Chronic Pain Clinical Trial
Official title:
Efficacy of a 1-Session Spanish "Empowered Relief" Videoconference-Delivered Group Intervention for Chronic Pain
Empowered Relief (ER) is a 1-session pain relief skills intervention that is delivered in-person or online by certified clinicians to groups of patients with acute or chronic pain. Prior work in has shown ER efficacy for reducing chronic pain, pain-related distress, and other symptoms 6 months post-treatment. The purpose of this randomized trial is to conduct the first feasibility and early efficacy test of online Spanish ER delivered to Spanish-speaking adult patients with chronic pain. Participants will be followed for 1 month via 3 follow-up surveys (immediately after treatment, 2 weeks and 1 month post-treatment).
Status | Not yet recruiting |
Enrollment | 110 |
Est. completion date | December 31, 2025 |
Est. primary completion date | December 31, 2025 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: 1. Age 18+ 2. Chronic pain (at least 3 months or more) 3. Spanish fluency 4. Ability to adhere to and complete study procedures Exclusion Criteria: 1. Cognitive impairment, or non-English speaking. 2. Previous participation in the Empowered Relief class. |
Country | Name | City | State |
---|---|---|---|
United States | 1070 Arastradero Rd | Palo Alto | California |
Lead Sponsor | Collaborator |
---|---|
Stanford University | SCAN Health Plan, The Cleveland Clinic |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Treatment appraisal | 7 items assess treatment appraisal/satisfaction using 7-point scales (0-6) where higher ratings represent greater appraisal/satisfaction with the treatment. The investigators hypothesize >=80% ratings for treatment appraisal/satisfaction rated immediately post-treatment. | Immediately post-treatment | |
Primary | Class Attendance | At least 70% attendance for the registered Empowered Relief online class cohorts. | At treatment | |
Secondary | Pain intensity | Pain intensity: within-subject baseline to 1 month using the Patient Reported Outcomes Measurement Information Systems (PROMIS) Pain Intensity 1-item scale assesses average pain intensity for the past 7 days (0= "No pain" to 10= "Worst pain imaginable") where a higher score represents a greater degree of pain intensity. | Post-treatment 1-month | |
Secondary | Pain interference | Pain interference: within-subject baseline to 1 month using the Patient-Reported Outcomes Measurement Information System (PROMIS) Pain Interference 8-item scale assesses pain interference with life enjoyment, concentration, and daily activities over the past 7 days. Responses range from 1 = "Not at all" to 5 = "Very much" where higher scores represent a greater degree of pain interference. | Post-treatment 1-month | |
Secondary | Sleep disturbance | Sleep disturbance: Within-subject baseline to 1 month using the Patient-reported Outcomes Measurement Information System (PROMIS) Sleep Disturbance 6-item scale assesses sleep quality over the past 7 days. Responses range from 1 to 5 where higher scores represent lower sleep quality. | Post-treatment 1-month | |
Secondary | Pain catastrophizing | Pain Catastrophizing: Within-subject baseline to 1 month, the Pain Catastrophizing 13-item scale quantifies an individual's pain experience. Scores range from 0-52 with higher scores indicating higher levels of pain catastrophizing. | Post-treatment 1-month | |
Secondary | Pain bothersomeness | Pain bothersomeness: Within-subject baseline to 1 month the Pain Bothersomeness 1-item scale rated 0-10 assesses pain bothersomeness over the past 7 days. Higher scores represent a greater degree of pain bothersomeness. | Post-treatment 1-month | |
Secondary | Anxiety | Anxiety: Within-subject baseline to 1 month the Patient Reported Outcomes Measurement Information System (PROMIS) Anxiety 6-item scale assesses fearfulness, worry and nervousness in the past 7 days. Responses range from 1 = "Never" to 5 = "Always" where higher scores represent greater degree of anxiety. | Post-treatment 1-month | |
Secondary | Satisfaction with participation in social roles | Satisfaction with participation in social roles: Within-subject baseline to 1 month the PROMIS Satisfaction with Participation in Social Roles 7-item scale assesses satisfaction with performing one's usual social roles and activities. Responses range from 1 = "Not at all" to 5 "Very much" where higher scores represent greater satisfaction. | Post-treatment 1-month | |
Secondary | Anger | Anger: Within-subject baseline to 1 month the Patient Reported Outcomes Measurement Information System (PROMIS) Anger 5-item scale assesses anger over the past 7 days. Responses range from 1 = "Never" to 5 = "Always" where higher scores represent a greater degree of anger. | Post-treatment 1-month | |
Secondary | Fatigue | Fatigue: Within-subject baseline to 1 month the Patient Reported Outcomes Measurement Information System (PROMIS) Fatigue 8-item scale assesses fatigue over the past 7 days. Responses range from 1 = "Not at all" and "Never" to 5 = "Very much" and "Always" where higher scores represent a greater degree of fatigue. | Post-treatment 1-month | |
Secondary | Depression | Depression: Within-subject baseline to 1 month with the Patient Reported Outcomes Measurement Information System (PROMIS) Depression 6-item scale assesses negative mood in the past 7 days. Responses range from 1 = "Never" to 5 = "Always" where higher scores represent greater degree of depression. | Post-treatment 1-month | |
Secondary | Pain Self-Efficacy | Pain Self-Efficacy: Within-subject baseline to 1 month with the Pain Self-Efficacy 2-item scale assessing confidence in functioning in the presence of pain. Responses range from 0 = "Not at all confident" to 6 = "Completely confident" where higher scores represent greater confidence in functioning. | Post-treatment 1-month |
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