Trial Outcomes & Findings for Adolescent Mindfulness Mobile App Study (RCT) (NCT NCT03900416)
NCT ID: NCT03900416
Last Updated: 2021-11-08
Results Overview
trait rumination (range = 0-39 with higher scores indicating more rumination)
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
152 participants
Primary outcome timeframe
baseline
Results posted on
2021-11-08
Participant Flow
Participant milestones
| Measure |
Mindfulness App
Guided mindfulness exercises will be delivered via mobile app for three weeks.
Mindfulness App: Mindfulness exercises will last 1-12 minutes. Each one asks participants to focus on something (e.g., breath, sounds, physical sensations) using guided instruction.
|
Control Condition
Participants will use app for assessment for three weeks, but no mindfulness exercises will be delivered.
|
|---|---|---|
|
Baseline
STARTED
|
72
|
80
|
|
Baseline
COMPLETED
|
72
|
80
|
|
Baseline
NOT COMPLETED
|
0
|
0
|
|
Post
STARTED
|
72
|
80
|
|
Post
COMPLETED
|
72
|
80
|
|
Post
NOT COMPLETED
|
0
|
0
|
|
Six Week Follow-up
STARTED
|
72
|
80
|
|
Six Week Follow-up
COMPLETED
|
70
|
80
|
|
Six Week Follow-up
NOT COMPLETED
|
2
|
0
|
|
Twelve Week Follow-up
STARTED
|
70
|
80
|
|
Twelve Week Follow-up
COMPLETED
|
69
|
76
|
|
Twelve Week Follow-up
NOT COMPLETED
|
1
|
4
|
|
Six Month Follow-up
STARTED
|
69
|
76
|
|
Six Month Follow-up
COMPLETED
|
64
|
72
|
|
Six Month Follow-up
NOT COMPLETED
|
5
|
4
|
Reasons for withdrawal
| Measure |
Mindfulness App
Guided mindfulness exercises will be delivered via mobile app for three weeks.
Mindfulness App: Mindfulness exercises will last 1-12 minutes. Each one asks participants to focus on something (e.g., breath, sounds, physical sensations) using guided instruction.
|
Control Condition
Participants will use app for assessment for three weeks, but no mindfulness exercises will be delivered.
|
|---|---|---|
|
Six Week Follow-up
Lost to Follow-up
|
1
|
0
|
|
Six Week Follow-up
Withdrawal by Subject
|
1
|
0
|
|
Twelve Week Follow-up
Lost to Follow-up
|
0
|
2
|
|
Twelve Week Follow-up
Withdrawal by Subject
|
0
|
1
|
|
Twelve Week Follow-up
Adverse Event
|
1
|
1
|
|
Six Month Follow-up
Lost to Follow-up
|
4
|
3
|
|
Six Month Follow-up
Withdrawal by Subject
|
1
|
1
|
Baseline Characteristics
Adolescent Mindfulness Mobile App Study (RCT)
Baseline characteristics by cohort
| Measure |
Mindfulness App
n=72 Participants
Guided mindfulness exercises will be delivered via mobile app for three weeks.
Mindfulness App: Mindfulness exercises will last 1-12 minutes. Each one asks participants to focus on something (e.g., breath, sounds, physical sensations) using guided instruction.
|
Control Condition
n=80 Participants
Participants will use app for assessment for three weeks, but no mindfulness exercises will be delivered.
|
Total
n=152 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
13.78 years
STANDARD_DEVIATION .93 • n=5 Participants
|
13.66 years
STANDARD_DEVIATION .86 • n=7 Participants
|
13.71 years
STANDARD_DEVIATION .89 • n=5 Participants
|
|
Sex/Gender, Customized
Female
|
44 Participants
n=5 Participants
|
45 Participants
n=7 Participants
|
89 Participants
n=5 Participants
|
|
Sex/Gender, Customized
Male
|
28 Participants
n=5 Participants
|
35 Participants
n=7 Participants
|
63 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
9 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
16 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
63 Participants
n=5 Participants
|
73 Participants
n=7 Participants
|
136 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Race · White
|
55 Participants
n=5 Participants
|
70 Participants
n=7 Participants
|
125 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Race · Black; African American
|
3 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Race · Asian; Asian American
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Race · Native Hawaiian or Pacific Islander
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Race · Native American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Race · Multi-racial
|
11 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
16 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Race · Other
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
72 participants
n=5 Participants
|
80 participants
n=7 Participants
|
152 participants
n=5 Participants
|
|
Children's Response Styles Questionnaire
|
33.47 units on a scale
STANDARD_DEVIATION 9.64 • n=5 Participants
|
30.73 units on a scale
STANDARD_DEVIATION 9.05 • n=7 Participants
|
32.03 units on a scale
STANDARD_DEVIATION 9.40 • n=5 Participants
|
|
Children's Depression Inventory
|
13.4 units on a scale
STANDARD_DEVIATION 8.77 • n=5 Participants
|
12.04 units on a scale
STANDARD_DEVIATION 7.72 • n=7 Participants
|
12.68 units on a scale
STANDARD_DEVIATION 8.23 • n=5 Participants
|
|
Multidimensional Anxiety Scale for Children
|
53.47 units on a scale
STANDARD_DEVIATION 16.51 • n=5 Participants
|
50.84 units on a scale
STANDARD_DEVIATION 17.35 • n=7 Participants
|
52.09 units on a scale
STANDARD_DEVIATION 16.95 • n=5 Participants
|
|
Self-injurious Thoughts and Behaviors Questionnaire
|
11 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
22 Participants
n=5 Participants
|
|
Pediatric Symptom Checklist Internalizing Scale
|
3.64 units on a scale
STANDARD_DEVIATION 2.38 • n=5 Participants
|
3.88 units on a scale
STANDARD_DEVIATION 2.45 • n=7 Participants
|
3.76 units on a scale
STANDARD_DEVIATION 2.411 • n=5 Participants
|
|
Five Facet Mindfulness Questionnaire Observing Subscale
|
22.28 units on a scale
STANDARD_DEVIATION 6.23 • n=5 Participants
|
21.38 units on a scale
STANDARD_DEVIATION 6.2 • n=7 Participants
|
21.80 units on a scale
STANDARD_DEVIATION 6.206 • n=5 Participants
|
|
Five Facet Mindfulness Questionnaire Describing Subscale
|
24.26 units on a scale
STANDARD_DEVIATION 5.75 • n=5 Participants
|
24.69 units on a scale
STANDARD_DEVIATION 5.75 • n=7 Participants
|
24.49 units on a scale
STANDARD_DEVIATION 5.74 • n=5 Participants
|
|
Five Facet Mindfulness Questionnaire Awareness Subscale
|
25.03 units on a scale
STANDARD_DEVIATION 6.23 • n=5 Participants
|
26.17 units on a scale
STANDARD_DEVIATION 5.84 • n=7 Participants
|
25.63 units on a scale
STANDARD_DEVIATION 6.04 • n=5 Participants
|
|
Five Facet Mindfulness Questionnaire Nonjudging Subscale
|
25.56 units on a scale
STANDARD_DEVIATION 7.46 • n=5 Participants
|
27.49 units on a scale
STANDARD_DEVIATION 7.58 • n=7 Participants
|
26.57 units on a scale
STANDARD_DEVIATION 7.561 • n=5 Participants
|
|
Five Facet Mindfulness Questionnaire Nonreactivity Subscale
|
19.58 units on a scale
STANDARD_DEVIATION 4.58 • n=5 Participants
|
19.44 units on a scale
STANDARD_DEVIATION 3.99 • n=7 Participants
|
19.51 units on a scale
STANDARD_DEVIATION 4.268 • n=5 Participants
|
PRIMARY outcome
Timeframe: baselinetrait rumination (range = 0-39 with higher scores indicating more rumination)
Outcome measures
| Measure |
Mindfulness App
n=72 Participants
Guided mindfulness exercises will be delivered via mobile app for three weeks.
