NCT06720909

Brief Summary

This study proposes a three-arm randomized-controlled trial (RCT) that evaluates the feasibility and acceptability of combining a mindfulness-based therapy (MBT) and open-label placebo (OLP) treatment for individuals with chronic pain. Individuals with chronic pain will be recruited to participate in an 8-week trial, with a subsequent 3-month post-treatment follow-up. Participants will be randomly assigned to one of the following three conditions:

  1. 1.Mindfulness-Based Stress Reduction (MBSR)
  2. 2.OLP treatment
  3. 3.combination of MBSR and OLP treatment

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
45

participants targeted

Target at P25-P50 for not_applicable chronic-pain

Timeline
9mo left

Started Jan 2025

Typical duration for not_applicable chronic-pain

Geographic Reach
1 country

2 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress61%
Jan 2025Mar 2027

First Submitted

Initial submission to the registry

December 3, 2024

Completed
3 days until next milestone

First Posted

Study publicly available on registry

December 6, 2024

Completed
2 months until next milestone

Study Start

First participant enrolled

January 27, 2025

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2027

Last Updated

March 11, 2026

Status Verified

March 1, 2026

Enrollment Period

2.1 years

First QC Date

December 3, 2024

Last Update Submit

March 9, 2026

Conditions

Chronic Pain

Keywords

chronic painpainmindfulnessplacebo

Outcome Measures

Primary Outcomes (12)

  • Feasibility - Feasibility of Participant Enrollment

    Feasibility of participant enrollment will be benchmarked at 100% (N=45) proposed participant enrollment during the study.

    Enrollment

  • Feasibility - Participant Retention

    Participant retention will be benchmarked at a ≥75% retention rate from baseline to 3-month follow-up.

    Enrollment to end of 3-month follow-up

  • Feasibility - MBSR Intervention Adherence

    Intervention adherence for MBSR will be benchmarked as an average of ≥75% (6 out of 8) MBSR session completion AND and average of ≥75% daily mindfulness homework completion.

    Enrollment to end of 8-week treatment

  • Feasibility - OLP Treatment Adherence

    Intervention adherence for OLP treatment will be benchmarked as an average of ≥75% adherence to OLP treatment based upon percent days OLP consumed measured by MEMS (Medication Event Monitoring System) SmartCap AND detection of riboflavin tracer in urine samples during both the mid- and post-treatment sessions.

    Enrollment to end of 8-week treatment

  • Feasibility - Daily Diary Assessment Compliance

    Daily diary assessment compliance will be benhcmarked as an average of ≥75% compliance throughout the study period including baseline, mid-treatment, post-treatment, and 3-month follow-up.

    Enrollment to end of 3-month follow-up

  • Acceptability - Global Satisfaction

    Global satisfaction will be benchmarked as an average score of ≥75 from a 0-100 scale.

    Enrollment to end of 8-week treatment

  • Acceptability - Perceived Intervention Effectiveness

    Perceived intervention effectiveness will be benchmarked as an average score of ≥75 from a 0-100 scale.

    Enrollment to end of 8-week treatment

  • Acceptability - Perceived Intervention Convenience

    Perceived intervention convenience will be benchmarked as an average score of ≥75 from a 0-100 scale.

    Enrollment to end of 8-week treatment

  • Acceptability - Perceived Intervention Side Effects

    Perceived intervention side effects will be benchmarked as an average score of ≥75 from a 0-100 scale.

    Enrollment to end of 8-week treatment

  • Acceptability - Appropriateness of Intervention Length and Frequency

    Appropriateness of intervention length and frequency will be benchmarked as an average score of ≥75 from a 0-100 scale.

    Enrollment to end of 8-week treatment

  • Acceptability - Appropriateness of Daily Diary Length and Frequency

    Appropriateness of daily diary length and frequency will be benchmarked as an average score of ≥75 from a 0-100 scale.

    Enrollment to end of 8-week treatment

  • Acceptability - Appropriateness of Other Study Measures

    Appropriateness of other study measures will be benchmarked as an average score of ≥75 from a 0-100 scale.

    Enrollment to end of 8-week treatment

Other Outcomes (12)

  • Pain Severity

    Enrollment to end of 3-month follow-up

  • Pain Interference

    Enrollment to end of 3-month follow-up

  • Physical Functioning

    Enrollment to end of 3-month follow-up

  • +9 more other outcomes

Study Arms (3)

MBSR-Only

EXPERIMENTAL

This experimental arm receives the 8-week MBSR program only.

