Chronic Pain
Conditions
Keywords
Mindfulness, Veteran, Chronic pain
Brief summary
The long-term goal of this two-phase project is to reduce chronic pain and co-morbid conditions among Veterans, through scalable, non-pharmacologic evidence-based strategies that are Veteran-Centric, designed to optimize engagement, adherence and sustainability, and are deliverable to large numbers of Veterans.
Detailed description
The investigators will conduct a 3-site 3-arm pragmatic clinical trial (N = 750) to test effectiveness of 2 Mindfulness-Based Interventions (MBIs), Mobile+Group LAMP and Mobile LAMP, compared to usual practice. Effectiveness will be assessed by pain functioning over the 12-month follow-up period using the Brief Pain Inventory (BPI) interference score. The investigators will test the following primary hypotheses: (1) Mobile LAMP will be more effective at improving chronic pain (as measured by change in the BPI interference score over the 12-month follow-up period) compared to usual practice, (2) Mobile+Group LAMP will be more effective at improving chronic pain (as measured by BPI interference score over the 12-month follow-up period) compared to usual practice, and (3) Mobile+Group LAMP will be more effective at improving chronic pain (as measured by BPI interference change over the 12-month follow-up period) compared to Mobile LAMP without the group component. The investigators will test the following secondary hypotheses: (1) Comparison of intervention group with secondary outcomes listed below, and (2) primary and secondary hypotheses comparisons will be confirmed in gender-specific strata. The primary outcome will be measured as change in BPI interference score over the 12-month follow-up period. Secondary outcomes will include patient-reported measures related to pain, comorbid mental health conditions and function, expected mediators of treatment effects, patient satisfaction, and adverse effects and measures captured in electronic health records. These outcomes will be assessed at 10 weeks, 6 months and 12 months. Implementation data will be collected and described, using the guided Reach, Effectiveness, Adoption, Implementation, and Maintenance (RE-AIM) framework.
Interventions
BEHAVIORALMobile+Group LAMP Mindfulness-Based Intervention
The Mobile+Group LAMP Mindfulness-Based Intervention (MBI) condition consists of eight 90-minute weekly group sessions, delivered via secure video-conferencing. The first session is preceded by a 90-minute technical session introducing the video-conference system and other logistics. The program consists of educational and instructional videos presented by a trained mindfulness instructor interspersed with workbook reflections and group discussions, and daily practice exercises that participants do on their own. A trained facilitator (who is not required to be an expert in mindfulness) leads the group. Participants also have access to a mobile app and a study website, with the same educational and instructional videos that are presented in the group sessions, and the accompanying workbook.
BEHAVIORALMobile LAMP Mindfulness-Based Intervention
The Mobile LAMP MBI consists of 8 self-paced, 30- to 60-minute weekly sessions, delivered on a mobile app and available on the study website, with an accompanying workbook. The program consists of educational and instructional videos presented by a trained mindfulness instructor, with workbook reflections and daily practice exercises that participants do on their own (the same content used in Mobile+Group LAMP). Participants also participate in 3 engagement phone calls with a facilitator. The 1st call (45-60 minutes), held at the beginning of the program, includes technical and logistical information on engaging with mobile app, website, and workbook; and discussion of goals, challenges and plans for practice. The 2nd (middle of program) and 3rd call (end of program) are 25-45 minutes long and address technical/logistical issues and discussion of goals, progress, plans for practice and strategies to address challenges.
Sponsors
United States Department of Defense
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Masking description
The randomization list will be concealed from the research team within the tracking portal, so team members will not know the next study assignment. Permuted blocks will be used to aid in the concealment of treatment assignment while ensuring balance in treatment arms across time.
