NCT01886885

Brief Summary

The primary objective for this pilot study is to determine if the Mindfulness-Based Chronic Pain Management (MBCPM) intervention would decrease pain and pain catastrophizing and increase pain acceptance in participants with chronic pain. The secondary objective is to explore if MBCPM will reduce depression and increase quality of life and mindfulness in the same group of participants. The additional aim of the pilot study is to evaluate the feasibility of conducting the MBCPM intervention in participants with chronic pain. We hypothesize that participants with chronic pain will show relatively good compliance with completing the MBCPM protocol and will show increased satisfaction associated with improvement in pain-related and other psychosocial indicators of functioning.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
20

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Jan 2013

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2013

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2013

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

February 5, 2013

Completed
5 months until next milestone

First Posted

Study publicly available on registry

June 26, 2013

Completed
Last Updated

November 8, 2023

Status Verified

June 1, 2013

Enrollment Period

Same day

First QC Date

February 5, 2013

Last Update Submit

November 6, 2023

Conditions

Keywords

MindfulnessMeditationChronic Pain

Outcome Measures

Primary Outcomes (1)

  • The primary objective for this pilot study is to determine if the Mindfulness-Based Chronic Pain Management (MBCPM) intervention would decrease pain and pain catastrophizing and increase pain acceptance in participants with chronic pain.

    The following assessments will be administered at the start of the intervention, at the end of the 13 week intervention, and at three month follow-up: Numerical Pain Rating Scale, Chronic Pain Acceptance Questionnaire, and the Pain Catastrophizing Scale

    6 months

Secondary Outcomes (1)

  • The secondary objective is to explore if MBCPM will reduce depression and increase quality of life and mindfulness in the same group of participants.

    6 months

Other Outcomes (1)

  • The additional aim of the pilot study is to evaluate the feasibility of conducting the MBCPM intervention in participants with chronic pain.

    6 months

Study Arms (1)

MBCPM

There is just one group of participants of no more than 20 people.

Behavioral: Mindfulness Based Chronic Pain Management Intervention

Interventions

Mindfulness-Based Chronic Pain Management (MBCPM) is an intervention developed by Jackie Gardner-Nix, MD for individuals suffering from chronic pain. The focus of MBCPM is to teach clients skills that will facilitate the development of detached observation and reduce the experience of suffering through cognitive re-appraisal. The activities used within MBCPM include mindfulness meditation, gentle stretching/mindful movement, guided imagery, art techniques, psychoeducation, and discussion. There are daily homework assignments of just 5-30 minutes a day in MBCPM. Each class is two hours long with a break in the middle.

MBCPM

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Participants are 18 years of age and older, English speaking, in chronic pain for 3 months or more,and willing to participate in the 13 sessions.

You may qualify if:

  • years of age
  • English speaking
  • Agree to participate
  • Chronic pain for 3 months or more

You may not qualify if:

  • Not speaking English
  • Cognitive impairment
  • Not able to commit to 13 week intervention

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Utah

Salt Lake City, Utah, 84103, United States

Location

MeSH Terms

Conditions

Chronic Pain

Condition Hierarchy (Ancestors)

PainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 5, 2013

First Posted

June 26, 2013

Study Start

January 1, 2013

Primary Completion

January 1, 2013

Study Completion

January 1, 2013

Last Updated

November 8, 2023

Record last verified: 2013-06

Locations