Veterans PTSD Study

EFFICACY OF Strategic Outcome Focused Therapy in the treatment of PTSD AMONGST RETURNING WAR VETERANS

David Kaye PhD ACS Executive Director &Principal Researcher 

Trained in the Assessment of Permanent Impairment –AMA 4^th & 5^th Edition

Psychiatric & Psychological Disorders –MAA, WorkCover & Comcare Australia

ATRI Level 4, Suite 406, 12 O’Connell Street Sydney NSW 2000

All Mail to:  GPO Box 5249,  Sydney  NSW  2001

Mobile: 0417 553 883

email: drdk63@gmail.com

Posttraumatic stress disorder (PTSD) is a complex psychiatric disorder that develops following exposure to actual or threatened death, serious injury, or sexual violence. There is an urgent need to develop measures to prevent the progression of the consequences of PTSD in high risk groups. Although it is known that the current treatment modalities for PTSD include cognitive behavioural therapy (CBT), eye movement desensitisation reprocessing (EMDR), stress management with or without antidepressants, there has been little research into the best means of delivering psychological treatment programs to high risk groups. Returning service men and women with PTSD are one such group which could be targeted. Furthermore, PTSD is becoming highly prevalent in this vulnerable cohort, a public health intervention directed at veterans with PTSD has the potential to exert an impact on the prevalence of this disabling condition. The goal of this study is to test the delivery of a  trauma focused therapy (Strategic Outcome Focused Therapy) to induce remission of symptoms associated with PTSD amongst this population.

BACKGROUND

POST TRAUMATIC STRESS DISORDER  & WAR VETERANS

PTSD develops in the aftermath of an acutely stressful or severe emotionally traumatic event or situation that is considered exceptionally threatening or catastrophic and which is likely to develop pervasive distress with significant psychological sequalae. Whilst PTSD can affect all ages, up to 25-30% of people experiencing a traumatic event may go onto develop PTSD¹. PTSD is one of the most common post-deployment mental conditions in returning service men and women. PTSD is associated with mental and physical health problems, functional incapacity (personal or work domain) and reduced quality of life^2-4. If PTSD is left untreated it has been shown to follow a chronic course leading to lifelong debilitation⁵.

  

1.       PTSD IS A PREVALENT PROBLEM

In the United States, the National Co-morbidity Survey Replication (NCS-R), conducted between February 2001 and April 2003, comprised interviews of a nationally representative sample of 9,282 Americans aged 18 years and older. PTSD was assessed among 5,692 participants, using DSM-IV criteria. The NCS-R estimated the lifetime prevalence of PTSD among adult Americans to be 6.8%⁶. The 12 month prevalence of PTSD estimated at 3.5%⁷, over a third of these cases (1.3% of the US adult population) are considered severe. The lifetime prevalence of PTSD among men was 3.6% and among women was 9.7%. The twelve month prevalence was 1.8% among men and 5.2% among women⁸.

A review of returning veterans was evaluated by Kang et al⁹. Kang and others conducted a study to estimate the prevalence of PTSD in a population-based sample of 11,441 Gulf War Veterans from 1995 to 1997. PTSD was assessed using the PTSD Checklist (PCL;9) rather than interviews, with those scoring 50 or higher considered to have met criteria for PTSD. The prevalence of current PTSD in this sample of Gulf War Veterans was 12.1%. Further, the authors estimated the prevalence of PTSD among the total Gulf War Veteran population to be 10.1%.More recently, in 2008, returning service men from the Iraq and Afghanistan conflict were assessed for PTSD. The prevalence rate of PTSD among the 1938 participants was 13.8%¹⁰.

In Australia, the National Mental Health and Wellbeing Survey was conducted in 1997, with a total of 10,641 participants. The 12 month prevalence of PTSD was 1.3% in Australia compared to 3.5% in the US survey¹¹.

2.       DEPLOYMENT  HAS BEEN SHOWN TO BE A HIGH RISK FOR CHRONIC MENTAL ILLNESS

Deployment to war can be a profoundly stressful and life altering event that leads to lasting mental health problems in a substantial number of service members^12,13.  One of the more recent deployment of service men was in 1991, the Gulf war. Several studies have shown that Gulf War veterans self-report higher than expected rates of psychiatric disorders and psychosomatic symptoms. Increased risk has been demonstrated for PTSD^14-16,  symptoms suggestive of alcohol abuse, depression and anxiety¹⁵. Others include non-specific psychological symptoms such as memory and concentration difficulties, sleep disturbances and agitation¹⁷.

