← Back to Search

ACT + Mindfulness for Chronic Pain & Opioid Use Disorder (HOPE Trial)

N/A

Recruiting

Led By Katie Witkiewitz, PhD

Research Sponsored by University of New Mexico

Eligibility Criteria Checklist

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

Must have

Aged 18 years or older.

Presence of chronic pain for > 6 months in duration.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up change from baseline through 12-week treatment period and 12-month follow-up period

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing a new treatment to help people with chronic pain & OUD reduce pain & prevent relapse. 160 people are recruited and randomized to two treatments. Results will show which is more effective.

Who is the study for?

The HOPE Trial is for adults over 18 with chronic pain and Opioid Use Disorder, who are patients at participating clinics. They must be willing to follow the study's procedures, have had chronic pain for more than six months, and been on a stable dose of buprenorphine for at least one month.

What is being tested?

This trial tests whether Acceptance and Commitment Therapy combined with Mindfulness Based Relapse Prevention (ACT + MBRP) is more effective than Enhanced Usual Care in reducing pain interference and preventing relapse in individuals stabilized on buprenorphine.

What are the potential side effects?

Since ACT + MBRP involves therapy without medications, side effects may include emotional discomfort or distress due to discussing personal issues but typically do not involve physical side effects.

Eligibility Criteria

Inclusion Criteria

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

Select...

I am 18 years old or older.

Select...

I have been experiencing chronic pain for more than 6 months.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ change from baseline through 12-week treatment period and 12-month follow-up period

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~change from baseline through 12-week treatment period and 12-month follow-up period

This trial's timeline: 3 weeks for screening, Varies for treatment, and change from baseline through 12-week treatment period and 12-month follow-up period for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Pain

Secondary study objectives

Change in Craving

Change in Depression

Change in Pain Acceptance

+3 more

Awards & Highlights

No Placebo-Only Group

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

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: ACT + MBRP InterventionExperimental Treatment1 Intervention

The ACT + MBRP group will follow a manualized clinical protocol. Treatment will include 12 weekly, virtual group-based sessions, each lasting 90 minutes. Group sizes will range from three to ten participants. All sessions will be audio recorded for fidelity. Over the course of the group meetings, participants identify areas of meaningful functioning that have been adversely impacted by pain, learn methods to enhance pain willingness in the service of these meaningful areas, and practice present-focused awareness skills. Group sessions include discussions of the impact of pain and distress avoidance, identifying alternatives to this avoidance and establishing plans for behavior change, demonstration and role-playing exercises, and homework assignments. Participants are provided with a treatment manual to help guide and inform practice outside of group sessions.

Group II: Enhanced Usual Care (EUC)Active Control1 Intervention

The Enhanced Usual Care (EUC) condition will supplement standard practices within the study sites related to chronic pain and OUD education. Participants randomized to the EUC condition will receive a brochure (in-person, via email, or via text message) with a list of chronic pain treatment resources, signs and management of opioid overdose including naloxone, and overdose prevention, and will encouraged to schedule an appointment with a clinical provider if they would like to discuss any current or past symptoms. In addition to receiving the brochure, EUC condition participants will meet with a therapist remotely for approximately 15 minutes for a descriptive overview of the brochure. In this session, the therapist will point out the resources in the brochure and read the helpful tips out loud to the participant. This session will be audio recorded for fidelity.

0 / 2Eligibility criteria met