RuminationAMMASRCTNCT03900416
Adolescent Mindfulness Mobile App Study (RCT)
A study testing Mindfulness App in people with Rumination and Depression, run by Lawrence University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 12 to 15 yearsHealthy volunteers can take part
- Conditions the study is for
- Rumination, Depression, Anxiety
- What is being tested?
- Mindfulness App
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 152 participants
- Where
- 1 siteUnited States
- Study dates
- 17 Jun 2019to 3 Feb 2021
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 to 15 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Mindfulness-based Mobile Application to Reduce Rumination in Adolescents
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.
Read the 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.
- Conditions
- Rumination, Depression, Anxiety, Self-Injurious Behavior
- Being tested
- Mindfulness App
- Keywords
- Mindfulness, Mobile Intervention, Brief Intervention, Adolescence
- Medical subject headings
- Rumination Syndrome, Depression, Anxiety Disorders, Self-Injurious Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mindfulness AppBehavioural
Mindfulness exercises will last 1-12 minutes. Each one asks participants to focus on something (e.g., breath, sounds, physical sensations) using guided instruction.
| Study group | Role | What they receive |
|---|---|---|
| Mindfulness App | Experimental | Guided mindfulness exercises will be delivered via mobile app for three weeks. Receives: Behavioral: Mindfulness App |
| Control condition | No intervention | Participants will use app for assessment for three weeks, but no mindfulness exercises will be delivered. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Children's Response Styles Questionnaire
trait rumination (range = 0-39 with higher scores indicating more rumination)
Measured: baseline
Children's Response Styles Questionnaire
trait rumination (range = 0-39 with higher scores indicating more rumination)
Measured: 3 weeks (i.e., immediately post-intervention)
Children's Response Styles Questionnaire
trait rumination (range = 0-39 with higher scores indicating more rumination)
Measured: 6 weeks post intervention
Children's Response Styles Questionnaire
trait rumination (range = 0-39 with higher scores indicating more rumination)
Measured: 12 weeks post intervention
Children's Response Styles Questionnaire
trait rumination (range = 0-39 with higher scores indicating more rumination)
Measured: 6 months post intervention
Children's Depression Inventory
self-reported depressive symptoms (range = 0-54 with higher scores indicating more symptoms)
Measured: baseline
Children's Depression Inventory
self-reported depressive symptoms (range = 0-54 with higher scores indicating more symptoms)
Measured: 3 weeks (immediately post-intervention)
Children's Depression Inventory
self-reported depressive symptoms (range = 0-54 with higher scores indicating more symptoms)
Measured: 6 weeks post intervention
Children's Depression Inventory
self-reported depressive symptoms (range = 0-54 with higher scores indicating more symptoms)
Measured: 12 weeks post intervention
Children's Depression Inventory
self-reported depressive symptoms (range = 0-54 with higher scores indicating more symptoms)
Measured: 6 months post intervention
Multidimensional Anxiety Scale for Children
self-reported anxiety symptoms (range = 0-117 with higher scores indicating more anxiety)
Measured: baseline
Multidimensional Anxiety Scale for Children
self-reported anxiety symptoms (range = 0-117 with higher scores indicating more anxiety)
Measured: 3 weeks (i.e., immediately post-intervention)
Multidimensional Anxiety Scale for Children
self-reported anxiety symptoms (range = 0-117 with higher scores indicating more anxiety)
Measured: 6 weeks post intervention
Multidimensional Anxiety Scale for Children
self-reported anxiety symptoms (range = 0-117 with higher scores indicating more anxiety)
Measured: 12 weeks post intervention
Multidimensional Anxiety Scale for Children
self-reported anxiety symptoms (range = 0-117 with higher scores indicating more anxiety)
Measured: 6 months post intervention
Self-injurious Thoughts and Behaviors Questionnaire
percent of participants engaged in self-injury over the past year
Measured: baseline
Self-injurious Thoughts and Behaviors Questionnaire
percent of participants that engaged in self-injury over the past 3 weeks
Measured: 3 weeks (i.e., immediately post-intervention)
Self-injurious Thoughts and Behaviors Questionnaire
percent of participants that engaged in self-injury over the past 6 weeks
Measured: 6 weeks post intervention
Self-injurious Thoughts and Behaviors Questionnaire
percent of time engaged in self-injury over the past 6 weeks
Measured: 12 weeks post intervention
