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

Chronic Musculoskeletal Pain Clinical Trial

— GPTVTCOVCP  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06004804
• Other study ID #: IIR 21-207
• Secondary ID: I01HX003494-01A2
• Status: Recruiting
• Phase: N/A
• Start date: October 1, 2023
• Est. completion date: September 30, 2027

Study information

• Verified date: October 2023
• Source: VA Office of Research and Development
• Contact: Alexander Alas, AA
• Phone: (310) 268-4651
• Email: alexander.alas[@]va.gov
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 216
• Est. completion date: September 30, 2027
• Est. primary completion date: September 30, 2027
• Accepts healthy volunteers: No
• Gender: All
• Age group: 60 Years to 95 Years

Eligibility

Inclusion Criteria:

Eligible individuals are

• Veterans;

• age 60-95 years;

• 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; and

• have an average daily pain intensity of at least 4 on a 0 to 10 scale.

Exclusion Criteria:

• 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; and

• 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.

Related Conditions & MeSH terms

• Chronic Musculoskeletal Pain
• Chronic Pain
• Musculoskeletal Pain

Intervention

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.
• 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.
• 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.

Locations

Country	Name	City	State
United States	VA Connecticut Healthcare System West Haven Campus, West Haven, CT	West Haven	Connecticut
United States	VA Greater Los Angeles Healthcare System, West Los Angeles, CA	West Los Angeles	California

Sponsors (1)

Lead Sponsor	Collaborator
VA Office of Research and Development

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Emotional Approach Coping Scales	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.	Change from baseline to 4 weeks
Other	Emotional Approach Coping Scales	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.	Change from baseline to 8 weeks
Other	Emotional Approach Coping Scales	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.	Change from baseline to 20 weeks
Other	Pain/Brain Attributions Scale	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.	Change from baseline to 4 weeks
Other	Pain/Brain Attributions Scale	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.	Change from baseline to 8 weeks
Other	Pain/Brain Attributions Scale	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.	Change from baseline to 20 weeks
Other	Survey of Pain Attitudes	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.	Change from baseline to 4 weeks
Other	Survey of Pain Attitudes	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.	Change from baseline to 8 weeks
Other	Survey of Pain Attitudes	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.	Change from baseline to 20 weeks
Other	Coping Strategies Questionnaire	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.	Change from baseline to 4 weeks
Other	Coping Strategies Questionnaire	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.	Change from baseline to 8 weeks
Other	Coping Strategies Questionnaire	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.	Change from baseline to 20 weeks
Other	Chronic Pain Acceptance Questionnaire-2 Item	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.	Change from baseline to 4 weeks
Other	Chronic Pain Acceptance Questionnaire-2 Item	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.	Change from baseline to 8 weeks
Other	Chronic Pain Acceptance Questionnaire-2 Item	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.	Change from baseline to 20 weeks
Other	Self-Compassion Scale-Short Form	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.	Change from baseline to 4 weeks
Other	Self-Compassion Scale-Short Form	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.	Change from baseline to 8 weeks
Other	Self-Compassion Scale-Short Form	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.	Change from baseline to 20 weeks
Other	Working Alliance Inventory	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.	Change from baseline to 4 weeks
Other	Working Alliance Inventory	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.	Change from baseline to 8 weeks
Other	Working Alliance Inventory	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.	Change from baseline to 20 weeks
Other	Pain Self-Efficacy Questionnaire	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.	Change from baseline to 4 weeks
Other	Pain Self-Efficacy Questionnaire	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.	Change from baseline to 8 weeks
Other	Pain Self-Efficacy Questionnaire	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.	Change from baseline to 20 weeks
Other	Life Events Checklist for DSM-5	Self report checklist on whether 17 potentially traumatic and life threatening events occurred (yes/no) in the subject's life.	Baseline
Other	Pain Catastrophizing Scale	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.	Baseline
Primary	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.	Change from baseline to 8 weeks
Primary	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.	Change from baseline to 20 weeks
Secondary	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.	Change from baseline to 8 weeks
Secondary	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.	Change from baseline to 20 weeks
Secondary	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.	Change from baseline to 8 weeks
Secondary	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.	Change from baseline to 20 weeks
Secondary	Generalized Anxiety Disorder 2-item	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.	Change from baseline to 8 weeks
Secondary	Generalized Anxiety Disorder 2-item	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.	Change from baseline to 20 weeks
Secondary	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.	Change from baseline to 8 weeks
Secondary	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.	Change from baseline to 20 weeks
Secondary	The Veterans RAND 12 Item Health Survey	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.	Change from baseline to 8 weeks
Secondary	The Veterans RAND 12 Item Health Survey	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.	Change from baseline to 20 weeks
Secondary	Satisfaction with Therapy and Therapist Scale-Revised	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.	8 weeks
Secondary	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).	8 weeks
Secondary	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).	20 weeks