Clinical trial NCT04307498: Predicting Treatment Outcomes With Intensive Outpatient Treatment for PTSD
Official title: Predicting Treatment Outcomes With Intensive Outpatient Treatment for Posttraumatic Stress Disorder
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Posttraumatic Stress Disorder
Keywords: Military
Veteran
Prolonged Exposure
Intensive Outpatient
Lead sponsor: The University of Texas Health Science Center at San Antonio
Sponsor class: OTHER
Collaborators: name: The Robert W. Woodruff Foundation
First posted: 2020-03-13
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: This is a prospective, one-group, exploratory clinical study.
Primary purpose: TREATMENT

Brief 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.

Eligibility criteria: Inclusion Criteria:

1. Active duty military service members or veterans (18 years or older) who were impacted by Hurricane Harvey.
2. Significant PTSD symptoms as measured by a Posttraumatic Stress Disorder Checklist (PCL-5) score of 34 or higher.
3. Able to speak and read English (due to standardization of outcome measures)
4. Able to participate in a three-week intensive outpatient program

Exclusion Criteria:

1. Current manic episode or psychotic symptoms requiring immediate stabilization or hospitalization (as determined by the bipolar and psychosis modules of the Mini International Neuropsychiatric Interview (MINI) and clinical judgment)
2. Current and severe alcohol use warranting immediate intervention based on clinical judgment.
3. Evidence of a moderate or severe traumatic brain injury (as determined by the inability to comprehend the baseline screening questionnaires)
4. Current suicidal ideation severe enough to warrant immediate attention (as determined by the Depressive Symptoms Index - Suicidality Subscale and the Self-Injurious Thoughts and Behaviors Interview short form) and corroborated by a clinical risk assessment by a credentialed provider.
5. Other psychiatric disorders severe enough to warrant designation as the primary disorder as determined by clinician judgment

Primary outcomes:
measure: PTSD Symptoms
timeFrame: Baseline and 1 month follow-up
Secondary outcomes:
Other outcomes:
Locations:
city: San Antonio
country: United States
facility: University of Texas Health Science Center at San Antonio
state: Texas
Study officials:
affiliation: UT Health San Antonio
name: Alan Peterson, PhD, ABPP
role: PRINCIPAL_INVESTIGATOR
References:
citation: Peterson AL, Foa EB, Blount TH, McLean CP, Shah DV, Young-McCaughan S, Litz BT, Schobitz RP, Castillo DT, Rentz TO, Yarvis JS, Dondanville KA, Fina BA, Hall-Clark BN, Brown LA, DeBeer BR, Jacoby VM, Hancock AK, Williamson DE, Evans WR, Synett S, Straud C, Hansen HR, Meyer EC, Javors MA, Sharrieff AM, Lara-Ruiz J, Koch LM, Roache JD, Mintz J, Keane TM; Consortium to Alleviate PTSD. Intensive prolonged exposure therapy for combat-related posttraumatic stress disorder: Design and methodology of a randomized clinical trial. Contemp Clin Trials. 2018 Sep;72:126-136. doi: 10.1016/j.cct.2018.07.016. Epub 2018 Jul 25.
citation: Foa EB, McLean CP, Zang Y, Rosenfield D, Yadin E, Yarvis JS, Mintz J, Young-McCaughan S, Borah EV, Dondanville KA, Fina BA, Hall-Clark BN, Lichner T, Litz BT, Roache J, Wright EC, Peterson AL; STRONG STAR Consortium. Effect of Prolonged Exposure Therapy Delivered Over 2 Weeks vs 8 Weeks vs Present-Centered Therapy on PTSD Symptom Severity in Military Personnel: A Randomized Clinical Trial. JAMA. 2018 Jan 23;319(4):354-364. doi: 10.1001/jama.2017.21242.