Behavioral: Mindfulness-Based Stress Reduction (MBSR)

OLP-Only

EXPERIMENTAL

This experimental arm receives the OLP treatment only.

Other: Open-Label Placebo (OLP)

MBSR+OLP

EXPERIMENTAL

This experimental arm receives the 8-week MBSR program AND the 8-week OLP treatment.

Other: MBSR+OLP

Interventions

MBSR+OLPOTHER

This condition involves a combination of interventions, where participants will receive both MBSR and OLP treatments.

MBSR+OLP
Mindfulness-Based Stress Reduction (MBSR)BEHAVIORAL

The standard 8-week MBSR program will be led by certified MBSR instructors from the UCSD Center for Mindfulness. The program content will consist of a variety of mindfulness and meditative techniques, such as sitting meditation, body scans, and mindful yoga. Participants will engage in weekly sessions via Zoom, participation in group discussions, and honing their other mindfulness skills. Throughout the program, participants will be instructed to commit to a daily mindfulness meditation practice lasting approximately 45 minutes, at least 6 days a week.

MBSR-Only
Open-Label Placebo (OLP)OTHER

The placebo pills will be size #1 capsules filled with (1) microcrystalline cellulose, a common inert excipient for pharmaceuticals, and (2) 25 mg riboflavin tracer. Participants will be informed that the placebo pills are inactive substances, like sugar pills, and contain no active medication. Then, they will watch a brief introduction video which will cover four main discussion points: (1) the placebo effect can be powerful and can have beneficial effects for diverse symptoms, (2) the body can respond to taking placebo pills automatically despite the knowledge that it is placebo (e.g., Pavlov's dogs), (3) a positive attitude or expectation can be beneficial but is not necessary, and (4) taking the pills faithfully throughout the intervention period is critical.

OLP-Only

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • ≥18 years old;
  • ability to speak, write, and read in English;
  • physical pain present on at least half the days in the past 3 months; and
  • average past week pain severity rating ≥3 on a 0-10 Numerical Rating Scale.

You may not qualify if:

  • acute pain due to recent injury or surgery;
  • self-reporting of chronic malignant pain (e.g., cancer, HIV);
  • self-reporting of Raynaud's disease (those who can be contraindicated for cold pressor testing);
  • severe psychopathology (e.g., a psychotic disorder) or significant cognitive deficits judged to interfere with study procedures;
  • currently pregnant or breastfeeding;
  • inability to discontinue use of vitamin B2 supplements or a multivitamin containing vitamin B2 throughout the study period (these interfere with riboflavin tracer-OLP treatment adherence-monitoring);
  • inability to commit to study period.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Arizona State University Downtown Phoenix Campus

Phoenix, Arizona, 85004, United States

RECRUITING

Arizona State University

Phoenix, Arizona, 85004, United States

NOT YET RECRUITING

Related Publications (1)

  • Mun CJ, Contreras E, Xiao Y, Eckert R, Harting A, Damera S, Perez I, Pandey HK, Mardian AS, LoVecchio F, Colloca L, Dunn KE, Todd M, Fillingim RB, Davis MC. Combining mindfulness intervention and open-label placebo treatment for chronic pain: a protocol for a feasibility study. Pilot Feasibility Stud. 2025 Aug 20;11(1):111. doi: 10.1186/s40814-025-01692-8.

    PMID: 40836262DERIVED

MeSH Terms

Conditions

Chronic PainPain

Interventions

Mindfulness-Based Stress Reduction

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

MindfulnessCognitive Behavioral TherapyBehavior TherapyPsychotherapyBehavioral Disciplines and Activities

Study Officials

  • Chung Jung Mun, PhD

    Arizona State University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Chung Jung Mun, PhD

CONTACT

602-496-0809chungjung.mun@asu.edu

Ryan Eckert, MS

CONTACT

602-496-0665ryan.eckert@asu.edu

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

December 3, 2024

First Posted

December 6, 2024

Study Start

January 27, 2025

Primary Completion (Estimated)

March 1, 2027

Study Completion (Estimated)

March 1, 2027

Last Updated

March 11, 2026

Record last verified: 2026-03

Locations

US(2)