Intervention model description
Three arm parallel assignment design
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Must have qualifying pain diagnoses on at least 2 occasions, at least 90 days apart, within the same pain category, during the previous 2 years * Must report having a pain duration of ≥ 6 months (pain chronicity threshold), and a pain severity score of ≥ 4 on the 0-10 Numeric Rating Scale (pain severity threshold). * Must have access to a smart phone that meets the requirement of the mobile app software * Must be willing and able to download the mobile app on their phone * Must have wireless or cellular internet access on a daily basis * Must be willing to meet via video conference on the dates and at the time when Mobile+Group LAMP sessions are held, and attend all sessions of the arm to which they are randomized.
Exclusion criteria
* new diagnosis of schizophrenia, bipolar disorder, major depressive disorder, or other psychosis within the past 18 months; or current active psychotic symptoms, suicidality, severe depression, manic episode, and/or poorly controlled bipolar disorder (as assessed by a medical chart review) * currently enrolled in a research study for pain * currently enrolled in mindfulness-based stress reduction (MBSR)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in the Brief Pain Inventory (BPI) Interference Score From Baseline, Over the 12-month Follow-up Period. | Weighted average over 10 weeks, 6 months, and 12 months. | Change in the Brief Pain Inventory (BPI) interference score. Minimum value: 0. Maximum value: 10. Higher scores indicate worse functioning. Change in the outcome measure operationalized as the weighted average of all of the time points during follow-up, adjusting for the baseline value prior to randomization. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Physical Functioning Over the 12-month Follow-up Period Assessed by Mean Score on the Patient-Reported Outcomes Measurement Information System (PROMIS)-29 Profile v.2.0 Measure of Physical Function | Weighted average over 10 weeks, 6 months, and 12 months. | Patient-Reported Outcomes Measurement Information System (PROMIS)-29 Profile v.2.0 measure of physical function. Minimum value: 4. Maximum value: 20. Lower scores indicate worse physical functioning. Change in the outcome measure operationalized as the weighted average of all of the time points during follow-up, adjusting for the baseline value prior to randomization. |
| Change in Anxiety Over the 12-month Follow-up Period Assessed by Mean Score on the Patient-Reported Outcomes Measurement Information System (PROMIS)-29 Profile v.2.0 Measure of Anxiety | Weighted average over 10 weeks, 6 months, and 12 months. | Patient-Reported Outcomes Measurement Information System (PROMIS)-29 Profile v.2.0 measure of anxiety. Minimum value: 4. Maximum value: 20. Higher scores indicate worse anxiety. Change in the outcome measure operationalized as the weighted average of all of the time points during follow-up, adjusting for the baseline value prior to randomization. |
| Change in Fatigue Over the 12-month Follow-up Period Assessed by Mean Score on the Patient-Reported Outcomes Measurement Information System (PROMIS)-29 Profile v.2.0 Measure of Fatigue | Weighted average over 10 weeks, 6 months, and 12 months. | Patient-Reported Outcomes Measurement Information System (PROMIS)-29 Profile v.2.0 measure of fatigue. Minimum value: 4. Maximum value: 20. Higher scores indicate worse fatigue. Change in the outcome measure operationalized as the weighted average of all of the time points during follow-up, adjusting for the baseline value prior to randomization. |
| Change in Sleep Disturbance Over the 12-month Follow-up Period Assessed by Mean Score on the Patient-Reported Outcomes Measurement Information System (PROMIS)-29 Profile v.2.0 Measure of Sleep Disturbance | Weighted average over 10 weeks, 6 months, and 12 months. | Patient-Reported Outcomes Measurement Information System (PROMIS)-29 Profile v.2.0 measure of sleep disturbance. Minimum value: 4. Maximum value: 20. Higher scores indicate worse sleep disturbance. Change in the outcome measure operationalized as the weighted average of all of the time points during follow-up, adjusting for the baseline value prior to randomization. |
