efficacy Questionnaire</measure>
      <time_frame>Change from baseline to 20 weeks</time_frame>
      <description>Sum of ten 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 60.</description>
    </other_outcome>
    <other_outcome>
      <measure>Life Events Checklist for DSM-5</measure>
      <time_frame>Baseline</time_frame>
      <description>Self report checklist on whether 17 potentially traumatic and life threatening events occurred (yes/no) in the subject's life.</description>
    </other_outcome>
    <other_outcome>
      <measure>Pain Catastrophizing Scale</measure>
      <time_frame>Baseline</time_frame>
      <description>Sum of thirteen self-report items assessing the types of thoughts and feelings experienced with pain. Items range from 0-4 (0 = not experiencing a type of thought / feeling; 5 = experiencing that thought / feeling all the time), yielding a total score between 0 and 52. Higher scores indicate the subject experiences thoughts and emotions that typically catastrophizes their pain.</description>
    </other_outcome>
    <number_of_arms>3</number_of_arms>
    <enrollment type="Anticipated">216</enrollment>
    <condition>Chronic Musculoskeletal Pain</condition>
    <arm_group>
      <arm_group_label>Emotional Awareness and Expression Therapy</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>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.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Mindfulness Meditation</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>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.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Cognitive Behavioral Therapy</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <description>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.</description>
    </arm_group>
    <intervention>
      <intervention_type>Behavioral</intervention_type>
      <intervention_name>Emotional Awareness and Expression Therapy</intervention_name>
      <description>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.</description>
      <arm_group_label>Emotional Awareness and Expression Therapy</arm_group_label>
      <other_name>EAET</other_name>
    </intervention>
    <intervention>
      <intervention_type>Behavioral</intervention_type>
      <intervention_name>Mindfulness Meditation</intervention_name>
      <description>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.</description>
      <arm_group_label>Mindfulness Meditation</arm_group_label>
      <other_name>MM</other_name>
    </intervention>
    <intervention>
      <intervention_type>Behavioral</intervention_type>
      <intervention_name>Cognitive Behavioral Therapy</intervention_name>
      <description>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.</description>
      <arm_group_label>Cognitive Behavioral Therapy</arm_group_label>
      <other_name>CBT</other_name>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
          Eligible individuals are&#xD;
  &#xD;
            -  Veterans;&#xD;
  &#xD;
            -  age 60-95 years;&#xD;
  &#xD;
            -  have at least 3 months of musculoskeletal pain, including the following conditions:&#xD;
               back, neck, leg, or pelvic pain; temporomandibular joint disorders; fibromyalgia;&#xD;
               tension headaches; or any combination of these disorders; and -have an average daily&#xD;
               pain intensity of at least 4 on a 0 to 10 scale.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  pain conditions likely to respond pharmacologic or surgical treatment only when they&#xD;
               are the primary or sole complaint: hip or knee osteoarthritis, leg pain greater than&#xD;
               back pain (to exclude radiculopathy), electromyography-confirmed &quot;tunnel&quot; syndromes&#xD;
               (e.g., carpal tunnel syndrome), gout, neuralgias, migraine, and cluster headaches;&#xD;
  &#xD;
            -  non-musculoskeletal pain conditions: autoimmune disease that typically generates pain&#xD;
               (e.g., rheumatoid arthritis), cancer pain, sickle cell disease, burn pain, infection&#xD;
               associated with pain, and cauda equina syndrome; and&#xD;
  &#xD;
            -  these conditions or circumstances: severe psychiatric disorder such as schizophrenia&#xD;
               or bipolar I disorder not controlled with medications, active suicide or violence&#xD;
               risk, active severe alcohol or substance use disorder, substantial cognitive&#xD;
               impairment or dementia (assessed using telephone Mini-Mental State Examination (tMMSE)&#xD;
               score &lt;19), previously completed EAET, CBT-CP, or MM/MBSR, currently enrolled in&#xD;
               another psychological pain treatment, currently in pain-related litigation or applying&#xD;
               for pain-related compensation or compensation increase, unable to fluently read or&#xD;
