Elsevier

Contemporary Clinical Trials

Volume 45, Part B, November 2015, Pages 210-216
Contemporary Clinical Trials

Evaluation of a hybrid treatment for Veterans with comorbid traumatic brain injury and posttraumatic stress disorder: Study protocol for a randomized controlled trial

https://doi.org/10.1016/j.cct.2015.10.009Get rights and content

Abstract

Comorbidity of posttraumatic stress disorder (PTSD) and history of traumatic brain injury (TBI) is high among Veterans of Operation Iraqi Freedom/Enduring Freedom/New Dawn (OIF/OEF/OND). Cognitive processing therapy (CPT) is empirically supported for the treatment of PTSD, but it is not specifically designed to accommodate the memory, attention, or problem solving deficits that are experienced by many Veterans with comorbid PTSD and TBI. Compensatory cognitive rehabilitation, including cognitive symptom management and rehabilitation therapy (CogSMART), is effective for cognitive deficits stemming from a variety of etiologies, including TBI. We have integrated components of CogSMART into CPT in order to address the unique challenges faced by Veterans with ongoing cognitive complaints related to PTSD and a history of mild TBI. Here we describe an ongoing randomized controlled trial investigating the efficacy of our novel hybrid treatment, SMART-CPT, as compared to standard CPT, for OIF/OEF/OND Veterans with PTSD and a history of mild to moderate TBI. We describe the development of this hybrid treatment as well as implementation of the randomized controlled trial.

Introduction

Approximately 8% of Operation Iraqi Freedom/Enduring Freedom/New Dawn (OIF/OEF/OND) Veterans are diagnosed with posttraumatic stress disorder (PTSD) [1], characterized by re-experiencing symptoms, intrusive thoughts, avoidance behaviors, cognitive distortions, and heightened physiological arousal. Cognitive complaints [2], [3] and objective neuropsychological deficits [4], [5] are also commonly present. Strong empirical support exists for use of cognitive-behavioral therapies (CBT) for PTSD, including cognitive processing therapy — cognitive version (CPT-C; retains the original cognitive restructuring components of CPT but omits a detailed account of the traumatic event) [6]. However, little work has examined effects of PTSD treatment on cognitive deficits or how they impact ability to benefit from standard PTSD therapies.

PTSD is highly comorbid with history of mild TBI (mTBI) in OIF/OEF/OND Veterans (43.9%) [7]. Although symptoms resolve rapidly following mTBI (typically within 7–10 days) in the majority of cases [8], almost 50% of Veterans with a mTBI history continue to report at least one post-concussive symptom after one year [9]. Individuals with both mTBI and psychiatric disorders have significantly poorer functional outcomes than those without comorbid conditions [8], [10], [11]. Standard practice for treatment of mTBI includes psychoeducation [12], expectation management regarding symptom recovery [12], and compensatory cognitive strategies for prospective memory, attention/concentration, learning/memory, and executive functioning [13]. These components are included in cognitive symptom management and rehabilitation therapy (CogSMART), a 12-week manualized treatment which improves persistent post-concussive symptoms (PCS; namely, cognitive and neurobehavioral symptoms) in OIF/OEF/OND Veterans with TBI [14], [15], [16].

Although limited, research suggests providing CBTs (including CPT-C) to people with comorbid TBI is feasible [17], may be prophylactic [18], and can reduce PTSD, depressive, and post-concussive symptoms [19], [20], [21]. However, concerns remain that the cognitive impairment and emotional control problems associated with PTSD and mTBI may complicate or impede recovery from either problem [22], [23], [24] and reduce the efficacy of psychotherapy [25]. PTSD and PCS may also share potential causal pathways and the relationship between the two is complex and likely bidirectional [26].

Modifications may need to be made to standard interventions to accommodate shared etiologies and neuropsychological symptoms. Managing the combination of cognitive symptoms and PTSD with either sequential or parallel treatments is cumbersome. As with other comorbidities (such as PTSD with comorbid substance use), it is often unclear in which order to address comorbid problems with a sequential approach (i.e., CPT or cognitive rehabilitation, etc.), and a parallel approach creates time and travel burdens. Due to these reasons, it has been suggested that integrated treatments may be the optimal strategy, though there has been a lack of research on this topic [27], [28], [29].

