Trials / Completed
CompletedNCT04307498
Predicting Treatment Outcomes With Intensive Outpatient Treatment for PTSD
Predicting Treatment Outcomes With Intensive Outpatient Treatment for Posttraumatic Stress Disorder
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 40 (actual)
- Sponsor
- The University of Texas Health Science Center at San Antonio · Academic / Other
- Sex
- All
- Age
- 18 Years – 70 Years
- Healthy volunteers
- Not accepted
Summary
The open-label clinical study explores potential modifiable predictors of treatment outcomes in a sample of 55 military service members and veterans with clinically significant PTSD symptoms who receive Intensive Outpatient Prolonged Exposure (IOP-PE).
Detailed description
Intensive Outpatient Prolonged Exposure (IOP-PE) is a three-week, intensive, individualized program that combines massed Prolonged Exposure with military-relevant treatment augmentations to treat posttraumatic stress disorder (PTSD; Peterson et al., 2018). Recent findings indicate that IOP-PE significantly decreased combat-related PTSD in post-9/11 service members and veterans (Peterson et al., 2019). However, IOP-PE is costly and requires a considerable commitment from the patient. Being able to prospectively identify which patients benefit most from IOP-PE will help treatment providers and patients make well-informed decisions about clinical care. The primary aim of this prospective, exploratory clinical study is to investigate potential predictors of treatment outcome following 15 sessions of IOP-PE delivered over 3-weeks in a sample of 55 military service members and veterans (i.e., individuals who have retired or separated from the US Armed forces, active duty personnel, reservists, and National Guardsmen/women) with significant PTSD symptoms. A follow-up assessment will be conducted one-month following the completion of treatment. Predictor variables will include the following: Aim 1: The PTSD Beliefs Inventory, the Dispositional Resilience and Disability Inventory, and the Credibility/ Expectancy Questionnaire. Aim 2: The Disability-Recovery Implicit Association Test. Aim 3: The Treatment Motivation Questionnaire and Service Connection Status Aim 4: The Insomnia Severity Index, the Dimension of Anger Reactions-5, Patient Health Questionnaire-9, the Quick Drinking Screen, and the Pain Intensity, Enjoyment, and General Activity (PEG) Scale.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BEHAVIORAL | Intensive Outpatient Program - Prolonged Exposure | Prolonged Exposure for Posttraumatic Stress Disorder (PE for PTSD; Foa, Hembree, \& Rothbaum, 2007) is an empirically supported behavioral therapy that utilizes exposure-based interventions to target the psychological mechanisms (i.e., avoidance; maladaptive cognitive changes) thought to maintain trauma-related symptoms. IOP-PE includes 15 days of PE treatment delivered over three consecutive weeks. The standard outpatient PE protocol has modified with seven treatment augmentations to meet the unique needs of post-9/11 veterans. |
Timeline
- Start date
- 2019-11-26
- Primary completion
- 2022-01-01
- Completion
- 2022-01-01
- First posted
- 2020-03-13
- Last updated
- 2022-03-22
Locations
1 site across 1 country: United States
Source: ClinicalTrials.gov record NCT04307498. Inclusion in this directory is not an endorsement.