Chronic PainNCT03104465
Adaptation of Mindfulness Training to Treat Chronic Pain in the Military
A study testing Mindfulness Training in people with Chronic Pain, run by RTI International at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Pain
- What is being tested?
- Mindfulness Training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 14 participants
- Where
- 1 siteUnited States
- Study dates
- 30 Apr 2017to 11 Jun 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult patients who have experienced chronic pain for at least 6 months
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Womack Army Medical Center at Ft. Bragg
Fort Bragg, North Carolina, 28301
About this study
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.
Read the detailed description
The overall aim of study is to test the acceptability and feasibility of an interactive, web-based mindfulness training with active duty soldiers being treated for chronic pain. We will adapt the evidence-based Mindfulness-based Stress Reduction (MBSR) training for use with this population. The adapted training will be enhanced by mobile applications (apps) for skills practice, using an existing apps platform.
- Conditions
- Chronic Pain
- Being tested
- Mindfulness Training
- Keywords
- Chronic Pain, Mindfulness, Behavioral Health, Quality of Life
- Medical subject headings
- Chronic Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mindfulness TrainingBehavioural
interactive. web-based mindfulness training complemented with mobile application
| Study group | Role | What they receive |
|---|---|---|
| Mindfulness training | Experimental | 6 90-minute sessions interactive, web-based mindfulness training complemented with mobile application Receives: Behavioral: Mindfulness Training |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 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
Measured: 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
Measured: 6 - 8 weeks post-treatment
Chronic Pain
Assess intensity of sensory and affective pain using Short-Form McGill Pain Questionnaire
Measured: Baseline
Chronic Pain
Assess intensity of sensory and affective pain using Short-Form McGill Pain Questionnaire
Measured: 6 - 8 weeks post-treatment
Secondary outcomes (26)
Co-Occurring Conditions - Depression
Assess depression using Patient Reported Outcomes Measurement Information System (PROMIS) Short Form (SF) v.1.0 - Emotional Distress - Depression 8a
Measured: Baseline
Co-Occurring Conditions - Depression
Assess depression using Patient Reported Outcomes Measurement Information System (PROMIS) Short Form (SF) v.1.0 - Emotional Distress - Depression 8a
Measured: 6 - 8 weeks post-treatment
Co-Occurring Conditions - Anxiety
Assess anxiety using Patient Reported Outcomes Measurement Information System (PROMIS) Short Form (SF) v1.0 - Emotional Distress- Anxiety 6a
Measured: Baseline
Co-Occurring Conditions - Anxiety
Assess anxiety using Patient Reported Outcomes Measurement Information System (PROMIS) Short Form (SF) v1.0 - Emotional Distress- Anxiety 6a
Measured: 6 - 8 weeks post-treatment
Co-Occurring Conditions - Alcohol Use
Assess hazardous and harmful alcohol use and dependence using the Alcohol Use Disorders Identification Test (AUDIT)
Measured: Baseline
Co-Occurring Conditions - Alcohol Use
Assess hazardous and harmful alcohol use and dependence using the Alcohol Use Disorders Identification Test (AUDIT)
Measured: 6 - 8 weeks post-treatment
Co-Occurring Conditions - Post Traumatic Stress Disorder
Assess trauma symptoms in response to stressful experiences using the Post Traumatic Stress Disorder (PTSD) Checklist - Civilian version (PCL-C)
Measured: Baseline
Co-Occurring Conditions - Post Traumatic Stress Disorder
Assess trauma symptoms in response to stressful experiences using the Post Traumatic Stress Disorder (PTSD) Checklist - Civilian version (PCL-C)
Measured: 6 - 8 weeks post-treatment
Co-Occurring Conditions - Prescription drug misuse
Assess use of drugs not prescribed, or use of more than recommended dose, to feel good/get high/buzzed
Measured: Baseline
Co-Occurring Conditions - Prescription drug misuse
Assess use of drugs not prescribed, or use of more than recommended dose, to feel good/get high/buzzed
Measured: 6 - 8 weeks post-treatment
Quality of Life - Physical Functioning