To address the above challenges and optimize the treatment of comorbid PTSD/TBI, we integrated the primary components of CogSMART into CPT-C, resulting in a novel hybrid treatment, SMART-CPT. Herein we discuss the development and organization of SMART-CPT and describe an ongoing randomized controlled trial comparing efficacy of SMART-CPT to standard CPT-C. The primary aim of the trial is to investigate the efficacy of SMART-CPT in reducing emotional and neurobehavioral symptom severity (including cognitive symptoms) in Veterans with comorbid TBI and PTSD. We hypothesize that those receiving SMART-CPT will have greater reductions in PTSD symptom severity (as measured by the PTSD Checklist [PCL]), greater improvements in quality of life (as measured by the Quality of Life Interview — Brief Version [QOLI-Brief]) [30], and greater reduction in neurobehavioral symptoms (as measured by the Neurobehavioral Symptom Inventory [NSI]) [31] than those receiving standard CPT-C.

Section snippets

Design and methods

We are currently conducting a randomized (two condition) single center (VA San Diego Healthcare System) controlled trial of SMART-CPT compared to CPT-C for Veterans with PTSD and a history of mild to moderate TBI with current cognitive complaints. Baseline assessment confirms diagnosis of PTSD and history of TBI, and participants are subsequently randomized (simple randomization) to receive CPT-C or SMART-CPT and enter the study on a consecutive admissions basis. The study was approved by the

Discussion

In OIF/OEF/OND Veterans with a history of TBI, approximately 44% also have comorbid PTSD [7] and in those with PTSD, 20% have a history of TBI [62]. Herein we have described the first randomized controlled trial to investigate a modified version of an evidence-based therapy (SMART-CPT) for the purpose of targeting comorbid PTSD and TBI. CPT has good efficacy in Veterans for PTSD and CogSMART has been shown to improve PCS and cognitive symptoms following TBI. There is recently emerging evidence

Acknowledgments

Funding was provided by U.S. Department of Defense award W81XWH-11-1-0641.

References (63)

  • C.W. Hoge

    Mild traumatic brain injury in U.S. soldiers returning from Iraq

    N. Engl. J. Med.

    (2008)
  • M. McCrea

    Mild Traumatic Brain Injury and Postconcussion Syndrome

    (2008)
  • H.G. Belanger

    Symptom complaints following combat-related traumatic brain injury: relationship to traumatic brain injury severity and posttraumatic stress disorder

    J. Int. Neuropsychol. Soc.

    (2009)
  • J.D. Corrigan et al.

    Increasing substance abuse treatment compliance for persons with traumatic brain injury

    Psychol. Addict. Behav.

    (2005)
  • M.A. Polusny

    Longitudinal effects of mild traumatic brain injury and posttraumatic stress disorder comorbidity on postdeployment outcomes in national guard soldiers deployed to Iraq

    Arch. Gen. Psychiatry

    (2011)
  • W. Mittenberg

    Treatment of post-concussion syndrome following mild head injury

    J. Clin. Exp. Neuropsychol.

    (2001)
  • M. Huckans

    A pilot study examining effects of group-based cognitive strategy training treatment on self-reported cognitive problems, psychiatric symptoms, functioning, and compensatory strategy use in OIF/OEF combat veterans with persistent mild cognitive disorder and history of traumatic brain injury

    J. Rehabil. Res. Dev.

    (2010)
  • E.W. Twamley

    Cognitive symptom management and rehabilitation therapy (CogSMART) for veterans with traumatic brain injury: a pilot randomized controlled trial

    J. Rehabil. Res. Dev.

    (2014)
  • E.W. Twamley et al.

    CogSMART compensatory cognitive training for traumatic brain injury: effects over 1 year

    J. Head Trauma Rehabil.

    (2015)
  • J.J. Davis et al.

    Treatment adherence in cognitive processing therapy for combat-related PTSD with history of mild TBI

    Rehabil. Psychol.

    (2013)
  • R.A. Bryant et al.

    Treating acute stress disorder following mild traumatic brain injury

    Am. J. Psychiatr.

    (2003)
  • K.M. Chard et al.

    Exploring the efficacy of a residential treatment program incorporating cognitive processing therapy-cognitive for veterans with PTSD and traumatic brain injury

    J. Trauma. Stress.

    (2011)
  • K.H. Walter

    Comparing effectiveness of CPT to CPT-C among U.S. Veterans in an interdisciplinar residential PTSD/TBI treatment program

    J. Trauma. Stress.

    (2014)
  • K.H. Walter et al.

    Relationship between posttraumatic stress disorder and postconcussive symptom improvement after completion of a posttraumatic stress disorder/traumatic brain injury residential treatment program

    Rehabil. Psychol.

    (2012)
  • Y. Bogdanova et al.

    Cognitive sequelae of blast-induced traumatic brain injury: recovery and rehabilitation

    Neuropsychol. Rev.

    (2012)
  • N.A. Sayer

    Veterans with history of mild traumatic brain injury and posttraumatic stress disorder: challenges from provider perspective

    J. Rehabil. Res. Dev.

    (2009)
  • M. Verfaellie et al.