Mindfulness App: Mindfulness exercises will last 1-12 minutes. Each one asks participants to focus on something (e.g., breath, sounds, physical sensations) using guided instruction.
|
Control Condition
n=80 Participants
Participants will use app for assessment for three weeks, but no mindfulness exercises will be delivered.
|
|---|---|---|
|
Children's Response Styles Questionnaire
|
33.47 score on a scale
Standard Deviation 9.64
|
30.73 score on a scale
Standard Deviation 9.05
|
PRIMARY outcome
Timeframe: 3 weeks (i.e., immediately post-intervention)Population: Number analyzed determined by number of adolescents that completed the questionnaire.
trait rumination (range = 0-39 with higher scores indicating more rumination)
Outcome measures
| Measure |
Mindfulness App
n=71 Participants
Guided mindfulness exercises will be delivered via mobile app for three weeks.
Mindfulness App: Mindfulness exercises will last 1-12 minutes. Each one asks participants to focus on something (e.g., breath, sounds, physical sensations) using guided instruction.
|
Control Condition
n=79 Participants
Participants will use app for assessment for three weeks, but no mindfulness exercises will be delivered.
|
|---|---|---|
|
Children's Response Styles Questionnaire
|
29.48 score on a scale
Standard Deviation 9.89
|
30.76 score on a scale
Standard Deviation 10.12
|
PRIMARY outcome
Timeframe: 6 weeks post interventiontrait rumination (range = 0-39 with higher scores indicating more rumination)
Outcome measures
| Measure |
Mindfulness App
n=66 Participants
Guided mindfulness exercises will be delivered via mobile app for three weeks.
Mindfulness App: Mindfulness exercises will last 1-12 minutes. Each one asks participants to focus on something (e.g., breath, sounds, physical sensations) using guided instruction.
|
Control Condition
n=76 Participants
Participants will use app for assessment for three weeks, but no mindfulness exercises will be delivered.
|
|---|---|---|
|
Children's Response Styles Questionnaire
|
27.71 score on a scale
Standard Deviation 9.46
|
29.17 score on a scale
Standard Deviation 10.64
|
PRIMARY outcome
Timeframe: 12 weeks post interventiontrait rumination (range = 0-39 with higher scores indicating more rumination)
Outcome measures
| Measure |
Mindfulness App
n=64 Participants
Guided mindfulness exercises will be delivered via mobile app for three weeks.
Mindfulness App: Mindfulness exercises will last 1-12 minutes. Each one asks participants to focus on something (e.g., breath, sounds, physical sensations) using guided instruction.
|
Control Condition
n=74 Participants
Participants will use app for assessment for three weeks, but no mindfulness exercises will be delivered.
|
|---|---|---|
|
Children's Response Styles Questionnaire
|
29.27 score on a scale
Standard Deviation 10.22
|
28.45 score on a scale
Standard Deviation 9.8
|
PRIMARY outcome
Timeframe: 6 months post interventiontrait rumination (range = 0-39 with higher scores indicating more rumination)
Outcome measures
| Measure |
Mindfulness App
n=63 Participants
Guided mindfulness exercises will be delivered via mobile app for three weeks.
Mindfulness App: Mindfulness exercises will last 1-12 minutes. Each one asks participants to focus on something (e.g., breath, sounds, physical sensations) using guided instruction.
|
Control Condition
n=71 Participants
Participants will use app for assessment for three weeks, but no mindfulness exercises will be delivered.
|
|---|---|---|
|
Children's Response Styles Questionnaire
|
29.4 score on a scale
Standard Deviation 10.79
|
29.77 score on a scale
Standard Deviation 10.05
|
PRIMARY outcome
Timeframe: baselineself-reported depressive symptoms (range = 0-54 with higher scores indicating more symptoms)
Outcome measures
| Measure |
Mindfulness App
n=72 Participants
Guided mindfulness exercises will be delivered via mobile app for three weeks.
Mindfulness App: Mindfulness exercises will last 1-12 minutes. Each one asks participants to focus on something (e.g., breath, sounds, physical sensations) using guided instruction.
|
Control Condition
n=80 Participants
Participants will use app for assessment for three weeks, but no mindfulness exercises will be delivered.
|
|---|---|---|
|
Children's Depression Inventory
|
13.4 score on a scale
Standard Deviation 8.77
|
12.04 score on a scale
Standard Deviation 7.72
|
PRIMARY outcome
Timeframe: 3 weeks (immediately post-intervention)self-reported depressive symptoms (range = 0-54 with higher scores indicating more symptoms)
Outcome measures
| Measure |
Mindfulness App
n=71 Participants
Guided mindfulness exercises will be delivered via mobile app for three weeks.
Mindfulness App: Mindfulness exercises will last 1-12 minutes. Each one asks participants to focus on something (e.g., breath, sounds, physical sensations) using guided instruction.
|
Control Condition
n=79 Participants
Participants will use app for assessment for three weeks, but no mindfulness exercises will be delivered.
|
|---|---|---|
|
Children's Depression Inventory
|
11.52 score on a scale
Standard Deviation 9.54
|
12.22 score on a scale
Standard Deviation 8.57
|
PRIMARY outcome
Timeframe: 6 weeks post interventionself-reported depressive symptoms (range = 0-54 with higher scores indicating more symptoms)
Outcome measures
| Measure |
Mindfulness App
n=66 Participants
Guided mindfulness exercises will be delivered via mobile app for three weeks.
Mindfulness App: Mindfulness exercises will last 1-12 minutes. Each one asks participants to focus on something (e.g., breath, sounds, physical sensations) using guided instruction.
|
Control Condition
n=76 Participants
Participants will use app for assessment for three weeks, but no mindfulness exercises will be delivered.
|
|---|---|---|
|
Children's Depression Inventory
|
10.68 score on a scale
Standard Deviation 9.04
|
10.82 score on a scale
Standard Deviation 8.23
|
PRIMARY outcome
Timeframe: 12 weeks post interventionself-reported depressive symptoms (range = 0-54 with higher scores indicating more symptoms)
Outcome measures
| Measure |
Mindfulness App
n=64 Participants
Guided mindfulness exercises will be delivered via mobile app for three weeks.