Assess physical functioning using Patient Reported Outcomes Measurement Information System (PROMIS) Short Form (SF) v.1.0 - Physical Function 12a
Measured: Baseline
Quality of Life - Physical Functioning
Assess physical functioning using Patient Reported Outcomes Measurement Information System (PROMIS) Short Form (SF) v.1.0 - Physical Function 12a
Measured: 6 - 8 weeks post-treatment
Quality of Life - Sleep disturbance
Assess sleep quality, depth and restoration using Patient Reported Outcomes Measurement Information System (PROMIS) Short Form (SF) v.1.0 - Sleep Disturbance 8a
Measured: Baseline
Quality of Life - Sleep disturbance
Assess sleep quality, depth and restoration using Patient Reported Outcomes Measurement Information System (PROMIS) Short Form (SF) v.1.0 - Sleep Disturbance 8a
Measured: 6 - 8 weeks post-treatment
Quality of Life - Fatigue
Assess fatigue using Patient Reported Outcomes Measurement Information System (PROMIS) Short Form (SF) v.1.0 - Fatigue 8a
Measured: Baseline
Quality of Life - Fatigue
Assess fatigue using Patient Reported Outcomes Measurement Information System (PROMIS) Short Form (SF) v.1.0 - Fatigue 8a
Measured: 6 - 8 weeks post-treatment
Quality of Life - Role satisfaction
Assess social satisfaction using Patient Reported Outcomes Measurement Information System (PROMIS) Short Form (SF) v.1.0 - Ability to Participate in Social Roles \& Activities 8a
Measured: Baseline
Quality of Life - Role satisfaction
Assess social satisfaction using Patient Reported Outcomes Measurement Information System (PROMIS) Short Form (SF) v.1.0 - Ability to Participate in Social Roles \& Activities 8a
Measured: 6 - 8 weeks post-treatment
Self-Regulation - Pain Catastrophizing Scale
Assess experience of pain through sub-scales of rumination, magnification and helplessness
Measured: Baseline
Self-Regulation - Pain Catastrophizing Scale
Assess experience of pain through sub-scales of rumination, magnification and helplessness
Measured: 6 - 8 weeks post-treatment
Self-Regulation - Chronic Pain Acceptance Scale
Assess behavioral aspects of chronic pain acceptance
Measured: Baseline
Self-Regulation - Chronic Pain Acceptance Scale
Assess behavioral aspects of chronic pain acceptance
Measured: 6 - 8 weeks post-treatment
Self-Regulation - Emotional Behavioral Dysregulation
Assess emotional behavioral dysregulation using Patient Reported Outcomes Measurement Information System (PROMIS) Short Form (SF) v.1.0 - Emotional and Behavioral Dyscontrol
Measured: Baseline
Self-Regulation - Emotional Behavioral Dysregulation
Assess emotional behavioral dysregulation using Patient Reported Outcomes Measurement Information System (PROMIS) Short Form (SF) v.1.0 - Emotional and Behavioral Dyscontrol
Measured: 6 - 8 weeks post-treatment
Mindfulness
Assess mindfulness using the Five Factor Mindfulness Questionnaire (FFMQ)
Measured: Baseline
Mindfulness
Assess mindfulness using the Five Factor Mindfulness Questionnaire (FFMQ)
Measured: 6 - 8 weeks post-treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Apr 2017
- Study start30 Apr 2017
- Primary completion11 Jun 2018
- Study completion11 Jun 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 14 participants (actual)
Sponsor and investigators
- Lead sponsor
- RTI International
- Sponsor type
- University, hospital or other
- Collaborators
- University of North Carolina, Chapel Hill
- Responsible party
- Sponsor
- Investigators
- Shari Miller, PhD, Principal investigator, RTI International
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03104465
- Sponsor's protocol ID
- R34AT008423-01
- Status last verified
- Jul 2018
- First submitted
- 3 Apr 2017
- Last updated
- 1 Aug 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Adaptation of Mindfulness Training to Treat Chronic Pain in the Military
- ClinicalTrials.gov ID
- NCT03104465
- Acronym / sponsor ID
- R34AT008423-01
- Conditions
- Chronic Pain
- Keywords
- Chronic Pain, Mindfulness, Behavioral Health, Quality of Life
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 14 participants (actual)
- Lead sponsor
- RTI InternationalUniversity, hospital or other
- Collaborators
- University of North Carolina, Chapel Hill
- Study start
- 30 Apr 2017 (actual)
- Primary completion
- 11 Jun 2018 (actual)
- Study completion
- 11 Jun 2018 (actual)
- First posted
- 7 Apr 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
