Adaptive Decision-making And Personalized Treatment for PTSD (ADAPT-PTSD)
ADAPT-PTSD
Changing the Treatment Course: Clinical Trial of Sequenced Interventions to Optimize Treatment for Veterans With PTSD
2 other identifiers
interventional
302
1 country
4
Brief Summary
By doing this research project, the investigators hope to learn which strategies work best to help veterans who are not benefiting from their first PTSD treatment or not completing between-session homework assignments regularly that might improve treatment response. The investigators also want to learn how best to match the right type and amount of treatment to each individual veteran. By conducting this research project, they hope to:
- See if trying a different treatment strategy for veterans not responding to their first PTSD treatment would be more helpful
- See if sending text message prompts between sessions encourages more completion of between-session homework
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Dec 2025
Typical duration for not_applicable
4 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 8, 2025
CompletedFirst Posted
Study publicly available on registry
September 16, 2025
CompletedStudy Start
First participant enrolled
December 12, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 22, 2028
ExpectedStudy Completion
Last participant's last visit for all outcomes
August 14, 2028
December 19, 2025
December 1, 2025
2.4 years
September 8, 2025
December 12, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Posttraumatic Stress Disorder Checklist (PCL-5)
The PCL-5 is a psychometrically valid measure and commonly used assessment of PTSD symptoms. A total score is calculated by adding up the ratings for each of the 20 items, which range from 0 to 4 (0=Not at all, 4=Extremely). Higher scores reflect more severe symptoms. A score below 31 generally suggests a sub-clinical range, while scores of 31 or above fall within the clinical range, indicating probable PTSD.
10 weeks, 20 weeks and 9 months
Secondary Outcomes (4)
Patient Health Questionnaire-9 (PHQ-9)
Baseline, 10-weeks, 20-weeks, 9-months
Columbia Suicide Severity Rating Scale (C-SSRS)
Baseline, 10-weeks, 20-weeks, 9-months
Quality of Life Enjoyment and Satisfaction Questionnaire-Short Form (Q-LES-Q-SF)
Baseline, 20-weeks, 9-months
Brief Inventory of Psychosocial Functioning (B-IPF)
Baseline, 10-weeks, 20-weeks, 9-months
Study Arms (8)
Early CPT Non-Responders Switch (Group A)
ACTIVE COMPARATOREarly NON-RESPONDERS to CPT will SWITCH to PE
Early CPT Non-Responders Modular (Group B)
ACTIVE COMPARATOREarly NON-RESPONDERS to CPT will transition to MODULAR CPT
Early CPT Responders Continue (Group C)
ACTIVE COMPARATOREarly RESPONDERS to CPT will CONTINUE in their CPT treatment
Early CPT Responders Step Down (Group D)
ACTIVE COMPARATOREarly RESPONDERS to CPT will STEP DOWN to self-managed CPT
Early PE Non-Responsers Switch (Group E)
ACTIVE COMPARATOREarly NON-RESPONDERS to PE will SWITCH to CPT
Early PE Non-Responders Modular (Group F)
ACTIVE COMPARATOREarly NON-RESPONDERS to PE will transition to MODULAR PE
Early PE Responders Continue (Group G)
ACTIVE COMPARATOREarly RESPONDERS will CONTINUE in their PE treatment
Early PE Responders Step Down (Group H)
ACTIVE COMPARATOREarly RESPONDERS to PE will STEP DOWN to self-managed PE
Interventions
PE is a first-line treatment for PTSD that includes the following core elements: (a) in vivo exposure and (b) imaginal exposure to the trauma memory. Modular PE is comprised of the same elements of standard PE, but clinicians select and dose modules (i.e., imaginal exposure, in vivo exposure) based on individual patient need.
Self-managed treatment will involve receiving a self-help version of the remaining treatment materials and ongoing use of the intervention companion app (CPT Coach or PE Coach).
The prompt will be a text message delivered through VA-approved technology (e.g., PETALS).
CPT is a first-line treatment for PTSD that includes the following core elements: (a) identification of "stuck points" in thinking that interfere with recovery and (b) using Socratic questioning and a series of progressive worksheets to examine stuck points, develop balanced beliefs, and facilitate the experience of natural emotions.
PE is a first-line treatment for PTSD that includes the following core elements: (a) in vivo exposure and (b) imaginal exposure to the trauma memory. In imaginal exposure, participants repeatedly, systematically approach their trauma memory and related thoughts and feelings. In in vivo exposure, participants repeatedly, systematically approach objectively safe people, places, objects, and situations that they avoid because these stimuli remind them of their trauma.
CPT is a first-line treatment for PTSD that includes the following core elements: (a) identification of "stuck points" in thinking that interfere with recovery and (b) using Socratic questioning and a series of Contains the same core elements of CPT, but content is repackaged into modules instead of sessions so that clinicians can select and dose treatment elements according to patient need. Modular CPT contains the same core elements of CPT, but content is repackaged into modules instead of sessions so that clinicians can select and dose treatment elements according to patient need.
Eligibility Criteria
You may qualify if:
- Veterans eligible for PE and CPT at the participating PTSD treatment-providing clinic who are
- At least 18 years or older
- Score ≥ 31 on the PCL-5 secondary to a Criterion A traumatic event
- Own a mobile device that can be used for the therapy companion mobile app (Prolonged Exposure (PE) coach or Cognitive Processing Therapy (CPT) coach).
You may not qualify if:
- Acute suicide risk requiring clinical intervention
- Need for detoxification
- Unmanaged psychosis or bipolar disorder
- Severe cognitive impairment that makes it unlikely that participants 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)
- Current or past 12-month engagement in PE or CPT.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (4)
Augusta VA
Augusta, Georgia, 30904, United States
Ann Arbor VA
Ann Arbor, Michigan, 48105, United States
Battle Creek VA
Battle Creek, Michigan, 49037, United States
Salt Lake City VA
Salt Lake City, Utah, 84148, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Stefanie LoSavio, PhD
The University of Texas Health Science Center at San Antonio
- PRINCIPAL INVESTIGATOR
Rebecca Sripada, PhD
VA Ann Arbor-506
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SEQUENTIAL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Assistant Professor of Psychiatry & Behavioral Sciences
Study Record Dates
First Submitted
September 8, 2025
First Posted
September 16, 2025
Study Start
December 12, 2025
Primary Completion (Estimated)
May 22, 2028
Study Completion (Estimated)
August 14, 2028
Last Updated
December 19, 2025
Record last verified: 2025-12
Data Sharing
- IPD Sharing
- Will not share