Comparative Effectiveness of Online 8-session CBT vs. 1-Session Empowered Relief for Chronic Pain - The PROGRESS Study

Pain, Chronic Clinical Trial

— PROGRESS  

Official title:

Comparative Effectiveness of Online Cognitive Behavioral Therapy vs. An Online Single-Session Pain Relief Skills Class for Chronic Pain - The PROGRESS Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05612750
• Other study ID #: IRB-65439
• Status: Recruiting
• Phase: N/A
• Start date: January 1, 2023
• Est. completion date: May 1, 2028

Study information

• Verified date: April 2023
• Source: Stanford University
• Contact: Emma A Adair, BS
• Phone: 6097448937
• Email: eadair[@]stanford.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1200
• Est. completion date: May 1, 2028
• Est. primary completion date: May 1, 2028
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Chronic Pain
• Pain, Chronic

Intervention

Behavioral:
• Education
Participants will receive one of two educational programs.

Locations

Country	Name	City	State
United States	Lehigh Valley Health Network	Allentown	Pennsylvania
United States	SCAN Health Plan	Long Beach	California
United States	Humana	Louisville	Kentucky
United States	Phoenix VA Health Care System	Phoenix	Arizona
United States	Intermountain Healthcare	Salt Lake City	Utah

Sponsors (2)

Lead Sponsor	Collaborator
Stanford University	Patient-Centered Outcomes Research Institute

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Exploratory Outcome Health Service Utilization	We will utilize EMR and database records to compare treatment groups for healthcare utilization (e.g., medical visits) during final 3 months of the study vs. 3 months prior to enrollment.	6 months
Primary	Pain Intensity	Compare study treatments for primary outcomes post-treatment with the Numeric Rating Scale (0-10)	1 months
Primary	Pain Intensity	Compare study treatments for primary outcomes post-treatment with the Numeric Rating Scale (0-10)	2 months
Primary	Pain Intensity	Compare study treatments for primary outcomes post-treatment with the Numeric Rating Scale (0-10)	3 months
Primary	Pain Intensity	Compare study treatments for primary outcomes post-treatment with the Numeric Rating Scale (0-10)	6 months
Primary	Pain Interference	Compare study treatments for primary outcomes post-treatment with the Numeric Rating Scale (0-10)	1 month
Primary	Pain Interference	Compare study treatments for primary outcomes post-treatment with the PROMIS Pain Interference 6-item scale.	2 months
Primary	Pain Interference	Compare study treatments for primary outcomes post-treatment with the PROMIS Pain Interference 6-item scale.	3 months
Primary	Pain Interference	Compare study treatments for primary outcomes post-treatment with the PROMIS Pain Interference 6-item scale.	6 months
Secondary	Sleep Disturbance	Compare treatment groups on the PROMIS Sleep Disturbance 6-item	1 month
Secondary	Sleep Disturbance	Compare treatment groups on the PROMIS Sleep Disturbance 6-item	2 months
Secondary	Sleep Disturbance	Compare treatment groups on the PROMIS Sleep Disturbance 6-item	3 months
Secondary	Sleep Disturbance	Compare treatment groups on the PROMIS Sleep Disturbance 6-item	6 months
Secondary	Pain Bothersomeness	Compare treatment groups for Pain Bothersomeness on a Numeric Rating Scale (0-10)	1 month
Secondary	Pain Bothersomeness	Compare treatment groups for Pain Bothersomeness on a Numeric Rating Scale (0-10)	2 months
Secondary	Pain Bothersomeness	Compare treatment groups for Pain Bothersomeness on a Numeric Rating Scale (0-10)	3 months
Secondary	Pain Bothersomeness	Compare treatment groups for Pain Bothersomeness on a Numeric Rating Scale (0-10)	6 months
Secondary	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.	1 months
Secondary	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.	2 months
Secondary	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	3 months
Secondary	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.	6 months
Secondary	Anxiety	Compare treatment groups for anxiety using the PROMIS Anxiety 6-item	1 month
Secondary	Anxiety	Compare treatment groups for anxiety using the PROMIS Anxiety 6-item	2 months
Secondary	Anxiety	Compare treatment groups for anxiety using the PROMIS Anxiety 6-item	3 months
Secondary	Anxiety	Compare treatment groups for anxiety using the PROMIS Anxiety 6-item	6 months
Secondary	Satisfaction with Social Roles/Responsibilities	Compare treatment groups for PROMIS 6 item Satisfaction with Social Roles/Responsibilities	1 month
Secondary	Satisfaction with Social Roles/Responsibilities	Compare treatment groups for PROMIS 6 item Satisfaction with Social Roles/Responsibilities	2 months
Secondary	Satisfaction with Social Roles/Responsibilities	Compare treatment groups for PROMIS 6 item Satisfaction with Social Roles/Responsibilities	3 months
Secondary	Satisfaction with Social Roles/Responsibilities	Compare treatment groups for PROMIS 6 item Satisfaction with Social Roles/Responsibilities	6 months
Secondary	Patient Global Impression of Change	Compare treatment groups for PROMISE 1 item Global Impression of Change scale	1months
Secondary	Patient Global Impression of Change	Compare treatment groups for PROMISE 1 item Global Impression of Change scale	2 month
Secondary	Patient Global Impression of Change	Compare treatment groups for PROMISE 1 item Global Impression of Change scale	3 months
Secondary	Patient Global Impression of Change	Compare treatment groups for PROMISE 1 item Global Impression of Change scale	6 months
Secondary	Depression	Compare study treatments for primary outcomes post-treatment with the PROMIS 6 item Depression scale.	1 month
Secondary	Depression	Compare study treatments for primary outcomes post-treatment with the PROMIS 6 item Depression scale.	2 months
Secondary	Depression	Compare study treatments for primary outcomes post-treatment with the PROMIS 6 item Depression scale.	3 months
Secondary	Depression	Compare study treatments for primary outcomes post-treatment with the PROMIS 6 item Depression scale.	6 months
Secondary	Fatigue	Compare study treatments for primary outcomes post-treatment with the PROMIS 6 item Fatigue scale.	1 month
Secondary	Fatigue	Compare study treatments for primary outcomes post-treatment with the PROMIS 6 item Fatigue scale.	2 months
Secondary	Fatigue	Compare study treatments for primary outcomes post-treatment with the PROMIS 6 item Fatigue scale.	3 months
Secondary	Fatigue	Compare study treatments for primary outcomes post-treatment with the PROMIS 6 item Fatigue scale.	6 months
Secondary	Anger	Compare study treatments for primary outcomes post-treatment with the PROMIS 5 item Anger scale.	1 month
Secondary	Anger	Compare study treatments for primary outcomes post-treatment with the PROMIS 5 item Anger scale.	2 months
Secondary	Anger	Compare study treatments for primary outcomes post-treatment with the PROMIS 5 item Anger scale.	3 months
Secondary	Anger	Compare study treatments for primary outcomes post-treatment with the PROMIS 5 item Anger scale.	6 months