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

ConditionsPain, Chronic Lupus Pelvic Pain

Trial statusRecruiting

Trial phaseNot applicable

Trial typeInterventional

Biological sexAll

Age18+

SponsorStanford University

About this trial

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).

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

At least 18 years of age or older of either sex (and all genders).

Chronic pain (pain that occurs on at least half of the days of 3 months or more).

Past-month average pain intensity score of at least 3/10.

Ability to adhere to and complete study protocols.

Disqualifiers

Inability to provide informed consent.

Cognitive impairment, non-English speaking, or psychological factors that would preclude comprehension of material and/or full participation in the study including group treatment.

Active suicidality documented in medical records.

Study staff may exclude individuals with a known history of disruptive behavior to minimize contamination of the learning environment for an entire treatment cohort.

Trial design

Design model

Parallel

Treatments tested in this trial

Cognitive Behavioral Therapy (CBT)
Behavioral
A trained psychologist delivers 8 sessions of low-literacy CBT (the LAMP protocol) to groups of patients who were randomized to this treatment arm.
Empowered Relief
Behavioral
A certified instructor delivers 1 session of pain relief skills intervention (Empowered Relief) to groups of patients who were randomized to this treatment arm.

Treatment groups

1,650 Participants

are divided into 4 treatment groups

Group A: Lupus Chronic Pain CohortExperimental treatment 2 interventions

Group B: Chronic Pelvic PainExperimental treatment 2 interventions

Group C: Young Adult (18-23) Chronic PainExperimental treatment 2 interventions

Group D: PRIME SampleExperimental treatment 2 interventions

Trial outcomes

Primary outcomes

Pain 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

Secondary outcomes

Sleep Disturbance

Compare treatment groups on the PROMIS Sleep Disturbance 6-item

Time frame

1 month

Sleep Disturbance

Compare treatment groups on the PROMIS Sleep Disturbance 6-item

Time frame

2 months

Sleep Disturbance

Compare treatment groups on the PROMIS Sleep Disturbance 6-item

Time frame

3 months

Sleep Disturbance

Compare treatment groups on the PROMIS Sleep Disturbance 6-item

Time frame

6 months

Other outcomes

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.

Time frame

6 months

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Stanford University

Lead sponsor

Patient-Centered Outcomes Research Institute

Collaborator

Source ClinicalTrials.gov

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