Anxiety & Depression Association of America

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

Purpose

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

Conditions

Posttraumatic Stress Disorder
PTSD

Eligibility

Eligible Ages: Over 18 Years
Eligible Sex: All
Accepts Healthy Volunteers: No

Inclusion Criteria

Veterans eligible for PE and CPT at the participating PTSD treatment-providing clinic who are 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

Acute suicide risk requiring clinical intervention 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.

Study Design

Phase: N/A
Study Type: Interventional
Allocation: Randomized
Intervention Model: Sequential Assignment
Intervention Model Description: This study is a randomized controlled effectiveness trial utilizing a Hybrid Experimental Design (HED) comprised of a Sequential Multiple Assignment Randomized Trial (SMART) and Micro-Randomized Trial (MRT)
Primary Purpose: Treatment
Masking: None (Open Label)

Arm Groups

Arm	Description	Assigned Intervention
Active Comparator Early CPT Non-Responders Switch (Group A)	Early NON-RESPONDERS to CPT will SWITCH to PE	Behavioral: Digital Interventions The prompt will be a text message delivered through VA-approved technology (e.g., PETALS). Other names: Daily Digital Prompts Behavioral: 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. Other names: CPT Behavioral: 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 names: PE
Active Comparator Early CPT Non-Responders Modular (Group B)	Early NON-RESPONDERS to CPT will transition to MODULAR CPT	Behavioral: 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. Other names: Modular CPT Behavioral: Digital Interventions The prompt will be a text message delivered through VA-approved technology (e.g., PETALS). Other names: Daily Digital Prompts Behavioral: 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. Other names: CPT
Active Comparator Early CPT Responders Continue (Group C)	Early RESPONDERS to CPT will CONTINUE in their CPT treatment	Behavioral: Digital Interventions The prompt will be a text message delivered through VA-approved technology (e.g., PETALS). Other names: Daily Digital Prompts Behavioral: 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. Other names: CPT
Active Comparator Early CPT Responders Step Down (Group D)	Early RESPONDERS to CPT will STEP DOWN to self-managed CPT	Behavioral: 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). Other names: Step Down Behavioral: Digital Interventions The prompt will be a text message delivered through VA-approved technology (e.g., PETALS). Other names: Daily Digital Prompts Behavioral: 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. Other names: CPT
Active Comparator Early PE Non-Responsers Switch (Group E)	Early NON-RESPONDERS to PE will SWITCH to CPT	Behavioral: Digital Interventions The prompt will be a text message delivered through VA-approved technology (e.g., PETALS). Other names: Daily Digital Prompts Behavioral: 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. Other names: CPT Behavioral: 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 names: PE
Active Comparator Early PE Non-Responders Modular (Group F)	Early NON-RESPONDERS to PE will transition to MODULAR PE	Behavioral: 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. Other names: Modular PE Behavioral: Digital Interventions The prompt will be a text message delivered through VA-approved technology (e.g., PETALS). Other names: Daily Digital Prompts Behavioral: 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 names: PE
Active Comparator Early PE Responders Continue (Group G)	Early RESPONDERS will CONTINUE in their PE treatment	Behavioral: Digital Interventions The prompt will be a text message delivered through VA-approved technology (e.g., PETALS). Other names: Daily Digital Prompts Behavioral: 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 names: PE
Active Comparator Early PE Responders Step Down (Group H)	Early RESPONDERS to PE will STEP DOWN to self-managed PE	Behavioral: 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). Other names: Step Down Behavioral: Digital Interventions The prompt will be a text message delivered through VA-approved technology (e.g., PETALS). Other names: Daily Digital Prompts Behavioral: 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 names: PE

Recruiting Locations

More Details

Status: Recruiting
Sponsor: The University of Texas Health Science Center at San Antonio

Study Contact

Stefanie LoSavio, PhD
210-562-6700
losavio@uthscsa.edu

Detailed Description

This study is designed to assist the investigators in answering the clinical question of how to address non-response to first line PTSD treatments. Utilizing an innovative Hybrid Experimental Design (HED), the proposed study involves multiple, sequential randomizations to both therapist-delivered and digital interventions operating on short and long timescales to determine the optimal combination and sequencing of evidence-based interventions to maximize response. This will result in actionable data and, consistent with a personalized medicine approach, an implementable, adaptive treatment regimen that optimizes clinical resource allocation. By recruiting and providing treatment in routine care settings serving veterans with PTSD, the study design maximizes generalizability, relevance to the VA mission, and implementation potential.

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.