Self-injurious Thoughts and Behaviors Questionnaire
percent of time engaged in self-injury over the past 3 months
Measured: 6 months post intervention
Pediatric Symptom Checklist Internalizing Scale
parent-reported internalizing symptoms (range = 0-10 with higher scores indicating more internalizing symptoms)
Measured: baseline
Pediatric Symptom Checklist Internalizing Scale
parent-reported internalizing symptoms (range = 0-10 with higher scores indicating more internalizing symptoms)
Measured: 3 weeks (i.e., immediately post-intervention)
Pediatric Symptom Checklist Internalizing Scale
parent-reported internalizing symptoms (range = 0-10 with higher scores indicating more internalizing symptoms)
Measured: 6 weeks post intervention
Pediatric Symptom Checklist Internalizing Scale
parent-reported internalizing symptoms (range = 0-10 with higher scores indicating more internalizing symptoms)
Measured: 12 weeks post intervention
Pediatric Symptom Checklist Internalizing Scale
parent-reported internalizing symptoms (range = 0-10 with higher scores indicating more internalizing symptoms)
Measured: 6 months post intervention
State Rumination
average state rumination during intervention period rated on a visual analog scale (range = 0-100 with higher scores indicating more rumination)
Measured: 3 weeks (i.e., immediately post-intervention)
State Mood
average sadness and anxiety during intervention period rated on visual analog scales (range = 0-100 with higher scores indicating more rumination)
Measured: 3 weeks (i.e., immediately post-intervention)
Daily App Use
Daily app use was determined by how many complete app uses were logged during the three-week intervention period.
Measured: 3 weeks (i.e., immediately post-intervention)
Continued Use
Number of times app was used after the 3 week intervention period
Measured: 6 months post intervention
Ease of Use
how easy app was to use (range = 1-7 with higher being easier to use)
Measured: 3 weeks (i.e., immediately post-intervention)
Secondary outcomes (27)
Five Facet Mindfulness Questionnaire Observing Subscale
trait mindfulness observing (range = 8-40 with higher scores indicating greater mindfulness)
Measured: baseline
Five Facet Mindfulness Questionnaire Observing Subscale
trait mindfulness observing (range = 8-40 with higher scores indicating greater mindfulness)
Measured: 3 weeks (i.e., immediately post-intervention)
Five Facet Mindfulness Questionnaire Observing Subscale
trait mindfulness observing (range = 8-40 with higher scores indicating greater mindfulness)
Measured: 6 weeks post intervention
Five Facet Mindfulness Questionnaire Observing Subscale
trait mindfulness observing (range = 8-40 with higher scores indicating greater mindfulness)
Measured: 12 weeks post intervention
Five Facet Mindfulness Questionnaire Observing Subscale
trait mindfulness observing (range = 8-40 with higher scores indicating greater mindfulness)
Measured: 6 months post intervention
Five Facet Mindfulness Questionnaire Describing Subscale
trait mindfulness describing (range = 8-40 with higher scores indicating greater mindfulness)
Measured: baseline
Five Facet Mindfulness Questionnaire Describing Subscale
trait mindfulness describing (range = 8-40 with higher scores indicating greater mindfulness)
Measured: 3 weeks (i.e., immediately post-intervention)
Five Facet Mindfulness Questionnaire Describing Subscale
trait mindfulness describing (range = 8-40 with higher scores indicating greater mindfulness)
Measured: 6 weeks post intervention
Five Facet Mindfulness Questionnaire Describing Subscale
trait mindfulness describing (range = 8-40 with higher scores indicating greater mindfulness)
Measured: 12 weeks post intervention
Five Facet Mindfulness Questionnaire Describing Subscale
trait mindfulness describing (range = 8-40 with higher scores indicating greater mindfulness)
Measured: 6 months post intervention
Five Facet Mindfulness Questionnaire Awareness Subscale
trait mindfulness acting with awareness (range = 8-40 with higher scores indicating greater mindfulness)
Measured: baseline
Five Facet Mindfulness Questionnaire Awareness Subscale
trait mindfulness acting with awareness (range = 8-40 with higher scores indicating greater mindfulness)
Measured: 3 weeks (i.e., immediately post-intervention)
Five Facet Mindfulness Questionnaire Awareness Subscale
trait mindfulness acting with awareness (range = 8-40 with higher scores indicating greater mindfulness)
Measured: 6 weeks post intervention
Five Facet Mindfulness Questionnaire Awareness Subscale
trait mindfulness acting with awareness (range = 8-40 with higher scores indicating greater mindfulness)
Measured: 12 weeks post intervention
Five Facet Mindfulness Questionnaire Awareness Subscale
trait mindfulness acting with awareness (range = 8-40 with higher scores indicating greater mindfulness)
