RRE App for Preventing Teen Depression

Overseen By CHIEH LI, EdD

Age: < 65

Sex: Any

Trial Phase: Academic

Sponsor: Northeastern University

Disqualifiers: Major depression, Mental disorders, others

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

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 6

Duration: 12 weeks

110 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a mobile app called Relax, Reflect, Empower (RRE) to determine its effectiveness in reducing depressive symptoms and boosting psychological well-being in Chinese American teenagers. Participants will either use the RRE app or receive daily wellness check-in text messages for three months. The trial aims to assess the app's usability and effectiveness in promoting mental health. It seeks Chinese American teens in the Greater Boston Area who are in school and can read at a sixth-grade level. As an unphased trial, participants can contribute to innovative research that may enhance mental health support for their community.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It seems focused on using a mobile app to improve wellbeing, so it's unlikely that medication changes are required.

What prior data suggests that this mobile health application is safe for Chinese American adolescents?

Research has shown that digital mental health tools can assist teenagers with depression and anxiety. The Relax, Reflect, Empower (RRE) app aims to enhance mental well-being through relaxation exercises and stress management, specifically for Chinese American teens.

While researchers are testing this app for effectiveness and usability, no specific studies have yet shown negative effects. Generally, mental health apps are considered low-risk because they do not involve medication or medical procedures. The goal is to provide a helpful tool to improve users' well-being, and current research suggests these apps are usually well-received.

Participants using the RRE app will engage in daily and weekly activities to boost mood and overall well-being. This approach is designed to be user-friendly and supportive, making it a potentially safe choice for teens seeking to improve their mental health. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Unlike traditional treatments for teen depression, which often involve medication or face-to-face therapy sessions, the RRE App uses a digital approach to engage teens in mental wellness. The app features personalized avatars and combines daily check-ins with meditation and reflection activities, making it interactive and accessible. Researchers are excited about this treatment because it offers a unique, tech-savvy way to promote mental health, potentially increasing engagement and adherence among teens who are comfortable with digital platforms.

What evidence suggests that the RRE app is effective for preventing teen depression?

In this trial, participants will either use the Relax, Reflect, Empower (RRE) application or receive daily check-in text messages. Earlier studies have shown that treatments like RRE can improve mental health among teenagers by incorporating relaxation exercises and stress management techniques. Research suggests that RRE, designed specifically for Chinese American teenagers, might help reduce symptoms of depression and enhance overall mental well-being. The app employs mindfulness (awareness and acceptance of feelings) and cognitive therapy (altering negative thought patterns), which have proven effective in other mental health treatments. Early results indicate that users of these apps often experience improved well-being and manage stress more effectively over time. While further research is necessary, these initial findings are promising for RRE's success. ^{1 2 6 7 8}

Who Is on the Research Team?

Chieh Li, EdD

Principal Investigator

Northeastern University

Huijun Li, PhD

Principal Investigator

Florida A&M University

Shengli Dong, PhD

Principal Investigator

Florida State University

Are You a Good Fit for This Trial?

This trial is for Chinese American adolescents aged 14-18, who can read at a sixth-grade level or higher. It's not suitable for those with severe depression or anxiety needing more treatment than the app provides, or other mental disorders.

Inclusion Criteria

Participants must be CAAs (ethnic Chinese descent, born or grew up in the U.S) and meet the following inclusion criteria:

I understand the study and have signed the consent form.

Sixth grade reading level (in order to understand and complete proposed tasks)

Exclusion Criteria

Those who do not have sixth grade reading level to understand and complete the measures

Those who have a score of 3 or above in Patient Health Questionnaire-2 or Generalized Anxiety Disorder-2 (who need more extensive treatment than the RRE program can provide)

I do not have major depression or mental disorders that require more than the RRE program.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants are assigned to either the RRE intervention or control group for 3 months, with daily and weekly wellness check-ins

12 weeks

5 check-ins per week (virtual)

Follow-up

Participants are monitored for changes in depressive symptoms, coping self-efficacy, and psychological wellbeing one month after the intervention

4 weeks

1 assessment (virtual)

What Are the Treatments Tested in This Trial?

Interventions

• Relax, Reflect, Empower-RRE

Trial Overview The study tests if a mobile app called Relax, Reflect, and Empower (RRE) can improve psychological well-being and reduce depressive symptoms in participants compared to a control group receiving wellness check-in texts over three months.

How Is the Trial Designed?

Group I: Relax, Reflect, and Empower application Experimental Treatment 1 Intervention

Participants in the RRE group will select an Avatar from a pool of 20 Avatars as their companion over the 3 months. The Avatar wellness check-in in the RRE group includes a daily brief check-in of 5-minute/day (4 days/week), and a weekly full wellness check-in of 15 minutes/week for 3 months. The daily brief check-in includes a wellbeing and mood check and a 3-minute relaxation meditation. The weekly full wellness check-in includes reflection activities in addition to the daily check-in activities.