Mindfulness App: Mindfulness exercises will last 1-12 minutes. Each one asks participants to focus on something (e.g., breath, sounds, physical sensations) using guided instruction.
|
Control Condition
n=74 Participants
Participants will use app for assessment for three weeks, but no mindfulness exercises will be delivered.
|
|---|---|---|
|
Children's Depression Inventory
|
9.33 score on a scale
Standard Deviation 7.97
|
10.54 score on a scale
Standard Deviation 8.57
|
PRIMARY outcome
Timeframe: 6 months post interventionself-reported depressive symptoms (range = 0-54 with higher scores indicating more symptoms)
Outcome measures
| Measure |
Mindfulness App
n=63 Participants
Guided mindfulness exercises will be delivered via mobile app for three weeks.
Mindfulness App: Mindfulness exercises will last 1-12 minutes. Each one asks participants to focus on something (e.g., breath, sounds, physical sensations) using guided instruction.
|
Control Condition
n=71 Participants
Participants will use app for assessment for three weeks, but no mindfulness exercises will be delivered.
|
|---|---|---|
|
Children's Depression Inventory
|
8.84 score on a scale
Standard Deviation 8.02
|
10.42 score on a scale
Standard Deviation 8.97
|
PRIMARY outcome
Timeframe: baselineself-reported anxiety symptoms (range = 0-117 with higher scores indicating more anxiety)
Outcome measures
| Measure |
Mindfulness App
n=72 Participants
Guided mindfulness exercises will be delivered via mobile app for three weeks.
Mindfulness App: Mindfulness exercises will last 1-12 minutes. Each one asks participants to focus on something (e.g., breath, sounds, physical sensations) using guided instruction.
|
Control Condition
n=80 Participants
Participants will use app for assessment for three weeks, but no mindfulness exercises will be delivered.
|
|---|---|---|
|
Multidimensional Anxiety Scale for Children
|
53.47 score on a scale
Standard Deviation 16.51
|
50.84 score on a scale
Standard Deviation 17.35
|
PRIMARY outcome
Timeframe: 3 weeks (i.e., immediately post-intervention)self-reported anxiety symptoms (range = 0-117 with higher scores indicating more anxiety)
Outcome measures
| Measure |
Mindfulness App
n=71 Participants
Guided mindfulness exercises will be delivered via mobile app for three weeks.
Mindfulness App: Mindfulness exercises will last 1-12 minutes. Each one asks participants to focus on something (e.g., breath, sounds, physical sensations) using guided instruction.
|
Control Condition
n=79 Participants
Participants will use app for assessment for three weeks, but no mindfulness exercises will be delivered.
|
|---|---|---|
|
Multidimensional Anxiety Scale for Children
|
50.94 score on a scale
Standard Deviation 16.82
|
52.37 score on a scale
Standard Deviation 17.64
|
PRIMARY outcome
Timeframe: 6 weeks post interventionself-reported anxiety symptoms (range = 0-117 with higher scores indicating more anxiety)
Outcome measures
| Measure |
Mindfulness App
n=66 Participants
Guided mindfulness exercises will be delivered via mobile app for three weeks.
Mindfulness App: Mindfulness exercises will last 1-12 minutes. Each one asks participants to focus on something (e.g., breath, sounds, physical sensations) using guided instruction.
|
Control Condition
n=76 Participants
Participants will use app for assessment for three weeks, but no mindfulness exercises will be delivered.
|
|---|---|---|
|
Multidimensional Anxiety Scale for Children
|
51.00 score on a scale
Standard Deviation 16.52
|
49.88 score on a scale
Standard Deviation 19.25
|
PRIMARY outcome
Timeframe: 12 weeks post interventionself-reported anxiety symptoms (range = 0-117 with higher scores indicating more anxiety)
Outcome measures
| Measure |
Mindfulness App
n=64 Participants
Guided mindfulness exercises will be delivered via mobile app for three weeks.
Mindfulness App: Mindfulness exercises will last 1-12 minutes. Each one asks participants to focus on something (e.g., breath, sounds, physical sensations) using guided instruction.
|
Control Condition
n=74 Participants
Participants will use app for assessment for three weeks, but no mindfulness exercises will be delivered.
|
|---|---|---|
|
Multidimensional Anxiety Scale for Children
|
50.34 score on a scale
Standard Deviation 18.18
|
49.82 score on a scale
Standard Deviation 19.11
|
PRIMARY outcome
Timeframe: 6 months post interventionself-reported anxiety symptoms (range = 0-117 with higher scores indicating more anxiety)
Outcome measures
| Measure |
Mindfulness App
n=63 Participants
Guided mindfulness exercises will be delivered via mobile app for three weeks.
Mindfulness App: Mindfulness exercises will last 1-12 minutes. Each one asks participants to focus on something (e.g., breath, sounds, physical sensations) using guided instruction.
|
Control Condition
n=71 Participants
Participants will use app for assessment for three weeks, but no mindfulness exercises will be delivered.
|
|---|---|---|
|
Multidimensional Anxiety Scale for Children
|
49.29 score on a scale
Standard Deviation 16.74
|
49.56 score on a scale
Standard Deviation 20.58
|
PRIMARY outcome
Timeframe: baselinepercent of participants engaged in self-injury over the past year
Outcome measures
| Measure |
Mindfulness App
n=72 Participants
Guided mindfulness exercises will be delivered via mobile app for three weeks.
Mindfulness App: Mindfulness exercises will last 1-12 minutes. Each one asks participants to focus on something (e.g., breath, sounds, physical sensations) using guided instruction.
|
Control Condition
n=80 Participants
Participants will use app for assessment for three weeks, but no mindfulness exercises will be delivered.
|
|---|---|---|
|
Self-injurious Thoughts and Behaviors Questionnaire
|
7 Participants
|
7 Participants
|
PRIMARY outcome
Timeframe: 3 weeks (i.e., immediately post-intervention)percent of participants that engaged in self-injury over the past 3 weeks
Outcome measures
| Measure |
Mindfulness App
n=71 Participants
Guided mindfulness exercises will be delivered via mobile app for three weeks.
Mindfulness App: Mindfulness exercises will last 1-12 minutes. Each one asks participants to focus on something (e.g., breath, sounds, physical sensations) using guided instruction.
|
Control Condition
n=79 Participants
Participants will use app for assessment for three weeks, but no mindfulness exercises will be delivered.
|
|---|---|---|
|
Self-injurious Thoughts and Behaviors Questionnaire
|
1 Participants
|
2 Participants
|
PRIMARY outcome
Timeframe: 6 weeks post interventionpercent of participants that engaged in self-injury over the past 6 weeks
Outcome measures
| Measure |
Mindfulness App
n=66 Participants
Guided mindfulness exercises will be delivered via mobile app for three weeks.
