Weyera Intervention for Mental Health Issues

Recruiting at 2 trial locations

Overseen By Sophia Hussen, MD, MPH

Age: 18 - 65

Sex: Any

Trial Phase: Academic

Sponsor: Emory University

Disqualifiers: Age, Consent, Residency

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

Compensation: Varies

Number of Visits: 11

60 Participants Needed

Trial Summary

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 Weyera Intervention treatment for mental health issues?

The research suggests that patients with psychological distress often respond quickly to treatment, and outcomes improve when patients stay engaged in their care. This implies that treatments like Weyera Intervention could be effective if they keep patients involved and are tailored to individual needs. ^{1 2 3 4 5}

Is the Weyera Intervention generally safe for humans?

In studies of psychosocial treatments, including those similar to the Weyera Intervention, serious adverse events (SAEs) were rare and not linked to the treatment itself. However, monitoring for adverse events in these types of interventions is not as thorough as in drug trials, so some side effects might not be fully documented. ^{6 7 8 9 10}

What is the purpose of this trial?

This study aims to pilot a group-level intervention focused on mental health and resilience among Ethiopian and Eritrean youth. The study follows previous work that showed high rates of mental health outcomes (depression, anxiety, post-traumatic stress disorder (PTSD)) among Ethiopian and Eritrean youth in Atlanta. The goal is to determine the acceptability, feasibility, and safety of this culturally relevant group-level intervention before a larger trial to improve resilience processes that support mental wellness in a community-based setting.

Research Team

Sophia Hussen, MD, MPH

Principal Investigator

Emory University

Eligibility Criteria

This trial is for Ethiopian and Eritrean youth in Atlanta who have mental health issues like depression, anxiety, or PTSD. It's a small test to see if the Weyera intervention works well and safely in their community before trying it with more people.

Inclusion Criteria

Ethiopian and/or Eritrean ethnicity by self-report

Able to read and understand English

Resident of Atlanta Metropolitan Statistical Area

Exclusion Criteria

Not a resident of the Atlanta Metropolitan Statistical Area

Unwilling or unable to provide informed consent

Timeline

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Intervention

Participants attend 8 weekly sessions including psychoeducation, interactive activities, and coping skills practice

8 weeks

8 visits (in-person)

Follow-up

Participants complete follow-up surveys at 2-, 4-, and 6-month post-enrollment to assess various mental health outcomes

6 months

3 visits (virtual)

Wait-list Control

Participants in the wait-list control group begin the full intervention starting at month 4 following their enrollment

4 months

Treatment Details

Interventions

• Weyera Intervention

Trial Overview The study tests the Weyera Intervention—a group activity designed to boost mental health and resilience. Participants are either put into the immediate treatment group or placed on a waitlist (delayed intervention) as a control to compare outcomes.

Participant Groups

Group I: Wait-List Control Group Experimental Treatment 1 Intervention

A wait-list control design ensures the ethical treatment of participants by guaranteeing that all individuals will have access to the potentially impactful intervention after a brief waiting period. Participants in the wait-list control group will begin the full intervention starting at month 4 following their enrollment.

Group II: Intervention Experimental Treatment 1 Intervention

Participants enrolled in the intervention group will begin the intervention 1-2 weeks after group assignment and will complete a baseline survey before the start of the intervention, satisfaction surveys at the end of each session, and an endline survey. At the end of the intervention, a subset of participants will also take part in in-depth interviews

Who Is Running the Clinical Trial?

Emory University

Lead Sponsor

Trials

1,735

Recruited

2,605,000+

National Institute on Minority Health and Health Disparities (NIMHD)

Collaborator

Trials

473

Recruited

1,374,000+

Findings from Research

In a large-scale outcomes management project involving over 7,000 clinicians, patients with significant psychological distress showed a quick response to treatment, indicating that timely intervention is crucial for effective care.

The study highlighted that while treatment duration and intensity vary, maintaining patient engagement is key; even those with poor initial responses can achieve positive outcomes if they stay involved in their treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Implementation of a feedback system in a managed care environment: what are patients teaching us? Brown, GS., Jones, ER.[2019]

A small trial with 59 participants showed that a phase-specific intervention combining low-dose risperidone and cognitive behavioral therapy significantly reduced the likelihood of developing psychosis in individuals with prodromal symptoms at a 6-month follow-up, compared to standard care.

