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

Conditions

• PTSD
• Posttraumatic Stress Disorder

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Modular Cognitive Processing Therapy — BEHAVIORAL
  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.
• Modular Prolonged Exposure Therapy — BEHAVIORAL
  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.
• Step Down Treatment — BEHAVIORAL
  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).
• Digital Interventions — BEHAVIORAL
  The prompt will be a text message delivered through VA-approved technology (e.g., PETALS).
• Cognitive Processing Therapy (CPT) — BEHAVIORAL
  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.
• Prolonged Exposure (PE) — BEHAVIORAL
  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.

Study Details

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

Key Dates

Start date

Dec 12, 2025

Status verified

Dec 2025

Primary completion

May 22, 2028

Completion

Aug 14, 2028

Study Design

Enrollment

302 participants (estimated)

Allocation

RANDOMIZED

Intervention model

SEQUENTIAL

Primary purpose

TREATMENT

Arms

• Active Comparator: Early CPT Non-Responders Switch (Group A)
  Early NON-RESPONDERS to CPT will SWITCH to PE
• Active Comparator: Early CPT Non-Responders Modular (Group B)
  Early NON-RESPONDERS to CPT will transition to MODULAR CPT
• Active Comparator: Early CPT Responders Continue (Group C)
  Early RESPONDERS to CPT will CONTINUE in their CPT treatment
• Active Comparator: Early CPT Responders Step Down (Group D)
  Early RESPONDERS to CPT will STEP DOWN to self-managed CPT
• Active Comparator: Early PE Non-Responsers Switch (Group E)
  Early NON-RESPONDERS to PE will SWITCH to CPT
• Active Comparator: Early PE Non-Responders Modular (Group F)
  Early NON-RESPONDERS to PE will transition to MODULAR PE
• Active Comparator: Early PE Responders Continue (Group G)
  Early RESPONDERS will CONTINUE in their PE treatment
• Active Comparator: Early PE Responders Step Down (Group H)
  Early RESPONDERS to PE will STEP DOWN to self-managed PE

Primary Outcome Measure

Posttraumatic Stress Disorder Checklist (PCL-5) [ Time Frame: 10 weeks, 20 weeks and 9 months ]

Central Contacts

• Stefanie LoSavio, PhD
  210-562-6700
  [email protected]
• Rebecca Sripada, PhD
  734-222-7432
  [email protected]

Locations (4)

Find similar trials in Augusta, GA

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