Anxiety, Depression, Rumination, Self-Injurious Behavior
Conditions
Keywords
Mindfulness, Mobile Intervention, Brief Intervention, Adolescence
Brief summary
Rumination involves focusing on negative emotions repeatedly and is a risk factor for developing depression, anxiety, and self-injury. These negative outcomes increase in adolescence. The main goal of this study is to examine whether a mobile application designed to reduce rumination works with adolescents. The mobile application involves mindfulness exercises. Mindfulness means nonjudgmentally and deliberately paying attention. Adolescents will be randomly assigned to either the mindfulness group or a control group who uses a mobile application without mindfulness exercises. Both groups will use the app three times per day for three weeks and we will follow up with participants for six months. The investigators hypothesize that the mindfulness group will experience a reduction in rumination and symptoms of depression, anxiety and self-injury. They also expect that the mindfulness group will find the mobile app to be more engaging and will continue to use it beyond the 3 weeks.
Detailed description
Rumination, a perseverative cognitive process that involves dwelling on negative emotions, is a transdiagnostic risk factor for the development of depression, anxiety, and self-injurious behaviors. Thus, reducing the tendency to ruminate in adolescence, a time when many psychological disorders often first develop, has the potential for a large public health impact. This protocol involves testing the acceptability and efficacy of a newly developed mindfulness mobile application designed to reduce rumination. Mindfulness involves paying attention to the present moment without judgement. If negative emotions arise, one notices them and how the body is feeling without becoming caught up in the emotion so that it can pass. In adult clinical studies, intensive mindfulness practice has been associated with successful treatment of psychopathology, including preventing the recurrence of depression, possibly through reducing rumination. Research with adolescents has suggested that a brief mindfulness exercise can interrupt the ruminative process. Thus, mindfulness appears to be a promising strategy to reduce the tendency to ruminate and prevent psychopathology. A diverse sample of 150 high-ruminating 12-15 year-olds will be recruited from the community and randomly assigned to a 3-week mobile mindfulness intervention or an ecological momentary assessment (EMA)-only control condition. In both conditions, adolescents will be notified to use the mobile app three times per day to complete EMA questions. Based on mood ratings, participants in the mindfulness condition have a chance to receive a brief mindfulness exercise (i.e., 1-12 minutes long) at each use. At pre- and post-intervention and three follow-up periods (6 weeks,12 weeks, and 6 months), participants and their parents will report on adolescent anxiety and depression. Adolescents will also report on self-injurious thoughts and behaviors (SITBs), trait rumination, and mindfulness. During the intervention period, participants will report on state levels of rumination, mindfulness, and mood using the app. Participants will also report on their satisfaction with the app, while their optional continued use of the app will be monitored electronically for 6 months following the intervention period. The investigators will test intervention effects using multilevel modeling, examining the role of both state- and trait-level mediators. Based on preliminary pilot data, the investigators expect that the mindfulness intervention will reduce symptoms, and we anticipate this effect to be due to the mediating role of decreased rumination.
Interventions
BEHAVIORALMindfulness 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.
Sponsors
Lawrence University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Intervention model description
Participants will be randomly assigned to the intervention group (i.e., mindfulness with ecological momentary assessment) or the control group (i.e., ecological momentary assessment only).
Eligibility
Sex/Gender
ALL
Age
12 Years to 15 Years
Healthy volunteers
Yes
Inclusion criteria
* adolescent between the ages of 12 and 15 years * at least moderate levels of rumination (mean score of 2 or above on a 1-4 scale) on the two screening questions
Exclusion criteria
* serious physical or cognitive disability that prevents adolescent from using a mobile device, because that is the intervention delivery method * inadequate English proficiency to complete questionnaires
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Ease of Use | 3 weeks (i.e., immediately post-intervention) | how easy app was to use (range = 1-7 with higher being easier to use) |
| Multidimensional Anxiety Scale for Children | baseline | self-reported anxiety symptoms (range = 0-117 with higher scores indicating more anxiety) |
| Self-injurious Thoughts and Behaviors Questionnaire | baseline | percent of participants engaged in self-injury over the past year |
| Pediatric Symptom Checklist Internalizing Scale | baseline | parent-reported internalizing symptoms (range = 0-10 with higher scores indicating more internalizing symptoms) |
| State Rumination | 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) |
| State Mood | 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) |