               converse in English, no home internet access.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>60 Years</minimum_age>
      <maximum_age>95 Years</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Brandon C Yarns, MD MS BME</last_name>
      <role>Principal Investigator</role>
      <affiliation>VA Greater Los Angeles Healthcare System, West Los Angeles, CA</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Alexander Alas, AA</last_name>
      <phone>(310) 268-4651</phone>
      <email>alexander.alas@va.gov</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Brandon C Yarns, MD MS BME</last_name>
      <phone>(310) 478-3711</phone>
      <phone_ext>42764</phone_ext>
      <email>Brandon.Yarns@va.gov</email>
    </overall_contact_backup>
    <location>
      <facility>
        <name>VA Greater Los Angeles Healthcare System, West Los Angeles, CA</name>
        <address>
          <city>West Los Angeles</city>
          <state>California</state>
          <zip>90073-1003</zip>
          <country>United States</country>
        </address>
      </facility>
      <contact>
        <last_name>Deborah M Delevan, MEd</last_name>
        <phone>310-478-3711</phone>
        <phone_ext>36101</phone_ext>
        <email>deborah.delevan@va.gov</email>
      </contact>
      <contact_backup>
        <last_name>Angela B Cohen, MPH</last_name>
        <phone>(818) 891-7711</phone>
        <phone_ext>36004</phone_ext>
        <email>Angela.Cohen2@va.gov</email>
      </contact_backup>
      <investigator>
        <last_name>Brandon C Yarns, MD MS BME</last_name>
        <role>Principal Investigator</role>
      </investigator>
    </location>
    <location>
      <facility>
        <name>VA Connecticut Healthcare System West Haven Campus, West Haven, CT</name>
        <address>
          <city>West Haven</city>
          <state>Connecticut</state>
          <zip>06516-2770</zip>
          <country>United States</country>
        </address>
      </facility>
      <contact>
        <last_name>Mary Driscoll, PhD</last_name>
        <phone>203-932-5711</phone>
        <email>mary.driscoll3@va.gov</email>
      </contact>
      <contact_backup>
        <last_name>Mary Driscoll, PhD</last_name>
        <phone>2039325711</phone>
        <email>mary.driscoll3@va.gov</email>
      </contact_backup>
    </location>
    <location_countries>
      <country>United States</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 16, 2023</study_first_submitted>
    <study_first_submitted_qc>August 16, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 22, 2023</study_first_posted>
    <last_update_submitted>August 16, 2023</last_update_submitted>
    <last_update_submitted_qc>August 16, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 22, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <keyword>Chronic pain</keyword>
    <keyword>Psychological intervention</keyword>
    <keyword>Musculoskeletal disease</keyword>
    <keyword>Telehealth</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Musculoskeletal Pain</mesh_term>
      <mesh_term>Chronic Pain</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>Yes</sharing_ipd>
      <ipd_description>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.</ipd_description>
      <ipd_info_type>Study Protocol</ipd_info_type>
      <ipd_info_type>Statistical Analysis Plan (SAP)</ipd_info_type>
      <ipd_info_type>Informed Consent Form (ICF)</ipd_info_type>
      <ipd_info_type>Analytic Code</ipd_info_type>
      <ipd_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.</ipd_time_frame>
      <ipd_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.</ipd_access_criteria>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: download date: ClinicalTrials.gov processed this data on September 20, 2023
  link text: Link to the current ClinicalTrials.gov record.
  url: https://clinicaltrials.gov/ct2/show/NCT06004804
  org study id: IIR 21-207
  secondary id: I01HX003494-01A2
  nct id: NCT06004804
  lead sponsor: 
  has dmc: Yes
  is fda regulated drug: No
  is fda regulated device: No
  is us export: No
  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.
  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.
  allocation: Randomized
  intervention model: Parallel Assignment
  intervention model description: Three-Group Parallel Comparison Trial
  primary purpose: Treatment
  masking: Double (Investigator, Outcomes Assessor)
  masking description: 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.
  measure: Brief Pain Inventory: Mean Pain Severity
  time frame: Change from baseline to 8 weeks
  description: 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.
  measure: Brief Pain Inventory: Mean Pain Severity
  time frame: Change from baseline to 20 weeks
  description: 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.
  measure: Brief Pain Inventory: Pain Interference
  time frame: Change from baseline to 8 weeks
  description: 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.
