My Pathway to Healing: Adaptation and Testing of a Common Elements Treatment Approach to Address Trauma, Suicide Ideation and Substance Abuse

My Pathway to Healing: Adaptation and Testing of a Common Elements Treatment Approach to Address Trauma, Suicide Ideation and Substance Abuse

Sponsors

Lead Sponsor: Johns Hopkins Bloomberg School of Public Health

Source Johns Hopkins Bloomberg School of Public Health
Brief Summary

The goal of this project is to test the effectiveness, 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 wait-list controlled randomized control trial with Apache adults ages 18-65 with recent suicide ideation and/or binge substance use.

Detailed Description

This is a mixed-methods study with qualitative data informing adaptation and evaluation of a common elements intervention delivered by community mental health specialists, named "My Pathway to Healing."

Apache partners selected a wait-list randomized control trial, as it is a rigorous study design for understanding whether an intervention works and was endorsed by the community, to evaluate the effectiveness of the My Pathway to Healing intervention delivered by community mental health specialists (CMHS). This intervention consists of an initial assessment to determine treatment priorities and safety. It integrates psychoeducation and addresses safety (when identified as a problem area). It can also include teaching relaxation, cognitive coping, exposure-trauma memories, exposure-live, cognitive restructuring, behavioral activation, and problem solving. The intervention used in the tested arm of our study will be adapted to the specific context and culture of White Mountain Apache.

Those randomized into the My Pathway to Healing group will receive 5-15 hour-long sessions with a community mental health specialist, taking place over 12 weeks. The exact number of sessions 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). Those randomized into the wait-list control will continue to receive the standard case management via the Apache surveillance system. These wait-list control participants will be asked to wait until all N=50 My Pathway to Healing participants have started the program and then will be offered the program on a rolling basis based on availability of providers

Participants, will be asked to partake in 5 study assessments. For intervention participants these assessments will take place at: baseline, after their last intervention session (endline) and 4, 8, and 12 weeks post-endline. For control participants, these assessments will take place at: baseline, 12 weeks post-baseline (the maximum time the intervention would last; will be referred to as an endline) and 4, 8 and 12 weeks post-endline. These assessment visits will be conducted by the Research Program Assistants who will serve as the independent evaluators. Assessments will take approximately 45-90 minutes to complete.

Overall Status Not yet recruiting
Start Date March 2021
Completion Date August 2023
Primary Completion Date August 2023
Phase N/A
Study Type Interventional
Primary Outcome
Measure Time Frame
Change in Post Traumatic Stress Symptoms Baseline, Endline (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)
Secondary Outcome
Measure Time Frame
International Depression Symptom Scale (IDSS) Baseline, Endline (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)
Anxiety Baseline, Endline (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)
Alcohol and Substance Use Baseline, Endline (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)
Alcohol and Substance Use Baseline, Weekly from baseline to 12 weeks post baseline (during intervention sessions), Follow Up 3 (24 weeks after baseline)
Suicidal behavior and risk Baseline, Endline (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)
Hope Baseline, Endline (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)
Communal Mastery Baseline, Endline (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)
Historical Loss Scale Baseline
Adverse Childhood Experience (ACE) Scale Baseline
Domestic Violence Baseline, Endline (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)
Emotional Abuse Baseline, Endline (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)
Self-Esteem Baseline, Endline (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)
Coping Baseline, Endline (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)
Functioning Baseline, Endline (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)
Mental Health and Wellbeing Weekly from baseline to 12 weeks post baseline (during intervention sessions)
Post-Training Knowledge Tests for Supervisors & Community mental Health Specialists 1 week after training, after piloting intervention (approximately 6 months after training), and 9 months after training
Community mental health specialist competency of intervention delivery 1 week after training, after piloting intervention (approximately 6 months after training), and 9 months after training
Enrollment 100
Condition
Intervention

Intervention Type: Behavioral

Intervention Name: Common Elements Treatment Approach

Description: The intervention integrates psychoeducation and addresses safety (when identified as a problem area). It can also include teaching relaxation, cognitive coping, exposure-trauma memories, exposure-live, cognitive restructuring, behavioral activation, and problem solving.

Eligibility

Criteria:

Inclusion Criteria:

- Adults aged 18-65

- Suicide ideation or binge alcohol and/or drug use within past 90 days confirmed by the Apache suicide surveillance system

- Experienced >3 adverse childhood experiences

- Native American

- Reside on or near the Fort Apache Indian Reservation.

- An average score of 1 or above on a measure of symptoms of posttraumatic stress

Exclusion Criteria:

- Unable to provide informed consent

- Have a serious developmental disorder

- Have active psychosis

- Had a suicide attempt in the past 3 months

Gender: All

Minimum Age: 18 Years

Maximum Age: 65 Years

Healthy Volunteers: No

Overall Official
Last Name Role Affiliation
Mary Cwik, PhD Principal Investigator Johns Hopkins Bloomberg School of Public Health
Overall Contact

Last Name: Mary Cwik, PhD

Phone: 443-287-5171

Email: [email protected]

Location
Facility: Contact: Johns Hopkins Center for American Indian Health Whiteriver Office Novalene Goklish 928-338-5215
Location Countries

United States

Verification Date

October 2020

Responsible Party

Type: Sponsor

Has Expanded Access No
Condition Browse
Number Of Arms 2
Arm Group

Label: Sessions with a community mental health specialist

Type: Experimental

Description: Those randomized into the intervention group will receive 5-15 hour-long sessions with a community mental health specialist, taking place over 12 weeks. The common elements treatment approach intervention includes psychoeducation and addresses safety (when identified as a problem area). It can also include teaching relaxation, cognitive coping, exposure-trauma memories, exposure-live, cognitive restructuring, behavioral activation, and problem solving.The exact number of sessions 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).

Label: Wait-list

Type: Active Comparator

Description: This study employs a wait-list control design. Participants in the control group will be asked to wait until the intervention group has all begun the intervention sessions before they begin.

Acronym MP2H
Patient Data No
Study Design Info

Allocation: Randomized

Intervention Model: Parallel Assignment

Intervention Model Description: Investigators will use a wait-list controlled design.

Primary Purpose: Treatment

Masking: Single (Outcomes Assessor)

Masking Description: Individuals conducting assessments with participants will be blinded to their randomization status.

Source: ClinicalTrials.gov