| Daily App Use | 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. |
| Continued Use | 6 months post intervention | Number of times app was used after the 3 week intervention period |
| Children's Response Styles Questionnaire | baseline | trait rumination (range = 0-39 with higher scores indicating more rumination) |
| Children's Depression Inventory | baseline | self-reported depressive symptoms (range = 0-54 with higher scores indicating more symptoms) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Five Facet Mindfulness Questionnaire Describing Subscale | baseline | trait mindfulness describing (range = 8-40 with higher scores indicating greater mindfulness) |
| Five Facet Mindfulness Questionnaire Awareness Subscale | baseline | trait mindfulness acting with awareness (range = 8-40 with higher scores indicating greater mindfulness) |
| Five Facet Mindfulness Questionnaire Nonjudging Subscale | baseline | trait mindfulness non-judging of inner experience (range = 8-40 with higher scores indicating greater mindfulness) |
| Five Facet Mindfulness Questionnaire Nonreactivity Subscale | baseline | trait mindfulness non-reactivity to inner experience (range = 7-35 with higher scores indicating greater mindfulness) |
| State Mindfulness Bodily Sensations | 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) |
| State Mindfulness Present Focus | 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 |
| Five Facet Mindfulness Questionnaire Observing Subscale | baseline | trait mindfulness observing (range = 8-40 with higher scores indicating greater mindfulness) |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 72 |
| Control Condition Participants will use app for assessment for three weeks, but no mindfulness exercises will be delivered. | 80 |
| Total | 152 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Six Month Follow-up | Lost to Follow-up | 4 | 3 |
| Six Month Follow-up | Withdrawal by Subject | 1 | 1 |
| Six Week Follow-up | Lost to Follow-up | 1 | 0 |
| Six Week Follow-up | Withdrawal by Subject | 1 | 0 |
| Twelve Week Follow-up | Adverse Event | 1 | 1 |
| Twelve Week Follow-up | Lost to Follow-up | 0 | 2 |
| Twelve Week Follow-up | Withdrawal by Subject | 0 | 1 |
Baseline characteristics
| Characteristic | Mindfulness App | Control Condition | Total |
|---|---|---|---|
| Age, Continuous | 13.78 years STANDARD_DEVIATION 0.93 | 13.66 years STANDARD_DEVIATION 0.86 | 13.71 years STANDARD_DEVIATION 0.89 |
| Children's Depression Inventory | 13.4 units on a scale STANDARD_DEVIATION 8.77 | 12.04 units on a scale STANDARD_DEVIATION 7.72 | 12.68 units on a scale STANDARD_DEVIATION 8.23 |
| Children's Response Styles Questionnaire | 33.47 units on a scale STANDARD_DEVIATION 9.64 | 30.73 units on a scale STANDARD_DEVIATION 9.05 | 32.03 units on a scale STANDARD_DEVIATION 9.4 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 9 Participants | 7 Participants | 16 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 63 Participants | 73 Participants | 136 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Five Facet Mindfulness Questionnaire Awareness Subscale | 25.03 units on a scale STANDARD_DEVIATION 6.23 | 26.17 units on a scale STANDARD_DEVIATION 5.84 | 25.63 units on a scale STANDARD_DEVIATION 6.04 |
| Five Facet Mindfulness Questionnaire Describing Subscale | 24.26 units on a scale STANDARD_DEVIATION 5.75 | 24.69 units on a scale STANDARD_DEVIATION 5.75 | 24.49 units on a scale STANDARD_DEVIATION 5.74 |
| Five Facet Mindfulness Questionnaire Nonjudging Subscale | 25.56 units on a scale STANDARD_DEVIATION 7.46 | 27.49 units on a scale STANDARD_DEVIATION 7.58 | 26.57 units on a scale STANDARD_DEVIATION 7.561 |
| Five Facet Mindfulness Questionnaire Nonreactivity Subscale | 19.58 units on a scale STANDARD_DEVIATION 4.58 | 19.44 units on a scale STANDARD_DEVIATION 3.99 | 19.51 units on a scale STANDARD_DEVIATION 4.268 |
| Five Facet Mindfulness Questionnaire Observing Subscale | 22.28 units on a scale STANDARD_DEVIATION 6.23 | 21.38 units on a scale STANDARD_DEVIATION 6.2 | 21.80 units on a scale STANDARD_DEVIATION 6.206 |
| Multidimensional Anxiety Scale for Children | 53.47 units on a scale STANDARD_DEVIATION 16.51 | 50.84 units on a scale STANDARD_DEVIATION 17.35 | 52.09 units on a scale STANDARD_DEVIATION 16.95 |
| Pediatric Symptom Checklist Internalizing Scale | 3.64 units on a scale STANDARD_DEVIATION 2.38 | 3.88 units on a scale STANDARD_DEVIATION 2.45 | 3.76 units on a scale STANDARD_DEVIATION 2.411 |
| Race/Ethnicity, Customized Race Asian; Asian American | 1 Participants | 2 Participants | 3 Participants |
| Race/Ethnicity, Customized Race Black; African American | 3 Participants | 2 Participants | 5 Participants |
| Race/Ethnicity, Customized Race Multi-racial | 11 Participants | 5 Participants | 16 Participants |
| Race/Ethnicity, Customized Race Native American | 0 Participants | 0 Participants | 0 Participants |
| Race/Ethnicity, Customized Race Native Hawaiian or Pacific Islander | 1 Participants | 0 Participants | 1 Participants |
| Race/Ethnicity, Customized Race Other | 1 Participants | 1 Participants | 2 Participants |
| Race/Ethnicity, Customized Race White | 55 Participants | 70 Participants | 125 Participants |
| Region of Enrollment United States | 72 participants | 80 participants | 152 participants |