| Change in the Brief Pain Inventory (BPI) Intensity Score From Baseline, Over the 12-month Follow-up Period. | Weighted average over 10 weeks, 6 months, and 12 months. | Brief Pain Inventory (BPI) intensity score. Minimum value: 0. Maximum value: 10. Higher scores indicate more severe pain. Change in the outcome measure operationalized as the weighted average of all of the time points during follow-up, adjusting for the baseline value prior to randomization. |
| Change in Depression Over the 12-month Follow-up Period Assessed by Score on the Eight-item Patient Health Questionnaire Depression Scale (PHQ8) | Weighted average over 10 weeks, 6 months, and 12 months. | Patient Health Questionnaire depression scale (PHQ8). Minimum value: 0. Maximum value: 24. Higher scores indicate greater depression. Change in the outcome measure operationalized as the weighted average of all of the time points during follow-up, adjusting for the baseline value prior to randomization. |
| Change in Post Traumatic Stress Disorder (PTSD), Over the 12-month Follow-up Period, Assessed by Participants' Scores on the Post Traumatic Stress Disorder Checklist for Diagnostic and Statistical Manual of Mental Disorders - 5 (PCL-5) | Weighted average over 10 weeks, 6 months, and 12 months. | Post Traumatic Stress Disorder Checklist for Diagnostic and Statistical Manual of Mental Disorders - 5 (PCL-5). Minimum value: 0. Maximum value: 80. Higher scores indicate greater PTSD. Change in the outcome measure operationalized as the weighted average of all of the time points during follow-up, adjusting for the baseline value prior to randomization. |
| Mean Global Improvement of Pain Score, Over the 12-month Follow-up Period | Weighted average over 10 weeks, 6 months, and 12 months. | Global impression of change scale from much better to much worse. Minimum value: 1. Maximum value: 7. Higher scores indicate worse outcome. Change in the outcome measure operationalized as the weighted average of all of the time points during follow-up. |
| BPI Interference Score Responder Analysis | Weighted average over 10 weeks, 6 months, and 12 months. | Change in Brief Pain Inventory (BPI) interference score over the 12-month follow-up period. Number with 30% improvement in BPI inference score. Change in the outcome measure operationalized as the weighted average of all of the time points during follow-up, adjusting for the baseline value prior to randomization. |
| Change in Participation in Social Roles and Activities Over the 12-month Follow-up Period Assessed by Mean Score on the PROMIS-29 Profile v.2.0 Measure of Participation in Social Roles and Activities | Weighted average over 10 weeks, 6 months, and 12 months. | PROMIS-29 Profile v.2.0 measure of participation in social roles and activities. Minimum value: 4. Maximum value: 20. Lower scores indicate greater participation in social roles and activities. Change in the outcome measure operationalized as the weighted average of all of the time points during follow-up, adjusting for the baseline value prior to randomization. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Mobile+Group LAMP Mindfulness-Based Intervention 8 weekly, synchronous interactive online group sessions; access to mobile app and a study website, with an accompanying workbook.
Mobile+Group LAMP Mindfulness-Based Intervention: The Mobile+Group LAMP Mindfulness-Based Intervention (MBI) condition consists of eight 90-minute weekly group sessions, delivered via secure video-conferencing. The first session is preceded by a 90-minute technical session introducing the video-conference system and other logistics. The program consists of educational and instructional videos presented by a trained mindfulness instructor interspersed with workbook reflections and group discussions, and daily practice exercises that participants do on their own. A trained facilitator (who is not required to be an expert in mindfulness) leads the group. Participants also have access to a mobile app and a study website, with the same educational and instructional videos that are presented in the group sessions, and the accompanying workbook. | 270 |
| Mobile LAMP Mindfulness-Based Intervention 8 weekly asynchronous sessions, delivered on mobile app and study website, with an accompanying workbook; 3 engagement calls at the middle, beginning and end of the program.
