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CompletedNCT02117921Updated Oct 1, 2024

Mind Body Syndrome (MBS) Therapy for the Treatment of Chronic Pain

An interventional study of One-on-one interview and educational sessions. Reading material for educational series provided. in Chronic Pain, sponsored by Beth Israel Deaconess Medical Center. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-10-01.

Sponsored by Beth Israel Deaconess Medical Center · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
20
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study summary

To determine if Mind Body Syndrome (MBS) therapy will reduce or eliminate pain in patients suffering from chronic pain syndromes without organic etiology.

02

Conditions studied

  • Chronic Pain

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Keywords

  • Mind Body Syndrome
  • MBS
  • Chronic Pain
03

In context

Chronic Pain

2,930 studies on the registry are indexed under Chronic Pain; 701 are open to participants now.

This study's planned enrollment of 20 is below the median of 60 across 2,161 interventional studies indexed under Chronic Pain.

Browse Chronic Pain studies →

Lead sponsor

Beth Israel Deaconess Medical Center is the lead sponsor of 560 studies on the registry; 80 are open to participants now.

Of its 75 completed or terminated interventional studies of FDA-regulated products, 61 (81%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Adult patient 18 > years old
  • Chronic pain without clear organic etiology after full evaluation by primary care physician or subspecialist
  • Pain persistent for a minimum of 3 days a week for the past three months prior to enrollment

Exclusion criteria

Exclusion Criteria:

  • Patients \< 18 years of age
  • Diagnosed organic disease as cause of pain, such as but not limited to malignancy, neurologic disorder (i.e., amyotrophic lateral sclerosis)
  • Patients with a diagnosis of significant psychiatric co-morbidities such as schizophrenia and bi-polar disorder. Mild to moderate depression and anxiety will not be considered as exclusions
  • Pregnancy
  • Severe depression or recent suicide attempt
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
20 participants (estimated)

Study arms

  • Experimental
    MBS therapy education

    Behavioral: One-on-one interview and educational sessions. Reading material for educational series provided.

Interventions

  • BehavioralOne-on-one interview and educational sessions. Reading material for educational series provided.

    A one-on-one interview with the patient and the principal investigator and group educational sessions.

06

What researchers measure

Primary outcomes

  1. Brief Pain Inventory Questionnaire

    To determine if Mind Body Syndrome (MBS) therapy will reduce or eliminate pain in patients suffering from chronic pain syndromes without organic etiology.

    Time frame: 4 weeks

  2. SF-12 Health Survey Scoring Demonstration

    Time frame: 4 weeks

Secondary outcomes

  1. SF-12 Health Survey Scoring Demonstration and Brief Pain Inventory Score

    Time frame: 2 weeks, 4 weeks, 6 months

07

Study locations

1 site
  • Beth Israel Deaconess Medical Center
    Boston, Massachusetts 02215, United States
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 1, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT02117921
Lead sponsor
Beth Israel Deaconess Medical Center
Responsible party
Michael Donnino (Michael W. Donnino, MA, Beth Israel Deaconess Medical Center) — Principal investigator
First posted
Apr 21, 2014
Start date
Feb 2014
Primary completion
Dec 2016
Completion
Dec 2016
Last update
Oct 1, 2024

Study contacts

Michael W Donnino, MD
principal investigator · Beth Israel Deaconess Medical Center

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Sep 2024. You cannot join it, but the record below documents what was studied.

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