| Self-injurious Thoughts and Behaviors Questionnaire | 11 Participants | 11 Participants | 22 Participants |
| Sex/Gender, Customized Female | 44 Participants | 45 Participants | 89 Participants |
| Sex/Gender, Customized Male | 28 Participants | 35 Participants | 63 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 72 | 0 / 80 |
| other Total, other adverse events | 8 / 72 | 5 / 80 |
| serious Total, serious adverse events | 1 / 72 | 0 / 80 |
Outcome results
Primary
Children's Depression Inventory
self-reported depressive symptoms (range = 0-54 with higher scores indicating more symptoms)
Time frame: 12 weeks post intervention
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Mindfulness App | Children's Depression Inventory | 9.33 score on a scale | Standard Deviation 7.97 |
| Control Condition | Children's Depression Inventory | 10.54 score on a scale | Standard Deviation 8.57 |
Primary
Children's Depression Inventory
self-reported depressive symptoms (range = 0-54 with higher scores indicating more symptoms)
Time frame: baseline
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Mindfulness App | Children's Depression Inventory | 13.4 score on a scale | Standard Deviation 8.77 |
| Control Condition | Children's Depression Inventory | 12.04 score on a scale | Standard Deviation 7.72 |
Primary
Children's Depression Inventory
self-reported depressive symptoms (range = 0-54 with higher scores indicating more symptoms)
Time frame: 3 weeks (immediately post-intervention)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Mindfulness App | Children's Depression Inventory | 11.52 score on a scale | Standard Deviation 9.54 |
| Control Condition | Children's Depression Inventory | 12.22 score on a scale | Standard Deviation 8.57 |
Primary
Children's Depression Inventory
self-reported depressive symptoms (range = 0-54 with higher scores indicating more symptoms)
Time frame: 6 months post intervention
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Mindfulness App | Children's Depression Inventory | 8.84 score on a scale | Standard Deviation 8.02 |
| Control Condition | Children's Depression Inventory | 10.42 score on a scale | Standard Deviation 8.97 |
Primary
Children's Depression Inventory
self-reported depressive symptoms (range = 0-54 with higher scores indicating more symptoms)
Time frame: 6 weeks post intervention
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Mindfulness App | Children's Depression Inventory | 10.68 score on a scale | Standard Deviation 9.04 |
| Control Condition | Children's Depression Inventory | 10.82 score on a scale | Standard Deviation 8.23 |
Primary
Children's Response Styles Questionnaire
trait rumination (range = 0-39 with higher scores indicating more rumination)
Time frame: 12 weeks post intervention
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Mindfulness App | Children's Response Styles Questionnaire | 29.27 score on a scale | Standard Deviation 10.22 |
| Control Condition | Children's Response Styles Questionnaire | 28.45 score on a scale | Standard Deviation 9.8 |
Primary
Children's Response Styles Questionnaire
trait rumination (range = 0-39 with higher scores indicating more rumination)
Time frame: baseline
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Mindfulness App | Children's Response Styles Questionnaire | 33.47 score on a scale | Standard Deviation 9.64 |
| Control Condition | Children's Response Styles Questionnaire | 30.73 score on a scale | Standard Deviation 9.05 |
Primary
Children's Response Styles Questionnaire
trait rumination (range = 0-39 with higher scores indicating more rumination)
Time frame: 6 months post intervention
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Mindfulness App | Children's Response Styles Questionnaire | 29.4 score on a scale | Standard Deviation 10.79 |
| Control Condition | Children's Response Styles Questionnaire | 29.77 score on a scale | Standard Deviation 10.05 |
Primary
Children's Response Styles Questionnaire
trait rumination (range = 0-39 with higher scores indicating more rumination)
Time frame: 6 weeks post intervention
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Mindfulness App | Children's Response Styles Questionnaire | 27.71 score on a scale | Standard Deviation 9.46 |
| Control Condition | Children's Response Styles Questionnaire | 29.17 score on a scale | Standard Deviation 10.64 |
Primary
Children's Response Styles Questionnaire
trait rumination (range = 0-39 with higher scores indicating more rumination)
Time frame: 3 weeks (i.e., immediately post-intervention)
Population: Number analyzed determined by number of adolescents that completed the questionnaire.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Mindfulness App | Children's Response Styles Questionnaire | 29.48 score on a scale | Standard Deviation 9.89 |
| Control Condition | Children's Response Styles Questionnaire | 30.76 score on a scale | Standard Deviation 10.12 |
Primary
Continued Use
Number of times app was used after the 3 week intervention period
Time frame: 6 months post intervention
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Mindfulness App | Continued Use | 40.24 number of app uses | Standard Deviation 78.98 |
| Control Condition | Continued Use | 39.74 number of app uses | Standard Deviation 70.22 |
Primary
Daily App Use
Daily app use was determined by how many complete app uses were logged during the three-week intervention period.
