Adaptive Decision-making And Personalized Treatment for PTSD (ADAPT-PTSD)
NCT ID: NCT07176273
Last Updated: 2025-12-19
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
302 participants
INTERVENTIONAL
2025-12-12
2028-08-14
Brief Summary
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* 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
Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
SEQUENTIAL
TREATMENT
NONE
Study Groups
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Early CPT Non-Responders Switch (Group A)
Early NON-RESPONDERS to CPT will SWITCH to PE
Digital Interventions
The prompt will be a text message delivered through VA-approved technology (e.g., PETALS).
Cognitive Processing Therapy (CPT)
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)
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.
Early CPT Non-Responders Modular (Group B)
Early NON-RESPONDERS to CPT will transition to MODULAR CPT
Modular Cognitive Processing Therapy
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.
Digital Interventions
The prompt will be a text message delivered through VA-approved technology (e.g., PETALS).
Cognitive Processing Therapy (CPT)
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.
Early CPT Responders Continue (Group C)
Early RESPONDERS to CPT will CONTINUE in their CPT treatment
Digital Interventions
The prompt will be a text message delivered through VA-approved technology (e.g., PETALS).
Cognitive Processing Therapy (CPT)
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.
Early CPT Responders Step Down (Group D)
Early RESPONDERS to CPT will STEP DOWN to self-managed CPT
Step Down Treatment
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
The prompt will be a text message delivered through VA-approved technology (e.g., PETALS).
Cognitive Processing Therapy (CPT)
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.
Early PE Non-Responsers Switch (Group E)
Early NON-RESPONDERS to PE will SWITCH to CPT
Digital Interventions
The prompt will be a text message delivered through VA-approved technology (e.g., PETALS).
Cognitive Processing Therapy (CPT)
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)
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.
Early PE Non-Responders Modular (Group F)
Early NON-RESPONDERS to PE will transition to MODULAR PE
Modular Prolonged Exposure Therapy
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.
Digital Interventions
The prompt will be a text message delivered through VA-approved technology (e.g., PETALS).
Prolonged Exposure (PE)
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.
Early PE Responders Continue (Group G)
Early RESPONDERS will CONTINUE in their PE treatment
Digital Interventions
The prompt will be a text message delivered through VA-approved technology (e.g., PETALS).
Prolonged Exposure (PE)
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.
Early PE Responders Step Down (Group H)
Early RESPONDERS to PE will STEP DOWN to self-managed PE
Step Down Treatment
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
The prompt will be a text message delivered through VA-approved technology (e.g., PETALS).
Prolonged Exposure (PE)
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.
Interventions
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Modular Cognitive Processing Therapy
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
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
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
The prompt will be a text message delivered through VA-approved technology (e.g., PETALS).
Cognitive Processing Therapy (CPT)
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)
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.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. At least 18 years or older
3. Score ≥ 31 on the PCL-5 secondary to a Criterion A traumatic event
4. Own a mobile device that can be used for the therapy companion mobile app (Prolonged Exposure (PE) coach or Cognitive Processing Therapy (CPT) coach).
Exclusion Criteria
2. Need for detoxification
3. Unmanaged psychosis or bipolar disorder
4. 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)
5. Current or past 12-month engagement in PE or CPT.
18 Years
ALL
No
Sponsors
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United States Department of Defense
FED
The University of Texas Health Science Center at San Antonio
OTHER
Responsible Party
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Stefanie LoSavio
Assistant Professor of Psychiatry & Behavioral Sciences
Principal Investigators
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Stefanie LoSavio, PhD
Role: PRINCIPAL_INVESTIGATOR
The University of Texas Health Science Center at San Antonio
Rebecca Sripada, PhD
Role: PRINCIPAL_INVESTIGATOR
VA Ann Arbor-506
Locations
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Augusta VA
Augusta, Georgia, United States
Ann Arbor VA
Ann Arbor, Michigan, United States
Battle Creek VA
Battle Creek, Michigan, United States
Salt Lake City VA
Salt Lake City, Utah, United States
Countries
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Central Contacts
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Facility Contacts
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J. Richard Monroe
Role: primary
Rebecca Sripada, PhD
Role: primary
Rebecca Sripada, PhD
Role: primary
Erika Roberge
Role: primary
Other Identifiers
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HT9425-24-1-1026
Identifier Type: OTHER_GRANT
Identifier Source: secondary_id
STUDY00001551
Identifier Type: -
Identifier Source: org_study_id