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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age60-95
SponsorVA Office of Research and Development

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Veterans

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

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

Disqualifiers

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

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • Emotional Awareness and Expression Therapy

    Behavioral

    Seeks to reduce physical (e.g., pain) and emotional (e.g., depression, anxiety) symptoms by helping individuals become aware of their emotions, express them, and resolve emotional conflicts. It will use techniques such as writing about stress, role playing how to handle difficult relationships, recognizing and expressing anger and other feelings, and being more open with others.

  • Mindfulness Meditation

    Behavioral

    Seeks to help individuals achieve present moment awareness, self-compassion, and acceptance of chronic pain. It will use techniques such as the body scan, grounding, mindful breathing, mindful walking, loving kindness, and compassionate breathing.

  • Cognitive Behavioral Therapy

    Behavioral

    Seeks to help individuals function better and improve symptoms by teaching various cognitive and behavioral skills to manage symptoms. It will use techniques such as relaxation training, engaging in pleasant activities, pacing yourself, and changing unhelpful ways of thinking.

Treatment groups

216 Participants
are divided into 3 treatment groups
Group A: Emotional Awareness and Expression TherapyExperimental treatment 1 intervention
Group B: Mindfulness MeditationExperimental treatment 1 intervention
Group C: Cognitive Behavioral TherapyActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

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.

Time frame
Change from baseline to 8 weeks
2

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.

Time frame
Change from baseline to 20 weeks

Secondary outcomes

1

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.

Time frame
Change from baseline to 8 weeks
2

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.

Time frame
Change from baseline to 20 weeks
3

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.

Time frame
Change from baseline to 8 weeks
4

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.

Time frame
Change from baseline to 20 weeks

Other outcomes

1

Emotional Approach Coping Scales

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
2

Emotional Approach Coping Scales

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
3

Emotional Approach Coping Scales

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
4

Pain/Brain Attributions Scale

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

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