Mobile LAMP Mindfulness-Based Intervention: The Mobile LAMP MBI consists of 8 self-paced, 30- to 60-minute weekly sessions, delivered on a mobile app and available on the study website, with an accompanying workbook. The program consists of educational and instructional videos presented by a trained mindfulness instructor, with workbook reflections and daily practice exercises that participants do on their own (the same content used in Mobile+Group LAMP). Participants also participate in 3 engagement phone calls with a facilitator. The 1st call (45-60 minutes), held at the beginning of the program, includes technical and logistical information on engaging with mobile app, website, and workbook; and discussion of goals, challenges and plans for practice. The 2nd (middle of program) and 3rd call (end of program) are 25-45 minutes long and address technical/logistical issues and discussion of goals, progress, plans for practice and strategies to address challenges. | 271 |
| Usual Care Engagement in usual care for 12 months as participants normally would. After the entire follow-up period is complete (12 months), participants in the usual care arm are given access to the Mobile LAMP materials MBI training on the app and study website, and the accompanying workbook. | 270 |
| Total | 811 |
Baseline characteristics
| Characteristic | Mobile+Group LAMP Mindfulness-Based Intervention | Total | Usual Care | Mobile LAMP Mindfulness-Based Intervention |
|---|---|---|---|---|
| Age, Continuous | 53.2 years STANDARD_DEVIATION 13.3 | 54.6 years STANDARD_DEVIATION 12.9 | 55.0 years STANDARD_DEVIATION 12.2 | 55.7 years STANDARD_DEVIATION 13 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 15 Participants | 51 Participants | 20 Participants | 16 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 255 Participants | 759 Participants | 250 Participants | 254 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 1 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 2 Participants | 10 Participants | 6 Participants | 2 Participants |
| Race (NIH/OMB) Asian | 1 Participants | 6 Participants | 2 Participants | 3 Participants |
| Race (NIH/OMB) Black or African American | 73 Participants | 208 Participants | 67 Participants | 68 Participants |
| Race (NIH/OMB) More than one race | 9 Participants | 36 Participants | 13 Participants | 14 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 1 Participants | 1 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 2 Participants | 4 Participants | 2 Participants | 0 Participants |
| Race (NIH/OMB) White | 182 Participants | 546 Participants | 180 Participants | 184 Participants |
| Region of Enrollment United States | 270 participants | 811 participants | 270 participants | 271 participants |
| Sex: Female, Male Female | 133 Participants | 387 Participants | 126 Participants | 128 Participants |
| Sex: Female, Male Male | 137 Participants | 424 Participants | 144 Participants | 143 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 270 | 0 / 271 | 0 / 270 |
| other Total, other adverse events | 0 / 270 | 0 / 271 | 0 / 270 |
| serious Total, serious adverse events | 0 / 270 | 0 / 271 | 0 / 270 |
Outcome results
Primary
Change in the Brief Pain Inventory (BPI) Interference Score From Baseline, Over the 12-month Follow-up Period.
Change in the Brief Pain Inventory (BPI) interference score. Minimum value: 0. Maximum value: 10. Higher scores indicate worse functioning. Change in the outcome measure operationalized as the weighted average of all of the time points during follow-up, adjusting for the baseline value prior to randomization.
Time frame: Weighted average over 10 weeks, 6 months, and 12 months.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Mobile+Group LAMP Mindfulness-Based Intervention | Change in the Brief Pain Inventory (BPI) Interference Score From Baseline, Over the 12-month Follow-up Period. | 4.8 score on a scale | Standard Error 0.1 |
| Mobile LAMP Mindfulness-Based Intervention | Change in the Brief Pain Inventory (BPI) Interference Score From Baseline, Over the 12-month Follow-up Period. | 4.5 score on a scale | Standard Error 0.1 |
| Usual Care | Change in the Brief Pain Inventory (BPI) Interference Score From Baseline, Over the 12-month Follow-up Period. | 5.2 score on a scale | Standard Error 0.1 |
p-value: 0.03195% CI: [0, 0.6]Mixed Models Analysis
p-value: 0.00295% CI: [-0.7, -0.2]Mixed Models Analysis
p-value: <0.00195% CI: [-1, -0.4]Mixed Models Analysis
Secondary
BPI Interference Score Responder Analysis
Change in Brief Pain Inventory (BPI) interference score over the 12-month follow-up period. Number with 30% improvement in BPI inference score. Change in the outcome measure operationalized as the weighted average of all of the time points during follow-up, adjusting for the baseline value prior to randomization.
