Mindfulness App Training for Rumination in Adolescents

Overseen By Christian Webb, Phd

Age: < 65

Sex: Any

Trial Phase: Academic

Sponsor: Mclean Hospital

Disqualifiers: Schizophrenia, Bipolar, Substance use, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 3 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 2

Duration: 8 weeks

158 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but if you are on psychotropic medication, you must be on a stable dose for at least 2 months before joining.

What data supports the effectiveness of this treatment for reducing rumination in adolescents?

Research shows that a mindfulness mobile app intervention significantly reduced rumination, worry, anxiety, and internalizing symptoms in adolescents, with effects lasting up to 12 weeks. Additionally, brief mindfulness interventions have been found helpful in reducing rumination in youth, suggesting potential benefits of using mobile apps for this purpose. ^{1 2 3 4 5}

Is the mindfulness app safe for adolescents?

The studies suggest that using the mindfulness app, like Headspace, is generally safe for adolescents. It has been shown to be engaging and helpful in reducing negative thinking and anxiety without any reported safety concerns. ^{1 2 6 7 8}

How does the Mindfulness (Headspace) App treatment differ from other treatments for rumination in adolescents?

The Mindfulness (Headspace) App is unique because it provides a convenient, engaging, and cost-effective way for adolescents to access mindfulness training, which focuses on present-moment awareness and reducing negative repetitive thinking. Unlike traditional therapies, this app-based approach allows for frequent, flexible use, making it more accessible for teens to incorporate into their daily lives. ^{1 2 3 8 9}

What is the purpose of this trial?

A growing body of research implicates rumination as being a transdiagnostic risk factor involved in the development of depression and anxiety in youth. Critically, mindfulness meditation has shown significant promise in targeting rumination, and ultimately improving depressive and anxiety symptoms. Mindfulness apps offer a convenient and cost-effective means for accessing mindfulness training, while being interactive and engaging for youth. Despite their growing popularity among teens, strikingly little research has been conducted on these apps. Two critical questions have yet to be addressed: (1) what are the underlying neural and cognitive mechanisms that account for the beneficial effects of these apps and (2) for whom is app-based mindfulness well-suited. To address these gaps, adolescents (ages 13-18) will be randomly assigned to an app-delivered mindfulness course vs. a control condition and will complete pre- and post-intervention resting state functional magnetic resonance imaging (fMRI) scans to probe static and dynamic functional connectivity within - and between - brain networks strongly implicated in mindfulness training and rumination. In addition, cognitive tasks will be administered at pre- and post-intervention to assess attentional control abilities putatively enhanced by mindfulness training. Finally, mindfulness skills and changes in rumination will be assessed via smartphone-based ecological momentary assessment (EMA). First, the investigators will test whether changes in (1) brain functional connectivity, (2) attentional control and (3) acquisition and use of mindfulness skills mediate between-group (i.e., app vs. control) differences in the reduction of rumination. Second, the investigators will test whether a machine learning model incorporating baseline clinical, demographic, and psychosocial characteristics can be used to identify which adolescents are predicted to benefit from app-based mindfulness training.

Eligibility Criteria

Adolescents aged 13-18, who are right-handed and fluent in English, can join this trial. They must have a personal smartphone and be on a stable dose of any psychotropic medication for at least two months. Those with certain psychiatric disorders, history of severe head trauma or substance abuse, or conditions that preclude fMRI scanning cannot participate.

Inclusion Criteria

I have been on the same dose of my mental health medication for at least 2 months.

CRSQ rumination subscale score

I am fluent in English.

Exclusion Criteria

I have undergone mindfulness-based therapy like MBCT, DBT, or ACT.

I have had seizures or a head injury that made me unconscious for more than 2 minutes.

I have completed at least 300 minutes of mindfulness or meditation practice.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants are randomly assigned to an app-delivered mindfulness course or a control condition, with pre- and post-intervention fMRI scans and cognitive tasks to assess attentional control and mindfulness skills.

8 weeks

2 visits (in-person for fMRI scans), ongoing app usage

Follow-up

Participants are monitored for changes in rumination and mindfulness skills via smartphone-based ecological momentary assessment (EMA).

4 weeks

Treatment Details

Interventions

• Active Control Condition ("Recharge" condition delivered in Headspace app)
• Mindfulness (Headspace) App
• Psychoeducational Active Control Condition

Trial Overview The study is testing an app-based mindfulness training against an active control condition using the Headspace app to see if it reduces rumination linked to depression and anxiety in teens. It includes brain scans before and after the intervention to understand how it might work.

Participant Groups

Group I: Mindfulness (Headspace app) Experimental Treatment 1 Intervention

Group II: Active Control Condition Active Control 1 Intervention

Mindfulness (Headspace) App is already approved in United States, European Union for the following indications:

Approved in United States as Headspace for:

• Anxiety
• Depression
• Stress Management

Approved in European Union as Headspace for:

• Anxiety
• Depression
• Stress Management

Who Is Running the Clinical Trial?

Mclean Hospital

Lead Sponsor

Trials

221

Recruited

22,500+

Cambridge Health Alliance

Collaborator

Trials

65

Recruited

22,400+

Lawrence University

Collaborator

Trials

3

Recruited

440+

Findings from Research

A mindfulness mobile app intervention significantly reduced rumination, depressive symptoms, and anxiety in adolescents (N=152) over a 3-week period, showing immediate benefits compared to a control group.

