What is the mechanism of action of this treatment?

Common treatments for psychological distress include cognitive-behavioral therapy (CBT), dialectical behavior therapy (DBT), and peer-delivered interventions. CBT works by helping patients identify and change negative thought patterns and behaviors, while DBT focuses on emotional regulation and interpersonal effectiveness. Peer-delivered interventions leverage the shared experiences of individuals who have faced similar challenges to provide support and guidance. Understanding these mechanisms is crucial for patients as it empowers them to actively participate in their treatment, fosters a sense of hope and relatability, and enhances the effectiveness of the therapeutic process.

What side effects are associated with this type of intervention?

Common treatments for psychological distress, such as cognitive-behavioral therapy (CBT), interpersonal therapy, and psychoeducation, generally have minimal physical side effects compared to pharmacological treatments. However, patients may experience emotional discomfort as they confront distressing thoughts and feelings during therapy sessions. Additionally, there can be variability in the effectiveness of these therapies, and some individuals may not experience significant improvement. Peer-delivered interventions, which involve support and guidance from individuals with similar experiences, share these characteristics and are generally well-tolerated, though the emotional challenges of discussing personal issues can still be present.

What prior FDA approvals exist?

The FDA has approved several medications for the treatment of psychological distress, particularly focusing on antidepressants such as SSRIs (e.g., fluoxetine, escitalopram) and SNRIs (e.g., duloxetine). These medications have been shown to be effective in reducing symptoms of depression and anxiety. Additionally, collaborative care models, which involve a team-based approach including primary care clinicians, case managers, and mental health specialists, have been recognized for their effectiveness in managing psychological distress. While the context does not provide specific details on peer-delivered interventions, these collaborative care models share similarities in providing support and guidance from a team, which can include individuals with similar experiences.

What other types of research exist?

Promising novel alternatives to Peer-Delivered Intervention for psychological distress patients include: 1) Internet-Based Cognitive Behavioral Therapy (iCBT), which has shown efficacy in treating various mental health conditions through guided online platforms. 2) Smartphone apps delivering transdiagnostic cognitive-behavioral interventions, providing accessible and flexible treatment options. 3) Pharmacotherapy advancements, such as the use of lisdexamfetamine for binge-eating disorder, which may also benefit other psychological distress conditions. 4) Combined nutritional, psychological, and pharmacological treatments, offering a holistic approach to mental health care. 5) Collaborative care models integrating psychotherapy and pharmacotherapy, enhancing treatment adherence and outcomes.

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Peer Intervention for Psychological Distress (EMBER Trial)

N/A

Waitlist Available

Led By Ellen Poleshuck, PhD

Research Sponsored by Syracuse VA Medical Center

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 6 months (post-intervention) and 9 months (3 months post-intervention)

Awards & highlights

No Placebo-Only Group

Summary

This trial tests a virtual support program called PSP, where peers help rural women Veterans, especially those of color, access mental health and social services. The goal is to see if this program improves their access to and engagement with these services. Personalized Support for Progress (PSP) is designed to support women Veterans with high stress by prioritizing their concerns and providing practical and emotional support.

Who is the study for?

This trial is for rural women Veterans, especially those of color, who have experienced psychological distress or have unmet social needs. Participants must be able to communicate in English and have a record of mental health concerns like depression or anxiety. They should live in rural areas and identify as women or gender fluid.

What is being tested?

The study tests 'Personalized Support for Progress' (PSP) and 'Tailored Referral' (TR), peer-delivered interventions aimed at improving access to mental health treatment and social services among the participants.

What are the potential side effects?

Since this trial involves support programs rather than medical treatments, traditional side effects are not expected. However, discussing sensitive topics may cause temporary emotional discomfort.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 6 months (post-intervention) and 9 months (3 months post-intervention)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~6 months (post-intervention) and 9 months (3 months post-intervention)

This trial's timeline: 3 weeks for screening, Varies for treatment, and 6 months (post-intervention) and 9 months (3 months post-intervention) for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Change in actual engagement with social resource services and mental health treatment

Change in perceived access to social resource services and mental health treatment

Secondary study objectives

Change in Perception of Quality of Life

Post-Traumatic Stress Disorder

Change in anxiety symptoms

+7 more

Other study objectives

Autonomy Support

Perceived Confidence

Therapeutic alliance

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Personalized Support for Progress (PSP)Experimental Treatment1 Intervention

PSP includes an initial 60-minute video or phone appointment and then follow-up tailored to the Veteran's preferences. The Peer Specialist guides the Veteran through a card-sorting task to prioritize concerns and then create a personalized care plan. The Peer then provides up to six months of outreach and support to implement the care plan. At the end of the six months, the Veteran and peer review the plan, determine next steps and consider other supports and resources to sustain progress made.

Group II: Tailored Referral (TR)Active Control1 Intervention

The Tailored Referral (TR) comparator will be comprised of written or emailed information describing resources and contact information for VHA and local social and mental health resources. Examples include information about the appropriate office/person to reach within the local VA or area, help scheduling an appointment, or information for a same-day Primary Care - Mental Health Integration (PCMHI) assessment.

Do I qualify?Apply below to find out

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for psychological distress include cognitive-behavioral therapy (CBT), dialectical behavior therapy (DBT), and peer-delivered interventions. CBT works by helping patients identify and change negative thought patterns and behaviors, while DBT focuses on emotional regulation and interpersonal effectiveness. Peer-delivered interventions leverage the shared experiences of individuals who have faced similar challenges to provide support and guidance. Understanding these mechanisms is crucial for patients as it empowers them to actively participate in their treatment, fosters a sense of hope and relatability, and enhances the effectiveness of the therapeutic process.

Problem-Focused Psychodynamic Psychotherapies.Psychological therapies for preventing seasonal affective disorder.