Mindfulness App: Mindfulness exercises will last 1-12 minutes. Each one asks participants to focus on something (e.g., breath, sounds, physical sensations) using guided instruction.
|
Control Condition
n=76 Participants
Participants will use app for assessment for three weeks, but no mindfulness exercises will be delivered.
|
|---|---|---|
|
Self-injurious Thoughts and Behaviors Questionnaire
|
3 Participants
|
3 Participants
|
PRIMARY outcome
Timeframe: 12 weeks post interventionpercent of time engaged in self-injury over the past 6 weeks
Outcome measures
| Measure |
Mindfulness App
n=64 Participants
Guided mindfulness exercises will be delivered via mobile app for three weeks.
Mindfulness App: Mindfulness exercises will last 1-12 minutes. Each one asks participants to focus on something (e.g., breath, sounds, physical sensations) using guided instruction.
|
Control Condition
n=74 Participants
Participants will use app for assessment for three weeks, but no mindfulness exercises will be delivered.
|
|---|---|---|
|
Self-injurious Thoughts and Behaviors Questionnaire
|
2 Participants
|
1 Participants
|
PRIMARY outcome
Timeframe: 6 months post interventionpercent of time engaged in self-injury over the past 3 months
Outcome measures
| Measure |
Mindfulness App
n=63 Participants
Guided mindfulness exercises will be delivered via mobile app for three weeks.
Mindfulness App: Mindfulness exercises will last 1-12 minutes. Each one asks participants to focus on something (e.g., breath, sounds, physical sensations) using guided instruction.
|
Control Condition
n=71 Participants
Participants will use app for assessment for three weeks, but no mindfulness exercises will be delivered.
|
|---|---|---|
|
Self-injurious Thoughts and Behaviors Questionnaire
|
3 Participants
|
2 Participants
|
PRIMARY outcome
Timeframe: baselineparent-reported internalizing symptoms (range = 0-10 with higher scores indicating more internalizing symptoms)
Outcome measures
| Measure |
Mindfulness App
n=72 Participants
Guided mindfulness exercises will be delivered via mobile app for three weeks.
Mindfulness App: Mindfulness exercises will last 1-12 minutes. Each one asks participants to focus on something (e.g., breath, sounds, physical sensations) using guided instruction.
|
Control Condition
n=80 Participants
Participants will use app for assessment for three weeks, but no mindfulness exercises will be delivered.
|
|---|---|---|
|
Pediatric Symptom Checklist Internalizing Scale
|
3.64 score on a scale
Standard Deviation 2.38
|
3.88 score on a scale
Standard Deviation 2.45
|
PRIMARY outcome
Timeframe: 3 weeks (i.e., immediately post-intervention)parent-reported internalizing symptoms (range = 0-10 with higher scores indicating more internalizing symptoms)
Outcome measures
| Measure |
Mindfulness App
n=71 Participants
Guided mindfulness exercises will be delivered via mobile app for three weeks.
Mindfulness App: Mindfulness exercises will last 1-12 minutes. Each one asks participants to focus on something (e.g., breath, sounds, physical sensations) using guided instruction.
|
Control Condition
n=79 Participants
Participants will use app for assessment for three weeks, but no mindfulness exercises will be delivered.
|
|---|---|---|
|
Pediatric Symptom Checklist Internalizing Scale
|
2.49 score on a scale
Standard Deviation 2.21
|
2.46 score on a scale
Standard Deviation 1.99
|
PRIMARY outcome
Timeframe: 6 weeks post interventionparent-reported internalizing symptoms (range = 0-10 with higher scores indicating more internalizing symptoms)
Outcome measures
| Measure |
Mindfulness App
n=68 Participants
Guided mindfulness exercises will be delivered via mobile app for three weeks.
Mindfulness App: Mindfulness exercises will last 1-12 minutes. Each one asks participants to focus on something (e.g., breath, sounds, physical sensations) using guided instruction.
|
Control Condition
n=75 Participants
Participants will use app for assessment for three weeks, but no mindfulness exercises will be delivered.
|
|---|---|---|
|
Pediatric Symptom Checklist Internalizing Scale
|
2.38 score on a scale
Standard Deviation 2.05
|
2.41 score on a scale
Standard Deviation 2.09
|
PRIMARY outcome
Timeframe: 12 weeks post interventionparent-reported internalizing symptoms (range = 0-10 with higher scores indicating more internalizing symptoms)
Outcome measures
| Measure |
Mindfulness App
n=66 Participants
Guided mindfulness exercises will be delivered via mobile app for three weeks.
Mindfulness App: Mindfulness exercises will last 1-12 minutes. Each one asks participants to focus on something (e.g., breath, sounds, physical sensations) using guided instruction.
|
Control Condition
n=74 Participants
Participants will use app for assessment for three weeks, but no mindfulness exercises will be delivered.
|
|---|---|---|
|
Pediatric Symptom Checklist Internalizing Scale
|
2.49 score on a scale
Standard Deviation 2.14
|
2.35 score on a scale
Standard Deviation 2.14
|
PRIMARY outcome
Timeframe: 6 months post interventionparent-reported internalizing symptoms (range = 0-10 with higher scores indicating more internalizing symptoms)
Outcome measures
| Measure |
Mindfulness App
n=63 Participants
Guided mindfulness exercises will be delivered via mobile app for three weeks.
Mindfulness App: Mindfulness exercises will last 1-12 minutes. Each one asks participants to focus on something (e.g., breath, sounds, physical sensations) using guided instruction.
|
Control Condition
n=72 Participants
Participants will use app for assessment for three weeks, but no mindfulness exercises will be delivered.
|
|---|---|---|
|
Pediatric Symptom Checklist Internalizing Scale
|
2.38 score on a scale
Standard Deviation 1.96
|
2.68 score on a scale
Standard Deviation 2.26
|
PRIMARY outcome
Timeframe: 3 weeks (i.e., immediately post-intervention)average state rumination during intervention period rated on a visual analog scale (range = 0-100 with higher scores indicating more rumination)
Outcome measures
| Measure |
Mindfulness App
n=72 Participants
Guided mindfulness exercises will be delivered via mobile app for three weeks.