    Chronic postconcussion symptoms and functional outcomes in OEF/OIF veterans with self-report of blast exposure

    J. Int. Neuropsychol. Soc.

    (2013)
  • J.M. Cook et al.

    Evaluation of an implementation model: a national investigation of VA residential programs

    Adm. Policy Ment. Health

    (2015)
  • J.J. Vasterling et al.

    PTSD and Mild Traumatic Brain Injury

    (2012)
  • R.A. Bryant et al.

    Implications for service delivery in the military

  • R.A. Bryant et al.

    Treatment of posttraumatic stress disorder following mild traumatic brain injury

  • Cited by (24)

    • Baseline sleep quality moderates symptom improvement in veterans with comorbid PTSD and TBI receiving trauma-focused treatment

      2021, Behaviour Research and Therapy
      Citation Excerpt :

      Individuals randomized to CPT received standard treatment without any modifications. Those in SMART-CPT (Jak et al., 2015) received an integrated treatment consisting of all standard components of CPT, with elements of CogSMART adapted and interwoven throughout each session. Briefly, these sessions included psychoeducation related to PTSD and TBI as well as compensatory strategies for improving attention, memory (prospective and retrospective), and executive functioning (planning, organizing, problem-solving).

    • Mild traumatic brain injury characteristics do not negatively influence cognitive processing therapy attendance or outcomes

      2019, Journal of Psychiatric Research
      Citation Excerpt :

      The sample was 47.7% Caucasian and 22.7% identified as Hispanic. The clinical trial (clinicaltrials.gov identifier NCT01943162) procedures are more thoroughly described elsewhere (see Jak et al., 2015, 2019). The study was approved by the local Institutional Review Board.

    • Posttraumatic stress disorder and neurocognition: A bidirectional relationship?

      2019, Clinical Psychology Review
      Citation Excerpt :

      Within the behavioral sphere, Cognitive rehabilitation may be incorporated into treatments for PTSD with the goal of improving treatment response. For example, SMART-CPT (Jak et al., 2015), in intervention aimed at comorbid TBI and PTSD, integrates cognitive processing therapy (Resick, Monson, & Chard, 2017) with features of cognitive rehabilitation, including instruction in compensatory strategies for attention, memory, and executive functioning, use of more concrete language, and simplified instructions and has been found to be associated with improvements in PTSD symptomatology, self-reported post-concussive symptoms, and improvements in neurocognitive performance at 3-months post-treatment (Jak et al., 2019). Though not directly addressed by Jak et al. (2019), it is possible that integration of cognitive rehabilitation strategies with first line PTSD interventions may not only improve neurocognitive functioning, but may also have implications for treatment response as individuals learn to compensate for neurocognitive difficulties that may affect their ability to respond to PTSD treatment.

    • Factors associated with completing evidence-based psychotherapy for PTSD among veterans in a national healthcare system

      2019, Psychiatry Research
      Citation Excerpt :

      One study also found that while both EBPs impact PTSD symptoms in those with TBI, veterans completing PE had greater symptom reduction than those completing CPT (Ragsdale et al., 2016). However, others argue that combining EBPs with cognitive rehabilitation may be key, and current trials are underway to test this hypothesis (Jak et al., 2015). In terms of drug dependence, while no known studies have examined CPT in a drug dependent population, one trial using PE combined with concurrent treatment of substance use found reductions in PTSD symptoms (Mills et al., 2012).

    • Unique Aspects of Traumatic Brain Injury in Military and Veteran Populations

      2017, Physical Medicine and Rehabilitation Clinics of North America
      Citation Excerpt :

      Furthermore, prolonged exposure therapy for PTSD has been found to be effective among those with TBI, with some studies documenting treatment effectiveness across varying levels of TBI severity.64–66 In addition to traditional PTSD treatments, several novel, integrative mental health interventions for those with comorbid PTSD and TBI, including mindfulness-based stress reduction and a hybrid program that integrates standard CPT with compensatory cognitive rehabilitation training, have been recently proposed to address both PTSD symptoms and cognitive difficulties often found in this population, although future randomized clinical trials are needed to further assess their effectiveness.63,67 As reviewed above, several factors specific to the military and Veteran environments differentiate identification and care of TBI from the civilian sector.

    View all citing articles on Scopus
    1

    East 67th Street, Tulsa, OK 74136.

    2

    3350 La Jolla Village Dr., 151B, San Diego, CA 92161.

    3

    9500 Gilman Drive #0855, La Jolla, CA 92093.

    4

    3350 La Jolla Village Dr., 116A, San Diego, CA 92161.

    View full text