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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how a mindfulness app can reduce rumination—overthinking bothersome issues—among teens, potentially improving symptoms of depression and anxiety. Participants will use the Mindfulness (Headspace) App to practice mindfulness and undergo brain scans to observe changes resulting from app use. Teens who frequently experience negative thoughts and have a smartphone might be a good fit for this study. As an unphased trial, this study offers a unique opportunity for teens to contribute to understanding how mindfulness can enhance mental health.

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 prior data suggests that this mindfulness app is safe for adolescents?

Research has shown that mindfulness apps, such as Headspace, are generally safe and easy to use. Studies have found that these apps can help reduce repetitive negative thinking in teenagers, particularly those who often dwell on negative thoughts. One study found that students using mindfulness apps felt less stressed and were likely to continue using them.

Mindfulness meditation, a main feature of these apps, has been linked to improvements in depression and anxiety. Users of similar apps have reported feeling less stressed and in a better mood. No major safety issues have emerged in these studies, suggesting that mindfulness apps are a safe choice for teens wanting to manage negative thinking and improve their mental health. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Mindfulness App Training for rumination in adolescents because it offers a unique, non-invasive approach to managing repetitive negative thinking. Unlike traditional therapies, which might involve medication or face-to-face counseling, this treatment leverages the Headspace app to deliver mindfulness training directly to users through their smartphones. This method is particularly appealing as it provides an accessible, flexible, and cost-effective solution that can be integrated easily into daily life, potentially increasing adherence and engagement among teens.

What evidence suggests that this trial's treatments could be effective for reducing rumination in adolescents?

Research has shown that mindfulness meditation can help reduce rumination, which involves repetitive negative thoughts. In this trial, some participants will use the Headspace mindfulness app. Studies have demonstrated that this app leads to greater reductions in negative thoughts compared to those who do not use it. In one study, many teenagers completed their mindfulness exercises and noticed improvements. Another study showed that using a mindfulness app helped reduce negative thinking in teenagers who often ruminate. These findings suggest that the Headspace app could be a helpful tool for young people to manage rumination and possibly improve symptoms of depression and anxiety. ^{1 2 6 7 8}

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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 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]

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]

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]

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]

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]

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]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9886135/

Which adolescents are well-suited to app-based ... Results: Adolescents in the mindfulness app condition reported significantly greater reductions in rumination than adolescents in the control condition.

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9009760/

App-based Mindfulness Training for Adolescent Rumination Results: Ninety percent (72/80) of adolescents completed the 3-week trial, and the mean number of mindfulness exercises completed was 28.7. Baseline ...

3. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0005789421000484

Acceptability and Preliminary Effects of a Mindfulness ... In the context of a within-subjects design, using a mindfulness mobile app reduced negative repetitive thinking in ruminative adolescents.

4. clinicaltrials.gov clinicaltrials.gov/study/NCT04697966

NCT04697966 | Mechanisms and Predictors of Change in ... Critically, mindfulness meditation has shown significant promise in targeting rumination, and ultimately improving depressive and anxiety symptoms. Mindfulness ...

5. massgeneralbrigham.org massgeneralbrigham.org/en/about/newsroom/articles/mindfulness-app-used-to-help-youths-who-ruminate-proves-promising

Mindfulness App, Used to Help Youths Who Ruminate ... The study at McLean that uses a version of the mindfulness app Headspace to quell repetitive negative thoughts (ie, rumination).

6. nature.com nature.com/articles/s44184-023-00048-5

The impact of mindfulness apps on psychological ... The goal of this review was to summarize the published evidence on the impact of mindfulness apps on the psychological processes known to mediate ...

7. mhealth.jmir.org mhealth.jmir.org/2019/6/e14273

Efficacy of the Mindfulness Meditation Mobile App “Calm” to ... The majority of students in the intervention group reported that Calm was helpful to reduce stress and stated they would use Calm in the future.

8. mdpi.com mdpi.com/2227-9032/13/10/1213

Effects of Short Video App Guided Mindfulness Meditation ... Video-guided MM delivered via short video apps significantly reduced communication anxiety, PTSD symptoms, and mood disorders, and improved anger management ...