Time frame: 3 weeks (i.e., immediately post-intervention)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Mindfulness App | Daily App Use | 51.72 App uses | Standard Deviation 16.37 |
| Control Condition | Daily App Use | 54.26 App uses | Standard Deviation 15.26 |
Primary
Ease of Use
how easy app was to use (range = 1-7 with higher being easier to use)
Time frame: 3 weeks (i.e., immediately post-intervention)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Mindfulness App | Ease of Use | 6.13 units on a scale | Standard Deviation 1.19 |
| Control Condition | Ease of Use | 6.27 units on a scale | Standard Deviation 1.07 |
Primary
Multidimensional Anxiety Scale for Children
self-reported anxiety symptoms (range = 0-117 with higher scores indicating more anxiety)
Time frame: 6 months post intervention
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Mindfulness App | Multidimensional Anxiety Scale for Children | 49.29 score on a scale | Standard Deviation 16.74 |
| Control Condition | Multidimensional Anxiety Scale for Children | 49.56 score on a scale | Standard Deviation 20.58 |
Primary
Multidimensional Anxiety Scale for Children
self-reported anxiety symptoms (range = 0-117 with higher scores indicating more anxiety)
Time frame: baseline
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Mindfulness App | Multidimensional Anxiety Scale for Children | 53.47 score on a scale | Standard Deviation 16.51 |
| Control Condition | Multidimensional Anxiety Scale for Children | 50.84 score on a scale | Standard Deviation 17.35 |
Primary
Multidimensional Anxiety Scale for Children
self-reported anxiety symptoms (range = 0-117 with higher scores indicating more anxiety)
Time frame: 3 weeks (i.e., immediately post-intervention)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Mindfulness App | Multidimensional Anxiety Scale for Children | 50.94 score on a scale | Standard Deviation 16.82 |
| Control Condition | Multidimensional Anxiety Scale for Children | 52.37 score on a scale | Standard Deviation 17.64 |
Primary
Multidimensional Anxiety Scale for Children
self-reported anxiety symptoms (range = 0-117 with higher scores indicating more anxiety)
Time frame: 6 weeks post intervention
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Mindfulness App | Multidimensional Anxiety Scale for Children | 51.00 score on a scale | Standard Deviation 16.52 |
| Control Condition | Multidimensional Anxiety Scale for Children | 49.88 score on a scale | Standard Deviation 19.25 |
Primary
Multidimensional Anxiety Scale for Children
self-reported anxiety symptoms (range = 0-117 with higher scores indicating more anxiety)
Time frame: 12 weeks post intervention
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Mindfulness App | Multidimensional Anxiety Scale for Children | 50.34 score on a scale | Standard Deviation 18.18 |
| Control Condition | Multidimensional Anxiety Scale for Children | 49.82 score on a scale | Standard Deviation 19.11 |
Primary
Pediatric Symptom Checklist Internalizing Scale
parent-reported internalizing symptoms (range = 0-10 with higher scores indicating more internalizing symptoms)
Time frame: baseline
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Mindfulness App | Pediatric Symptom Checklist Internalizing Scale | 3.64 score on a scale | Standard Deviation 2.38 |
| Control Condition | Pediatric Symptom Checklist Internalizing Scale | 3.88 score on a scale | Standard Deviation 2.45 |
Primary
Pediatric Symptom Checklist Internalizing Scale
parent-reported internalizing symptoms (range = 0-10 with higher scores indicating more internalizing symptoms)
Time frame: 3 weeks (i.e., immediately post-intervention)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Mindfulness App | Pediatric Symptom Checklist Internalizing Scale | 2.49 score on a scale | Standard Deviation 2.21 |
| Control Condition | Pediatric Symptom Checklist Internalizing Scale | 2.46 score on a scale | Standard Deviation 1.99 |
Primary
Pediatric Symptom Checklist Internalizing Scale
parent-reported internalizing symptoms (range = 0-10 with higher scores indicating more internalizing symptoms)
Time frame: 6 weeks post intervention
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Mindfulness App | Pediatric Symptom Checklist Internalizing Scale | 2.38 score on a scale | Standard Deviation 2.05 |
| Control Condition | Pediatric Symptom Checklist Internalizing Scale | 2.41 score on a scale | Standard Deviation 2.09 |
Primary
Pediatric Symptom Checklist Internalizing Scale
parent-reported internalizing symptoms (range = 0-10 with higher scores indicating more internalizing symptoms)
