Posttraumatic Stress Disorder, PTSD
Conditions
Keywords
Veterans
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
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
BEHAVIORALModular 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.
BEHAVIORALModular 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.
BEHAVIORALStep 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).
BEHAVIORALDigital Interventions
The prompt will be a text message delivered through VA-approved technology (e.g., PETALS).
BEHAVIORALCognitive 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.
BEHAVIORALProlonged 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.
Sponsors
United States Department of Defense
The University of Texas Health Science Center at San Antonio
Study design
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
NONE
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)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. 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
1. 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Posttraumatic Stress Disorder Checklist (PCL-5) | 10 weeks, 20 weeks and 9 months | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Patient Health Questionnaire-9 (PHQ-9) | Baseline, 10-weeks, 20-weeks, 9-months | The PHQ-9 score indicates the severity of depressive symptoms. There are 9 items with scores ranging from 0-3 for each. Total scores range from 0 to 27, with higher scores indicating more severe symptoms. A score of 5-9 is considered mild, 10-14 is moderate, 15-19 is moderately severe, and 20-27 is severe. The PHQ-9 score is not a diagnosis, but rather a screening tool to assess depression severity and guide treatment decisions. |
| Columbia Suicide Severity Rating Scale (C-SSRS) | Baseline, 10-weeks, 20-weeks, 9-months | The C-SSRS is a standardized measure used to assess suicide risk, primarily through the presence and severity of suicidal ideation and behavior. The screener version of the C-SSRS consists of 2-6 Yes or No questions. Responses to questions 1 and 2 determine if questions 3, 4, and 5 are asked. A 'Yes' answer to question 2 prompts questions 3, 4, 5, and 6. A 'No' answer to question 2 directs the responder to question 6. Affirmative (Yes) responses are summed, with each 'Yes' counting as 1 point. This summation provides a score on a scale of 0-6 indicating suicide risk level. 0 = No risk reported (all No responses). 1 - 2 = Low risk. 3 - 6 = Moderate to high risk. A Yes response to question 3 or 6a indicates moderate risk (potential plan or lifetime engagement in preparatory behavior). A Yes response to question 4, 5, or 6b indicates high risk (active plan, possible intent, or recent preparatory behaviors). |
| Quality of Life Enjoyment and Satisfaction Questionnaire-Short Form (Q-LES-Q-SF) | Baseline, 20-weeks, 9-months | The Q-LES-Q-SF contains 16 questions scored on a 5-point Likert scale with values from 1 (Very Poor) to 5 (Very Good). A total score is calculated by summing the first 14 item responses and ranges from 14 to 70; higher scores are associated with greater life satisfaction and enjoyment. The total score is expressed as a percentage based on the maximum total score of the items completed (1-100). The normal range that represents community sample scores is 70-100, and thus scores below 70 are clinically significant. Note, the last two items (items 15 and 16) ask about medication and overall contentment and are stand-alone items; they are not included in the total score. |
| Brief Inventory of Psychosocial Functioning (B-IPF) | Baseline, 10-weeks, 20-weeks, 9-months | The B-IPF is a 7-item self-report instrument that evaluates PTSD-related psychosocial functional impairment within the last 30 days across seven functional domains (romantic relationships, family relationships, work, friendships and socializing, parenting, education, and self-care). Items on the B-IPF are scored on a Likert scale from 0 (never) to 6 (always). The B-IPF was designed so that respondents complete only temporally relevant items that reflect a domain that they have participated in over the past 30 days (e.g., participants who were not enrolled in school within the past 30 days are instructed to skip the education item). The BIPF is scored by summing the scored items to create a total score, dividing the total score by the maximum possible score based on the number of items scored, and multiplying by 100. Thus, the B-IPF represents an overall index of functioning, with higher scores indicating greater functional impairment |
Countries
United States
Contacts
Primary ContactStefanie LoSavio, PhD
Backup ContactRebecca Sripada, PhD
Outcome results
None listed