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Behavioral Intervention

Social Intervention + Online CBT for Pain (PANDA Trial)

N/A

Recruiting

Led By Dennis Ang, MD

Research Sponsored by Wake Forest University Health Sciences

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

* Patients with daily pain for 3 months or longer

* Chronic daily musculoskeletal pain with Pain, Enjoyment, General Activity (PEG) Survey score \>=4

Timeline

Screening 3 weeks

Treatment Varies

Follow Up through study completion, on average 16 months

Awards & highlights

No Placebo-Only Group

Summary

This trial aims to determine if patients with chronic pain can better manage their pain and daily activities by working with a care manager and learning pain coping skills from an online tool.

Who is the study for?

This trial is for individuals who have been experiencing daily pain for at least three months, with a significant impact on their enjoyment and general activity. They must be under the care of an Atrium provider and face social challenges like financial insecurity or food scarcity. It's not open to those without these specific criteria.

What is being tested?

The study tests whether chronic pain management can improve by using a patient navigator—a type of care manager—and an online tool called PainTrainer that teaches coping skills.

What are the potential side effects?

Since this trial involves non-medical interventions such as social support and web-based therapy, traditional side effects are not expected; however, participants may experience emotional discomfort or fatigue from engaging in therapy.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I have been experiencing pain daily for at least 3 months.

Select...

I experience daily pain that affects my enjoyment and activity.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ through study completion, on average 16 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~through study completion, on average 16 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and through study completion, on average 16 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Rate of Participant Engagement with PainTrainer

Rate of Participant Engagement with Patient Navigator

Rate of Participant Recruitment

+1 more

Other study objectives

GAD-7

PHQ-8

PROMIS Physical Functioning Short Form 6b

+5 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

3Treatment groups

Experimental Treatment

Group I: Social Intervention Followed by PainTrainerExperimental Treatment2 Interventions

Participants will have social intervention at study entry. Social intervention includes at least six phone call visits, plus or minus 4, with patient navigator to coordinate care. At week 12, web-based cognitive behavior therapy (PainTrainer) will begin. PainTrainer is a self-guided program that contains 8 modules, lasting 30-40 minutes each and can be completed in 8 to 12 weeks. Each module teaches behavioral coping strategies for pain management and recommends practice exercises.

Group II: PainTrainer OnlyExperimental Treatment1 Intervention

Group III: PainTrainer Followed by Social InterventionExperimental Treatment2 Interventions

At study entry participants will receive web-based cognitive behavior therapy (PainTrainer) which is a self-guided program that contains 8 modules, lasting 30-40 minutes each and can be completed in 8 to 12 weeks. Each module teaches behavioral coping strategies for pain management and recommends practice exercises. At Week 12, social intervention will begin. Social intervention includes at least six phone call visits, plus or minus 4, with patient navigator to coordinate care.

0 / 2Eligibility criteria met