Clinical trial NCT02290639: Brief Cognitive Behavioral Treatment of Deployment-Related PTSD Symptoms in Primary Care Settings
Official title: Brief Cognitive Behavioral Treatment of Deployment-Related PTSD Symptoms in Primary Care Settings: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Post-Traumatic Stress Disorder
Keywords: Posttraumatic Stress
Posttraumatic Stress Disorder
Military
Primary Care
Cognitive Behavioral Therapy
Prolonged Exposure
Cognitive Processing Therapy
Behavioral Health Optimization Program
Behavioral Health Consultant
Lead sponsor: The University of Texas Health Science Center at San Antonio
Sponsor class: OTHER
Collaborators: name: San Antonio Military Medical Center
name: 59th Medical Wing
name: Wright State University
First posted: 2014-11-14
Enrollment: 74
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: A significant number of veterans of the wars in Iraq and Afghanistan are affected by posttraumatic stress disorder (PTSD). The limited reach of effective treatments for PTSD into the veteran population is at least partially due to the perceived stigma by service members for seeking help in traditional specialty mental health clinics. A comprehensive approach to PTSD treatment in a veteran population should provide alternative sources for accessing effective psychotherapy treatments. The purpose of study is to conduct a randomized clinical trial comparing a brief (four 30-minute sessions delivered over 6 weeks) cognitive-behavioral therapy (CBT) protocol designed specifically for use by behavioral health consultants working in an integrated primary care setting to a minimal contact 6-week control. The primary outcome measure is PTSD symptom relief.

Detailed description: A significant number of veterans of the wars in Iraq and Afghanistan are affected by posttraumatic stress disorder (PTSD) yet relatively few are receiving evidence-based treatments (Tanielian, Jaycox, Schell, Marshall, Burnham, Eibner, et al. 2008). The limited reach of effective treatments for PTSD into the veteran population is at least partially due to the perceived stigma by service members for seeking help in traditional specialty mental health clinics (Hoge, Castro, Messer, McGurk, Cotting, \& Koffman, 2004). A comprehensive approach to PTSD treatment in a veteran population should provide alternative sources for accessing effective psychotherapy treatments. This study builds upon a pilot study conducted at Brooke Army Medical Center and the Wilford Hall Medical Center (now the Wilford Hall Ambulatory Surgical Center) (C.2009.022, IRBNet 363516). Using the treatment protocol developed and found to be effective as part of this pilot, the purpose of study is to conduct a randomized clinical trial comparing a brief (four 30-minute sessions delivered over 6 weeks) cognitive-behavioral therapy (CBT) protocol designed specifically for use by behavioral health consultants working in an integrated primary care setting to a minimal contact 6-week control. Up to 75 Service Members with deployment-related PTSD symptoms will be consented, enrolled, and treated until treatment has been completed for 60. The primary outcome measure is PTSD symptom relief.

OBJECTIVES/SPECIFIC AIMS/RESEARCH QUESTIONS:

1. Will Operation Iraqi Freedom/Operation Enduring Freedom/Operation New Dawn (OIF/OEF/OND) veterans with PTSD symptoms accept an offer of cognitive behavioral therapy (CBT) treatment in the primary care setting versus a referral to specialty care?
2. Will a brief (four 30-minute appointments) CBT protocol designed for use by behavioral health consultants working in primary care significantly reduce PTSD symptom severity in OIF/OEF/OND veterans in comparison to a minimal contact condition?
3. Are there characteristics of patients at pre-treatment, e.g., demographic variables, level of co-morbid depression, that predict a relatively better or worse response to PTSD treatment in primary care?

Eligibility criteria: Inclusion Criteria:

1. active duty, reserve, guard, separated, or retired OIF/OEF/OND veterans seeking care in primary care for deployment-related PTSD symptoms
2. Symptomatic for PTSD will be defined as a minimum score of 32 on the PTSD CheckList -Stressor-specific (PCL-S)
3. English speaking
4. If individuals are taking psychotropic medication, a 4-week stabilization period may be required prior to enrollment, depending upon the medication, half-life, and anticipated interaction with the ability to engage in behavioral therapy

Exclusion Criteria:

1. moderate to severe suicide risk
2. current alcohol dependence, psychotic disorder, significant dissociative disorder
3. severe brain injury
4. Patients who are currently receiving talk therapy for trauma-related symptoms will also be excluded

Primary outcomes:
measure: PTSD Symptom Scale, Interview Version (PSS-I); to assess change in PTSD symptomatology and/or diagnosis from baseline to multiple follow up time points
timeFrame: Baseline, 2 weeks post-tx, 8 weeks post-tx, 6 months post-tx
measure: PTSD Checklist - Stressor-Specific Version (PCL-S); to assess change in PTSD symptomatology from baseline throughout treatment and at multiple follow up time points
timeFrame: Baseline, Weekly during treatment (4 time points), 2 weeks post-tx, 8 weeks post-tx, 6 months post-tx
Secondary outcomes:
Other outcomes:
Locations:
city: Lackland AFB
country: United States
facility: Wilford Hall Ambulatory Surgical Center Family Medicine Clinic
state: Texas
city: Randolph AFB
country: United States
facility: Joint Base San Antonio
state: Texas
Study officials:
affiliation: The University of Texas Health Science Center at San Antonio
name: Alan L Peterson, PhD, ABPP
role: PRINCIPAL_INVESTIGATOR
References:
citation: Cigrang JA, Rauch SA, Mintz J, Brundige AR, Mitchell JA, Najera E, Litz BT, Young-McCaughan S, Roache JD, Hembree EA, Goodie JL, Sonnek SM, Peterson AL; STRONG STAR Consortium. Moving effective treatment for posttraumatic stress disorder to primary care: A randomized controlled trial with active duty military. Fam Syst Health. 2017 Dec;35(4):450-462. doi: 10.1037/fsh0000315.