NCT03711266

Brief Summary

The purpose of this project is to expand access to trauma-focused treatment among Medicaid Enrollees with PTSD, thereby improving the quality of mental health services delivered to this population. Specifically, the project goals are to evaluate the delivery and sustainability of a brief trauma-focused treatment, Prolonged Exposure for Primary Care (PE-PC), an evidence-based intervention for PTSD, when delivered via telehealth to patients enrolled at CHCs in Michigan.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
35

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Nov 2018

Typical duration for not_applicable

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 12, 2018

Completed
6 days until next milestone

First Posted

Study publicly available on registry

October 18, 2018

Completed
14 days until next milestone

Study Start

First participant enrolled

November 1, 2018

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2020

Completed
1.4 years until next milestone

Results Posted

Study results publicly available

February 18, 2022

Completed
Last Updated

February 18, 2022

Status Verified

December 1, 2021

Enrollment Period

1.9 years

First QC Date

October 12, 2018

Results QC Date

September 30, 2021

Last Update Submit

December 6, 2021

Conditions

PTSD

Outcome Measures

Primary Outcomes (1)

  • Change in PTSD Symptoms (as Measured by the PCL-5)

    The PCL-5 is a 20-item self-report measure designed to assess PTSD symptoms as defined by the DSM-5. Each item of the PCL-5 is scored on a five point scale ranging from 0 ("not at all") to 4 ("extremely"). Items are summed to provide a total severity score (range = 0-80).The PCL-5 has strong internal consistency, test-retest reliability, and convergent and discriminant validity. Scores ≥ 33 indicate a probable diagnosis of PTSD. Data presented represent a change from baseline PCL-5 assessment to the 4-month PCL-5 assessment (e.g., value at baseline minus value at 4 months).

    Baseline, 4-months

Secondary Outcomes (3)

  • Change in Depressive Symptoms (as Measured by the PHQ-9)

    Baseline, 4-months

  • Change in Recovery Goals (Measured by the Recovery Assessment Scale; RAS)

    Baseline, 4-months

  • Change in Posttraumatic Cognitions (Measured by the Post-Traumatic Cognitions Inventory; PTCI)

    Baseline, 4-months

Study Arms (1)

PE-PC

EXPERIMENTAL

Eligible participants who present to participating CHCs and screen positive for PTSD will be offered PE-PC via telepsychiatry.

Behavioral: PE-PC

Interventions

PE-PCBEHAVIORAL

PE-PC treatment will follow the PE-PC manual and patient workbook. Treatment content for PE-PC is drawn from the PE model and condensed so as to deliver the most efficacious components of PE. PE-PC consists of four, 30-minute appointments scheduled approximately once a week over 4-6 weeks

PE-PC

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • receive care at a Michigan CHC
  • have a PCL-5 score ≥33
  • have had psychotropic medication stability for at least 4 weeks

You may not qualify if:

  • substantially cognitively impaired (according to the Mini-Cog)
  • unable to agree to study procedures for any reason (including incompetency)
  • at high risk of suicide
  • currently engaged in a trauma-focused behavioral treatment (such as Prolonged Exposure or Cognitive Processing Therapy)
  • unable to speak English

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Baldwin Family Health Care-Cadillac Clinic

Cadillac, Michigan, 49349, United States

Location

Hamilton Community Health Network-Flint Clinic

Flint, Michigan, 48503, United States

Location

Related Publications (1)

  • Sripada RK, Walters HM, Ganoczy D, Avallone KM, Cigrang JA, Rauch SAM. Feasibility and Acceptability of Prolonged Exposure in Primary Care (PE-PC) for Posttraumatic Stress Disorder in Federally Qualified Health Centers: A Pilot Study. Adm Policy Ment Health. 2022 Sep;49(5):722-734. doi: 10.1007/s10488-022-01195-1. Epub 2022 Apr 20.

    PMID: 35445362DERIVED

MeSH Terms

Conditions

Stress Disorders, Post-Traumatic

Condition Hierarchy (Ancestors)

Stress Disorders, TraumaticTrauma and Stressor Related DisordersMental Disorders

Results Point of Contact

Title
Rebecca Sripada
Organization
Michigan Medicine
rekaufma@med.umich.edu
734-222-7432

Study Officials

  • Rebecca Sripada, PhD

    University of Michigan

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

October 12, 2018

First Posted

October 18, 2018

Study Start

November 1, 2018

Primary Completion

September 30, 2020

Study Completion

September 30, 2020

Last Updated

February 18, 2022

Results First Posted

February 18, 2022

Record last verified: 2021-12

Data Sharing

IPD Sharing
Will not share

Locations

US(2)