Time frame: Weighted average over 10 weeks, 6 months, and 12 months.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Mobile+Group LAMP Mindfulness-Based Intervention | BPI Interference Score Responder Analysis | 89 Participants |
| Mobile LAMP Mindfulness-Based Intervention | BPI Interference Score Responder Analysis | 109 Participants |
| Usual Care | BPI Interference Score Responder Analysis | 56 Participants |
95% CI: [-13.9, -1.2]Mixed Models Analysis
95% CI: [6.4, 17.6]Mixed Models Analysis
95% CI: [13.6, 25.4]Mixed Models Analysis
Secondary
Change in Anxiety Over the 12-month Follow-up Period Assessed by Mean Score on the Patient-Reported Outcomes Measurement Information System (PROMIS)-29 Profile v.2.0 Measure of Anxiety
Patient-Reported Outcomes Measurement Information System (PROMIS)-29 Profile v.2.0 measure of anxiety. Minimum value: 4. Maximum value: 20. Higher scores indicate worse anxiety. Change in the outcome measure operationalized as the weighted average of all of the time points during follow-up, adjusting for the baseline value prior to randomization.
Time frame: Weighted average over 10 weeks, 6 months, and 12 months.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Mobile+Group LAMP Mindfulness-Based Intervention | Change in Anxiety Over the 12-month Follow-up Period Assessed by Mean Score on the Patient-Reported Outcomes Measurement Information System (PROMIS)-29 Profile v.2.0 Measure of Anxiety | 9.2 score on a scale | Standard Error 0.1 |
| Mobile LAMP Mindfulness-Based Intervention | Change in Anxiety Over the 12-month Follow-up Period Assessed by Mean Score on the Patient-Reported Outcomes Measurement Information System (PROMIS)-29 Profile v.2.0 Measure of Anxiety | 8.8 score on a scale | Standard Error 0.2 |
| Usual Care | Change in Anxiety Over the 12-month Follow-up Period Assessed by Mean Score on the Patient-Reported Outcomes Measurement Information System (PROMIS)-29 Profile v.2.0 Measure of Anxiety | 9.4 score on a scale | Standard Error 0.1 |
p-value: 0.07995% CI: [0, 0.8]Mixed Models Analysis
p-value: 0.29695% CI: [-0.6, 0.2]Mixed Models Analysis
p-value: 0.00595% CI: [-1, -0.2]Mixed Models Analysis
Secondary
Change in Depression Over the 12-month Follow-up Period Assessed by Score on the Eight-item Patient Health Questionnaire Depression Scale (PHQ8)
Patient Health Questionnaire depression scale (PHQ8). Minimum value: 0. Maximum value: 24. Higher scores indicate greater depression. Change in the outcome measure operationalized as the weighted average of all of the time points during follow-up, adjusting for the baseline value prior to randomization.
Time frame: Weighted average over 10 weeks, 6 months, and 12 months.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Mobile+Group LAMP Mindfulness-Based Intervention | Change in Depression Over the 12-month Follow-up Period Assessed by Score on the Eight-item Patient Health Questionnaire Depression Scale (PHQ8) | 8.2 score on a scale | Standard Error 0.2 |
| Mobile LAMP Mindfulness-Based Intervention | Change in Depression Over the 12-month Follow-up Period Assessed by Score on the Eight-item Patient Health Questionnaire Depression Scale (PHQ8) | 8.2 score on a scale | Standard Error 0.2 |
| Usual Care | Change in Depression Over the 12-month Follow-up Period Assessed by Score on the Eight-item Patient Health Questionnaire Depression Scale (PHQ8) | 9.1 score on a scale | Standard Error 0.2 |
p-value: 0.8995% CI: [-0.7, 0.6]Mixed Models Analysis
p-value: 0.00395% CI: [-1.5, -0.3]Mixed Models Analysis
p-value: 0.00795% CI: [-1.5, -0.2]Mixed Models Analysis
Secondary
Change in Fatigue Over the 12-month Follow-up Period Assessed by Mean Score on the Patient-Reported Outcomes Measurement Information System (PROMIS)-29 Profile v.2.0 Measure of Fatigue
Patient-Reported Outcomes Measurement Information System (PROMIS)-29 Profile v.2.0 measure of fatigue. Minimum value: 4. Maximum value: 20. Higher scores indicate worse fatigue. Change in the outcome measure operationalized as the weighted average of all of the time points during follow-up, adjusting for the baseline value prior to randomization.
