Clinical trial NCT05612750: Comparative Effectiveness of Online 8-session CBT Vs. 1-Session Empowered Relief for Chronic Pain - the PROGRESS Study
Official title: Comparative Effectiveness of Online Cognitive Behavioral Therapy Vs. an Online Single-Session Pain Relief Skills Class for Chronic Pain - the PROGRESS Study
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Pain, Chronic
Lupus
Pelvic Pain
Keywords: Young adult
Lupus
Pelvic Pain
Behavioral Health
Lead sponsor: Stanford University
Sponsor class: OTHER
Collaborators: name: Patient-Centered Outcomes Research Institute
First posted: 2022-11-10
Enrollment: 1650
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
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).
Primary purpose: SUPPORTIVE_CARE

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.

Eligibility criteria: 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 at screening.
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.

Primary outcomes:
measure: Pain Intensity
timeFrame: 1 months
measure: Pain Intensity
timeFrame: 2 months
measure: Pain Intensity
timeFrame: 3 months
measure: Pain Intensity
timeFrame: 6 months
measure: Pain Interference
timeFrame: 1 month
measure: Pain Interference
timeFrame: 2 months
measure: Pain Interference
timeFrame: 3 months
measure: Pain Interference
timeFrame: 6 months
Secondary outcomes:
measure: Sleep Disturbance
timeFrame: 1 month
measure: Sleep Disturbance
timeFrame: 2 months
measure: Sleep Disturbance
timeFrame: 3 months
measure: Sleep Disturbance
timeFrame: 6 months
measure: Pain Bothersomeness
timeFrame: 1 month
measure: Pain Bothersomeness
timeFrame: 2 months
measure: Pain Bothersomeness
timeFrame: 3 months
measure: Pain Bothersomeness
timeFrame: 6 months
measure: Pain Catastrophizing
timeFrame: 1 months
measure: Pain Catastrophizing
timeFrame: 2 months
measure: Pain Catastrophizing
timeFrame: 3 months
measure: Pain Catastrophizing
timeFrame: 6 months
measure: Anxiety
timeFrame: 1 month
measure: Anxiety
timeFrame: 2 months
measure: Anxiety
timeFrame: 3 months
measure: Anxiety
timeFrame: 6 months
measure: Satisfaction with Social Roles/Responsibilities
timeFrame: 1 month
measure: Satisfaction with Social Roles/Responsibilities
timeFrame: 2 months
measure: Satisfaction with Social Roles/Responsibilities
timeFrame: 3 months
measure: Satisfaction with Social Roles/Responsibilities
timeFrame: 6 months
measure: Patient Global Impression of Change
timeFrame: 1months
measure: Patient Global Impression of Change
timeFrame: 2 month
measure: Patient Global Impression of Change
timeFrame: 3 months
measure: Patient Global Impression of Change
timeFrame: 6 months
measure: Depression
timeFrame: 1 month
measure: Depression
timeFrame: 2 months
measure: Depression
timeFrame: 3 months
measure: Depression
timeFrame: 6 months
measure: Fatigue
timeFrame: 1 month
measure: Fatigue
timeFrame: 2 months
measure: Fatigue
timeFrame: 3 months
measure: Fatigue
timeFrame: 6 months
measure: Anger
timeFrame: 1 month
measure: Anger
timeFrame: 2 months
measure: Anger
timeFrame: 3 months
measure: Anger
timeFrame: 6 months
Other outcomes:
measure: Exploratory Outcome Health Service Utilization
timeFrame: 6 months
Locations:
city: Phoenix
country: United States
facility: Phoenix VA Health Care System
state: Arizona
city: Long Beach
country: United States
facility: SCAN Health Plan
state: California
city: Louisville
country: United States
facility: Humana
state: Kentucky
city: Allentown
country: United States
facility: Lehigh Valley Health Network
state: Pennsylvania
city: Salt Lake City
country: United States
facility: Intermountain Healthcare
state: Utah
Study officials:
References: