Lupus, Pain, Chronic, Pelvic Pain
Conditions
Keywords
Young adult, Lupus, Pelvic Pain, Behavioral Health
Brief summary
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).
Detailed description
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.
Interventions
BEHAVIORALCognitive Behavioral Therapy (CBT)
A trained psychologist delivers 8 sessions of low-literacy CBT (the LAMP protocol) to groups of patients who were randomized to this treatment arm.
BEHAVIORALEmpowered Relief
A certified instructor delivers 1 session of pain relief skills intervention (Empowered Relief) to groups of patients who were randomized to this treatment arm.
Sponsors
Stanford University
Patient-Centered Outcomes Research Institute
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
DOUBLE (Investigator, Outcomes Assessor)
Masking description
Participants and research staff will know arm assignment. Co-investigators, project statisticians, and the protocol director at each study site will remain blinded until final assessment.
Intervention model description
A pragmatic clinical trial randomizing to one of two (standard of care) online group behavioral treatments: (1) 8-session cognitive behavioral therapy for chronic pain (pain-CBT); and (2) single-session pain relief skills intervention for chronic pain (Empowered Relief).
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. At least 18 years of age or older of either sex (and all genders). 2. Chronic pain (pain that occurs on at least half of the days of 3 months or more). 3. Past-month average pain intensity score of at least 3/10. 4. Ability to adhere to and complete study protocols.
Exclusion criteria
1. Inability to provide informed consent. 2. Cognitive impairment, non-English speaking, or psychological factors that would preclude comprehension of material and/or full participation in the study including group treatment. 3. Active suicidality documented in medical records. 4. Study staff may exclude individuals with a known history of disruptive behavior to minimize contamination of the learning environment for an entire treatment cohort. 5. Receipt of either study treatment in the past 3 months.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pain Intensity | 1 months | Compare study treatments for primary outcomes post-treatment with the Numeric Rating Scale (0-10) |
| Pain Interference | 1 month | Compare study treatments for primary outcomes post-treatment with the Numeric Rating Scale (0-10) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Sleep Disturbance | 1 month | Compare treatment groups on the PROMIS Sleep Disturbance 6-item |
| Pain Bothersomeness | 1 month | Compare treatment groups for Pain Bothersomeness on a Numeric Rating Scale (0-10) |
| Pain Catastrophizing | 1 months | Pain Catastrophizing Scale is a 13-item measure with a total score ranging from 0-52 with higher scores indicative of more catastrophizing. |
| Anxiety | 1 month | Compare treatment groups for anxiety using the PROMIS Anxiety 6-item |
| Satisfaction with Social Roles/Responsibilities | 1 month | Compare treatment groups for PROMIS 6 item Satisfaction with Social Roles/Responsibilities |
| Patient Global Impression of Change | 1months | Compare treatment groups for PROMISE 1 item Global Impression of Change scale |
| Depression | 1 month | Compare study treatments for primary outcomes post-treatment with the PROMIS 6 item Depression scale. |
| Fatigue | 1 month | Compare study treatments for primary outcomes post-treatment with the PROMIS 6 item Fatigue scale. |
| Anger | 1 month | Compare study treatments for primary outcomes post-treatment with the PROMIS 5 item Anger scale. |
Countries
United States
Contacts
CONTACTEmma A Adair, BS
CONTACTCorinne Jung, PhD
Outcome results
None listed