  measure: Brief Pain Inventory: Pain Interference
  time frame: Change from baseline to 20 weeks
  description: 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.
  measure: Patient Health Questionnaire-8
  time frame: Change from baseline to 8 weeks
  description: 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.
  measure: Patient Health Questionnaire-8
  time frame: Change from baseline to 20 weeks
  description: 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.
  measure: Generalized Anxiety Disorder 2-item
  time frame: Change from baseline to 8 weeks
  description: Sum of 2 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 6.
  measure: Generalized Anxiety Disorder 2-item
  time frame: Change from baseline to 20 weeks
  description: Sum of 2 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 6.
  measure: PTSD Checklist for DSM-5
  time frame: Change from baseline to 8 weeks
  description: 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.
  measure: PTSD Checklist for DSM-5
  time frame: Change from baseline to 20 weeks
  description: 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.
  measure: The Veterans RAND 12 Item Health Survey
  time frame: Change from baseline to 8 weeks
  description: Includes 12 self report items assessing mental and physical health quality of life. Scores range from 0 to 100 with 50 being an average score and higher scores representing better health related quality of life.
  measure: The Veterans RAND 12 Item Health Survey
  time frame: Change from baseline to 20 weeks
  description: Includes 12 self report items assessing mental and physical health quality of life. Scores range from 0 to 100 with 50 being an average score and higher scores representing better health related quality of life.
  measure: Satisfaction with Therapy and Therapist Scale-Revised
  time frame: 8 weeks
  description: Satisfaction with therapy subscale is the summation of 6 items, each scored 1-5 (1 = maximum dissatisfaction; 5 = maximum satisfaction), yielding a total score between 6 and 30. Satisfaction with therapist subscale is the summation of 6 items, each scored 1-5 (1 = maximum dissatisfaction; 5 = maximum satisfaction), yielding a total score between 6 and 30. Overall satisfaction is an additional single item scored 1-5 (1 = maximum dissatisfaction; 5 = maximum satisfaction). The two subscales and the overall satisfaction item are each reported separately.
  measure: Patient's Global Impression of Change
  time frame: 8 weeks
  description: 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).
  measure: Patient's Global Impression of Change
  time frame: 20 weeks
  description: 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).
  measure: Emotional Approach Coping Scales
  time frame: Change from baseline to 4 weeks
  description: Sum of eight 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 8 and 32.
  measure: Emotional Approach Coping Scales
  time frame: Change from baseline to 8 weeks
  description: Sum of eight 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 8 and 32.
  measure: Emotional Approach Coping Scales
  time frame: Change from baseline to 20 weeks
  description: Sum of eight 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 8 and 32.
  measure: Pain/Brain Attributions Scale
  time frame: Change from baseline to 4 weeks
  description: Sum of seven 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 28.
  measure: Pain/Brain Attributions Scale
  time frame: Change from baseline to 8 weeks
  description: Sum of seven 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 28.
  measure: Pain/Brain Attributions Scale
  time frame: Change from baseline to 20 weeks
  description: Sum of seven 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 28.
  measure: Survey of Pain Attitudes
  time frame: Change from baseline to 4 weeks
  description: Sum of fourteen self-report items assessing the subject's attitude towards their pain. Items range from 0-4 (0 = this attitude is very untrue for me; 4 = this attitude is very true for me), yielding a total score between 0 and 56.
  measure: Survey of Pain Attitudes
  time frame: Change from baseline to 8 weeks
  description: Sum of fourteen self-report items assessing the subject's attitude towards their pain. Items range from 0-4 (0 = this attitude is very untrue for me; 4 = this attitude is very true for me), yielding a total score between 0 and 56.
  measure: Survey of Pain Attitudes
  time frame: Change from baseline to 20 weeks
  description: Sum of fourteen self-report items assessing the subject's attitude towards their pain. Items range from 0-4 (0 = this attitude is very untrue for me; 4 = this attitude is very true for me), yielding a total score between 0 and 56.
  measure: Coping Strategies Questionnaire
  time frame: Change from baseline to 4 weeks
  description: Sum of fourteen 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), yielding a total score between 0 and 84.
  measure: Coping Strategies Questionnaire
  time frame: Change from baseline to 8 weeks
  description: Sum of fourteen 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), yielding a total score between 0 and 84.