Time frame: Weighted average over 10 weeks, 6 months, and 12 months.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Mobile+Group LAMP Mindfulness-Based Intervention | Change in Fatigue Over the 12-month Follow-up Period Assessed by Mean Score on the Patient-Reported Outcomes Measurement Information System (PROMIS)-29 Profile v.2.0 Measure of Fatigue | 12.9 score on a scale | Standard Error 0.2 |
| Mobile LAMP Mindfulness-Based Intervention | Change in Fatigue Over the 12-month Follow-up Period Assessed by Mean Score on the Patient-Reported Outcomes Measurement Information System (PROMIS)-29 Profile v.2.0 Measure of Fatigue | 12.7 score on a scale | Standard Error 0.2 |
| Usual Care | Change in Fatigue Over the 12-month Follow-up Period Assessed by Mean Score on the Patient-Reported Outcomes Measurement Information System (PROMIS)-29 Profile v.2.0 Measure of Fatigue | 13.5 score on a scale | Standard Error 0.2 |
p-value: 0.46495% CI: [-0.3, 0.7]Mixed Models Analysis
p-value: 0.01995% CI: [-1.1, -0.1]Mixed Models Analysis
p-value: 0.00295% CI: [-1.3, -0.3]Mixed Models Analysis
Secondary
Change in Participation in Social Roles and Activities Over the 12-month Follow-up Period Assessed by Mean Score on the PROMIS-29 Profile v.2.0 Measure of Participation in Social Roles and Activities
PROMIS-29 Profile v.2.0 measure of participation in social roles and activities. Minimum value: 4. Maximum value: 20. Lower scores indicate greater participation in social roles and activities. Change in the outcome measure operationalized as the weighted average of all of the time points during follow-up, adjusting for the baseline value prior to randomization.
Time frame: Weighted average over 10 weeks, 6 months, and 12 months.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Mobile+Group LAMP Mindfulness-Based Intervention | Change in Participation in Social Roles and Activities Over the 12-month Follow-up Period Assessed by Mean Score on the PROMIS-29 Profile v.2.0 Measure of Participation in Social Roles and Activities | 12.0 score on a scale | Standard Error 0.2 |
| Mobile LAMP Mindfulness-Based Intervention | Change in Participation in Social Roles and Activities Over the 12-month Follow-up Period Assessed by Mean Score on the PROMIS-29 Profile v.2.0 Measure of Participation in Social Roles and Activities | 11.9 score on a scale | Standard Error 0.2 |
| Usual Care | Change in Participation in Social Roles and Activities Over the 12-month Follow-up Period Assessed by Mean Score on the PROMIS-29 Profile v.2.0 Measure of Participation in Social Roles and Activities | 11.0 score on a scale | Standard Error 0.1 |
p-value: 0.7695% CI: [-0.4, 0.5]Mixed Models Analysis
p-value: <0.00195% CI: [0.6, 1.4]Mixed Models Analysis
p-value: <0.00195% CI: [0.5, 1.3]Mixed Models Analysis
Secondary
Change in Physical Functioning Over the 12-month Follow-up Period Assessed by Mean Score on the Patient-Reported Outcomes Measurement Information System (PROMIS)-29 Profile v.2.0 Measure of Physical Function
Patient-Reported Outcomes Measurement Information System (PROMIS)-29 Profile v.2.0 measure of physical function. Minimum value: 4. Maximum value: 20. Lower scores indicate worse physical functioning. Change in the outcome measure operationalized as the weighted average of all of the time points during follow-up, adjusting for the baseline value prior to randomization.