Mindfulness App: Mindfulness exercises will last 1-12 minutes. Each one asks participants to focus on something (e.g., breath, sounds, physical sensations) using guided instruction.
|
Control Condition
n=80 Participants
Participants will use app for assessment for three weeks, but no mindfulness exercises will be delivered.
|
|---|---|---|
|
State Rumination
Emotion-Focused Rumination
|
41.88 units on a scale
Standard Deviation 20.44
|
42.53 units on a scale
Standard Deviation 20.17
|
|
State Rumination
Problem-Focused Rumination
|
34.80 units on a scale
Standard Deviation 18.47
|
37.58 units on a scale
Standard Deviation 18.69
|
PRIMARY outcome
Timeframe: 3 weeks (i.e., immediately post-intervention)average sadness and anxiety during intervention period rated on visual analog scales (range = 0-100 with higher scores indicating more rumination)
Outcome measures
| Measure |
Mindfulness App
n=72 Participants
Guided mindfulness exercises will be delivered via mobile app for three weeks.
Mindfulness App: Mindfulness exercises will last 1-12 minutes. Each one asks participants to focus on something (e.g., breath, sounds, physical sensations) using guided instruction.
|
Control Condition
n=80 Participants
Participants will use app for assessment for three weeks, but no mindfulness exercises will be delivered.
|
|---|---|---|
|
State Mood
Anxiety
|
36.62 units on a scale
Standard Deviation 19.35
|
39.08 units on a scale
Standard Deviation 20.05
|
|
State Mood
Sadness
|
25.00 units on a scale
Standard Deviation 17.72
|
25.02 units on a scale
Standard Deviation 14.10
|
PRIMARY outcome
Timeframe: 3 weeks (i.e., immediately post-intervention)Daily app use was determined by how many complete app uses were logged during the three-week intervention period.
Outcome measures
| Measure |
Mindfulness App
n=72 Participants
Guided mindfulness exercises will be delivered via mobile app for three weeks.
Mindfulness App: Mindfulness exercises will last 1-12 minutes. Each one asks participants to focus on something (e.g., breath, sounds, physical sensations) using guided instruction.
|
Control Condition
n=80 Participants
Participants will use app for assessment for three weeks, but no mindfulness exercises will be delivered.
|
|---|---|---|
|
Daily App Use
|
51.72 App uses
Standard Deviation 16.37
|
54.26 App uses
Standard Deviation 15.26
|
PRIMARY outcome
Timeframe: 6 months post interventionNumber of times app was used after the 3 week intervention period
Outcome measures
| Measure |
Mindfulness App
n=72 Participants
Guided mindfulness exercises will be delivered via mobile app for three weeks.
Mindfulness App: Mindfulness exercises will last 1-12 minutes. Each one asks participants to focus on something (e.g., breath, sounds, physical sensations) using guided instruction.
|
Control Condition
n=80 Participants
Participants will use app for assessment for three weeks, but no mindfulness exercises will be delivered.
|
|---|---|---|
|
Continued Use
|
40.24 number of app uses
Standard Deviation 78.98
|
39.74 number of app uses
Standard Deviation 70.22
|
PRIMARY outcome
Timeframe: 3 weeks (i.e., immediately post-intervention)how easy app was to use (range = 1-7 with higher being easier to use)
Outcome measures
| Measure |
Mindfulness App
n=71 Participants
Guided mindfulness exercises will be delivered via mobile app for three weeks.
Mindfulness App: Mindfulness exercises will last 1-12 minutes. Each one asks participants to focus on something (e.g., breath, sounds, physical sensations) using guided instruction.
|
Control Condition
n=79 Participants
Participants will use app for assessment for three weeks, but no mindfulness exercises will be delivered.
|
|---|---|---|
|
Ease of Use
|
6.13 units on a scale
Standard Deviation 1.19
|
6.27 units on a scale
Standard Deviation 1.07
|
SECONDARY outcome
Timeframe: baselinetrait mindfulness observing (range = 8-40 with higher scores indicating greater mindfulness)
Outcome measures
| Measure |
Mindfulness App
n=72 Participants
Guided mindfulness exercises will be delivered via mobile app for three weeks.
Mindfulness App: Mindfulness exercises will last 1-12 minutes. Each one asks participants to focus on something (e.g., breath, sounds, physical sensations) using guided instruction.
|
Control Condition
n=80 Participants
Participants will use app for assessment for three weeks, but no mindfulness exercises will be delivered.
|
|---|---|---|
|
Five Facet Mindfulness Questionnaire Observing Subscale
|
22.28 score on a scale
Standard Deviation 6.23
|
21.38 score on a scale
Standard Deviation 6.2
|
SECONDARY outcome
Timeframe: 3 weeks (i.e., immediately post-intervention)trait mindfulness observing (range = 8-40 with higher scores indicating greater mindfulness)
Outcome measures
| Measure |
Mindfulness App
n=71 Participants
Guided mindfulness exercises will be delivered via mobile app for three weeks.
Mindfulness App: Mindfulness exercises will last 1-12 minutes. Each one asks participants to focus on something (e.g., breath, sounds, physical sensations) using guided instruction.
|
Control Condition
n=79 Participants
Participants will use app for assessment for three weeks, but no mindfulness exercises will be delivered.
|
|---|---|---|
|
Five Facet Mindfulness Questionnaire Observing Subscale
|
22.66 score on a scale
Standard Deviation 6.39
|
22.05 score on a scale
Standard Deviation 6.22
|
SECONDARY outcome
Timeframe: 6 weeks post interventiontrait mindfulness observing (range = 8-40 with higher scores indicating greater mindfulness)
Outcome measures
| Measure |
Mindfulness App
n=66 Participants
Guided mindfulness exercises will be delivered via mobile app for three weeks.
Mindfulness App: Mindfulness exercises will last 1-12 minutes. Each one asks participants to focus on something (e.g., breath, sounds, physical sensations) using guided instruction.
|
Control Condition
n=76 Participants
Participants will use app for assessment for three weeks, but no mindfulness exercises will be delivered.
|
|---|---|---|
|
Five Facet Mindfulness Questionnaire Observing Subscale
|
23.05 score on a scale
Standard Deviation 5.69
|
21.97 score on a scale
Standard Deviation 5.74
|
SECONDARY outcome
Timeframe: 12 weeks post interventiontrait mindfulness observing (range = 8-40 with higher scores indicating greater mindfulness)
Outcome measures
| Measure |
Mindfulness App
n=64 Participants
Guided mindfulness exercises will be delivered via mobile app for three weeks.
Mindfulness App: Mindfulness exercises will last 1-12 minutes. Each one asks participants to focus on something (e.g., breath, sounds, physical sensations) using guided instruction.
|
Control Condition
n=74 Participants
Participants will use app for assessment for three weeks, but no mindfulness exercises will be delivered.
|
|---|---|---|
|
Five Facet Mindfulness Questionnaire Observing Subscale
|
23.77 score on a scale
Standard Deviation 5.83
|
22.45 score on a scale
Standard Deviation 5.95
|
SECONDARY outcome
Timeframe: 6 months post interventiontrait mindfulness observing (range = 8-40 with higher scores indicating greater mindfulness)
Outcome measures
| Measure |
Mindfulness App
n=63 Participants
Guided mindfulness exercises will be delivered via mobile app for three weeks.