While the positive effects on rumination were maintained for up to 6 weeks post-intervention, the lack of sustained differences at later follow-ups suggests that ongoing practice may be necessary to keep these benefits.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Randomized Controlled Trial of a Mindfulness Mobile Application for Ruminative Adolescents. Hilt, LM., Swords, CM., Webb, CA.[2023]

A mindfulness mobile app intervention was tested on 80 adolescents aged 12-15 with moderate-to-high rumination, showing significant reductions in rumination, worry, anxiety, and internalizing symptoms after 3 weeks of use.

The positive effects on rumination and anxiety persisted for up to 12 weeks post-intervention, indicating that the app was not only acceptable but also effective in helping adolescents manage negative repetitive thinking.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Acceptability and Preliminary Effects of a Mindfulness Mobile Application for Ruminative Adolescents. Hilt, LM., Swords, CM.[2021]

In a study with 102 youth participants, both distraction and mindfulness techniques were effective in reducing rumination after a negative mood induction, while problem-solving did not show the same effectiveness.

These findings suggest that brief interventions like distraction or mindfulness could be useful tools for helping young people disengage from ruminative thoughts, potentially leading to applications in mobile device apps for mental health support.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Getting out of rumination: comparison of three brief interventions in a sample of youth. Hilt, LM., Pollak, SD.[2021]

In a study involving 198 adolescents, mindfulness meditation significantly improved working memory capacity (WMC) compared to hatha yoga and a waitlist control group, highlighting its effectiveness as a cognitive enhancement tool.

The findings suggest that short-term mindfulness meditation can be beneficial for adolescents' cognitive function, indicating its potential for integration into school programs and treatment protocols.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Randomized Controlled Trial Examining the Effect of Mindfulness Meditation on Working Memory Capacity in Adolescents. Quach, D., Jastrowski Mano, KE., Alexander, K.[2022]

In a study of 52 adolescents, rumination was linked to difficulties in inhibiting negative information, particularly when switching from negative to positive tasks, highlighting a specific cognitive control challenge associated with rumination.

Unlike adults, the adolescents did not show a general cognitive flexibility impairment related to rumination, suggesting that the cognitive control difficulties may manifest differently in youth compared to adults, which has important implications for understanding and treating mental health issues in this age group.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cognitive Control and Rumination in Youth: The Importance of Emotion. Hilt, LM., Leitzke, BT., Pollak, SD.[2020]

A study using the mindfulness app Headspace found that 4 weeks of access significantly reduced anxiety symptoms in participants with moderate to high anxiety, and this effect was maintained at 8 weeks, indicating the app's effectiveness.

While the app also showed potential in reducing worry, the analysis did not find a significant difference in worry reduction between 4 and 8 weeks of access, suggesting that longer use may not necessarily lead to greater benefits.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Does Using a Mindfulness App Reduce Anxiety and Worry? A Randomized-Controlled Trial. Abbott, D., Lack, CW., Anderson, P.[2023]

A review of 93 studies found that meditation apps, particularly Headspace, primarily focus on mindfulness meditation and are most commonly used to address stress-related health issues.

Future research should explore the effects of meditation apps on a broader range of mental health conditions beyond just stress to fully understand their potential benefits.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Features of Meditation Apps: A Scoping Review. Muhiyaddin, R., Abd-Alrazaq, A., Alajlani, M., et al.[2022]

The '8-sam' mindfulness training program, implemented over four weeks with 48 ninth-grade students, was well accepted and feasible in a school setting.

Students who participated in the mindfulness training experienced reduced mind-wandering compared to a control group, suggesting that mindfulness can enhance self-regulation and resilience among adolescents.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Promoting Self-Regulation of Adolescents in School Through Mindfulness]. Frenkel, MO., Georg, A., Plessner, H.[2020]

A study involving 80 adolescents with high levels of rumination showed that app-based mindfulness training can effectively reduce both problem-focused and emotion-focused rumination, with 90% of participants completing the 3-week program.

Higher initial levels of rumination and lower emotional suppression were linked to greater benefits from mindfulness training, suggesting that certain adolescent characteristics can predict who may benefit most from such interventions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

App-based Mindfulness Training for Adolescent Rumination: Predictors of Immediate and Cumulative Benefit. Webb, CA., Swords, CM., Murray, L., et al.[2022]

References

1. England pubmed.ncbi.nlm.nih.gov

Randomized Controlled Trial of a Mindfulness Mobile Application for Ruminative Adolescents. [2023]

2. England pubmed.ncbi.nlm.nih.gov

Acceptability and Preliminary Effects of a Mindfulness Mobile Application for Ruminative Adolescents. [2021]

3. United States pubmed.ncbi.nlm.nih.gov

Getting out of rumination: comparison of three brief interventions in a sample of youth. [2021]

4. United States pubmed.ncbi.nlm.nih.gov

A Randomized Controlled Trial Examining the Effect of Mindfulness Meditation on Working Memory Capacity in Adolescents. [2022]

5. England pubmed.ncbi.nlm.nih.gov

Cognitive Control and Rumination in Youth: The Importance of Emotion. [2020]

6. United States pubmed.ncbi.nlm.nih.gov

Does Using a Mindfulness App Reduce Anxiety and Worry? A Randomized-Controlled Trial. [2023]

7. Netherlands pubmed.ncbi.nlm.nih.gov

Features of Meditation Apps: A Scoping Review. [2022]

8. Germany pubmed.ncbi.nlm.nih.gov

[Promoting Self-Regulation of Adolescents in School Through Mindfulness]. [2020]

9. United States pubmed.ncbi.nlm.nih.gov

App-based Mindfulness Training for Adolescent Rumination: Predictors of Immediate and Cumulative Benefit. [2022]