The overall aim of study is to test the acceptability and feasibility of an interactive, web-based mindfulness training with active duty soldiers being treated for chronic pain. We will adapt the evidence-based Mindfulness-based Stress Reduction (MBSR) training for use with this population. The adapted training will be enhanced by mobile applications (apps) for skills practice, using an existing apps platform.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Mindfulness training | Experimental | Behavioral: Mindfulness Training6 90-minute sessions interactive, web-based mindfulness training complemented with mobile application |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Adult patients who have experienced chronic pain for at least 6 months
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Mindfulness Traininginteractive. web-based mindfulness training complemented with mobile application | Behavioural | Mindfulness training |
Primary outcome
Chronic Pain - Pain Intensity
Time frame: Baseline
Assess pain intensity using the Patient Reported Outcomes Measurement Information System (PROMIS) Short Form (SF) v.1.0 - Pain Intensity 3a
Chronic Pain - Pain Intensity
Time frame: 6 - 8 weeks post-treatment
Assess pain intensity using the Patient Reported Outcomes Measurement Information System (PROMIS) Short Form (SF) v.1.0 - Pain Intensity 3a
Chronic Pain - Pain Interference
Time frame: Baseline
Assess pain intensity using the Patient Reported Outcomes Measurement Information System (PROMIS) Short Form (SF) v.1.0 - Pain Interference 8a
Chronic Pain - Pain Interference
Time frame: 6 - 8 weeks post-treatment
Assess pain intensity using the Patient Reported Outcomes Measurement Information System (PROMIS) Short Form (SF) v.1.0 - Pain Interference 8a
Chronic Pain
Time frame: Baseline
Assess intensity of sensory and affective pain using Short-Form McGill Pain Questionnaire
Chronic Pain
Time frame: 6 - 8 weeks post-treatment
Assess intensity of sensory and affective pain using Short-Form McGill Pain Questionnaire
26 secondary outcomes
Co-Occurring Conditions - Depression
Time frame: Baseline
Co-Occurring Conditions - Depression
Time frame: 6 - 8 weeks post-treatment
Co-Occurring Conditions - Anxiety
Time frame: Baseline
Co-Occurring Conditions - Anxiety
Time frame: 6 - 8 weeks post-treatment
Co-Occurring Conditions - Alcohol Use
Time frame: Baseline
Co-Occurring Conditions - Alcohol Use
Time frame: 6 - 8 weeks post-treatment
Co-Occurring Conditions - Post Traumatic Stress Disorder
Time frame: Baseline
Co-Occurring Conditions - Post Traumatic Stress Disorder
Time frame: 6 - 8 weeks post-treatment
Co-Occurring Conditions - Prescription drug misuse
Time frame: Baseline
Co-Occurring Conditions - Prescription drug misuse
Time frame: 6 - 8 weeks post-treatment
Quality of Life - Physical Functioning
Time frame: Baseline
Quality of Life - Physical Functioning
Time frame: 6 - 8 weeks post-treatment
Quality of Life - Sleep disturbance
Time frame: Baseline
Quality of Life - Sleep disturbance
Time frame: 6 - 8 weeks post-treatment
Quality of Life - Fatigue
Time frame: Baseline
Quality of Life - Fatigue
Time frame: 6 - 8 weeks post-treatment
Quality of Life - Role satisfaction
Time frame: Baseline
Quality of Life - Role satisfaction
Time frame: 6 - 8 weeks post-treatment
Self-Regulation - Pain Catastrophizing Scale
Time frame: Baseline
Self-Regulation - Pain Catastrophizing Scale
Time frame: 6 - 8 weeks post-treatment
Self-Regulation - Chronic Pain Acceptance Scale
Time frame: Baseline
Self-Regulation - Chronic Pain Acceptance Scale
Time frame: 6 - 8 weeks post-treatment
Self-Regulation - Emotional Behavioral Dysregulation
Time frame: Baseline
Self-Regulation - Emotional Behavioral Dysregulation
Time frame: 6 - 8 weeks post-treatment
Mindfulness
Time frame: Baseline
Mindfulness
Time frame: 6 - 8 weeks post-treatment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Aug 2018.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Shari Miller, PhD principal investigator
RTI International
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mindfulness Training in people with Chronic Pain, run by RTI International at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Aug 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Chronic Pain - Pain Intensity (time frame: Baseline). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Aug 2018.