Mindfulness App: Mindfulness exercises will last 1-12 minutes. Each one asks participants to focus on something (e.g., breath, sounds, physical sensations) using guided instruction.
|
Control Condition
n=71 Participants
Participants will use app for assessment for three weeks, but no mindfulness exercises will be delivered.
|
|---|---|---|
|
Five Facet Mindfulness Questionnaire Observing Subscale
|
24.19 score on a scale
Standard Deviation 5.76
|
21.48 score on a scale
Standard Deviation 6.99
|
SECONDARY outcome
Timeframe: baselinetrait mindfulness describing (range = 8-40 with higher scores indicating greater mindfulness)
Outcome measures
| Measure |
Mindfulness App
n=72 Participants
Guided mindfulness exercises will be delivered via mobile app for three weeks.
Mindfulness App: Mindfulness exercises will last 1-12 minutes. Each one asks participants to focus on something (e.g., breath, sounds, physical sensations) using guided instruction.
|
Control Condition
n=80 Participants
Participants will use app for assessment for three weeks, but no mindfulness exercises will be delivered.
|
|---|---|---|
|
Five Facet Mindfulness Questionnaire Describing Subscale
|
24.26 score on a scale
Standard Deviation 5.75
|
24.69 score on a scale
Standard Deviation 5.75
|
SECONDARY outcome
Timeframe: 3 weeks (i.e., immediately post-intervention)trait mindfulness describing (range = 8-40 with higher scores indicating greater mindfulness)
Outcome measures
| Measure |
Mindfulness App
n=71 Participants
Guided mindfulness exercises will be delivered via mobile app for three weeks.
Mindfulness App: Mindfulness exercises will last 1-12 minutes. Each one asks participants to focus on something (e.g., breath, sounds, physical sensations) using guided instruction.
|
Control Condition
n=79 Participants
Participants will use app for assessment for three weeks, but no mindfulness exercises will be delivered.
|
|---|---|---|
|
Five Facet Mindfulness Questionnaire Describing Subscale
|
25 score on a scale
Standard Deviation 5.98
|
23.94 score on a scale
Standard Deviation 5.1
|
SECONDARY outcome
Timeframe: 6 weeks post interventiontrait mindfulness describing (range = 8-40 with higher scores indicating greater mindfulness)
Outcome measures
| Measure |
Mindfulness App
n=66 Participants
Guided mindfulness exercises will be delivered via mobile app for three weeks.
Mindfulness App: Mindfulness exercises will last 1-12 minutes. Each one asks participants to focus on something (e.g., breath, sounds, physical sensations) using guided instruction.
|
Control Condition
n=76 Participants
Participants will use app for assessment for three weeks, but no mindfulness exercises will be delivered.
|
|---|---|---|
|
Five Facet Mindfulness Questionnaire Describing Subscale
|
25.17 score on a scale
Standard Deviation 6.17
|
25.25 score on a scale
Standard Deviation 5.35
|
SECONDARY outcome
Timeframe: 12 weeks post interventiontrait mindfulness describing (range = 8-40 with higher scores indicating greater mindfulness)
Outcome measures
| Measure |
Mindfulness App
n=64 Participants
Guided mindfulness exercises will be delivered via mobile app for three weeks.
Mindfulness App: Mindfulness exercises will last 1-12 minutes. Each one asks participants to focus on something (e.g., breath, sounds, physical sensations) using guided instruction.
|
Control Condition
n=74 Participants
Participants will use app for assessment for three weeks, but no mindfulness exercises will be delivered.
|
|---|---|---|
|
Five Facet Mindfulness Questionnaire Describing Subscale
|
25.55 score on a scale
Standard Deviation 5.96
|
24.3 score on a scale
Standard Deviation 5.41
|
SECONDARY outcome
Timeframe: 6 months post interventiontrait mindfulness describing (range = 8-40 with higher scores indicating greater mindfulness)
Outcome measures
| Measure |
Mindfulness App
n=63 Participants
Guided mindfulness exercises will be delivered via mobile app for three weeks.
Mindfulness App: Mindfulness exercises will last 1-12 minutes. Each one asks participants to focus on something (e.g., breath, sounds, physical sensations) using guided instruction.
|
Control Condition
n=71 Participants
Participants will use app for assessment for three weeks, but no mindfulness exercises will be delivered.
|
|---|---|---|
|
Five Facet Mindfulness Questionnaire Describing Subscale
|
25.56 score on a scale
Standard Deviation 6.16
|
24.97 score on a scale
Standard Deviation 5.54
|
SECONDARY outcome
Timeframe: baselinetrait mindfulness acting with awareness (range = 8-40 with higher scores indicating greater mindfulness)
Outcome measures
| Measure |
Mindfulness App
n=72 Participants
Guided mindfulness exercises will be delivered via mobile app for three weeks.
Mindfulness App: Mindfulness exercises will last 1-12 minutes. Each one asks participants to focus on something (e.g., breath, sounds, physical sensations) using guided instruction.
|
Control Condition
n=80 Participants
Participants will use app for assessment for three weeks, but no mindfulness exercises will be delivered.
|
|---|---|---|
|
Five Facet Mindfulness Questionnaire Awareness Subscale
|
25.03 score on a scale
Standard Deviation 6.23
|
26.18 score on a scale
Standard Deviation 5.84
|
SECONDARY outcome
Timeframe: 3 weeks (i.e., immediately post-intervention)trait mindfulness acting with awareness (range = 8-40 with higher scores indicating greater mindfulness)
Outcome measures
| Measure |
Mindfulness App
n=71 Participants
Guided mindfulness exercises will be delivered via mobile app for three weeks.
Mindfulness App: Mindfulness exercises will last 1-12 minutes. Each one asks participants to focus on something (e.g., breath, sounds, physical sensations) using guided instruction.
|
Control Condition
n=79 Participants
Participants will use app for assessment for three weeks, but no mindfulness exercises will be delivered.
|
|---|---|---|
|
Five Facet Mindfulness Questionnaire Awareness Subscale
|
25.42 score on a scale
Standard Deviation 6.55
|
24.94 score on a scale
Standard Deviation 6.41
|
SECONDARY outcome
Timeframe: 6 weeks post interventiontrait mindfulness acting with awareness (range = 8-40 with higher scores indicating greater mindfulness)
Outcome measures
| Measure |
Mindfulness App
n=66 Participants
Guided mindfulness exercises will be delivered via mobile app for three weeks.
Mindfulness App: Mindfulness exercises will last 1-12 minutes. Each one asks participants to focus on something (e.g., breath, sounds, physical sensations) using guided instruction.
|
Control Condition
n=76 Participants
Participants will use app for assessment for three weeks, but no mindfulness exercises will be delivered.
|
|---|---|---|
|
Five Facet Mindfulness Questionnaire Awareness Subscale
|
25.12 score on a scale
Standard Deviation 6.34
|
25.7 score on a scale
Standard Deviation 5.42
|
SECONDARY outcome
Timeframe: 12 weeks post interventiontrait mindfulness acting with awareness (range = 8-40 with higher scores indicating greater mindfulness)
Outcome measures
| Measure |
Mindfulness App
n=64 Participants
Guided mindfulness exercises will be delivered via mobile app for three weeks.
