What side effects are associated with this type of intervention?

Common treatments for Substance Use Disorders (SUDs) include cognitive-behavioral therapy (CBT), 12-step facilitation, and motivational enhancement therapy. Known side effects of these treatments are generally minimal but can include emotional distress during therapy sessions, especially when confronting personal issues related to substance use. Some patients may experience increased anxiety or depressive symptoms initially as they work through challenging topics. Additionally, there may be a risk of dropout due to the emotional intensity of the sessions. However, these therapies are generally well-tolerated and have been shown to be effective in reducing substance use and improving overall mental health.

What prior FDA approvals exist?

The FDA has approved several medications for the treatment of Substance Use Disorders (SUDs). For opioid use disorder, methadone, buprenorphine, and naltrexone are commonly used. For alcohol use disorder, disulfiram, naltrexone, and acamprosate are approved. Nicotine replacement therapies (patches, gums, lozenges), bupropion, and varenicline are approved for smoking cessation. These medications are often used in conjunction with psychosocial interventions to improve outcomes. The First Face for Mental Health Training focuses on education and empowerment, which complements these pharmacological treatments by addressing mental health crises and reducing stigma.

What other types of research exist?

Promising alternatives to First Face for Mental Health Training for SUD patients include: 1) Assertive Community Treatment (ACT) which provides comprehensive, community-based psychiatric treatment, rehabilitation, and support to individuals with severe mental illness, including those with co-occurring substance use disorders. 2) Digital health tools such as mobile apps and web-based interventions that offer cognitive-behavioral therapy (CBT), motivational enhancement therapy, and contingency management. 3) 12-Step Facilitation programs adapted for stimulant drug users, which have shown efficacy in increasing participation in support groups and improving substance use outcomes. These alternatives focus on enhancing crisis response, reducing stigma, and providing tailored support to SUD patients.

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Behavioral Intervention

First Face Training for Mental Health Support in Tribal Communities

N/A

Recruiting

Led By Sarah E. Nelson, Ph.D.

Research Sponsored by Cambridge Health Alliance

Eligibility Criteria Checklist

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

Must have

Timeline

Screening 3 weeks

Treatment Varies

Follow Up pre-baseline (6 months before baseline); baseline (0 months); post-training (0 months); 6 month follow-up; 12 month follow-up; 18 month follow-up; 24 month follow-up

Awards & highlights

No Placebo-Only Group

Summary

This trial evaluates a training program called 'First Face for Mental Health' designed for Tribal community members. The program teaches them how to recognize and help people experiencing mental health crises. The goal is to improve mental health support and reduce stigma within these communities. Mental Health First Aid (MHFA) aims to improve mental health literacy and support for those experiencing mental health issues.

Who is the study for?

This trial is for individuals aged 14 or older who live or work in one of the seven Tribal Nations affiliated with the Healing Lodge of the Seven Nations in Northwestern U.S. It's not open to those younger than 14 or outside these tribal communities.

What is being tested?

The study tests a culturally tailored training program, First Face for Mental Health, designed to help Tribal community members respond effectively to mental health crises. The effectiveness will be measured through surveys before and after training, comparing immediate trainees with a waitlist group.

What are the potential side effects?

Since this trial involves an educational training program rather than a medical intervention, traditional side effects associated with medications are not applicable. However, participants may experience emotional or psychological responses related to discussing mental health.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ pre-baseline (6 months before baseline); baseline (0 months); 6 month follow-up; 12 month follow-up; 18 month follow-up; 24 month follow-up

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~pre-baseline (6 months before baseline); baseline (0 months); 6 month follow-up; 12 month follow-up; 18 month follow-up; 24 month follow-up

This trial's timeline: 3 weeks for screening, Varies for treatment, and pre-baseline (6 months before baseline); baseline (0 months); 6 month follow-up; 12 month follow-up; 18 month follow-up; 24 month follow-up for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Ability to Respond Measured via Situational Judgement Tasks

Mental Health Knowledge

Perceived Competence to Respond

+1 more

Secondary study objectives

Cultural Identity

Mental Health Stigma Measure 1

Mental Health Stigma Measure 2

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

Group I: Waitlist-control groupExperimental Treatment1 Intervention

Participants who are trained in the First Face training program 6 months after the initial training group

Group II: Initial training groupExperimental Treatment1 Intervention

Participants who are initially trained in the First Face training program

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 Substance Use Disorders (SUDs) often focus on education, empowerment, and behavioral change. Cognitive-Behavioral Therapy (CBT) helps patients identify and modify biased cognitions and behaviors that contribute to substance use. Motivational Interviewing (MI) enhances intrinsic motivation to change by resolving ambivalence. Behavioral Couples Therapy (BCT) addresses relationship dynamics that may sustain substance use. These treatments are crucial as they not only provide patients with the skills and knowledge to manage their conditions but also empower them to make informed decisions, thereby improving their overall mental health and reducing stigma associated with SUDs.

Curative factors in alcohol and drug treatment: behavioral and disease model perspectives.A Process Evaluation of a Substance Use Brief Intervention for Adolescents in a Psychiatric Inpatient Program.On treatment mechanisms--what can we learn from the COMBINE study?