Measured: 6 months post intervention
Five Facet Mindfulness Questionnaire Nonjudging Subscale
trait mindfulness non-judging of inner experience (range = 8-40 with higher scores indicating greater mindfulness)
Measured: baseline
Five Facet Mindfulness Questionnaire Nonjudging Subscale
trait mindfulness non-judging of inner experience (range = 8-40 with higher scores indicating greater mindfulness)
Measured: 3 weeks (i.e., immediately post-intervention)
Five Facet Mindfulness Questionnaire Nonjudging Subscale
trait mindfulness non-judging of inner experience (range = 8-40 with higher scores indicating greater mindfulness)
Measured: 6 weeks post intervention
Five Facet Mindfulness Questionnaire Nonjudging Subscale
trait mindfulness non-judging of inner experience (range = 8-40 with higher scores indicating greater mindfulness)
Measured: 12 weeks post intervention
Five Facet Mindfulness Questionnaire Nonjudging Subscale
trait mindfulness non-judging of inner experience (range = 8-40 with higher scores indicating greater mindfulness)
Measured: 6 months post intervention
Five Facet Mindfulness Questionnaire Nonreactivity Subscale
trait mindfulness non-reactivity to inner experience (range = 7-35 with higher scores indicating greater mindfulness)
Measured: baseline
Five Facet Mindfulness Questionnaire Nonreactivity Subscale
trait mindfulness non-reactivity to inner experience (range = 7-35 with higher scores indicating greater mindfulness)
Measured: 3 weeks (i.e., immediately post-intervention)
Five Facet Mindfulness Questionnaire Nonreactivity Subscale
trait mindfulness non-reactivity to inner experience (range = 7-35 with higher scores indicating greater mindfulness)
Measured: 6 weeks post intervention)
Five Facet Mindfulness Questionnaire Nonreactivity Subscale
trait mindfulness non-reactivity to inner experience (range = 7-35 with higher scores indicating greater mindfulness)
Measured: 12 weeks post intervention)
Five Facet Mindfulness Questionnaire Nonreactivity Subscale
trait mindfulness non-reactivity to inner experience (range = 7-35 with higher scores indicating greater mindfulness)
Measured: 6 months post intervention)
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)
Measured: 3 weeks (i.e., immediately post-intervention)
State Mindfulness Present Focus
average % focus on present moment (as opposed to past or future focus) during intervention period indicating more mindfulness
Measured: 3 weeks (i.e., immediately post-intervention)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Apr 2019
- Study start17 Jun 2019
- Primary completion3 Feb 2021
- Study completion3 Feb 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for RuminationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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).
- Masking
- None (open label)
- Enrolment
- 152 participants (actual)
Sponsor and investigators
- Lead sponsor
- Lawrence University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Lori Hilt, Lawrence University
- Investigators
- Lori M Hilt, PhD, Principal investigator, Lawrence University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03900416
- Sponsor's protocol ID
- 7_25_18_Hilt
- Acronym
- AMMASRCT
- Status last verified
- Oct 2021
- First submitted
- 22 Mar 2019
- Last updated
- 8 Nov 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Hilt LM, Swords CM, Webb CA. Randomized Controlled Trial of a Mindfulness Mobile Application for Ruminative Adolescents. J Clin Child Adolesc Psychol. 2025 Jan-Feb;54(1):99-112. doi: 10.1080/15374416.2022.2158840. Epub 2023 Jan 9.
PubMed 36622879Webb CA, Swords CM, Lawrence HR, Hilt LM. Which adolescents are well-suited to app-based mindfulness training? A randomized clinical trial and data-driven approach for personalized recommendations. J Consult Clin Psychol. 2022 Sep;90(9):655-669. doi: 10.1037/ccp0000763.
PubMed 36279218
Study at a glance
From the registry record, last updated by the sponsor on 8 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mindfulness-based Mobile Application to Reduce Rumination in Adolescents
- ClinicalTrials.gov ID
- NCT03900416
- Acronym / sponsor ID
- AMMASRCT / 7_25_18_Hilt
- Conditions
- Rumination, Depression, Anxiety, Self-Injurious Behavior
- Keywords
- Mindfulness, Mobile Intervention, Brief Intervention, Adolescence
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 152 participants (actual)
- Lead sponsor
- Lawrence UniversityUniversity, hospital or other
- Study start
- 17 Jun 2019 (actual)
- Primary completion
- 3 Feb 2021 (actual)
- Study completion
- 3 Feb 2021 (actual)
- First posted
- 3 Apr 2019 (actual)
- Results
- Posted 8 Nov 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- 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).
