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

Trial Summary

What is the purpose of this trial?

The overarching objective of this protocol is to (1) adapt and (2) disseminate an evidence-based, brief (approximately 30 minute) single session intervention (SSI) to better reflect the cultural and linguistic diversity of Latin, Haitian, and Haitian-American individuals via a fully online platform.

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 data supports the effectiveness of the treatment Adapted Project BRAVE for Depression?

Research shows that online self-help programs can help reduce depression symptoms, especially when guided by a therapist. These programs have been effective in improving mood and quality of life for people with mild to moderate depression. ^{1 2 3 4 5}

Is the Adapted Project BRAVE treatment generally safe for humans?

The available research on web-based interventions, including those similar to Adapted Project BRAVE, suggests they are generally safe for use in humans, as they focus on behavioral activation and cognitive-behavioral techniques, which are non-invasive and have been used safely in various populations. ^{3 6 7 8 9}

How is the Adapted Project BRAVE treatment for depression different from other treatments?

Adapted Project BRAVE is unique because it is an online self-help program designed to be accessible and convenient, helping people manage depression without needing face-to-face therapy, which can be beneficial for those facing barriers to traditional treatment. ^{1 2 3 10 11}

Research Team

Jill Ehrenreich-May, PhD

Principal Investigator

University of Miami

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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 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]

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]

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 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 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 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]

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]

References

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

A randomized controlled trial of internet-based therapy in depression. [2022]

2. Netherlands 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. [2022]

3. Canada 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. [2020]

4. England 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. [2022]

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

Enhancing inpatient psychotherapeutic treatment with online self-help: study protocol for a randomized controlled trial. [2022]

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

Feasibility assessment of a brief, web-based behavioral activation intervention for adolescents with depressed mood. [2014]

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

Web-based interventions for youth internalizing problems: a systematic review. [2022]

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

Development and pilot evaluation of an Internet-facilitated cognitive-behavioral intervention for maternal depression. [2022]

9. Canada 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. [2022]

10. Netherlands pubmed.ncbi.nlm.nih.gov

Preliminary evaluation of a web site for depressive symptoms management. [2019]

11. England pubmed.ncbi.nlm.nih.gov

Screening people with anxiety/depression for suitability for guided self-help. [2018]