The purpose of this study is to conduct a pragmatic clinical trial comparing the effectiveness of: (1) 8-week cognitive behavioral therapy for chronic pain (pain-CBT; sixteen hours total treatment time); and (2) a 1-session pain relief skills intervention for chronic pain (Empowered Relief; two hours total treatment time).
The purpose of this study is to conduct a pragmatic clinical trial comparing the effectiveness: (1) 8-session cognitive behavioral therapy for chronic pain (pain-CBT); and (2) a 1-session pain relief skills intervention for chronic pain (Empowered Relief). The investigators aim to understand for patients which treatment works best. Online evidence-based behavioral treatment for pain will greatly expand access to patients across the U.S. living with diverse chronic pain conditions. Results from this study will fill several critical gaps in evidence that are preventing patients and physicians from making informed decisions about their pain care. This study will provide a low-cost, relatively low-risk, widely available and feasible protocol that directly addresses the needs of millions of community-based outpatients and their physicians.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
DOUBLE
Enrollment
1,650
A trained psychologist delivers 8 sessions of low-literacy CBT (the LAMP protocol) to groups of patients who were randomized to this treatment arm.
A certified instructor delivers 1 session of pain relief skills intervention (Empowered Relief) to groups of patients who were randomized to this treatment arm.
Phoenix VA Health Care System
Phoenix, Arizona, United States
NOT_YET_RECRUITINGSCAN Health Plan
Long Beach, California, United States
RECRUITINGHumana
Louisville, Kentucky, United States
NOT_YET_RECRUITINGPain Intensity
Compare study treatments for primary outcomes post-treatment with the Numeric Rating Scale (0-10)
Time frame: 1 months
Pain Intensity
Compare study treatments for primary outcomes post-treatment with the Numeric Rating Scale (0-10)
Time frame: 2 months
Pain Intensity
Compare study treatments for primary outcomes post-treatment with the Numeric Rating Scale (0-10)
Time frame: 3 months
Pain Intensity
Compare study treatments for primary outcomes post-treatment with the Numeric Rating Scale (0-10)
Time frame: 6 months
Pain Interference
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Time frame: 1 month
Pain Interference
Compare study treatments for primary outcomes post-treatment with the PROMIS Pain Interference 6-item scale.
Time frame: 2 months
Pain Interference
Compare study treatments for primary outcomes post-treatment with the PROMIS Pain Interference 6-item scale.
Time frame: 3 months
Pain Interference
Compare study treatments for primary outcomes post-treatment with the PROMIS Pain Interference 6-item scale.
Time frame: 6 months
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Lehigh Valley Health Network
Allentown, Pennsylvania, United States
RECRUITINGIntermountain Healthcare
Salt Lake City, Utah, United States
RECRUITINGSleep Disturbance
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Time frame: 1 month
Sleep Disturbance
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Time frame: 2 months
Sleep Disturbance
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Time frame: 3 months
Sleep Disturbance
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Time frame: 6 months
Pain Bothersomeness
Compare treatment groups for Pain Bothersomeness on a Numeric Rating Scale (0-10)
Time frame: 1 month
Pain Bothersomeness
Compare treatment groups for Pain Bothersomeness on a Numeric Rating Scale (0-10)
Time frame: 2 months
Pain Bothersomeness
Compare treatment groups for Pain Bothersomeness on a Numeric Rating Scale (0-10)
Time frame: 3 months
Pain Bothersomeness
Compare treatment groups for Pain Bothersomeness on a Numeric Rating Scale (0-10)
Time frame: 6 months
Pain Catastrophizing
Pain Catastrophizing Scale is a 13-item measure with a total score ranging from 0-52 with higher scores indicative of more catastrophizing.
Time frame: 1 months
Pain Catastrophizing
Pain Catastrophizing Scale is a 13-item measure with a total score ranging from 0-52 with higher scores indicative of more catastrophizing.
Time frame: 2 months
Pain Catastrophizing
Pain Catastrophizing Scale is a 13-item measure with a total score ranging from 0-52 with higher scores indicative of more catastrophizing. We aim to obtain \>30% reduction in PCS scores after the intervention
Time frame: 3 months
Pain Catastrophizing
Pain Catastrophizing Scale is a 13-item measure with a total score ranging from 0-52 with higher scores indicative of more catastrophizing.
Time frame: 6 months
Anxiety
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Time frame: 1 month
Anxiety
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Time frame: 2 months
Anxiety
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Time frame: 3 months
Anxiety
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Time frame: 6 months
Satisfaction with Social Roles/Responsibilities
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Time frame: 1 month
Satisfaction with Social Roles/Responsibilities
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Time frame: 2 months
Satisfaction with Social Roles/Responsibilities
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Time frame: 3 months
Satisfaction with Social Roles/Responsibilities
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Time frame: 6 months
Patient Global Impression of Change
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Time frame: 1months
Patient Global Impression of Change
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Time frame: 2 month
Patient Global Impression of Change
Compare treatment groups for PROMISE 1 item Global Impression of Change scale
Time frame: 3 months
Patient Global Impression of Change
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Time frame: 6 months
Depression
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Time frame: 1 month
Depression
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Time frame: 2 months
Depression
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Time frame: 3 months
Depression
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Time frame: 6 months
Fatigue
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Time frame: 1 month
Fatigue
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Time frame: 2 months
Fatigue
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Time frame: 3 months
Fatigue
Compare study treatments for primary outcomes post-treatment with the PROMIS 6 item Fatigue scale.
Time frame: 6 months
Anger
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Time frame: 1 month
Anger
Compare study treatments for primary outcomes post-treatment with the PROMIS 5 item Anger scale.
Time frame: 2 months
Anger
Compare study treatments for primary outcomes post-treatment with the PROMIS 5 item Anger scale.
Time frame: 3 months
Anger
Compare study treatments for primary outcomes post-treatment with the PROMIS 5 item Anger scale.
Time frame: 6 months