Your session is about to expire
← Back to Search
Behavioral Intervention
Common Elements Treatment for Suicide and Excessive Alcohol Consumption (MP2H Trial)
N/A
Waitlist Available
Led By Emily Haroz, PhD
Research Sponsored by Johns Hopkins Bloomberg School of Public Health
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
An average score of 1 or above on a measure of symptoms of posttraumatic stress
Adults aged 25-65
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline
Awards & highlights
MP2H Trial Summary
This trial will test a common elements intervention delivered by community mental health workers to see if it is effective, feasible, and acceptable for Apache adults who have experienced adverse childhood experiences.
Who is the study for?
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.Check my eligibility
What is being tested?
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.See study design
What are the potential side effects?
Since this intervention focuses on psychological therapy rather than medication, side effects may include emotional discomfort or increased distress as individuals confront traumatic experiences during treatment.
MP2H Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have symptoms of posttraumatic stress.
Select...
I am between 25 and 65 years old.
MP2H Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline, endline (8-12 weeks after baseline), follow up 1 (16 weeks after baseline), follow up 2 (20 weeks after baseline) follow up 3 (24 weeks after baseline)
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline, endline (8-12 weeks after baseline), follow up 1 (16 weeks after baseline), follow up 2 (20 weeks after baseline) follow up 3 (24 weeks after baseline)
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Change in Post Traumatic Stress Symptoms
Secondary outcome measures
Adverse Childhood Experience (ACE) Scale
Alcohol or Other Drugs use
Anxiety
+11 moreMP2H Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Sessions with a community mental health specialistExperimental Treatment1 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 managementActive Control1 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.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Common Elements Treatment Approach
2012
N/A
~870
Find a Location
Who is running the clinical trial?
Johns Hopkins Bloomberg School of Public HealthLead Sponsor
410 Previous Clinical Trials
2,116,895 Total Patients Enrolled
Native American Research Centers for HealthUNKNOWN
3 Previous Clinical Trials
502 Total Patients Enrolled
Emily Haroz, PhDPrincipal InvestigatorJohns Hopkins Bloomberg School of Public Health
2 Previous Clinical Trials
210 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You currently have a mental condition that causes you to lose touch with reality.I have symptoms of posttraumatic stress.I am unable to understand and agree to the study's details on my own.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.I am between 25 and 65 years old.You have had at least two negative experiences during your childhood.You have a severe developmental disorder.
Research Study Groups:
This trial has the following groups:- Group 1: Sessions with a community mental health specialist
- Group 2: Case management
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Can individuals under 45 years of age join the experiment?
"Prospective participants must be between 25 and 65 years old to qualify for this trial. Those younger than 18 will find 254 trials on offer, while those older than 65 have access to 957 clinical studies."
Answered by AI
Are there any vacancies in this clinical experiment?
"According to the clinicaltrials.gov webpage, this clinical trial is actively seeking enrolment with an initial posting date of July 19th 2022 and most recent update on August 9th 2022."
Answered by AI
May I join the experiment for this clinical trial?
"The desired cohort for this clinical study consists of 100 adults aged 25-65 with a history of suicide ideation, self-injurious behaviour or substance abuse over the past 90 days. In addition to these criteria, candidates must have experienced at least two adverse childhood experiences and live on or near the Fort Apache Indian Reservation as well as having an average score of 1 or more on a posttraumatic stress measure."
Answered by AI
What is the size of the cohort contributing to this medical experiment?
"Yes, the study is actively recruiting. The trial was first posted on July 19th 2022 and it has since been revised once, as of August 9th. They are looking to enrol 100 patients from a single clinical site."
Answered by AI
Other Trials to Consider
Popular Categories
Share this study with friends
Copy Link
Messenger