Common Elements Treatment for Suicide and Excessive Alcohol Consumption

(MP2H Trial)

Overseen By Emily Haroz, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Johns Hopkins Bloomberg School of Public Health

Disqualifiers: Developmental disorder, Active psychosis, others

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

Compensation: Varies

Number of Visits: 7

Duration: 8-12 weeks

36 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

The goal of this project is to test the feasibility and acceptability of a common elements intervention delivered by community mental health workers for adults with a history of adverse childhood experiences. "Common elements" interventions build cognitive, emotional, interpersonal, and behavioral skills to help address trauma-related distress and build resilience. This will be accomplished using a randomized control trial with Apache adults ages 25-65 with recent suicidal behaviors, self-injurious behaviors, and/or binge substance use.

Who Is on the Research Team?

Emily Haroz, PhD

Principal Investigator

Johns Hopkins Bloomberg School of Public Health

Are You a Good Fit for This Trial?

This trial is for Native American adults aged 25-65 living near the Fort Apache Indian Reservation who've had at least two adverse childhood experiences and recent suicidal behaviors, self-injury, or binge substance use. Participants must have symptoms of posttraumatic stress but cannot join if they can't consent, have active psychosis, or serious developmental disorders.

Inclusion Criteria

I have symptoms of posttraumatic stress.

You have thought about suicide or attempted it, hurt yourself on purpose, or excessively consumed drugs or alcohol in the last three months as confirmed by the Apache suicide surveillance system.

You are a member of a Native American community.

Exclusion Criteria

You currently have a mental condition that causes you to lose touch with reality.

I am unable to understand and agree to the study's details on my own.

You have a severe developmental disorder.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive 4-8 hour-long sessions with a community mental health specialist over 8-12 weeks

8-12 weeks

4-8 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

12 weeks

3 visits (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• Common Elements Treatment Approach

Trial Overview The 'My Pathway to Healing' trial tests a 'Common Elements Treatment Approach,' which aims to build cognitive, emotional, interpersonal, and behavioral skills in adults with trauma-related distress. It's a randomized control trial focusing on improving resilience among participants.

How Is the Trial Designed?

Group I: Sessions with a community mental health specialist Experimental Treatment 1 Intervention

Those randomized into the intervention group will receive 4-8 hour-long sessions with a community mental health specialist, taking place over approximately 12 weeks. The common elements treatment approach intervention (called "My Pathway to Healing") includes psychoeducation and addresses safety (when identified as a problem area). It also includes relaxation techniques, problem solving, and cognitive coping. The exact number of sessions delivered will depend on presentation and symptom level using a stepped care approach where participants receive only what they need, but the provider can provide additional sessions if needed (i.e., increased element dosage; additional optional elements for specific issues).

Group II: Case management Active Control 1 Intervention

This study employs a randomized control design in which participants in the control group will receive case management and offered the intervention upon completion of their enrollment period.

Who Is Running the Clinical Trial?

Johns Hopkins Bloomberg School of Public Health

Lead Sponsor

Trials

441

Recruited

2,157,000+

National Institute of General Medical Sciences (NIGMS)

Collaborator

Trials

315

Recruited

251,000+

Native American Research Centers for Health

Collaborator

Trials

5

Recruited

890+

Native American Research Center for Health

Collaborator

Trials

6

Recruited

1,300+