| Arm | Type | Receives |
|---|---|---|
| Mindfulness App | Experimental | Behavioral: Mindfulness AppGuided mindfulness exercises will be delivered via mobile app for three weeks. |
| Control condition | No intervention | –Participants will use app for assessment for three weeks, but no mindfulness exercises will be delivered. |
Who may qualify
- Ages
- 12 to 15 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (2 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Mindfulness AppMindfulness exercises will last 1-12 minutes. Each one asks participants to focus on something (e.g., breath, sounds, physical sensations) using guided instruction. | Behavioural | Mindfulness App |
Primary outcome
Children's Response Styles Questionnaire
Time frame: baseline
trait rumination (range = 0-39 with higher scores indicating more rumination)
Children's Response Styles Questionnaire
Time frame: 3 weeks (i.e., immediately post-intervention)
trait rumination (range = 0-39 with higher scores indicating more rumination)
Children's Response Styles Questionnaire
Time frame: 6 weeks post intervention
trait rumination (range = 0-39 with higher scores indicating more rumination)
Children's Response Styles Questionnaire
Time frame: 12 weeks post intervention
trait rumination (range = 0-39 with higher scores indicating more rumination)
Children's Response Styles Questionnaire
Time frame: 6 months post intervention
trait rumination (range = 0-39 with higher scores indicating more rumination)
Children's Depression Inventory
Time frame: baseline
self-reported depressive symptoms (range = 0-54 with higher scores indicating more symptoms)
Children's Depression Inventory
Time frame: 3 weeks (immediately post-intervention)
self-reported depressive symptoms (range = 0-54 with higher scores indicating more symptoms)
Children's Depression Inventory
Time frame: 6 weeks post intervention
self-reported depressive symptoms (range = 0-54 with higher scores indicating more symptoms)
Children's Depression Inventory
Time frame: 12 weeks post intervention
self-reported depressive symptoms (range = 0-54 with higher scores indicating more symptoms)
Children's Depression Inventory
Time frame: 6 months post intervention
self-reported depressive symptoms (range = 0-54 with higher scores indicating more symptoms)
Multidimensional Anxiety Scale for Children
Time frame: baseline
self-reported anxiety symptoms (range = 0-117 with higher scores indicating more anxiety)
Multidimensional Anxiety Scale for Children
Time frame: 3 weeks (i.e., immediately post-intervention)
self-reported anxiety symptoms (range = 0-117 with higher scores indicating more anxiety)
Multidimensional Anxiety Scale for Children
Time frame: 6 weeks post intervention
self-reported anxiety symptoms (range = 0-117 with higher scores indicating more anxiety)
Multidimensional Anxiety Scale for Children
Time frame: 12 weeks post intervention
self-reported anxiety symptoms (range = 0-117 with higher scores indicating more anxiety)
Multidimensional Anxiety Scale for Children
Time frame: 6 months post intervention
self-reported anxiety symptoms (range = 0-117 with higher scores indicating more anxiety)
Self-injurious Thoughts and Behaviors Questionnaire
Time frame: baseline
percent of participants engaged in self-injury over the past year
Self-injurious Thoughts and Behaviors Questionnaire
Time frame: 3 weeks (i.e., immediately post-intervention)
percent of participants that engaged in self-injury over the past 3 weeks
Self-injurious Thoughts and Behaviors Questionnaire
Time frame: 6 weeks post intervention
percent of participants that engaged in self-injury over the past 6 weeks
Self-injurious Thoughts and Behaviors Questionnaire
Time frame: 12 weeks post intervention
percent of time engaged in self-injury over the past 6 weeks
Self-injurious Thoughts and Behaviors Questionnaire
Time frame: 6 months post intervention
percent of time engaged in self-injury over the past 3 months
Pediatric Symptom Checklist Internalizing Scale
Time frame: baseline
parent-reported internalizing symptoms (range = 0-10 with higher scores indicating more internalizing symptoms)
Pediatric Symptom Checklist Internalizing Scale
Time frame: 3 weeks (i.e., immediately post-intervention)
parent-reported internalizing symptoms (range = 0-10 with higher scores indicating more internalizing symptoms)
Pediatric Symptom Checklist Internalizing Scale
Time frame: 6 weeks post intervention
parent-reported internalizing symptoms (range = 0-10 with higher scores indicating more internalizing symptoms)
Pediatric Symptom Checklist Internalizing Scale
