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Cognitive Behavioral Therapy

Tailored Non-Pharmacotherapy Services for Chronic Pain (RESOLVE Trial)

N/A

Waitlist Available

Led By Lynn L DeBar, PhD, MPH

Research Sponsored by Kaiser Permanente

Eligibility Criteria Checklist

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

Must have

English speaking or do not need interpreter services

Do not have two or more separate encounters with a malignant cancer diagnosis other than non-melanoma skin cancer within past 60 days

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline to 3, 6, and 12 months

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing whether CBT-CP delivered via a web-based application or live, coach-led, virtual sessions is more effective for chronic pain.

Who is the study for?

This trial is for adults over 18 with chronic pain who are enrolled in one of the participating health care systems. They must speak English, have internet and phone access, and have had recent healthcare visits for non-cancer-related musculoskeletal pain. People can't join if they've had recent CBT for pain, substance abuse treatment, or planned surgeries related to their condition.

What is being tested?

The RESOLVE study tests two telehealth treatments for chronic pain: an online cognitive behavioral therapy-based program (CBT-CP) and a similar program led by a virtual coach via calls or video. Participants will receive either method to see which is more effective.

What are the potential side effects?

Since this trial involves non-pharmacological interventions like online programs and coaching sessions, there aren't typical medication side effects. 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

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I speak English or don't need an interpreter.

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I have not been diagnosed with cancer, other than non-melanoma skin cancer, more than once in the last 60 days.

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I am 18 years old or older.

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I have ongoing pain.

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I experience severe, long-lasting pain.

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I have not received hospice or palliative care in the last year.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline to 3, 6, and 12 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline to 3, 6, and 12 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline to 3, 6, and 12 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

Achieving minimal clinically important difference (MCID) in pain severity at 3 months (yes/no)

Secondary study objectives

Achieving MCID in pain severity at 6 and 12 months (yes / no)

Cost and incremental cost-effectiveness

Pain intensity

+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

Active Control

Group I: Usual Care plus informationActive Control1 Intervention

Receipt of a bound copy of the 2020 edition of the American Chronic Pain Association Resource Guide to Chronic Pain Management and any pharmacologic and nonpharmacologic treatments available to them without restriction

Group II: Online CBT-CP based programActive Control1 Intervention

Self-completed, online program in which participants complete eight, interactive sessions (approximately one per week) focused on training in one or more evidence-based pain coping skills (no usual care services restricted)

Group III: Virtual coach-led CBT-CP based programActive Control1 Intervention

Live, coach-led program delivered by telephone or videoconference in which participants complete eight, interactive sessions (approximately one per week) focused on training in one or more evidence-based pain coping skills (no usual care services restricted)

0 / 6Eligibility criteria met