Adapted Project BRAVE for Depression

Overseen By Jill Ehrenreich-May

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Miami

Disqualifiers: Not a caregiver

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: Unknown

2000 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a brief, 30-minute online session called the Adapted Project BRAVE, designed to help manage depression. The treatment adapts to the cultural and language needs of Latin, Haitian, and Haitian-American communities. The trial targets caregivers, such as parents or legal guardians, of children aged 4 to 10. Participants join by checking a consent box after reading the study details. As an unphased trial, this study provides a unique opportunity to contribute to culturally tailored mental health solutions.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

What prior data suggests that this protocol is safe?

Research shows that online cognitive-behavioral therapy (CBT) programs like Project BRAVE are generally easy for participants to manage. Studies on similar programs for treating anxiety in children and teens have found that participants usually handle the treatment well without major issues.

The BRAVE program, on which Project BRAVE is based, is available for free to young people in Australia and has been widely used. This suggests it is safe for young people. Although specific data for the version of Project BRAVE adapted for depression is not available, the success of similar programs indicates its safety.

In summary, treatments like Project BRAVE are considered safe and are designed to help without causing harm. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Unlike the standard depression treatments, which often rely on medication or lengthy therapy sessions, Adapted Project BRAVE offers a unique approach through a single session intervention. This treatment is especially exciting because it is culturally and linguistically adapted, potentially making it more accessible and relatable for diverse populations. Researchers are enthusiastic about its potential to provide quicker and more personalized support for individuals struggling with depression.

What evidence suggests that the Adapted Project BRAVE might be an effective treatment for depression?

Research shows that Project BRAVE effectively helps children and teenagers with anxiety through online cognitive behavioral therapy (CBT) techniques. Studies have found that the program is easy to use, and participants generally express satisfaction with it. While Project BRAVE primarily targets anxiety, similar digital tools have also helped young people manage depression. In this trial, participants will receive an adapted version of Project BRAVE, tailored to meet the cultural and language needs of Latin, Haitian, and Haitian-American communities. This adaptation aims to make the program more accessible and effective for these groups by aligning it with their experiences. ^{1 4 6 7 8}

Who Is on the Research Team?

Jill Ehrenreich-May, PhD

Principal Investigator

University of Miami

Are You a Good Fit for This Trial?

This trial is for caregivers of children aged 4-10 who are dealing with anxiety. Participants must be able to read and affirm consent language on an online platform. It's specifically designed to cater to the cultural and linguistic needs of Latin, Haitian, and Haitian-American communities.

Inclusion Criteria

I am the parent or legal guardian of a child aged 4-10.

Affirm that they have read the consent language and study overview on REDCap by checking a box.

Exclusion Criteria

You do not meet all the requirements to participate in the study.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Single Session Intervention

Participants receive a culturally and linguistically adapted single session intervention (SSI) via an online platform

Approximately 30 minutes

Follow-up

Participants are monitored for changes in anxiety and program feedback

2 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Adapted Project BRAVE

Trial Overview The study is testing 'Adapted Project BRAVE,' a culturally-tailored single session intervention (SSI) that lasts about 30 minutes and is delivered through an online platform, aiming to help youth with anxiety.

How Is the Trial Designed?

Group I: Adapted Project BRAVE Group Experimental Treatment 1 Intervention

Participants in this group will receive a single session intervention of a culturally and linguistically adapted Project BRAVE.

Who Is Running the Clinical Trial?

University of Miami

Lead Sponsor

Trials

976

Recruited

423,000+

Published Research Related to This Trial

The Mom-Net intervention, an Internet-facilitated cognitive-behavioral treatment for depression, was found to be feasible and effective for economically disadvantaged mothers, with 70 participants showing low dropout rates and high satisfaction.

Mothers who participated in Mom-Net experienced significant reductions in depressive symptoms and improvements in parenting satisfaction and behavior, indicating the intervention's potential to positively impact both mental health and parenting practices.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Development and pilot evaluation of an Internet-facilitated cognitive-behavioral intervention for maternal depression. Sheeber, LB., Seeley, JR., Feil, EG., et al.[2022]

The study will evaluate the effectiveness of an online self-help program (deprexis®) combined with inpatient psychotherapy in 240 depressed patients, aiming to enhance treatment outcomes and maintain benefits after discharge.

Participants will be assessed at multiple points, with the primary focus on changes in depression scores using the Beck Depression Inventory-II, which will help determine if the online program improves overall mental health compared to standard information access.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Enhancing inpatient psychotherapeutic treatment with online self-help: study protocol for a randomized controlled trial. Zwerenz, R., Becker, J., Knickenberg, RJ., et al.[2022]

Guided web-based self-help programs for individuals with mild to moderate depressive symptoms are more effective than unguided programs, with a significant increase in working alliance with treatment providers contributing to better outcomes.

The study found that both the working alliance and adherence to the program mediate the relationship between guidance and improvement in depressive symptoms, suggesting that aligning the program with participants' goals and ensuring they stick to it are crucial for success.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Working alliance and adherence mediate the effect of guidance in a web-based program for participants with mild to moderate depressive symptoms: A secondary mediation analysis. Bur, OT., Bielinski, LL., Krauss, S., et al.[2022]

A computer-assisted intervention for managing depressive symptoms was found to be as effective as traditional face-to-face treatment, which is significant for addressing mental health stigma in Korea.

The study developed a dedicated website for depressive symptoms management, which had 582 users in its first year, indicating a growing interest in online mental health resources.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Preliminary evaluation of a web site for depressive symptoms management. Bae, JY., Lee, SW., Yoon, SH., et al.[2019]

In a study of 229 patients, adding a Web-based self-help program (Deprexis) to multimodal inpatient psychotherapy significantly reduced depressive symptoms, anxiety, and improved quality of life and self-esteem at a 6-month follow-up.