Mindfulness App: Mindfulness exercises will last 1-12 minutes. Each one asks participants to focus on something (e.g., breath, sounds, physical sensations) using guided instruction.
|
Control Condition
n=74 Participants
Participants will use app for assessment for three weeks, but no mindfulness exercises will be delivered.
|
|---|---|---|
|
Five Facet Mindfulness Questionnaire Awareness Subscale
|
24.98 score on a scale
Standard Deviation 5.9
|
25.27 score on a scale
Standard Deviation 5.62
|
SECONDARY outcome
Timeframe: 6 months post interventiontrait mindfulness acting with awareness (range = 8-40 with higher scores indicating greater mindfulness)
Outcome measures
| Measure |
Mindfulness App
n=63 Participants
Guided mindfulness exercises will be delivered via mobile app for three weeks.
Mindfulness App: Mindfulness exercises will last 1-12 minutes. Each one asks participants to focus on something (e.g., breath, sounds, physical sensations) using guided instruction.
|
Control Condition
n=71 Participants
Participants will use app for assessment for three weeks, but no mindfulness exercises will be delivered.
|
|---|---|---|
|
Five Facet Mindfulness Questionnaire Awareness Subscale
|
25.43 score on a scale
Standard Deviation 6.25
|
26.07 score on a scale
Standard Deviation 6.32
|
SECONDARY outcome
Timeframe: baselinetrait mindfulness non-judging of inner experience (range = 8-40 with higher scores indicating greater mindfulness)
Outcome measures
| Measure |
Mindfulness App
n=72 Participants
Guided mindfulness exercises will be delivered via mobile app for three weeks.
Mindfulness App: Mindfulness exercises will last 1-12 minutes. Each one asks participants to focus on something (e.g., breath, sounds, physical sensations) using guided instruction.
|
Control Condition
n=80 Participants
Participants will use app for assessment for three weeks, but no mindfulness exercises will be delivered.
|
|---|---|---|
|
Five Facet Mindfulness Questionnaire Nonjudging Subscale
|
25.56 score on a scale
Standard Deviation 7.46
|
27.49 score on a scale
Standard Deviation 7.58
|
SECONDARY outcome
Timeframe: 3 weeks (i.e., immediately post-intervention)trait mindfulness non-judging of inner experience (range = 8-40 with higher scores indicating greater mindfulness)
Outcome measures
| Measure |
Mindfulness App
n=71 Participants
Guided mindfulness exercises will be delivered via mobile app for three weeks.
Mindfulness App: Mindfulness exercises will last 1-12 minutes. Each one asks participants to focus on something (e.g., breath, sounds, physical sensations) using guided instruction.
|
Control Condition
n=79 Participants
Participants will use app for assessment for three weeks, but no mindfulness exercises will be delivered.
|
|---|---|---|
|
Five Facet Mindfulness Questionnaire Nonjudging Subscale
|
27.86 score on a scale
Standard Deviation 6.79
|
27.05 score on a scale
Standard Deviation 7.52
|
SECONDARY outcome
Timeframe: 6 weeks post interventiontrait mindfulness non-judging of inner experience (range = 8-40 with higher scores indicating greater mindfulness)
Outcome measures
| Measure |
Mindfulness App
n=66 Participants
Guided mindfulness exercises will be delivered via mobile app for three weeks.
Mindfulness App: Mindfulness exercises will last 1-12 minutes. Each one asks participants to focus on something (e.g., breath, sounds, physical sensations) using guided instruction.
|
Control Condition
n=76 Participants
Participants will use app for assessment for three weeks, but no mindfulness exercises will be delivered.
|
|---|---|---|
|
Five Facet Mindfulness Questionnaire Nonjudging Subscale
|
28.23 score on a scale
Standard Deviation 7.23
|
27.93 score on a scale
Standard Deviation 6.94
|
SECONDARY outcome
Timeframe: 12 weeks post interventiontrait mindfulness non-judging of inner experience (range = 8-40 with higher scores indicating greater mindfulness)
Outcome measures
| Measure |
Mindfulness App
n=64 Participants
Guided mindfulness exercises will be delivered via mobile app for three weeks.
Mindfulness App: Mindfulness exercises will last 1-12 minutes. Each one asks participants to focus on something (e.g., breath, sounds, physical sensations) using guided instruction.
|
Control Condition
n=74 Participants
Participants will use app for assessment for three weeks, but no mindfulness exercises will be delivered.
|
|---|---|---|
|
Five Facet Mindfulness Questionnaire Nonjudging Subscale
|
27.88 score on a scale
Standard Deviation 7.4
|
27.74 score on a scale
Standard Deviation 7.15
|
SECONDARY outcome
Timeframe: 6 months post interventiontrait mindfulness non-judging of inner experience (range = 8-40 with higher scores indicating greater mindfulness)
Outcome measures
| Measure |
Mindfulness App
n=63 Participants
Guided mindfulness exercises will be delivered via mobile app for three weeks.
Mindfulness App: Mindfulness exercises will last 1-12 minutes. Each one asks participants to focus on something (e.g., breath, sounds, physical sensations) using guided instruction.
|
Control Condition
n=71 Participants
Participants will use app for assessment for three weeks, but no mindfulness exercises will be delivered.
|
|---|---|---|
|
Five Facet Mindfulness Questionnaire Nonjudging Subscale
|
28.87 score on a scale
Standard Deviation 7.45
|
28.01 score on a scale
Standard Deviation 6.72
|
SECONDARY outcome
Timeframe: baselinetrait mindfulness non-reactivity to inner experience (range = 7-35 with higher scores indicating greater mindfulness)
Outcome measures
| Measure |
Mindfulness App
n=72 Participants
Guided mindfulness exercises will be delivered via mobile app for three weeks.
Mindfulness App: Mindfulness exercises will last 1-12 minutes. Each one asks participants to focus on something (e.g., breath, sounds, physical sensations) using guided instruction.
|
Control Condition
n=80 Participants
Participants will use app for assessment for three weeks, but no mindfulness exercises will be delivered.
|
|---|---|---|
|
Five Facet Mindfulness Questionnaire Nonreactivity Subscale
|
19.58 score on a scale
Standard Deviation 4.58
|
19.44 score on a scale
Standard Deviation 3.99
|
SECONDARY outcome
Timeframe: 3 weeks (i.e., immediately post-intervention)trait mindfulness non-reactivity to inner experience (range = 7-35 with higher scores indicating greater mindfulness)
Outcome measures
| Measure |
Mindfulness App
n=71 Participants
Guided mindfulness exercises will be delivered via mobile app for three weeks.