Time frame: 12 weeks post intervention
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Mindfulness App | Pediatric Symptom Checklist Internalizing Scale | 2.49 score on a scale | Standard Deviation 2.14 |
| Control Condition | Pediatric Symptom Checklist Internalizing Scale | 2.35 score on a scale | Standard Deviation 2.14 |
Primary
Pediatric Symptom Checklist Internalizing Scale
parent-reported internalizing symptoms (range = 0-10 with higher scores indicating more internalizing symptoms)
Time frame: 6 months post intervention
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Mindfulness App | Pediatric Symptom Checklist Internalizing Scale | 2.38 score on a scale | Standard Deviation 1.96 |
| Control Condition | Pediatric Symptom Checklist Internalizing Scale | 2.68 score on a scale | Standard Deviation 2.26 |
Primary
Self-injurious Thoughts and Behaviors Questionnaire
percent of time engaged in self-injury over the past 3 months
Time frame: 6 months post intervention
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Mindfulness App | Self-injurious Thoughts and Behaviors Questionnaire | 3 Participants |
| Control Condition | Self-injurious Thoughts and Behaviors Questionnaire | 2 Participants |
Primary
Self-injurious Thoughts and Behaviors Questionnaire
percent of time engaged in self-injury over the past 6 weeks
Time frame: 12 weeks post intervention
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Mindfulness App | Self-injurious Thoughts and Behaviors Questionnaire | 2 Participants |
| Control Condition | Self-injurious Thoughts and Behaviors Questionnaire | 1 Participants |
Primary
Self-injurious Thoughts and Behaviors Questionnaire
percent of participants that engaged in self-injury over the past 6 weeks
Time frame: 6 weeks post intervention
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Mindfulness App | Self-injurious Thoughts and Behaviors Questionnaire | 3 Participants |
| Control Condition | Self-injurious Thoughts and Behaviors Questionnaire | 3 Participants |
Primary
Self-injurious Thoughts and Behaviors Questionnaire
percent of participants that engaged in self-injury over the past 3 weeks
Time frame: 3 weeks (i.e., immediately post-intervention)
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Mindfulness App | Self-injurious Thoughts and Behaviors Questionnaire | 1 Participants |
| Control Condition | Self-injurious Thoughts and Behaviors Questionnaire | 2 Participants |
Primary
Self-injurious Thoughts and Behaviors Questionnaire
percent of participants engaged in self-injury over the past year
Time frame: baseline
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Mindfulness App | Self-injurious Thoughts and Behaviors Questionnaire | 7 Participants |
| Control Condition | Self-injurious Thoughts and Behaviors Questionnaire | 7 Participants |
Primary
State Mood
average sadness and anxiety during intervention period rated on visual analog scales (range = 0-100 with higher scores indicating more rumination)
Time frame: 3 weeks (i.e., immediately post-intervention)
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Mindfulness App | State Mood | Anxiety | 36.62 units on a scale | Standard Deviation 19.35 |
| Mindfulness App | State Mood | Sadness | 25.00 units on a scale | Standard Deviation 17.72 |
| Control Condition | State Mood | Anxiety | 39.08 units on a scale | Standard Deviation 20.05 |
| Control Condition | State Mood | Sadness | 25.02 units on a scale | Standard Deviation 14.1 |
Primary
State Rumination
average state rumination during intervention period rated on a visual analog scale (range = 0-100 with higher scores indicating more rumination)
Time frame: 3 weeks (i.e., immediately post-intervention)
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Mindfulness App | State Rumination | Emotion-Focused Rumination | 41.88 units on a scale | Standard Deviation 20.44 |
| Mindfulness App | State Rumination | Problem-Focused Rumination | 34.80 units on a scale | Standard Deviation 18.47 |
| Control Condition | State Rumination | Emotion-Focused Rumination | 42.53 units on a scale | Standard Deviation 20.17 |
| Control Condition | State Rumination | Problem-Focused Rumination | 37.58 units on a scale | Standard Deviation 18.69 |
Secondary
Five Facet Mindfulness Questionnaire Awareness Subscale
trait mindfulness acting with awareness (range = 8-40 with higher scores indicating greater mindfulness)
Time frame: baseline
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Mindfulness App | Five Facet Mindfulness Questionnaire Awareness Subscale | 25.03 score on a scale | Standard Deviation 6.23 |
