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NCT Number: NCT05457985

Testing Adaptive Interventions to Improve Posttraumatic Stress Disorder Treatment Outcomes in Federally Qualified Health Centers

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.

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Key information

Conditions

PTSD Mental Disorders Stress Disorders, Post-Traumatic Stress Disorders, Traumatic Trauma and Stressor Related Disorders

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Family Health Care, Baldwin, Michigan, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Prolonged Exposure for Primary Care (PE-PC)

Behavioral

Treatment follows the standardized PE-PC manual and workbook.PE-PC consists of four weekly 30-minute sessions. In vivo and imaginal exposure are introduced at the first session and reviewed at Sessions 2-4. To conduct in vivo exposure, participants repeatedly and systematically approach objectively safe people, places, objects, and situations that they avoid because these stimuli remind them of their trauma. At the 4th session or 9-week assessment point (whichever comes first), early responders will step down to every-other-week sessions for the duration of the second stage.

Full Prolonged Exposure

Behavioral

Treatment will follow the standardized PE manual. Participants will have 60 minute sessions once a week for eight weeks During these sessions, participants will practice in vivo, imaginal, and emotional exposure as well as continue these exposure exercises every day at home.

Clinician Supported PTSD Coach App

Behavioral

This is a brief psychotherapy that uses the PTSD Coach mobile app developed by the study team. The PTSD Coach app incorporates evidence-based assessment, psychoeducation, and cognitive behavioral therapy and self-management strategies that are customizable to the user.

Primary outcomes

  1. Change in PTSD symptoms as measured by the Clinician-Administered PTSD Scale for Diagnostic and Statistical Manual of Mental Disorders (DSM)-5 (CAPS-5)

    Time frame: Baseline, 3-months

    The CAPS-5 is a clinician-rated PTSD rating scale consisting of 30 items; the total score is calculated as the sum of 20 items assessing the 20 DSM-5 PTSD symptoms. These symptom items are scored on a 5-point scale from 0 (absent) to 4 (extreme/incapacitating). The total score of the 20 items ranges from 0 to 80 with higher scores indicating more severe PTSD symptoms. Therefore, a decrease in the total score indicates symptom improvement.

Secondary outcomes

  1. Change in PTSD symptoms by the PTSD Checklist (PCL-5)

    Time frame: Baseline, 3-months

    The PTSD Checklist for DSM-5 (PCL-5) is a 20-item self-report measure that assesses symptoms of PTSD. The PCL-5 has a variety of purposes, including monitoring symptom change during and after treatment. The minimum score is 0, the maximum is 80 (higher scores indicate increased PTSD severity).

  2. Change in depressive symptoms measured by the Patient Health Questionnaire (PHQ-9)

    Time frame: Baseline, 3-months

    There are 9 questions that reflects the overall functioning and impairment due to the depressive symptoms. Scores ranges from 0 to 27, with a higher score indicating more severe symptoms.

  3. Change in quality of life and functioning measured by the EuroQol-5 Domain (EQ-5D-5L)

    Time frame: Baseline, 3-months

    The EQ-5D-5L assesses patients' overall quality of life and health. This measure asks questions related to mobility, self-care, activity, pain, and anxiety/depression. Each dimension has five response levels: no problems, slight problems, moderate problems, severe problems, unable to /extreme problems. The participant indicates his/her health state by checking the box next to the most appropriate response level for each of the five dimensions. Higher scores mean better quality of life. Minimum score is 1 and the maximum score is 5 for each dimension. The measure also includes one 0-100 scale assessing how patients perceive their overall health.

Study contacts

Contact information is provided by the study sponsor or research team.

Heather Walters

CONTACT

[email protected]

734-845-3650

Kayla Longuski, MS

CONTACT

[email protected]

734-647-6258

Sponsors and collaborators

Lead sponsor

University of Michigan

Other

Collaborators

  • National Institute of Mental Health (NIMH)

Registry information

Official study title

Testing Adaptive Interventions to Improve Posttraumatic Stress Disorder (PTSD) Treatment Outcomes in Federally Qualified Health Centers

Important dates

Study start
2022
Primary completion
2027
Study completion
2027
First posted
Jul 14, 2022
Registry last updated
Jul 1, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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