NCT03104465

Brief Summary

The overall aim of this study is to test the acceptability and feasibility of an interactive, web-based mindfulness training with active duty soldiers being treated for chronic pain.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
14

participants targeted

Target at below P25 for not_applicable chronic-pain

Timeline
Completed

Started Apr 2017

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 3, 2017

Completed
4 days until next milestone

First Posted

Study publicly available on registry

April 7, 2017

Completed
23 days until next milestone

Study Start

First participant enrolled

April 30, 2017

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 11, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 11, 2018

Completed
Last Updated

August 1, 2018

Status Verified

July 1, 2018

Enrollment Period

1.1 years

First QC Date

April 3, 2017

Last Update Submit

July 30, 2018

Conditions

Chronic Pain

Keywords

Chronic PainMindfulnessBehavioral HealthQuality of Life

Outcome Measures

Primary Outcomes (6)

  • Chronic Pain - Pain Intensity

    Assess pain intensity using the Patient Reported Outcomes Measurement Information System (PROMIS) Short Form (SF) v.1.0 - Pain Intensity 3a

    Baseline

  • Chronic Pain - Pain Intensity

    Assess pain intensity using the Patient Reported Outcomes Measurement Information System (PROMIS) Short Form (SF) v.1.0 - Pain Intensity 3a

    6 - 8 weeks post-treatment

  • Chronic Pain - Pain Interference

    Assess pain intensity using the Patient Reported Outcomes Measurement Information System (PROMIS) Short Form (SF) v.1.0 - Pain Interference 8a

    Baseline

  • Chronic Pain - Pain Interference

    Assess pain intensity using the Patient Reported Outcomes Measurement Information System (PROMIS) Short Form (SF) v.1.0 - Pain Interference 8a

    6 - 8 weeks post-treatment

  • Chronic Pain

    Assess intensity of sensory and affective pain using Short-Form McGill Pain Questionnaire

    Baseline

  • Chronic Pain

    Assess intensity of sensory and affective pain using Short-Form McGill Pain Questionnaire

    6 - 8 weeks post-treatment

Secondary Outcomes (26)

  • Co-Occurring Conditions - Depression

    Baseline

  • Co-Occurring Conditions - Depression

    6 - 8 weeks post-treatment

  • Co-Occurring Conditions - Anxiety

    Baseline

  • Co-Occurring Conditions - Anxiety

    6 - 8 weeks post-treatment

  • Co-Occurring Conditions - Alcohol Use

    Baseline

  • +21 more secondary outcomes

Study Arms (1)

Mindfulness training

EXPERIMENTAL

6 90-minute sessions interactive, web-based mindfulness training complemented with mobile application

Behavioral: Mindfulness Training

Interventions

Mindfulness TrainingBEHAVIORAL

interactive. web-based mindfulness training complemented with mobile application

Mindfulness training

Eligibility Criteria

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

You may qualify if:

  • Adult patients who have experienced chronic pain for at least 6 months

You may not qualify if:

  • Do not have any of the following conditions: substance abuse or dependence, psychosis, suicidal ideation in the last 2 months, high levels of trauma symptoms,
  • plans to have a permanent change of station or deploy in the coming 6 months, or
  • pregnancy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Womack Army Medical Center at Ft. Bragg

Fort Bragg, North Carolina, 28301, United States

Location

MeSH Terms

Conditions

Chronic Pain

Condition Hierarchy (Ancestors)

PainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Shari Miller, PhD

    RTI International

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 3, 2017

First Posted

April 7, 2017

Study Start

April 30, 2017

Primary Completion

June 11, 2018

Study Completion

June 11, 2018

Last Updated

August 1, 2018

Record last verified: 2018-07

Data Sharing

IPD Sharing
Will not share

Locations

US(1)