Participants using the Web-based self-help were nearly three times more likely to achieve remission compared to those receiving only standard information, highlighting the effectiveness of this digital intervention as an adjunct to traditional therapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Improving the Course of Depressive Symptoms After Inpatient Psychotherapy Using Adjunct Web-Based Self-Help: Follow-Up Results of a Randomized Controlled Trial. Zwerenz, R., Baumgarten, C., Becker, J., et al.[2020]

The online self-help program for depression, called Deprexis, significantly reduced symptoms in participants compared to a wait-list control group, particularly benefiting those with moderate symptoms and those not currently in therapy.

The study, which included reminders and incentives to improve participation, showed a high completion rate of 82% and confirmed clinical diagnoses in 29% of participants, indicating the program's efficacy and reliability.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A randomized controlled trial of internet-based therapy in depression. Moritz, S., Schilling, L., Hauschildt, M., et al.[2022]

A systematic review of 25 articles identified 9 Web-based programs for treating depression and anxiety in youth, with 10 out of 17 trials showing significant reductions in symptoms, indicating potential efficacy.

Despite some positive results, the overall evidence for Web-based interventions is limited, with many studies having small sample sizes and methodological weaknesses, highlighting the need for further research and development in this area.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Web-based interventions for youth internalizing problems: a systematic review. Reyes-Portillo, JA., Mufson, L., Greenhill, LL., et al.[2022]

The second version of the Help for Depression (HDep) web-based intervention showed moderate levels of satisfaction and acceptability among users, with 98.9% of participants reporting high levels of depressive symptoms, indicating a need for effective online support in low- and middle-income countries.

Factors such as gender, age, employment status, and previous therapy experiences influenced user satisfaction and acceptability, suggesting that tailoring web-based interventions to specific user demographics could enhance their effectiveness and adherence.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Satisfaction and Acceptability Ratings of a Web-Based Self-help Intervention for Depression: Retrospective Cross-sectional Study From a Resource-Limited Country. Lara, MA., Patiño, P., Tiburcio, M., et al.[2022]

A web-based behavioral activation intervention called Bounce Back Now (BBN) was developed to help adolescents with depression, showing promising feasibility based on usability evaluations with 24 adolescents and preliminary data from 2,000 disaster-affected youth.

The intervention received positive feedback from users and demonstrated moderate levels of access, suggesting that web-based approaches could effectively improve treatment access for adolescents who might not seek traditional therapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Feasibility assessment of a brief, web-based behavioral activation intervention for adolescents with depressed mood. Davidson, TM., Yuen, EK., Felton, JW., et al.[2014]

Therapist-guided web-based cognitive behavioral therapy (web-CBT) significantly improved symptoms of mild to moderate depression in a study of 54 participants, with recovery rates of 49% in the treatment group compared to only 6% in the wait-list control group.

The positive effects of web-CBT were stable for up to 18 months, although the use of medication was a strong predictor of relapse, highlighting the importance of ongoing support in managing depression.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Standardized web-based cognitive behavioural therapy of mild to moderate depression: a randomized controlled trial with a long-term follow-up. Ruwaard, J., Schrieken, B., Schrijver, M., et al.[2022]

The study involved 196 referrals and aimed to evaluate a screening questionnaire for identifying individuals with anxiety or depression who could benefit from computer-guided self-help, showing good inter-clinician agreement on problem type and suitability.

While the questionnaire effectively identified suitable patients for self-help, it struggled with detecting unsuitable patients, indicating that some items in the questionnaire need improvement for better accuracy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Screening people with anxiety/depression for suitability for guided self-help. Gega, L., Kenwright, M., Mataix-Cols, D., et al.[2018]

Citations

1. sciencedirect.com sciencedirect.com/science/article/pii/S2214782918300873

Examination of the uptake and effectiveness of BRAVE ... BRAVE_TA has shown to be an acceptable and effective 'e' therapy tool in a 'real world' primary care setting for children/adolescents with anxiety.

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11566077/

Feasibility study of the e-learning version of the “Journey ... The BRAVE Self-Help, an open-access online program available to all Australian children aged 7–17, reported moderate levels of satisfaction ...

3. c4tbh.org c4tbh.org/program-review/brave-online/

BRAVE Online BRAVE Online is a trans-diagnostic program that uses CBT techniques to treat a range of anxiety disorders among children and adolescents.

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10374830/

Digital technologies to support adolescents with depression ... This clinical review gives an overview of digital technologies to support the prevention and management of depression and anxiety in adolescence.

5. bmcpsychiatry.biomedcentral.com bmcpsychiatry.biomedcentral.com/articles/10.1186/s12888-023-05134-8

The effects of a Journey of the Brave Counseling Program on ... Study 2 aimed to explore the immediate and follow-up effects of Journey of the Brave Counseling Program (JBCP) on children's' anxiety, well-being, and life ...

6. healthdirect.gov.au healthdirect.gov.au/partners/the-brave-program

The BRAVE Program The BRAVE program was converted into a self-directed therapy program (BRAVE Self-Help), which is now freely available to all Australian young people, aged 8-17 ...

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6053603/

Large-Scale Dissemination of Internet-Based Cognitive ... The objective of our study was to examine the feasibility and acceptability of a publicly available online, self-help iCBT program (BRAVE Self-Help)

8. researchgate.net researchgate.net/publication/29469226_Online_CBT_in_the_Treatment_of_Child_and_Adolescent_Anxiety_Disorders_Issues_in_the_Development_of_BRAVE-ONLINE_and_Two_Case_Illustrations

(PDF) Online CBT in the Treatment of Child and ... This paper describes the rationale for and development of an online cognitive-behavioural treatment for child and adolescent anxiety (BRAVE-ONLINE).