Time frame: 12 weeks post intervention
parent-reported internalizing symptoms (range = 0-10 with higher scores indicating more internalizing symptoms)
Pediatric Symptom Checklist Internalizing Scale
Time frame: 6 months post intervention
parent-reported internalizing symptoms (range = 0-10 with higher scores indicating more internalizing symptoms)
State Rumination
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 6 months post intervention
Number of times app was used after the 3 week intervention period
Ease of Use
Time frame: 3 weeks (i.e., immediately post-intervention)
how easy app was to use (range = 1-7 with higher being easier to use)
27 secondary outcomes
Five Facet Mindfulness Questionnaire Observing Subscale
Time frame: baseline
Five Facet Mindfulness Questionnaire Observing Subscale
Time frame: 3 weeks (i.e., immediately post-intervention)
Five Facet Mindfulness Questionnaire Observing Subscale
Time frame: 6 weeks post intervention
Five Facet Mindfulness Questionnaire Observing Subscale
Time frame: 12 weeks post intervention
Five Facet Mindfulness Questionnaire Observing Subscale
Time frame: 6 months post intervention
Five Facet Mindfulness Questionnaire Describing Subscale
Time frame: baseline
Five Facet Mindfulness Questionnaire Describing Subscale
Time frame: 3 weeks (i.e., immediately post-intervention)
Five Facet Mindfulness Questionnaire Describing Subscale
Time frame: 6 weeks post intervention
Five Facet Mindfulness Questionnaire Describing Subscale
Time frame: 12 weeks post intervention
Five Facet Mindfulness Questionnaire Describing Subscale
Time frame: 6 months post intervention
Five Facet Mindfulness Questionnaire Awareness Subscale
Time frame: baseline
Five Facet Mindfulness Questionnaire Awareness Subscale
Time frame: 3 weeks (i.e., immediately post-intervention)
Five Facet Mindfulness Questionnaire Awareness Subscale
Time frame: 6 weeks post intervention
Five Facet Mindfulness Questionnaire Awareness Subscale
Time frame: 12 weeks post intervention
Five Facet Mindfulness Questionnaire Awareness Subscale
Time frame: 6 months post intervention
Five Facet Mindfulness Questionnaire Nonjudging Subscale
Time frame: baseline
Five Facet Mindfulness Questionnaire Nonjudging Subscale
Time frame: 3 weeks (i.e., immediately post-intervention)
Five Facet Mindfulness Questionnaire Nonjudging Subscale
Time frame: 6 weeks post intervention
Five Facet Mindfulness Questionnaire Nonjudging Subscale
Time frame: 12 weeks post intervention
Five Facet Mindfulness Questionnaire Nonjudging Subscale
Time frame: 6 months post intervention
Five Facet Mindfulness Questionnaire Nonreactivity Subscale
Time frame: baseline
Five Facet Mindfulness Questionnaire Nonreactivity Subscale
Time frame: 3 weeks (i.e., immediately post-intervention)
Five Facet Mindfulness Questionnaire Nonreactivity Subscale
Time frame: 6 weeks post intervention)
Five Facet Mindfulness Questionnaire Nonreactivity Subscale
Time frame: 12 weeks post intervention)
Five Facet Mindfulness Questionnaire Nonreactivity Subscale
Time frame: 6 months post intervention)
State Mindfulness Bodily Sensations
Time frame: 3 weeks (i.e., immediately post-intervention)
State Mindfulness Present Focus
Time frame: 3 weeks (i.e., immediately post-intervention)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Nov 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 36622879Hilt LM, Swords CM, Webb CA. Randomized Controlled Trial of a Mindfulness Mobile Application for Ruminative Adolescents. J Clin Child Adolesc Psychol. 2025 Jan-Feb;54(1):99-112. doi: 10.1080/15374416.2022.2158840. Epub 2023 Jan 9.
- Derived from this study: PubMed 36279218Webb CA, Swords CM, Lawrence HR, Hilt LM. Which adolescents are well-suited to app-based mindfulness training? A randomized clinical trial and data-driven approach for personalized recommendations. J Consult Clin Psychol. 2022 Sep;90(9):655-669. doi: 10.1037/ccp0000763.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lori M Hilt, PhD principal investigator
Lawrence University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mindfulness App in people with Rumination and Depression, run by Lawrence University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Nov 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 8 Nov 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Children's Response Styles Questionnaire (time frame: baseline). The study lists 30 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03900416, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Nov 2021; AzTrials last refreshed its copy on 27 Oct 2026.