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

Overview

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.

Interventions

• Behavioral Prolonged Exposure for Primary Care (PE-PC)
  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
• Behavioral Full Prolonged Exposure
  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.
• Behavioral Clinician Supported PTSD Coach App
  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 outcome measures

• 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]

Secondary outcome measures (3)

• Change in PTSD symptoms by the PTSD Checklist (PCL-5) [Time frame: Baseline, 3-months]
• Change in depressive symptoms measured by the Patient Health Questionnaire (PHQ-9) [Time frame: Baseline, 3-months]
• Change in quality of life and functioning measured by the EuroQol-5 Domain (EQ-5D-5L) [Time frame: Baseline, 3-months]

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Sequential

Masking

Single blind

Primary purpose

Treatment

Study locations

United States · 13 centers

• Family Health Care — Baldwin
• Grace Health — Battle Creek
• Genesee Community Health Center — Flint
• Hamilton Community Health Network — Flint
• Cherry Health — Grand Rapids
• MidMichigan Community Health Services — Houghton Lake
• Upper Great Lakes Family Health Care Center — Menominee
• Family Medical Center of Michigan — Monroe
• … and 5 more centers

Identifiers

NCT: NCT05457985 · HUM00203165 · 1R01MH125857-01A1

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