Clinical trial NCT05457985: Testing Adaptive Interventions to Improve Posttraumatic Stress Disorder Treatment Outcomes in Federally Qualified Health Centers
Official title: Testing Adaptive Interventions to Improve Posttraumatic Stress Disorder (PTSD) Treatment Outcomes in Federally Qualified Health Centers
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: PTSD
Keywords: Prolonged Exposure for Primary Care
Mobile device
Clinician Supported PTSD Coach App
PTSD symptoms
Prolonged Exposure/PE
Lead sponsor: University of Michigan
Sponsor class: OTHER
Collaborators: name: National Institute of Mental Health (NIMH)
First posted: 2022-07-14
Enrollment: 430
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Intervention model description: All eligible participants will initially be randomized to one of the two first-stage options, either PE-PC or PTSD coach with clinician support. Participants that have experienced less than a 15-point reduction, have a PCL score of greater than 60 ("very severe"), or cannot be reached for assessment will be classified as slow responders and will be re-randomized to one of two second-stage tactics, either (a) continue in their first-stage treatment strategy, or (b) step up to full PE. Participants who have experienced at least a 15-point symptom reduction or have a PCL score of less than 29 will be classified as early responders and will step down to a lower intensity of their current treatment strategy (i.e., early responders will not be re-randomized).
Primary purpose: TREATMENT

Brief summary: This trial is being completed to develop a stepped-care talk therapy model for patients with PTSD. Specifically, this study is testing whether beginning with one type of therapy is better than beginning with another type of therapy, and whether moving to a different therapy after four sessions is more helpful than staying with the same therapy, depending on how well it is working.

The central hypothesis is that beginning with a low- or medium-intensity PTSD intervention and then titrating intensity based on early indications of response will result in clinically significant PTSD symptom reduction with parsimony of resources.


Eligibility criteria: Inclusion Criteria:

* Receive care at a participating federally qualified health center (FQHC)
* Have a Posttraumatic Stress Disorder checklist (PCL-5) score greater or equal (≥) to 33
* Own a mobile device that can be used for the PTSD Coach App
* Have had psychotropic medication stability for at least 4 weeks

Exclusion Criteria:

* Severe cognitive impairment that in the judgment of the investigators makes it unlikely that the participant can adhere to the study regimen (as evidenced by confusion, inability to track discussion or answer questions, or other clear and significant indicators of cognitive impairment)
* High risk of suicide (defined as meeting criteria for Action Step 3 on the Participant Suicide Risk Screening form
* Severe alcohol or substance use disorder (moderate-severe alcohol use disorder on Alcohol Use Disorders Identification Test (AUDIT) (scores ≥ 15) or high risk on National Institute on Drug Abuse Quick Screen (scores ≥ 27))
* Active psychosis or unmanaged bipolar disorder
* Unstable housing
* Current engagement in a trauma-focused behavioral treatment (such as Prolonged Exposure or Cognitive Processing Therapy).
* Patients who do not speak English will be excluded for logistical reasons.

Primary outcomes:
measure: Change in PTSD symptoms as measured by the Clinician-Administered PTSD Scale for Diagnostic and Statistical Manual of Mental Disorders (DSM)-5 (CAPS-5)
timeFrame: Baseline, 3-months
Secondary outcomes:
measure: Change in PTSD symptoms by the PTSD Checklist (PCL-5)
timeFrame: Baseline, 3-months
measure: Change in depressive symptoms measured by the Patient Health Questionnaire (PHQ-9)
timeFrame: Baseline, 3-months
measure: Change in quality of life and functioning measured by the EuroQol-5 Domain (EQ-5D-5L)
timeFrame: Baseline, 3-months
Other outcomes:
Locations:
city: Baldwin
country: United States
facility: Family Health Care
state: Michigan
city: Battle Creek
country: United States
facility: Grace Health
state: Michigan
city: Flint
country: United States
facility: Genesee Community Health Center
state: Michigan
city: Flint
country: United States
facility: Hamilton Community Health Network
state: Michigan
city: Grand Rapids
country: United States
facility: Cherry Health
state: Michigan
city: Houghton Lake
country: United States
facility: MidMichigan Community Health Services
state: Michigan
city: Menominee
country: United States
facility: Upper Great Lakes Family Health Care Center
state: Michigan
city: Monroe
country: United States
facility: Family Medical Center of Michigan
state: Michigan
city: Sterling
country: United States
facility: Sterling Area Health Center
state: Michigan
city: Saint Louis
country: United States
facility: Family Care Health Centers
state: Missouri
city: Asheville
country: United States
facility: Western North Carolina Community Health Services
state: North Carolina
city: Austin
country: United States
facility: CommUnityCare Health Centers
state: Texas
city: Bellingham
country: United States
facility: Unity Care NW
state: Washington
Study officials:
References: