Community-based Psychological Services for Mental Health

(RECOUP-NY Trial)

Overseen By Manaswi Sangraula, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: George Washington University

Disqualifiers: Acute suicide risk, 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: Unknown

Duration: 20 weeks

1000 Participants Needed

Trial Summary

What is the purpose of this trial?

This trial aims to improve mental health and COVID-19 prevention behaviors among minority and vulnerable groups in New York City by training community workers to provide basic mental health support using Problem Management Plus (PM+).

Do I need to stop my current medications to join the trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What data supports the effectiveness of the treatment Problem Management Plus (PM+) for mental health?

Research shows that Problem Management Plus (PM+) is effective in reducing psychological distress in various settings, including earthquake-affected communities in Nepal and conflict-affected women in Pakistan. It is a low-intensity treatment that can be delivered by non-specialists, making it accessible and practical for communities with limited mental health resources. ^{1 2 3 4 5}

Is community-based psychological treatment generally safe for humans?

Research shows that adverse events (unwanted effects) can occur in psychotherapy, affecting more than one in ten participants, with serious events in more than one in 21 participants. However, the way these events are recorded and reported varies, making it hard to compare results across studies. ^{6 7 8 9 10}

How is the treatment Problem Management Plus (PM+) different from other mental health treatments?

Problem Management Plus (PM+) is unique because it is a brief, five-session psychological treatment that can be delivered by non-specialists, making it accessible in low-resource settings. It is designed to help people in communities affected by adversity, such as natural disasters or conflict, and has been adapted for various cultural contexts, demonstrating its flexibility and effectiveness in diverse environments. ^{1 3 11 12 13}

Research Team

Brandon A Kohrt, MD

Principal Investigator

George Washington University

Eligibility Criteria

This trial is for individuals in New York City who are experiencing depression, anxiety, or other psychological distress after SARS-CoV-2. Participants should have a certain score on a health questionnaire and be struggling with daily activities due to their mental state. People at acute suicide risk or without functional impairment cannot join.

Inclusion Criteria

My mental health issues are affecting my daily activities.

Persons with Patient Health Questionnaire 4 scores equal to or above 3

Exclusion Criteria

Acute suicide risk

Patient Health Questionnaire 4 score below 3

I do not have any disabilities that affect my daily activities.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive mental health services through community-based organizations, including Problem Management Plus for those in the intervention arm

20 weeks

Follow-up

Participants are monitored for mental health outcomes and adherence to SARS-CoV-2 prevention behaviors

4 weeks

Treatment Details

Interventions

• Problem Management Plus
• Services as Usual

Trial Overview The study tests 'Problem Management Plus', a mental health service, against the usual services provided. It aims to see if this can improve behaviors related to preventing SARS-CoV-2 spread, vaccination uptake, and safe healthcare use among minority and vulnerable groups.

Participant Groups

Group I: Problem Management Plus Experimental Treatment 1 Intervention

Persons screening positive for depression will be offered Problem Management Plus delivered by community based organization staff.

Group II: Services as usual Active Control 1 Intervention

Persons screening positive for depression will be referred from community-based organizations. The referrals will be made to mental health specialists who will provide care based on their standard of care.

Problem Management Plus is already approved in United States for the following indications:

Approved in United States as Problem Management Plus for:

• Post-traumatic stress disorder
• Anxiety
• Depression
• Psychological distress related to COVID-19

Who Is Running the Clinical Trial?

George Washington University

Lead Sponsor

Trials

263

Recruited

476,000+

The New School

Collaborator

Trials

5

Recruited

1,400+

Duke University

Collaborator

Trials

2,495

Recruited

5,912,000+

Human Sciences Research Council

Collaborator

Trials

12

Recruited

33,400+

Findings from Research

Problem Management Plus (PM+) is an effective low-intensity psychological intervention that can be delivered by nonspecialists to help people with common mental health issues, especially in challenging situations.

The adaptation of PM+ for use in Rwanda, Peru, Mexico, and Malawi highlights the importance of tailoring psychological interventions to fit local contexts while preserving their core elements, which is crucial for successful implementation in public health settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Adapting Problem Management Plus for Implementation: Lessons Learned from Public Sector Settings Across Rwanda, Peru, Mexico and Malawi. Coleman, SF., Mukasakindi, H., Rose, AL., et al.[2022]

Problem Based Method groups (PBM) can effectively reduce symptoms of anxiety and depression in individuals on sick leave, but Cognitive Behavioral Therapy (CBT) is more effective overall in addressing mental health issues.

In terms of work ability, CBT demonstrated superior results compared to PBM, significantly improving more aspects of work ability, although both methods showed some positive effects.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Problem-based self-care groups versus cognitive behavioural therapy for persons on sick leave due to common mental disorders: a randomised controlled study. Jansson, I., Gunnarsson, AB., Björklund, A., et al.[2021]

The Group PM+ intervention, a brief psychological support program, was found to be feasible and acceptable for delivery by local non-specialists in an earthquake-affected region of rural Nepal, with 121 participants (83% women) showing good attendance and engagement.

