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

Official title

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

Overview

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

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.

Interventions

• 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 ses
• 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.
• 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).
• Behavioral Digital Interventions
  The prompt will be a text message delivered through VA-approved technology (e.g., PETALS).
• 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.
• 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.

Primary outcome measures

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

Secondary outcome measures (4)

• Patient Health Questionnaire-9 (PHQ-9) [Time frame: Baseline, 10-weeks, 20-weeks, 9-months]
• Columbia Suicide Severity Rating Scale (C-SSRS) [Time frame: Baseline, 10-weeks, 20-weeks, 9-months]
• Quality of Life Enjoyment and Satisfaction Questionnaire-Short Form (Q-LES-Q-SF) [Time frame: Baseline, 20-weeks, 9-months]
• Brief Inventory of Psychosocial Functioning (B-IPF) [Time frame: Baseline, 10-weeks, 20-weeks, 9-months]

Eligibility criteria

Inclusion criteria

• 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).

Exclusion criteria

• 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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Sequential

Masking

Open label

Primary purpose

Treatment

Study locations

United States · 4 centers

• Augusta VA — Augusta
• Ann Arbor VA — Ann Arbor
• Battle Creek VA — Battle Creek
• Salt Lake City VA — Salt Lake City

Identifiers

NCT: NCT07176273 · STUDY00001551 · HT9425-24-1-1026

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