Time frame: Weighted average over 10 weeks, 6 months, and 12 months.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Mobile+Group LAMP Mindfulness-Based Intervention | Change in Physical Functioning Over the 12-month Follow-up Period Assessed by Mean Score on the Patient-Reported Outcomes Measurement Information System (PROMIS)-29 Profile v.2.0 Measure of Physical Function | 13.3 score on a scale | Standard Error 0.1 |
| Mobile LAMP Mindfulness-Based Intervention | Change in Physical Functioning Over the 12-month Follow-up Period Assessed by Mean Score on the Patient-Reported Outcomes Measurement Information System (PROMIS)-29 Profile v.2.0 Measure of Physical Function | 13.3 score on a scale | Standard Error 0.1 |
| Usual Care | Change in Physical Functioning Over the 12-month Follow-up Period Assessed by Mean Score on the Patient-Reported Outcomes Measurement Information System (PROMIS)-29 Profile v.2.0 Measure of Physical Function | 12.7 score on a scale | Standard Error 0.1 |
p-value: 0.82995% CI: [-0.4, 0.4]Mixed Models Analysis
p-value: 0.00595% CI: [0.2, 0.9]Mixed Models Analysis
p-value: 0.00495% CI: [0.2, 1]Mixed Models Analysis
Secondary
Change in Post Traumatic Stress Disorder (PTSD), Over the 12-month Follow-up Period, Assessed by Participants' Scores on the Post Traumatic Stress Disorder Checklist for Diagnostic and Statistical Manual of Mental Disorders - 5 (PCL-5)
Post Traumatic Stress Disorder Checklist for Diagnostic and Statistical Manual of Mental Disorders - 5 (PCL-5). Minimum value: 0. Maximum value: 80. Higher scores indicate greater PTSD. Change in the outcome measure operationalized as the weighted average of all of the time points during follow-up, adjusting for the baseline value prior to randomization.
Time frame: Weighted average over 10 weeks, 6 months, and 12 months.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Mobile+Group LAMP Mindfulness-Based Intervention | Change in Post Traumatic Stress Disorder (PTSD), Over the 12-month Follow-up Period, Assessed by Participants' Scores on the Post Traumatic Stress Disorder Checklist for Diagnostic and Statistical Manual of Mental Disorders - 5 (PCL-5) | 22.8 score on a scale | Standard Error 0.6 |
| Mobile LAMP Mindfulness-Based Intervention | Change in Post Traumatic Stress Disorder (PTSD), Over the 12-month Follow-up Period, Assessed by Participants' Scores on the Post Traumatic Stress Disorder Checklist for Diagnostic and Statistical Manual of Mental Disorders - 5 (PCL-5) | 22.7 score on a scale | Standard Error 0.6 |
| Usual Care | Change in Post Traumatic Stress Disorder (PTSD), Over the 12-month Follow-up Period, Assessed by Participants' Scores on the Post Traumatic Stress Disorder Checklist for Diagnostic and Statistical Manual of Mental Disorders - 5 (PCL-5) | 24.9 score on a scale | Standard Error 0.6 |
p-value: 0.88695% CI: [-1.6, 1.9]Mixed Models Analysis
p-value: 0.01795% CI: [-3.7, -0.4]Mixed Models Analysis
p-value: 0.01395% CI: [-3.9, -0.5]Mixed Models Analysis
Secondary
Change in Sleep Disturbance Over the 12-month Follow-up Period Assessed by Mean Score on the Patient-Reported Outcomes Measurement Information System (PROMIS)-29 Profile v.2.0 Measure of Sleep Disturbance
Patient-Reported Outcomes Measurement Information System (PROMIS)-29 Profile v.2.0 measure of sleep disturbance. Minimum value: 4. Maximum value: 20. Higher scores indicate worse sleep disturbance. Change in the outcome measure operationalized as the weighted average of all of the time points during follow-up, adjusting for the baseline value prior to randomization.
