RRE App for Preventing Teen Depression

Overseen by Shengli Dong, PhD

Age: < 65

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: Northeastern University

Disqualifiers: Major depression, Mental disorders, others

No Placebo Group

Approved in 1 Jurisdiction

Trial Summary

What is the purpose of this trial?

This trial tests a mobile app called RRE to help Chinese American teenagers feel better mentally. The app provides relaxation exercises and stress management activities with guidance from a virtual companion. Participants can earn rewards for using the app.

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 data supports the effectiveness of the RRE treatment for preventing teen depression?

Research shows that mobile apps and computer-based programs using cognitive behavioral therapy (CBT) can help reduce depression symptoms in teens. Similar treatments like SPARX and MEMO have been effective in preventing or reducing depression in adolescents. ^{1 2 3 4 5}

Is the RRE App safe for preventing teen depression?

There is no specific safety data available for the RRE App, but similar digital cognitive-behavioral interventions have been used safely in adolescents for conditions like anxiety and depression. ^{6 7 8 9 10}

How is the RRE treatment different from other treatments for preventing teen depression?

The RRE treatment is unique because it focuses on empowering teens through relaxation, reflection, and empowerment techniques, which may improve interpersonal relationships and self-regulation, unlike other treatments that often focus on cognitive behavioral therapy (CBT) or medication. ^{4 5 8 11 12}

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

Eligibility Criteria

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 am between 14 and 18 years old and currently enrolled in school.

I understand the study and have signed the consent form.

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.

Trial Timeline

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)

Treatment Details

Interventions

• Relax, Reflect, Empower-RRE (Behavioral Intervention)

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.

Participant Groups

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.

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+

Findings from Research

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 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 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]

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 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]

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]

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]

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]

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]

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]

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]

References

1. Australia pubmed.ncbi.nlm.nih.gov

Feasibility and preliminary efficacy of a smartphone application intervention for subthreshold depression. [2019]

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

MEMO: an mHealth intervention to prevent the onset of depression in adolescents: a double-blind, randomised, placebo-controlled trial. [2019]

3. Netherlands pubmed.ncbi.nlm.nih.gov

Development and Open Trial of a Technology-Enhanced Family Intervention for Adolescents at Risk for Mood Disorders. [2022]

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

Computerized CBT for adolescent depression ("Stressbusters") and its initial evaluation through an extended case series. [2022]

5. England 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. [2022]

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

Exploring needs, interests and preferences for digital mind-body tools for adolescents. [2023]

7. England pubmed.ncbi.nlm.nih.gov

Pilot evaluation of the Sleep Ninja: a smartphone application for adolescent insomnia symptoms. [2020]

8. Switzerland pubmed.ncbi.nlm.nih.gov

Revising Computerized Therapy for Wider Appeal Among Adolescents: Youth Perspectives on a Revised Version of SPARX. [2023]

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

A Digital Cognitive-Behavioral Intervention for Depression and Anxiety Among Adolescents and Young Adults. [2023]

10. England 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. [2022]

11. Switzerland pubmed.ncbi.nlm.nih.gov

A qualitative investigation of adolescents' perceived mechanisms of change from a universal school-based depression prevention program. [2021]

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

The efficacy of a universal school-based program to prevent adolescent depression. [2022]