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Can a Stepped-Care approach make PTSD therapy more effective?

NCT ID NCT05457985

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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

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

About 430 people

The number the study aims to enrol. It can still change while the study runs.

Started

Jun 2022

Expected to finish

Sep 2027

An estimate. End dates often move.

Lead sponsor

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

18 years and older

Sex

Anyone

Healthy volunteers

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

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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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.

  1. The places running it

    12 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. 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

  • Cherry Health

    RECRUITING

    Grand Rapids, Michigan, 49503, United States

  • CommUnityCare Health Centers

    RECRUITING

    Austin, Texas, 78702, United States

  • Family Care Health Centers

    RECRUITING

    St Louis, Missouri, 63111, United States

  • Family Health Care

    TERMINATED

    Baldwin, Michigan, 49304, United States

  • Family Medical Center of Michigan

    RECRUITING

    Monroe, Michigan, 48162, United States

  • Genesee Community Health Center

    RECRUITING

    Flint, Michigan, 48503, United States

  • Grace Health

    RECRUITING

    Battle Creek, Michigan, 49037, United States

  • Hamilton Community Health Network

    RECRUITING

    Flint, Michigan, 48503, United States

  • MidMichigan Community Health Services

    RECRUITING

    Houghton Lake, Michigan, 48629, United States

  • Sterling Area Health Center

    RECRUITING

    Sterling, Michigan, 48659, United States

  • Unity Care NW

    RECRUITING

    Bellingham, Washington, 98225, United States

  • Upper Great Lakes Family Health Care Center

    RECRUITING

    Menominee, Michigan, 49858, United States

  • Western North Carolina Community Health Services

    RECRUITING

    Asheville, North Carolina, 28801, United States

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