While the study was not designed to measure effectiveness, preliminary results indicated that participants receiving Group PM+ experienced greater improvements in depression symptoms compared to those receiving enhanced usual care, suggesting potential benefits that warrant further investigation in a larger trial.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Feasibility of Group Problem Management Plus (PM+) to improve mental health and functioning of adults in earthquake-affected communities in Nepal. Sangraula, M., Turner, EL., Luitel, NP., et al.[2020]

Community mental health services in the UK showed that patients with severe common mental disorders and psychoses improved in their clinical status, indicating effective treatment for these groups.

Conversely, patients with mild to moderate common mental disorders experienced a deterioration in their health after intervention, suggesting that current community mental health strategies may not be effective for this population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Desperately seeking outcomes: quantifying the effectiveness of community mental healthcare using Health of the Nation Outcome Scales. Laugharne, R., Eaves, S., Mascas, A., et al.[2020]

In a study involving 171 depressed, disabled, low-income patients aged 60 and older, both clinical case management (CM) and integrated problem-solving therapy (CM-PST) showed similar effectiveness in reducing depressive symptoms over 12 weeks, indicating that CM alone is sufficient for this population.

The development of problem-solving skills did not mediate the improvement in depression, suggesting that the benefits of CM do not rely on this specific therapeutic approach.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Clinical Case Management versus Case Management with Problem-Solving Therapy in Low-Income, Disabled Elders with Major Depression: A Randomized Clinical Trial. Alexopoulos, GS., Raue, PJ., McCulloch, C., et al.[2022]

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]

The safety of psychological interventions is critical, as adverse events (AEs) can occur and must be carefully evaluated to ensure that these interventions do not cause harm before being deemed beneficial.

There is a pressing need for standardized protocols for assessing and reporting AEs in psychological interventions to improve transparency, consistency, and ultimately enhance clinical practice.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Editorial: Primum non nocere - are adverse events accurately reported in studies on psychological interventions for children? Purgato, M., Cortese, S.[2023]

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]

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 development of a Mental Health Quality and Safety Framework involved extensive consultations and thematic analysis, resulting in 32 categories grouped into seven key themes aimed at improving mental health services.

The proposed Framework emphasizes a shift from a centralized approach to a more localized model that includes input from frontline staff, consumers, and carers, which is expected to enhance patient safety, clinical outcomes, and staff morale.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A new paradigm for mental-health quality and safety: are we ready? Short, B., Marr, C., Wright, M.[2019]

Community-based mental health systems for children and adolescents improve access and effectiveness of services by integrating care within local communities, addressing the rising demand for mental health support.

This model is particularly beneficial in managing costs and resources, making it a promising approach as mental health needs grow in diverse populations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Community-based systems of care for children's mental health services. Pumariega, AJ.[2005]

A randomized controlled trial involving 176 patients with severe mental illness showed that aftercare services provided by trained nurses and general practitioners significantly improved patient outcomes, including psychopathology scores and caregivers' satisfaction over 12 months.

The nurse-led aftercare model was found to be the most cost-effective approach for improving health-related quality of life in patients, making it suitable for Iran's socio-economic context with limited resources.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Clinical outcomes and cost effectiveness of two aftercare models provided by general physicians and nurses to patients with severe mental illness. Malakouti, SK., Mirabzadeh, A., Nojomi, M., et al.[2019]

The study will evaluate the effectiveness of the Problem Management Plus (PM+) program, a 5-session psychological intervention, in reducing psychological distress among patients in Pakistan, with 192 participants randomized to either PM+ plus treatment as usual or treatment as usual only.

Primary outcomes will assess changes in anxiety and depression levels after 20 weeks, providing insights into the efficacy of training non-specialists to deliver psychological interventions in low-resource settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Problem Management Plus (PM+) in the management of common mental disorders in a specialized mental healthcare facility in Pakistan; study protocol for a randomized controlled trial. Hamdani, SU., Ahmed, Z., Sijbrandij, M., et al.[2020]

References

1. India pubmed.ncbi.nlm.nih.gov

Adapting Problem Management Plus for Implementation: Lessons Learned from Public Sector Settings Across Rwanda, Peru, Mexico and Malawi. [2022]

2. Netherlands pubmed.ncbi.nlm.nih.gov

Problem-based self-care groups versus cognitive behavioural therapy for persons on sick leave due to common mental disorders: a randomised controlled study. [2021]

3. England pubmed.ncbi.nlm.nih.gov

Feasibility of Group Problem Management Plus (PM+) to improve mental health and functioning of adults in earthquake-affected communities in Nepal. [2020]

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

Desperately seeking outcomes: quantifying the effectiveness of community mental healthcare using Health of the Nation Outcome Scales. [2020]

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

Clinical Case Management versus Case Management with Problem-Solving Therapy in Low-Income, Disabled Elders with Major Depression: A Randomized Clinical Trial. [2022]

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

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

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

Editorial: Primum non nocere - are adverse events accurately reported in studies on psychological interventions for children? [2023]

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

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

9. England pubmed.ncbi.nlm.nih.gov

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

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

A new paradigm for mental-health quality and safety: are we ready? [2019]

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

Community-based systems of care for children's mental health services. [2005]

12. Iran pubmed.ncbi.nlm.nih.gov

Clinical outcomes and cost effectiveness of two aftercare models provided by general physicians and nurses to patients with severe mental illness. [2019]

13. England pubmed.ncbi.nlm.nih.gov

Problem Management Plus (PM+) in the management of common mental disorders in a specialized mental healthcare facility in Pakistan; study protocol for a randomized controlled trial. [2020]