Brief Cognitive Behavioral Treatment of Deployment-Related PTSD Symptoms in Primary Care Settings

NCT02290639 | Completed DMC

• 3 other identifiers: HSC20130057HC.2012.184dW81XWH-08-2-0109
• Study Type: interventional
• Target: 74
• Locations: 1 country
• Sites: 2

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.

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

Outcome Measures

Primary Outcomes (2)

• PTSD Symptom Scale, Interview Version (PSS-I); to assess change in PTSD symptomatology and/or diagnosis from baseline to multiple follow up time points

  The PSS-I is a 20-minute, 17-item clinical interview that evaluates each of the DSM-IV PTSD symptoms during the past 2 weeks on a frequency/severity scale (Foa, Riggs, Dancu, \& Rothbaum, 1993). The PSS-I is comparable to the gold standard employed in studies of veterans (the Clinician Administered PTSD Scale; CAPS) yet takes considerably less time to administer (Foa \& Tolin, 2000). Each symptom is rated on a 4-point scale ranging from 0 (not at all) to 3 (very much). Subscale scores are calculated by summing items in each of the PTSD symptom clusters: re-experiencing, avoidance, and arousal. The scale has excellent internal consistency (α = .85), test-retest reliability (.80), and inter-rater reliability (kappa = .97; Foa et al, 1993). This measure will be administered by a blinded Independent Evaluator at each study site.

  Baseline, 2 weeks post-tx, 8 weeks post-tx, 6 months post-tx

• PTSD Checklist - Stressor-Specific Version (PCL-S); to assess change in PTSD symptomatology from baseline throughout treatment and at multiple follow up time points

  The PCL-S is a 17 item self-report measure based upon the PTSD Checklist - Military (PCL-M; Weathers, Litz, Herman, Huska, \& Keane, 1993) that evaluates how much participants have been bothered by PTSD symptoms in the past month as a result of the stressful life events identified by either the participant, or by the Independent Evaluator following administration of the PSS-I. Each item of the PCL-S is scored on a five-point scale ranging from 1 (-not at all‖) to 5 (-extremely‖). The measure is divided into 3 subscales: Re-experiencing symptoms (items 1- 5); Avoidance/ Emotional Numbing symptoms (items 6- 12); and Hyper-arousal symptoms (items 12-17).

  Baseline, Weekly during treatment (4 time points), 2 weeks post-tx, 8 weeks post-tx, 6 months post-tx

Study Arms (2)

Immediate Treatment

EXPERIMENTAL

Four 30-minute sessions of Brief Cognitive Behavioral treatment starting immediately upon randomization.

Behavioral: Brief Cognitive Behavioral Treatment

Minimal Contact followed by treatment

ACTIVE COMPARATOR

6-week Minimal Contact period consisting of weekly phone calls starting immediately upon randomization. Experimental treatment will be provided to all subjects upon completion of Minimal Contact period.

Behavioral: Brief Cognitive Behavioral Treatment; Behavioral: Minimal Contact

Interventions

Brief Cognitive Behavioral Treatment BEHAVIORAL

Cognitive-behavioral therapy (CBT) protocol designed specifically for use by behavioral health consultants (BHC) working in an integrated primary care setting. The treatment will be provided by a BHC in four 30-minute appointments scheduled approximately once a week in primary care over a one month period. Treatment content was largely drawn from a Prolonged Exposure model, but also includes elements of Cognitive Processing Therapy.

Immediate Treatment; Minimal Contact followed by treatment

Minimal Contact BEHAVIORAL

Participants assigned to minimal contact (MC) will be asked to not work with another therapist or seek additional treatment for trauma-related difficulties during the 6-week MC period. They will be called once per week by the Behavioral Health Consultant (BHC) in order to monitor their status and to provide support as needed. The calls will be limited to 5-10 minutes.

Minimal Contact followed by treatment

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• active duty, reserve, guard, separated, or retired OIF/OEF/OND veterans seeking care in primary care for deployment-related PTSD symptoms
• Symptomatic for PTSD will be defined as a minimum score of 32 on the PTSD CheckList -Stressor-specific (PCL-S)
• English speaking
• 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

You may not qualify if:

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

Sponsors & Collaborators

• The University of Texas Health Science Center at San Antonio: lead
• San Antonio Military Medical Center: collaborator
• 59th Medical Wing: collaborator
• Wright State University: collaborator

Study Sites (2)

Wilford Hall Ambulatory Surgical Center Family Medicine Clinic

Lackland Air Force Base, Texas, 78236, United States

Location

Joint Base San Antonio

Randolph Air Force Base, Texas, 78148, United States

Location

Related Publications (1)

• 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.

  PMID: 29283612 DERIVED

MeSH Terms

Conditions

Stress Disorders, Post-Traumatic

Condition Hierarchy (Ancestors)

Stress Disorders, Traumatic; Trauma and Stressor Related Disorders; Mental Disorders

Study Officials

• Alan L Peterson, PhD, ABPP

  The University of Texas Health Science Center at San Antonio

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 7, 2014
• First Posted: November 14, 2014
• Study Start: December 1, 2012
• Primary Completion: March 1, 2015
• Study Completion: November 1, 2015
• Last Updated: January 12, 2016

Record last verified: 2016-01

Locations

US (2)