| Control Condition | Five Facet Mindfulness Questionnaire Awareness Subscale | 26.18 score on a scale | Standard Deviation 5.84 |
Secondary
Five Facet Mindfulness Questionnaire Awareness Subscale
trait mindfulness acting with awareness (range = 8-40 with higher scores indicating greater mindfulness)
Time frame: 3 weeks (i.e., immediately post-intervention)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Mindfulness App | Five Facet Mindfulness Questionnaire Awareness Subscale | 25.42 score on a scale | Standard Deviation 6.55 |
| Control Condition | Five Facet Mindfulness Questionnaire Awareness Subscale | 24.94 score on a scale | Standard Deviation 6.41 |
Secondary
Five Facet Mindfulness Questionnaire Awareness Subscale
trait mindfulness acting with awareness (range = 8-40 with higher scores indicating greater mindfulness)
Time frame: 6 weeks post intervention
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Mindfulness App | Five Facet Mindfulness Questionnaire Awareness Subscale | 25.12 score on a scale | Standard Deviation 6.34 |
| Control Condition | Five Facet Mindfulness Questionnaire Awareness Subscale | 25.7 score on a scale | Standard Deviation 5.42 |
Secondary
Five Facet Mindfulness Questionnaire Awareness Subscale
trait mindfulness acting with awareness (range = 8-40 with higher scores indicating greater mindfulness)
Time frame: 12 weeks post intervention
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Mindfulness App | Five Facet Mindfulness Questionnaire Awareness Subscale | 24.98 score on a scale | Standard Deviation 5.9 |
| Control Condition | Five Facet Mindfulness Questionnaire Awareness Subscale | 25.27 score on a scale | Standard Deviation 5.62 |
Secondary
Five Facet Mindfulness Questionnaire Awareness Subscale
trait mindfulness acting with awareness (range = 8-40 with higher scores indicating greater mindfulness)
Time frame: 6 months post intervention
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Mindfulness App | Five Facet Mindfulness Questionnaire Awareness Subscale | 25.43 score on a scale | Standard Deviation 6.25 |
| Control Condition | Five Facet Mindfulness Questionnaire Awareness Subscale | 26.07 score on a scale | Standard Deviation 6.32 |
Secondary
Five Facet Mindfulness Questionnaire Describing Subscale
trait mindfulness describing (range = 8-40 with higher scores indicating greater mindfulness)
Time frame: 6 weeks post intervention
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Mindfulness App | Five Facet Mindfulness Questionnaire Describing Subscale | 25.17 score on a scale | Standard Deviation 6.17 |
| Control Condition | Five Facet Mindfulness Questionnaire Describing Subscale | 25.25 score on a scale | Standard Deviation 5.35 |
Secondary
Five Facet Mindfulness Questionnaire Describing Subscale
trait mindfulness describing (range = 8-40 with higher scores indicating greater mindfulness)
Time frame: baseline
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Mindfulness App | Five Facet Mindfulness Questionnaire Describing Subscale | 24.26 score on a scale | Standard Deviation 5.75 |
| Control Condition | Five Facet Mindfulness Questionnaire Describing Subscale | 24.69 score on a scale | Standard Deviation 5.75 |
Secondary
Five Facet Mindfulness Questionnaire Describing Subscale
trait mindfulness describing (range = 8-40 with higher scores indicating greater mindfulness)
Time frame: 3 weeks (i.e., immediately post-intervention)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Mindfulness App | Five Facet Mindfulness Questionnaire Describing Subscale | 25 score on a scale | Standard Deviation 5.98 |
| Control Condition | Five Facet Mindfulness Questionnaire Describing Subscale | 23.94 score on a scale | Standard Deviation 5.1 |
Secondary
Five Facet Mindfulness Questionnaire Describing Subscale
trait mindfulness describing (range = 8-40 with higher scores indicating greater mindfulness)
Time frame: 12 weeks post intervention
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Mindfulness App | Five Facet Mindfulness Questionnaire Describing Subscale | 25.55 score on a scale | Standard Deviation 5.96 |
| Control Condition | Five Facet Mindfulness Questionnaire Describing Subscale | 24.3 score on a scale | Standard Deviation 5.41 |
Secondary
Five Facet Mindfulness Questionnaire Describing Subscale
trait mindfulness describing (range = 8-40 with higher scores indicating greater mindfulness)
Time frame: 6 months post intervention