Time frame: Weighted average over 10 weeks, 6 months, and 12 months.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Mobile+Group LAMP Mindfulness-Based Intervention | Change in Sleep Disturbance Over the 12-month Follow-up Period Assessed by Mean Score on the Patient-Reported Outcomes Measurement Information System (PROMIS)-29 Profile v.2.0 Measure of Sleep Disturbance | 13.3 score on a scale | Standard Error 0.2 |
| Mobile LAMP Mindfulness-Based Intervention | Change in Sleep Disturbance Over the 12-month Follow-up Period Assessed by Mean Score on the Patient-Reported Outcomes Measurement Information System (PROMIS)-29 Profile v.2.0 Measure of Sleep Disturbance | 13.3 score on a scale | Standard Error 0.2 |
| Usual Care | Change in Sleep Disturbance Over the 12-month Follow-up Period Assessed by Mean Score on the Patient-Reported Outcomes Measurement Information System (PROMIS)-29 Profile v.2.0 Measure of Sleep Disturbance | 13.9 score on a scale | Standard Error 0.2 |
p-value: 0.88995% CI: [-0.5, 0.4]Mixed Models Analysis
p-value: 0.00495% CI: [-1.1, -0.2]Mixed Models Analysis
p-value: 0.00695% CI: [-1.1, -0.2]Mixed Models Analysis
Secondary
Change in the Brief Pain Inventory (BPI) Intensity Score From Baseline, Over the 12-month Follow-up Period.
Brief Pain Inventory (BPI) intensity score. Minimum value: 0. Maximum value: 10. Higher scores indicate more severe pain. Change in the outcome measure operationalized as the weighted average of all of the time points during follow-up, adjusting for the baseline value prior to randomization.
Time frame: Weighted average over 10 weeks, 6 months, and 12 months.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Mobile+Group LAMP Mindfulness-Based Intervention | Change in the Brief Pain Inventory (BPI) Intensity Score From Baseline, Over the 12-month Follow-up Period. | 4.7 score on a scale | Standard Error 0.1 |
| Mobile LAMP Mindfulness-Based Intervention | Change in the Brief Pain Inventory (BPI) Intensity Score From Baseline, Over the 12-month Follow-up Period. | 4.6 score on a scale | Standard Error 0.1 |
| Usual Care | Change in the Brief Pain Inventory (BPI) Intensity Score From Baseline, Over the 12-month Follow-up Period. | 5.1 score on a scale | Standard Error 0.1 |
p-value: 0.73695% CI: [-0.2, 0.3]Mixed Models Analysis
p-value: <0.00195% CI: [-0.6, -0.2]Mixed Models Analysis
p-value: <0.00195% CI: [-0.7, -0.2]Mixed Models Analysis
Secondary
Mean Global Improvement of Pain Score, Over the 12-month Follow-up Period
Global impression of change scale from much better to much worse. Minimum value: 1. Maximum value: 7. Higher scores indicate worse outcome. Change in the outcome measure operationalized as the weighted average of all of the time points during follow-up.
Time frame: Weighted average over 10 weeks, 6 months, and 12 months.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Mobile+Group LAMP Mindfulness-Based Intervention | Mean Global Improvement of Pain Score, Over the 12-month Follow-up Period | 3.4 units on a scale | Standard Error 0.1 |
| Mobile LAMP Mindfulness-Based Intervention | Mean Global Improvement of Pain Score, Over the 12-month Follow-up Period | 3.3 units on a scale | Standard Error 0.1 |
| Usual Care | Mean Global Improvement of Pain Score, Over the 12-month Follow-up Period | 4.1 units on a scale | Standard Error 0.1 |
p-value: 0.43795% CI: [-0.1, 0.3]Mixed Models Analysis
p-value: <0.00195% CI: [-0.9, -0.5]Mixed Models Analysis
p-value: <0.00195% CI: [-1, -0.6]Mixed Models Analysis