Mindfulness App: Mindfulness exercises will last 1-12 minutes. Each one asks participants to focus on something (e.g., breath, sounds, physical sensations) using guided instruction.
|
Control Condition
n=79 Participants
Participants will use app for assessment for three weeks, but no mindfulness exercises will be delivered.
|
|---|---|---|
|
Five Facet Mindfulness Questionnaire Nonreactivity Subscale
|
20.09 score on a scale
Standard Deviation 4.64
|
19.72 score on a scale
Standard Deviation 4.34
|
SECONDARY outcome
Timeframe: 6 weeks post intervention)trait mindfulness non-reactivity to inner experience (range = 7-35 with higher scores indicating greater mindfulness)
Outcome measures
| Measure |
Mindfulness App
n=66 Participants
Guided mindfulness exercises will be delivered via mobile app for three weeks.
Mindfulness App: Mindfulness exercises will last 1-12 minutes. Each one asks participants to focus on something (e.g., breath, sounds, physical sensations) using guided instruction.
|
Control Condition
n=76 Participants
Participants will use app for assessment for three weeks, but no mindfulness exercises will be delivered.
|
|---|---|---|
|
Five Facet Mindfulness Questionnaire Nonreactivity Subscale
|
20.72 score on a scale
Standard Deviation 5.61
|
19.65 score on a scale
Standard Deviation 4.26
|
SECONDARY outcome
Timeframe: 12 weeks post intervention)trait mindfulness non-reactivity to inner experience (range = 7-35 with higher scores indicating greater mindfulness)
Outcome measures
| Measure |
Mindfulness App
n=64 Participants
Guided mindfulness exercises will be delivered via mobile app for three weeks.
Mindfulness App: Mindfulness exercises will last 1-12 minutes. Each one asks participants to focus on something (e.g., breath, sounds, physical sensations) using guided instruction.
|
Control Condition
n=74 Participants
Participants will use app for assessment for three weeks, but no mindfulness exercises will be delivered.
|
|---|---|---|
|
Five Facet Mindfulness Questionnaire Nonreactivity Subscale
|
21.19 score on a scale
Standard Deviation 4.16
|
20.14 score on a scale
Standard Deviation 3.86
|
SECONDARY outcome
Timeframe: 6 months post intervention)trait mindfulness non-reactivity to inner experience (range = 7-35 with higher scores indicating greater mindfulness)
Outcome measures
| Measure |
Mindfulness App
n=63 Participants
Guided mindfulness exercises will be delivered via mobile app for three weeks.
Mindfulness App: Mindfulness exercises will last 1-12 minutes. Each one asks participants to focus on something (e.g., breath, sounds, physical sensations) using guided instruction.
|
Control Condition
n=71 Participants
Participants will use app for assessment for three weeks, but no mindfulness exercises will be delivered.
|
|---|---|---|
|
Five Facet Mindfulness Questionnaire Nonreactivity Subscale
|
21.3 score on a scale
Standard Deviation 4.67
|
20.03 score on a scale
Standard Deviation 4.52
|
SECONDARY outcome
Timeframe: 3 weeks (i.e., immediately post-intervention)average focus on bodily sensations during intervention period rated on visual analog scale (range = 0-100 with higher scores indicating more mindfulness)
Outcome measures
| Measure |
Mindfulness App
n=72 Participants
Guided mindfulness exercises will be delivered via mobile app for three weeks.
Mindfulness App: Mindfulness exercises will last 1-12 minutes. Each one asks participants to focus on something (e.g., breath, sounds, physical sensations) using guided instruction.
|
Control Condition
n=80 Participants
Participants will use app for assessment for three weeks, but no mindfulness exercises will be delivered.
|
|---|---|---|
|
State Mindfulness Bodily Sensations
|
36.59 units on a scale
Standard Deviation 21.06
|
38.67 units on a scale
Standard Deviation 21.35
|
SECONDARY outcome
Timeframe: 3 weeks (i.e., immediately post-intervention)average % focus on present moment (as opposed to past or future focus) during intervention period indicating more mindfulness
Outcome measures
| Measure |
Mindfulness App
n=72 Participants
Guided mindfulness exercises will be delivered via mobile app for three weeks.
Mindfulness App: Mindfulness exercises will last 1-12 minutes. Each one asks participants to focus on something (e.g., breath, sounds, physical sensations) using guided instruction.
|
Control Condition
n=80 Participants
Participants will use app for assessment for three weeks, but no mindfulness exercises will be delivered.
|
|---|---|---|
|
State Mindfulness Present Focus
|
.633 percentage of time focused on present
Standard Deviation .22
|
.558 percentage of time focused on present
Standard Deviation .23
|
Adverse Events
Mindfulness App
Serious events: 1 serious events
Other events: 8 other events
Deaths: 0 deaths
Control Condition
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Mindfulness App
n=72 participants at risk
Guided mindfulness exercises will be delivered via mobile app for three weeks.
Mindfulness App: Mindfulness exercises will last 1-12 minutes. Each one asks participants to focus on something (e.g., breath, sounds, physical sensations) using guided instruction.
|
Control Condition
n=80 participants at risk
Participants will use app for assessment for three weeks, but no mindfulness exercises will be delivered.
|
|---|---|---|
|
Social circumstances
Suicide Attempt
|
1.4%
1/72 • Number of events 1 • Baseline through 6-month follow-up.
|
0.00%
0/80 • Baseline through 6-month follow-up.
|
Other adverse events
| Measure |
Mindfulness App
n=72 participants at risk
Guided mindfulness exercises will be delivered via mobile app for three weeks.
Mindfulness App: Mindfulness exercises will last 1-12 minutes. Each one asks participants to focus on something (e.g., breath, sounds, physical sensations) using guided instruction.
|
Control Condition
n=80 participants at risk
Participants will use app for assessment for three weeks, but no mindfulness exercises will be delivered.
|
|---|---|---|
|
Psychiatric disorders
Stress from noticing negative emotions
|
1.4%
1/72 • Number of events 1 • Baseline through 6-month follow-up.
|
3.8%
3/80 • Number of events 3 • Baseline through 6-month follow-up.
|
|
Psychiatric disorders
Onset of Non-suicidal Self-Injury
|
2.8%
2/72 • Number of events 2 • Baseline through 6-month follow-up.
|
1.2%
1/80 • Number of events 1 • Baseline through 6-month follow-up.
|
|
Psychiatric disorders
Onset of Passive Suicidal Ideation
|
4.2%
3/72 • Number of events 3 • Baseline through 6-month follow-up.
|
1.2%
1/80 • Number of events 1 • Baseline through 6-month follow-up.
|
|
Psychiatric disorders
Discomfort from Mindfulness Activity
|
2.8%
2/72 • Number of events 2 • Baseline through 6-month follow-up.
|
0.00%
0/80 • Baseline through 6-month follow-up.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place