Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
ID07176273

Changing the Treatment Course: Clinical Trial of Sequenced Interventions to Optimize Treatment for Veterans With PTSD

Led by The University of Texas Health Science Center at San Antonio · Updated on 2025-12-19

302

Participants Needed

4

Research Sites

12 weeks

Total Duration

On this page

Sponsors

T

The University of Texas Health Science Center at San Antonio

Lead Sponsor

U

United States Department of Defense

Collaborating Sponsor

AI-Summary

What this Trial Is About

Researchers are evaluating different treatment strategies for veterans with posttraumatic stress disorder (PTSD) who do not respond well to their first PTSD treatment or who do not regularly complete homework assignments between sessions. The goal is to find the best way to match the right type and amount of treatment to each individual veteran. This study uses a Hybrid Experimental Design to test various therapist-delivered and digital interventions to determine the optimal combination and sequence of evidence-based treatments. The study involves multiple groups where veterans who do not respond early to Cognitive Processing Therapy (CPT) may switch to Prolonged Exposure (PE) or modular versions of CPT or PE, while early responders may continue or step down to self-managed CPT or PE using companion mobile apps. Text message prompts are sent between sessions to encourage homework completion. Treatments are delivered in routine care settings for veterans. Participants will undergo assessments at baseline, 10 weeks, 20 weeks, and 9 months, including the Posttraumatic Stress Disorder Checklist (PCL-5) and other questionnaires to measure depression, suicide risk, quality of life, and psychosocial functioning. Researchers will monitor how treatments are completed and their effects over time. The study aims to optimize treatment response by personalizing care for veterans with PTSD over several months of follow-up.

CONDITIONS

Brief Title

Adaptive Decision-making And Personalized Treatment for PTSD (ADAPT-PTSD)

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Veterans eligible for Prolonged Exposure and Cognitive Processing Therapy at the participating PTSD clinic
  • At least 18 years or older
  • Score 31 or higher on the PTSD Checklist (PCL-5) related to a traumatic event
  • Own a mobile device that can be used for therapy companion apps (PE Coach or CPT Coach)
Not Eligible

You will not qualify if you...

  • Acute suicide risk requiring clinical intervention
  • Need for detoxification
  • Unmanaged psychosis or bipolar disorder
  • Severe cognitive impairment that makes adherence to the study unlikely
  • Current or past 12-month engagement in Prolonged Exposure or Cognitive Processing Therapy

AI-Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Treatment

Duration - Up to 9 months

Participants receive therapist-delivered and digital interventions including Cognitive Processing Therapy, Prolonged Exposure Therapy, modular versions of these therapies, or step-down self-managed treatments depending on their response status and randomization group. Treatment is adaptive and sequenced to optimize outcomes for PTSD.

Multiple visits scheduled over the course of treatment depending on therapy type and response

Follow-up

Duration - Up to 9 months post-treatment start

Participants are monitored at multiple time points to assess PTSD symptoms and other health outcomes after treatment completion.

Visits at 10 weeks, 20 weeks, and 9 months for outcome assessments

Trial Site Locations

Total: 4 locations

1

Augusta VA

Augusta, Georgia, United States, 30904

Actively Recruiting

2

Ann Arbor VA

Ann Arbor, Michigan, United States, 48105

Actively Recruiting

3

Battle Creek VA

Battle Creek, Michigan, United States, 49037

Not Yet Recruiting

4

Salt Lake City VA

Salt Lake City, Utah, United States, 84148

Actively Recruiting

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Research Team

S

Stefanie LoSavio, PhD

R

Rebecca Sripada, PhD

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

SEQUENTIAL

Primary Purpose

TREATMENT

Number of Arms

8

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