Another trial with 83 participants indicated that family therapy combined with outpatient care led to significantly lower admission rates for individuals experiencing their first episode of psychosis, suggesting that phase-specific treatments can improve outcomes, although the applicability of the findings is uncertain.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Early Intervention for psychosis. Marshall, M., Lockwood, A.[2018]

Evidence-based interventions for schizophrenia, including medication management, illness self-management training, and family psychoeducation, have been shown to significantly improve patient outcomes.

Despite the proven effectiveness of these interventions, they are often not provided in routine mental health settings, highlighting a critical need for better implementation of these treatments in practice.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evidence-based treatment of schizophrenia. Drake, RE., Mueser, KT., Torrey, WC., et al.[2019]

In a study involving 1,687 substance-abusing participants over 27,198 person-weeks, 12% experienced serious adverse events (SAEs), but none were deemed related to the psychosocial interventions being tested.

There were no significant differences in the incidence rates of SAEs between those receiving standard care and those receiving additional interventions like contingency management or motivational enhancement, suggesting that these psychosocial treatments are safe in terms of serious adverse events.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Serious adverse events in randomized psychosocial treatment studies: safety or arbitrary edicts? Petry, NM., Roll, JM., Rounsaville, BJ., et al.[2021]

In a systematic review of 117 studies on psychosocial interventions for childhood mental disorders, only 31% monitored adverse events, highlighting a significant gap in safety reporting.

Among the studies that did monitor adverse events, there was a lack of consistency in how these events were defined and assessed, with only 11% evaluating the causes of the events, which is crucial for understanding the risks associated with these treatments.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Review: Adverse event monitoring and reporting in studies of pediatric psychosocial interventions: a systematic review. Lodewyk, K., Bagnell, A., Courtney, DB., et al.[2023]

The EVAD tool was developed to evaluate and classify the severity of adverse events in psychotherapeutic clinical trials, filling a gap in the existing frameworks for such evaluations.

Content validation showed strong agreement among experts, with perfect scores for relevance and high scores for clarity and coherence, indicating that EVAD is a reliable and meaningful tool for assessing adverse events.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Development and content validity of EVAD: A novel tool for evaluating and classifying the severity of adverse events for psychotherapeutic clinical trials. Mejía-Castrejón, J., Sierra-Madero, JG., Belaunzarán-Zamudio, PF., et al.[2023]

Current clinical trials for behavioral health interventions often do not monitor adverse events as thoroughly as those for medications and medical devices, focusing mainly on serious incidents like suicide attempts and hospitalizations.

There is a need for expanded monitoring of adverse events in psychotherapy trials to better inform patients about potential risks, including temporary increases in anxiety, which are often overlooked but can impact treatment outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The need for expanded monitoring of adverse events in behavioral health clinical trials. Peterson, AL., Roache, JD., Raj, J., et al.[2012]

A systematic review of 85 randomized controlled trials involving 14,420 participants found that adverse events (AEs) from psychotherapy can affect more than 10% of participants, with serious AEs occurring in more than 1 in 21 participants.

The study highlighted that the reporting and recording of AEs were inconsistent across trials, suggesting a need for standardized harm monitoring to better evaluate the risks and benefits of psychotherapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Adverse events in psychotherapy randomized controlled trials: A systematic review. Klatte, R., Strauss, B., Flückiger, C., et al.[2023]

References

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

Why study treatment outcome? [2019]

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

Implementation of a feedback system in a managed care environment: what are patients teaching us? [2019]

3. Germany pubmed.ncbi.nlm.nih.gov

Quality of mental health service care: the forgotten pathway from process to outcome. [2019]

4. England pubmed.ncbi.nlm.nih.gov

Early Intervention for psychosis. [2018]

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

Evidence-based treatment of schizophrenia. [2019]

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

Serious adverse events in randomized psychosocial treatment studies: safety or arbitrary edicts? [2021]

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

Review: Adverse event monitoring and reporting in studies of pediatric psychosocial interventions: a systematic review. [2023]

8. England pubmed.ncbi.nlm.nih.gov

Development and content validity of EVAD: A novel tool for evaluating and classifying the severity of adverse events for psychotherapeutic clinical trials. [2023]

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

The need for expanded monitoring of adverse events in behavioral health clinical trials. [2012]

10. England pubmed.ncbi.nlm.nih.gov

Adverse events in psychotherapy randomized controlled trials: A systematic review. [2023]