Can a Stepped-Care approach make PTSD therapy more effective?
NCT ID NCT05457985
First seen Jul 01, 2026 · Last updated Jul 02, 2026 · Updated 1 time
Summary
This trial tests whether starting PTSD treatment with one type of talk therapy and then switching to another based on early progress leads to better symptom relief. About 430 adults receiving care at federally qualified health centers will take part. The study compares different sequences of prolonged exposure therapy and cognitive processing therapy to see which approach works best.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- talk therapy (prolonged exposure for primary care and cognitive processing therapy)
- What this could lead to
- If successful, this could point toward a more efficient, personalized approach to PTSD treatment that uses fewer resources while still reducing symptoms.
- What could go wrong
- This is a behavioral intervention study, so results depend on participant engagement and may not apply to all PTSD patients. The therapies may not work better than standard care.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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About 430 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Jun 2022
- Expected to finish
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Sep 2027
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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.
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Get notified about this study
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
12 sites. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Cherry Health
RECRUITINGGrand Rapids, Michigan, 49503, United States
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CommUnityCare Health Centers
RECRUITINGAustin, Texas, 78702, United States
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Family Care Health Centers
RECRUITINGSt Louis, Missouri, 63111, United States
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Family Health Care
TERMINATEDBaldwin, Michigan, 49304, United States
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Family Medical Center of Michigan
RECRUITINGMonroe, Michigan, 48162, United States
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Genesee Community Health Center
RECRUITINGFlint, Michigan, 48503, United States
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Grace Health
RECRUITINGBattle Creek, Michigan, 49037, United States
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Hamilton Community Health Network
RECRUITINGFlint, Michigan, 48503, United States
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MidMichigan Community Health Services
RECRUITINGHoughton Lake, Michigan, 48629, United States
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Sterling Area Health Center
RECRUITINGSterling, Michigan, 48659, United States
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Unity Care NW
RECRUITINGBellingham, Washington, 98225, United States
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Upper Great Lakes Family Health Care Center
RECRUITINGMenominee, Michigan, 49858, United States
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Western North Carolina Community Health Services
RECRUITINGAsheville, North Carolina, 28801, United States
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Can a personalized mix of nerve stimulation and therapy rewire the brain for better mental health?
- Can a therapist on a screen ease both trauma and pain?
- Zapping the Brain's fear hub: a new hope for PTSD?
- Can a drug combo or therapy dogs ease PTSD?
- Can six short writing sessions ease PTSD in underserved patients?
- Can a psychedelic compound help veterans and first responders with PTSD and alcohol use disorder?