Group II: Daily check-in text messages Active Control 1 Intervention

Participants will receive a wellness check-in text message 5 days/week \[4 daily wellness check-in (2-3 minutes/day) +1 weekly wellness check-in (4-5 minutes/week)\] for 3 months.

Relax, Reflect, Empower-RRE is already approved in United States for the following indications:

Approved in United States as RRE for:

• Prevention of depressive symptoms in Chinese American adolescents

Who Is Running the Clinical Trial?

Northeastern University

Lead Sponsor

Trials

103

Recruited

72,600+

Florida A&M University

Collaborator

Trials

8

Recruited

5,100+

Florida State University

Collaborator

Trials

234

Recruited

41,100+

Published Research Related to This Trial

The SPARX computerised cognitive behavioural therapy intervention was found to be as effective as traditional treatment for reducing depressive symptoms in adolescents, with a significant remission rate of 43.7% compared to 26.4% in the treatment as usual group.

The study involved 187 adolescents aged 12-19 and showed that SPARX not only matched the efficacy of standard face-to-face counseling but also had a similar safety profile, with no significant difference in adverse events between the two groups.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The effectiveness of SPARX, a computerised self help intervention for adolescents seeking help for depression: randomised controlled non-inferiority trial. Merry, SN., Stasiak, K., Shepherd, M., et al.[2022]

A pilot study involving 22 adolescents and their parents showed that integrating a mobile app with family-focused therapy (FFT) led to significant improvements in depression scores over 27 weeks, indicating the potential efficacy of this approach.

Participants engaged with the app, completing 46%-65% of assessments and skill practices, and reported reduced parental criticism, suggesting that mobile apps can enhance treatment engagement and provide valuable feedback for clinicians.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Development and Open Trial of a Technology-Enhanced Family Intervention for Adolescents at Risk for Mood Disorders. Miklowitz, DJ., Weintraub, MJ., Posta, F., et al.[2022]

Research indicates that technology-based mind-body interventions can help improve sleep in early adolescents, but challenges like establishing routines and busy schedules hinder engagement.

To enhance adherence, it is recommended that digital mind-body tools be tailored for adolescents with age-appropriate content, engaging features like games and rewards, and customizable sharing options.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Exploring needs, interests and preferences for digital mind-body tools for adolescents. Sangameswaran, S., Xie, SJ., Garrison, MM., et al.[2023]

A study involving 855 adolescents (ages 13-17) tested a multimedia mobile phone cognitive behavioral therapy program (MEMO CBT) against a control program, but found no significant difference in depression scores after 12 months, indicating that the intervention did not effectively reduce depression symptoms.

Despite high follow-up rates (93% for MEMO CBT and 91% for control), the results suggest that universal prevention strategies for adolescent depression, like MEMO CBT, still face challenges in achieving efficacy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

MEMO: an mHealth intervention to prevent the onset of depression in adolescents: a double-blind, randomised, placebo-controlled trial. Whittaker, R., Stasiak, K., McDowell, H., et al.[2019]

A qualitative analysis of 109 Grade 9 students revealed that over half reported specific benefits from the Resourceful Adolescent Program (RAP-A), highlighting its effectiveness in preventing depression.

The main benefits identified were improved interpersonal relationships and self-regulation, suggesting that these factors may work together to enhance the overall effectiveness of depression prevention programs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A qualitative investigation of adolescents' perceived mechanisms of change from a universal school-based depression prevention program. Shochet, I., Montague, R., Smith, C., et al.[2021]

The 'Stressbusters' program, an interactive computer-based cognitive behavioral therapy (CBT) designed for teenagers with mild to moderate depression, showed significant efficacy, reducing the number of participants meeting criteria for a depressive disorder from 95% to 22% after treatment.

Participants also experienced notable improvements in global functioning and reductions in anxiety and depressive symptoms, with these benefits maintained at a 3-month follow-up, indicating the program's potential as a valid treatment option for adolescents.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Computerized CBT for adolescent depression ("Stressbusters") and its initial evaluation through an extended case series. Abeles, P., Verduyn, C., Robinson, A., et al.[2022]

The StayFine app, which combines personalized monitoring and guided interventions, is being tested in a study with 254 participants aged 13-21 who are in remission from depression or anxiety, to see if it can effectively prevent relapse over a 36-month period.

The study aims to identify high-risk groups for relapse and resilience, using a randomized controlled trial design to compare the efficacy of the StayFine app against standard monitoring, with outcomes measured through various assessments including diagnostic interviews and ecological momentary assessments.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Personalised app-based relapse prevention of depressive and anxiety disorders in remitted adolescents and young adults: a protocol of the StayFine RCT. Robberegt, SJ., Kooiman, BEAM., Albers, CJ., et al.[2022]

The smartphone app designed to improve self-confidence in individuals with subthreshold depression showed a significant reduction in depressive symptoms after 5 weeks of use, as measured by the CES-D scale.

The study involved 22 young adults, and while no adverse events were reported, the adherence rate was only 50%, indicating a need for improvements to encourage more consistent app usage.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Feasibility and preliminary efficacy of a smartphone application intervention for subthreshold depression. Takahashi, K., Takada, K., Hirao, K.[2019]

A coach-enhanced digital cognitive-behavioral intervention (dCBI) was prescribed to 506 adolescents and young adults, with 278 enrolling and showing significant engagement, as 58% actively used the app and 63% communicated with their coach.

The dCBI app led to significant reductions in anxiety and depression symptoms at both 1 and 3 months, demonstrating its effectiveness and feasibility as a routine part of pediatric care for emotional distress.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Digital Cognitive-Behavioral Intervention for Depression and Anxiety Among Adolescents and Young Adults. Szigethy, EM., Silfee, V., Marroquin, MA., et al.[2023]

A universal school-based program, the Resourceful Adolescent Program (RAP), effectively reduced depressive symptoms and hopelessness in adolescents, with 260 Year 9 students participating in the study.

Both versions of the RAP program (with and without parental involvement) showed significant improvements at post-intervention and 10-month follow-up, indicating the program's long-term efficacy and high satisfaction among students.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The efficacy of a universal school-based program to prevent adolescent depression. Shochet, IM., Dadds, MR., Holland, D., et al.[2022]

The Sleep Ninja app, designed for adolescents aged 12-16 with sleep difficulties, was found to be feasible and acceptable, with significant improvements in insomnia, sleep quality, depression, and anxiety after a 6-week intervention.

Participants showed a large effect size for insomnia improvement (d=-0.90) and moderate improvements in sleep quality (d=-0.46), depression (d=-0.36), and anxiety (d=-0.41), indicating the app's potential effectiveness in addressing sleep-related issues in young people.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pilot evaluation of the Sleep Ninja: a smartphone application for adolescent insomnia symptoms. Werner-Seidler, A., Wong, Q., Johnston, L., et al.[2020]

Adolescents found both versions of the computerized cognitive behavioral therapy (CCBT) useful, but preferred the SPARX-R version, which presents the program as a tool for managing various feelings rather than explicitly labeling it as a treatment for depression.

The study revealed that while some participants appreciated the validation of naming depression, many felt that an explicit focus on depression could be off-putting, suggesting that the presentation of mental health interventions can significantly influence their acceptance and effectiveness among young people.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Revising Computerized Therapy for Wider Appeal Among Adolescents: Youth Perspectives on a Revised Version of SPARX. Fleming, TM., Stasiak, K., Moselen, E., et al.[2023]

Citations

1. withpower.com withpower.com/trial/phase-depression-7-2023-6e015

RRE App for Preventing Teen Depression This trial tests a mobile app called RRE to help Chinese American teenagers feel better mentally. The app provides relaxation exercises and stress ...

2. peearz.com peearz.com/trialsindex?nctid=NCT05921201

Preventing Depression of Chinese American Adolescents by ... The goal of this clinical trial is to test if a culturally sensitive mobile health application (Relax, Reflect, Empower-RRE) is feasible and effective in ...

3. bouve.northeastern.edu bouve.northeastern.edu/institute-for-health-equity-and-social-justice-research/projects/preventing-depression-of-chinese-american-adolescents/

Preventing Depression of Chinese American Adolescents Aims to prevent mental health concerns in Chinese American adolescents through Mindfulness-Based Cognitive Therapy and Critical Consciousness.

4. ncbi.nlm.nih.gov ncbi.nlm.nih.gov/books/NBK575986/

WE CAN TAKE ACTION - Protecting Youth Mental Health - NCBI Mental health is no less important than physical health. And that must be reflected in our how we communicate about and prioritize mental health. Empower youth ...

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10538359/

Evaluating a Peer-Support Mobile App for Mental ... The aim of this study was to evaluate the efficacy of the Mind your Mate program, a digital peer-support program, in improving mental health symptoms.

6. clinconnect.io clinconnect.io/trials/NCT05921201

Preventing Depression of Chinese American Adolescents by This clinical trial is focused on finding out if a mobile health app called Relax, Reflect, Empower (RRE) can help improve the mental health of Chinese American ...

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11904364/

Provider Perspectives on the Use of Mental Health Apps, ... This study aims to explore health care providers' opinions and concerns regarding the use of mental health apps for youth at significant risk of suicidal ...

8. sciencedirect.com sciencedirect.com/science/article/pii/S2214782925000855

Adolescents' and youths' perceived barriers and facilitators ... Abstract. Digital mental health interventions (DMHIs) can be effective for adolescents and young people experiencing depression and anxiety.