Trial Outcomes & Findings for Learning to Apply Mindfulness to Pain (NCT NCT04526158)
NCT ID: NCT04526158
Last Updated: 2024-11-05
Results Overview
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.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
811 participants
Primary outcome timeframe
Weighted average over 10 weeks, 6 months, and 12 months.
Results posted on
2024-11-05
Participant Flow
Participant milestones
| Measure |
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.
|
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.
|
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.
|
|---|---|---|---|
|
Overall Study
STARTED
|
270
|
271
|
270
|
|
Overall Study
COMPLETED
|
225
|
225
|
244
|
|
Overall Study
NOT COMPLETED
|
45
|
46
|
26
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Learning to Apply Mindfulness to Pain
Baseline characteristics by cohort
| Measure |
Mobile+Group LAMP Mindfulness-Based Intervention
n=270 Participants
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.
|
Mobile LAMP Mindfulness-Based Intervention
n=271 Participants
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.
|
Usual Care
n=270 Participants
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.
|
Total
n=811 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
53.2 years
STANDARD_DEVIATION 13.3 • n=99 Participants
|
55.7 years
STANDARD_DEVIATION 13.0 • n=107 Participants
|
55.0 years
STANDARD_DEVIATION 12.2 • n=206 Participants
|
54.6 years
STANDARD_DEVIATION 12.9 • n=7 Participants
|
|
Sex: Female, Male
Female
|
133 Participants
n=99 Participants
|
128 Participants
n=107 Participants
|
126 Participants
n=206 Participants
|
387 Participants
n=7 Participants
|
|
Sex: Female, Male
Male
|
137 Participants
n=99 Participants
|
143 Participants
n=107 Participants
|
144 Participants
n=206 Participants
|
424 Participants
n=7 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
15 Participants
n=99 Participants
|
16 Participants
n=107 Participants
|
20 Participants
n=206 Participants
|
51 Participants
n=7 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
255 Participants
n=99 Participants
|
254 Participants
n=107 Participants
|
250 Participants
n=206 Participants
|
759 Participants
n=7 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
1 Participants
n=7 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
2 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
6 Participants
n=206 Participants
|
10 Participants
n=7 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
6 Participants
n=7 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
1 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
1 Participants
n=7 Participants
|
|
Race (NIH/OMB)
Black or African American
|
73 Participants
n=99 Participants
|
68 Participants
n=107 Participants
|
67 Participants
n=206 Participants
|
208 Participants
n=7 Participants
|
|
Race (NIH/OMB)
White
|
182 Participants
n=99 Participants
|
184 Participants
n=107 Participants
|
180 Participants
n=206 Participants
|
546 Participants
n=7 Participants
|
|
Race (NIH/OMB)
More than one race
|
9 Participants
n=99 Participants
|
14 Participants
n=107 Participants
|
13 Participants
n=206 Participants
|
36 Participants
n=7 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
4 Participants
n=7 Participants
|
|
Region of Enrollment
United States
|
270 participants
n=99 Participants
|
271 participants
n=107 Participants
|
270 participants
n=206 Participants
|
811 participants
n=7 Participants
|
PRIMARY outcome
Timeframe: 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.
Outcome measures
| Measure |
Mobile+Group LAMP Mindfulness-Based Intervention
n=270 Participants
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.
|
Mobile LAMP Mindfulness-Based Intervention
n=271 Participants
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.
|
Usual Care
n=270 Participants
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.
|
|---|---|---|---|
|
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
|
4.5 score on a scale
Standard Error 0.1
|
5.2 score on a scale
Standard Error 0.1
|
SECONDARY outcome
Timeframe: 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.
Outcome measures
| Measure |
Mobile+Group LAMP Mindfulness-Based Intervention
n=270 Participants
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.
|
Mobile LAMP Mindfulness-Based Intervention
n=271 Participants
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.
|
Usual Care
n=270 Participants
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.
|
|---|---|---|---|
|
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
|
4.6 score on a scale
Standard Error 0.1
|
5.1 score on a scale
Standard Error 0.1
|
SECONDARY outcome
Timeframe: 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.