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Mindfulness App | Five Facet Mindfulness Questionnaire Describing Subscale | 25.56 score on a scale | Standard Deviation 6.16 |
| Control Condition | Five Facet Mindfulness Questionnaire Describing Subscale | 24.97 score on a scale | Standard Deviation 5.54 |
Secondary
Five Facet Mindfulness Questionnaire Nonjudging Subscale
trait mindfulness non-judging of inner experience (range = 8-40 with higher scores indicating greater mindfulness)
Time frame: 6 weeks post intervention
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Mindfulness App | Five Facet Mindfulness Questionnaire Nonjudging Subscale | 28.23 score on a scale | Standard Deviation 7.23 |
| Control Condition | Five Facet Mindfulness Questionnaire Nonjudging Subscale | 27.93 score on a scale | Standard Deviation 6.94 |
Secondary
Five Facet Mindfulness Questionnaire Nonjudging Subscale
trait mindfulness non-judging of inner experience (range = 8-40 with higher scores indicating greater mindfulness)
Time frame: baseline
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Mindfulness App | Five Facet Mindfulness Questionnaire Nonjudging Subscale | 25.56 score on a scale | Standard Deviation 7.46 |
| Control Condition | Five Facet Mindfulness Questionnaire Nonjudging Subscale | 27.49 score on a scale | Standard Deviation 7.58 |
Secondary
Five Facet Mindfulness Questionnaire Nonjudging Subscale
trait mindfulness non-judging of inner experience (range = 8-40 with higher scores indicating greater mindfulness)
Time frame: 3 weeks (i.e., immediately post-intervention)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Mindfulness App | Five Facet Mindfulness Questionnaire Nonjudging Subscale | 27.86 score on a scale | Standard Deviation 6.79 |
| Control Condition | Five Facet Mindfulness Questionnaire Nonjudging Subscale | 27.05 score on a scale | Standard Deviation 7.52 |
Secondary
Five Facet Mindfulness Questionnaire Nonjudging Subscale
trait mindfulness non-judging of inner experience (range = 8-40 with higher scores indicating greater mindfulness)
Time frame: 12 weeks post intervention
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Mindfulness App | Five Facet Mindfulness Questionnaire Nonjudging Subscale | 27.88 score on a scale | Standard Deviation 7.4 |
| Control Condition | Five Facet Mindfulness Questionnaire Nonjudging Subscale | 27.74 score on a scale | Standard Deviation 7.15 |
Secondary
Five Facet Mindfulness Questionnaire Nonjudging Subscale
trait mindfulness non-judging of inner experience (range = 8-40 with higher scores indicating greater mindfulness)
Time frame: 6 months post intervention
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Mindfulness App | Five Facet Mindfulness Questionnaire Nonjudging Subscale | 28.87 score on a scale | Standard Deviation 7.45 |
| Control Condition | Five Facet Mindfulness Questionnaire Nonjudging Subscale | 28.01 score on a scale | Standard Deviation 6.72 |
Secondary
Five Facet Mindfulness Questionnaire Nonreactivity Subscale
trait mindfulness non-reactivity to inner experience (range = 7-35 with higher scores indicating greater mindfulness)
Time frame: 6 weeks post intervention)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Mindfulness App | Five Facet Mindfulness Questionnaire Nonreactivity Subscale | 20.72 score on a scale | Standard Deviation 5.61 |
| Control Condition | Five Facet Mindfulness Questionnaire Nonreactivity Subscale | 19.65 score on a scale | Standard Deviation 4.26 |
Secondary
Five Facet Mindfulness Questionnaire Nonreactivity Subscale
trait mindfulness non-reactivity to inner experience (range = 7-35 with higher scores indicating greater mindfulness)
Time frame: 6 months post intervention)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Mindfulness App | Five Facet Mindfulness Questionnaire Nonreactivity Subscale | 21.3 score on a scale | Standard Deviation 4.67 |
| Control Condition | Five Facet Mindfulness Questionnaire Nonreactivity Subscale | 20.03 score on a scale | Standard Deviation 4.52 |
Secondary
Five Facet Mindfulness Questionnaire Nonreactivity Subscale
trait mindfulness non-reactivity to inner experience (range = 7-35 with higher scores indicating greater mindfulness)
Time frame: 12 weeks post intervention)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Mindfulness App | Five Facet Mindfulness Questionnaire Nonreactivity Subscale | 21.19 score on a scale | Standard Deviation 4.16 |
| Control Condition | Five Facet Mindfulness Questionnaire Nonreactivity Subscale | 20.14 score on a scale | Standard Deviation 3.86 |
Secondary
Five Facet Mindfulness Questionnaire Nonreactivity Subscale
