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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to evaluate the effectiveness of a new therapy called the Common Elements Treatment Approach in helping Apache adults who have experienced difficult childhoods and now face challenges such as suicidal thoughts or heavy drinking. The therapy focuses on developing key skills to manage stress and enhance emotional health. Participants will either engage in several sessions with a mental health specialist or receive standard case management, which provides basic support and follow-up. Individuals who have experienced suicidal thoughts, self-harm behavior, or binge drinking in the past 90 days and have a history of childhood trauma may be suitable candidates. As an unphased trial, this study offers a unique opportunity to contribute to the understanding and improvement of mental health treatments for individuals with similar backgrounds.

Do I need to stop my current medications for 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 prior data suggests that the Common Elements Treatment Approach is safe?

Research shows that the Common Elements Treatment Approach (CETA) is generally easy for participants to handle. Past studies have demonstrated that CETA helps with various issues, such as reducing alcohol use and managing stress. These studies have not identified any major safety problems or serious side effects. Instead, many participants found the sessions helpful.

In one study, trained community counselors provided CETA, and it showed good results without significant negative effects. This suggests that the approach is safe for use by community mental health workers.

Although this trial does not have a specific phase, it aims to understand participants' responses to the treatment by evaluating both its effectiveness and safety. Since CETA is used in different settings and has not shown major safety issues, it appears to be a safe option for addressing trauma-related stress and building resilience. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Common Elements Treatment Approach because it offers a personalized and flexible method for addressing both suicide risk and excessive alcohol consumption. Unlike traditional treatments that might follow a rigid protocol, this approach adapts to each individual's needs, providing 4–8 sessions with a community mental health specialist based on the participant's symptoms. The treatment includes psychoeducation, relaxation techniques, problem-solving, and cognitive coping strategies, making it a comprehensive option that targets multiple aspects of mental health. This flexibility and customization can potentially make the treatment more effective and accessible for individuals with varying levels of need.

What evidence suggests that the Common Elements Treatment Approach is effective for addressing trauma-related distress and building resilience?

Research has shown that the Common Elements Treatment Approach (CETA), which participants in this trial may receive, effectively reduces risky alcohol use and interpersonal violence, particularly in high-risk groups such as couples in Zambia. This method teaches skills to improve thinking, emotions, relationships, and behavior, helping to ease trauma and build resilience. Studies have also found that integrated behavioral treatments like CETA significantly reduce heavy drinking compared to standard care. These findings suggest that CETA could help address issues like excessive alcohol use and suicidal behaviors by providing tools to manage stress and make safer choices. ^{1 3 4 6 7}

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+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7164585/

Effectiveness of the Common Elements Treatment Approach ... Results showed that CETA was more effective than TAU-Plus in reducing IPV and hazardous alcohol use among high-risk couples in Zambia. Future ...

2. withpower.com withpower.com/trial/phase-suicide-2022-91cc1

Common Elements Treatment for Suicide and Excessive ... "Common elements" interventions build cognitive, emotional, interpersonal, and behavioral skills to help address trauma-related distress and build resilience.

3. cdn.clinicaltrials.gov cdn.clinicaltrials.gov/large-docs/85/NCT03966885/Prot_SAP_000.pdf

Zambia Common Elements Treatment Approach Pilot ... We will collect mixed methods implementation data and clinical outcomes data on alcohol, comorbidities, and HIV (ART retention and VL collected through routine ...

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12512866/

study protocol for a randomised controlled trial The current study aims to evaluate the effectiveness and cost-effectiveness of a transdiagnostic intervention (CHANGE) to address alcohol misuse ...

5. sciencedirect.com sciencedirect.com/science/article/pii/S0376871624003296

Integrated behavioral interventions for adults with alcohol ... Studies revealed that integrated intervention led to significant reductions in heavy drinking compared to usual care or other interventions. •.

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8322829/

Efficacy of the Common Elements Treatment Approach ... This randomized controlled trial tested the efficacy of a multi-session, evidence-based, lay counselor-delivered transdiagnostic therapy, ...

7. sciencedirect.com sciencedirect.com/science/article/pii/S2352853220300201

Study protocol of the ZCAP randomized controlled trial The trial is a first step in establishing the effectiveness of CETA at reducing unhealthy alcohol use and comorbidities among PLWH in SSA.