Outcome measures
| Measure |
Mobile+Group LAMP Mindfulness-Based Intervention
n=270 Participants
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.
|
Mobile LAMP Mindfulness-Based Intervention
n=271 Participants
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.
|
Usual Care
n=270 Participants
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.
|
|---|---|---|---|
|
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
|
13.3 score on a scale
Standard Error 0.1
|
12.7 score on a scale
Standard Error 0.1
|
SECONDARY outcome
Timeframe: 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.
Outcome measures
| Measure |
Mobile+Group LAMP Mindfulness-Based Intervention
n=270 Participants
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.
|
Mobile LAMP Mindfulness-Based Intervention
n=271 Participants
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.
|
Usual Care
n=270 Participants
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.
|
|---|---|---|---|
|
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
|
8.8 score on a scale
Standard Error 0.2
|
9.4 score on a scale
Standard Error 0.1
|
SECONDARY outcome
Timeframe: 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.
Outcome measures
| Measure |
Mobile+Group LAMP Mindfulness-Based Intervention
n=270 Participants
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.
|
Mobile LAMP Mindfulness-Based Intervention
n=271 Participants
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.
|
Usual Care
n=270 Participants
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.
|
|---|---|---|---|
|
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
|
12.7 score on a scale
Standard Error 0.2
|
13.5 score on a scale
Standard Error 0.2
|
SECONDARY outcome
Timeframe: 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.
Outcome measures
| Measure |
Mobile+Group LAMP Mindfulness-Based Intervention
n=270 Participants
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.
|
Mobile LAMP Mindfulness-Based Intervention
n=271 Participants
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.
|
Usual Care
n=270 Participants
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.
|
|---|---|---|---|
|
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
|
13.3 score on a scale
Standard Error 0.2
|
13.9 score on a scale
Standard Error 0.2
|
SECONDARY outcome
Timeframe: 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.
Outcome measures
| Measure |
Mobile+Group LAMP Mindfulness-Based Intervention
n=270 Participants
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.
|
Mobile LAMP Mindfulness-Based Intervention
n=271 Participants
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.
|
Usual Care
n=270 Participants
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.
|
|---|---|---|---|
|
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
|
11.9 score on a scale
Standard Error 0.2
|
11.0 score on a scale
Standard Error 0.1
|
SECONDARY outcome
Timeframe: 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.
Outcome measures
| Measure |
Mobile+Group LAMP Mindfulness-Based Intervention
n=270 Participants
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.
|
Mobile LAMP Mindfulness-Based Intervention
n=271 Participants
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.
|
Usual Care
n=270 Participants
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.
|
|---|---|---|---|
|
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
|
8.2 score on a scale
Standard Error 0.2
|
9.1 score on a scale
Standard Error 0.2
|
SECONDARY outcome
Timeframe: 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.
Outcome measures
| Measure |
Mobile+Group LAMP Mindfulness-Based Intervention
n=270 Participants
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.
|
Mobile LAMP Mindfulness-Based Intervention
n=271 Participants
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.
|
Usual Care
n=270 Participants
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.
|
|---|---|---|---|
|
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
|
22.7 score on a scale
Standard Error 0.6
|
24.9 score on a scale
Standard Error 0.6
|
SECONDARY outcome
Timeframe: 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.
Outcome measures
| Measure |
Mobile+Group LAMP Mindfulness-Based Intervention
n=270 Participants
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.
|
Mobile LAMP Mindfulness-Based Intervention
n=271 Participants
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.
|
Usual Care
n=270 Participants
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.
|
|---|---|---|---|
|
Mean Global Improvement of Pain Score, Over the 12-month Follow-up Period
|
3.4 units on a scale
Standard Error 0.1
|
3.3 units on a scale
Standard Error 0.1
|
4.1 units on a scale
Standard Error 0.1
|
SECONDARY outcome
Timeframe: 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.
Outcome measures
| Measure |
Mobile+Group LAMP Mindfulness-Based Intervention
n=270 Participants
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.
|
Mobile LAMP Mindfulness-Based Intervention
n=271 Participants
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.
|
Usual Care
n=270 Participants
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.
|
|---|---|---|---|
|
BPI Interference Score Responder Analysis
|
89 Participants
|
109 Participants
|
56 Participants
|
Adverse Events
Mobile+Group LAMP Mindfulness-Based Intervention
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Mobile LAMP Mindfulness-Based Intervention
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Usual Care
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place