trait mindfulness non-reactivity to inner experience (range = 7-35 with higher scores indicating greater mindfulness)
Time frame: 3 weeks (i.e., immediately post-intervention)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Mindfulness App | Five Facet Mindfulness Questionnaire Nonreactivity Subscale | 20.09 score on a scale | Standard Deviation 4.64 |
| Control Condition | Five Facet Mindfulness Questionnaire Nonreactivity Subscale | 19.72 score on a scale | Standard Deviation 4.34 |
Secondary
Five Facet Mindfulness Questionnaire Nonreactivity Subscale
trait mindfulness non-reactivity to inner experience (range = 7-35 with higher scores indicating greater mindfulness)
Time frame: baseline
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Mindfulness App | Five Facet Mindfulness Questionnaire Nonreactivity Subscale | 19.58 score on a scale | Standard Deviation 4.58 |
| Control Condition | Five Facet Mindfulness Questionnaire Nonreactivity Subscale | 19.44 score on a scale | Standard Deviation 3.99 |
Secondary
Five Facet Mindfulness Questionnaire Observing Subscale
trait mindfulness observing (range = 8-40 with higher scores indicating greater mindfulness)
Time frame: 3 weeks (i.e., immediately post-intervention)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Mindfulness App | Five Facet Mindfulness Questionnaire Observing Subscale | 22.66 score on a scale | Standard Deviation 6.39 |
| Control Condition | Five Facet Mindfulness Questionnaire Observing Subscale | 22.05 score on a scale | Standard Deviation 6.22 |
Secondary
Five Facet Mindfulness Questionnaire Observing Subscale
trait mindfulness observing (range = 8-40 with higher scores indicating greater mindfulness)
Time frame: baseline
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Mindfulness App | Five Facet Mindfulness Questionnaire Observing Subscale | 22.28 score on a scale | Standard Deviation 6.23 |
| Control Condition | Five Facet Mindfulness Questionnaire Observing Subscale | 21.38 score on a scale | Standard Deviation 6.2 |
Secondary
Five Facet Mindfulness Questionnaire Observing Subscale
trait mindfulness observing (range = 8-40 with higher scores indicating greater mindfulness)
Time frame: 12 weeks post intervention
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Mindfulness App | Five Facet Mindfulness Questionnaire Observing Subscale | 23.77 score on a scale | Standard Deviation 5.83 |
| Control Condition | Five Facet Mindfulness Questionnaire Observing Subscale | 22.45 score on a scale | Standard Deviation 5.95 |
Secondary
Five Facet Mindfulness Questionnaire Observing Subscale
trait mindfulness observing (range = 8-40 with higher scores indicating greater mindfulness)
Time frame: 6 months post intervention
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Mindfulness App | Five Facet Mindfulness Questionnaire Observing Subscale | 24.19 score on a scale | Standard Deviation 5.76 |
| Control Condition | Five Facet Mindfulness Questionnaire Observing Subscale | 21.48 score on a scale | Standard Deviation 6.99 |
Secondary
Five Facet Mindfulness Questionnaire Observing Subscale
trait mindfulness observing (range = 8-40 with higher scores indicating greater mindfulness)
Time frame: 6 weeks post intervention
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Mindfulness App | Five Facet Mindfulness Questionnaire Observing Subscale | 23.05 score on a scale | Standard Deviation 5.69 |
| Control Condition | Five Facet Mindfulness Questionnaire Observing Subscale | 21.97 score on a scale | Standard Deviation 5.74 |
Secondary
State Mindfulness Bodily Sensations
average focus on bodily sensations during intervention period rated on visual analog scale (range = 0-100 with higher scores indicating more mindfulness)
Time frame: 3 weeks (i.e., immediately post-intervention)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Mindfulness App | State Mindfulness Bodily Sensations | 36.59 units on a scale | Standard Deviation 21.06 |
| Control Condition | State Mindfulness Bodily Sensations | 38.67 units on a scale | Standard Deviation 21.35 |
Secondary
State Mindfulness Present Focus
average % focus on present moment (as opposed to past or future focus) during intervention period indicating more mindfulness
Time frame: 3 weeks (i.e., immediately post-intervention)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Mindfulness App | State Mindfulness Present Focus | .633 percentage of time focused on present | Standard Deviation 0.22 |
| Control Condition | State Mindfulness Present Focus | .558 percentage of time focused on present | Standard Deviation 0.23 |