  measure: Coping Strategies Questionnaire
  time frame: Change from baseline to 20 weeks
  description: Sum of fourteen 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), yielding a total score between 0 and 84.
  measure: Chronic Pain Acceptance Questionnaire-2 Item
  time frame: Change from baseline to 4 weeks
  description: 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.
  measure: Chronic Pain Acceptance Questionnaire-2 Item
  time frame: Change from baseline to 8 weeks
  description: 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.
  measure: Chronic Pain Acceptance Questionnaire-2 Item
  time frame: Change from baseline to 20 weeks
  description: 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.
  measure: Self-Compassion Scale-Short Form
  time frame: Change from baseline to 4 weeks
  description: 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.
  measure: Self-Compassion Scale-Short Form
  time frame: Change from baseline to 8 weeks
  description: 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.
  measure: Self-Compassion Scale-Short Form
  time frame: Change from baseline to 20 weeks
  description: 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.
  measure: Working Alliance Inventory
  time frame: Change from baseline to 4 weeks
  description: Sum of twelve 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 12 and 84.
  measure: Working Alliance Inventory
  time frame: Change from baseline to 8 weeks
  description: Sum of twelve 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 12 and 84.
  measure: Working Alliance Inventory
  time frame: Change from baseline to 20 weeks
  description: Sum of twelve 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 12 and 84.
  measure: Pain Self-Efficacy Questionnaire
  time frame: Change from baseline to 4 weeks
  description: Sum of ten 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 60.
  measure: Pain Self-Efficacy Questionnaire
  time frame: Change from baseline to 8 weeks
  description: Sum of ten 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 60.
  measure: Pain Self-Efficacy Questionnaire
  time frame: Change from baseline to 20 weeks
  description: Sum of ten 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 60.
  measure: Life Events Checklist for DSM-5
  time frame: Baseline
  description: Self report checklist on whether 17 potentially traumatic and life threatening events occurred (yes/no) in the subject's life.
  measure: Pain Catastrophizing Scale
  time frame: Baseline
  description: Sum of thirteen self-report items assessing the types of thoughts and feelings experienced with pain. Items range from 0-4 (0 = not experiencing a type of thought / feeling; 5 = experiencing that thought / feeling all the time), yielding a total score between 0 and 52. Higher scores indicate the subject experiences thoughts and emotions that typically catastrophizes their pain.
  arm group label: Emotional Awareness and Expression Therapy
  arm group type: Experimental
  description: 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.
  arm group label: Mindfulness Meditation
  arm group type: Experimental
  description: 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.
  arm group label: Cognitive Behavioral Therapy
  arm group type: Active Comparator
  description: 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.
  intervention type: Behavioral
  intervention name: Emotional Awareness and Expression Therapy
  description: 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.
  arm group label: Emotional Awareness and Expression Therapy
  other name: EAET
  intervention type: Behavioral
  intervention name: Mindfulness Meditation
  description: 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.
  arm group label: Mindfulness Meditation
  other name: MM
  intervention type: Behavioral
  intervention name: Cognitive Behavioral Therapy
  description: 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.
  arm group label: Cognitive Behavioral Therapy
  other name: CBT
  criteria: 
  gender: All
  minimum age: 60 Years
  maximum age: 95 Years
  healthy volunteers: No
  last name: Brandon C Yarns, MD MS BME
  role: Principal Investigator
  affiliation: VA Greater Los Angeles Healthcare System, West Los Angeles, CA
  last name: Alexander Alas, AA
  phone: (310) 268-4651
  email: alexander.alas@va.gov
  last name: Brandon C Yarns, MD MS BME
  phone: (310) 478-3711
  phone ext: 42764
  email: Brandon.Yarns@va.gov
  facility: 
  contact: 
  contact backup: 
  investigator: 
  facility: 
  contact: 
  contact backup: 
  country: United States
  responsible party type: Sponsor
  mesh term: Musculoskeletal Pain
  mesh term: Chronic Pain
  sharing ipd: Yes
  ipd description: 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.
  ipd info type: Study Protocol
  ipd info type: Statistical Analysis Plan (SAP)
  ipd info type: Informed Consent Form (ICF)
  ipd info type: Analytic Code
  ipd 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.
  ipd 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.