Australian Gulf War veterans were at a greater risk of developing post-Gulf War anxiety disorders including post-traumatic stress disorder, affective disorders and substance use disorders compared to non-deployed military personnel of the era. The prevalence of such disorders remained elevated a decade after deployment. The current PTSD rate assessed by structured clinical interviews 10 years after deployment was 5.4%. There was a strong dose response relationship between psychological disorders and the number of reported gulf war related psychological stressors¹⁸.

This was similarly demonstrated in a further study by Kelsall and colleagues. More than 10-years following deployment, Australian returning Gulf War veterans had a higher prevalence of all self reported health symptoms, particularly PTSD than the comparison group (who were not deployed) and more of the gulf war veterans had severe symptoms¹⁹.

TRAUMA FOCUSED THERAPY IN THE TREATMENT OF PTSD

1.       PSYCHOLOGICAL  THERAPIES IN PTSD

Psychological therapies since their conception have been used in the treatment of PTSD.  The four commonly used therapies for treating veterans and service members with PTSD include; i. Exposure based therapy (particularly prolonged exposure; PE), ii. Cognitive therapy (particularly cognitive processing therapy; CPT), iii.  Stress inoculation training (SIT) and iv. Eye-movement desensitization and reprocessing (EMDR) therapy.

a)      Exposure Based Therapy (PE: Prolonged Exposure)

There have been four RCTs  that have been conducted on PE in veterans. PE involves assisting patients to re-live and confront avoided trauma-related stimuli through repeated and prolonged emotional engagement (in imagination and in vivo) to extinguish conditioned fear responses and organize traumatic memories

These four trials demonstrated efficacy of prolonged exposure in the reduction of PTSD symptoms. The largest trial²⁰, a multi-site trial (N=284) comparing PE to present centered therapy in female veterans (n=277) and active duty personnel (n=7; Both treatment conditions effectively reduced PTSD symptoms from pre- to post-treatment, and at post-treatment those receiving PE were more likely to no longer meet criteria for PTSD (41% compared to 28% in the control condition).

A smaller cohort (n=30) of Israeli patients,  but the first RCT of PE in male veterans²¹, compared PE to psychodynamically-based treatment-as-usual (TAU). The conclusion prolonged exposure, but not treatment-as-usual, led to significant PTSD symptom reduction from pre-treatment up to 12-months at follow-up.

b)      CPT

CPT targets maladaptive ways of thinking about trauma that are posited to maintain PTSD symptoms and includes an optional written exposure element. Compared to PE, there are relatively fewer clinical trials of CPT among veterans, with one published RCT.

This one RCT compared (mostly male, Vietnam) veterans (N=60) with chronic military-related PTSD receiving CPT to waitlist controls ²². At post-treatment, 40% of patients receiving CPT no longer met criteria for PTSD, compared to 3% of the wait-list condition.

c)       SIT

SIT focuses on expanding patients' coping skills and emphasizes applied in-vivo relaxation strategies but also includes cognitive techniques and, in some cases, exposure strategies. Currently no study has examined SIT in the treatment of military-related PTSD.

d)      EMDR

EMDR is a multi-component treatment that primarily involves recalling the trauma while simultaneously focusing on an external stimulus, typically the therapist's finger being moved back and forth in front of the patient. A review of the current available trials of EMDR in veterans, the support for its use in the treatment of PTSD in this cohort was limited with the absence of evidence that EMDR reduced PTSD in combat veterans sparse²³.

2.       STRATEGIC OUTCOME FOCUSED THERAPY

Strategic Outcome Focused Therapy is a cognitive and lifestyle restructuring therapy which applies practical and experiential micro strategies to achieve productive simultaneous outcomes in seven life domains over a 12 week period. The seven life domains consist of health (physical, psychological and spiritual), family, relationship, profession, education, finances and self. Whilst there is anecdotal evidence of its efficacy in the treatment of depression, anxiety, eating disorders, impulse control disorders and PTSD, this is the first study looking at the empirical evidence for its efficacy.

RATIONALE FOR THE INTERVENTION MODEL OF THE CURRENT PROPOSAL

The current proposal aims to provide an alternate model of treatment to the current psychological therapy options available.

RESEARCH PLAN

AIM

The aim of this study is to test the efficacy of Strategic Outcome Focused Therapy in the treatment of returning war veterans suffering PTSD .

STUDY DESIGN AND IMPLEMENTATION

60 Patients with Diagnostic and Statistical Manual of Mental Disorders Fifth Edition PTSD and no co-morbid disorders will be randomized to:

        I.            Group 1  (n=30) Strategic Outcome Focused Therapy for 12 weeks

      II.            Group 2  (n-30) placebo for 12 weeks

Inclusion Criteria:

Participants are required to fulfil DSM-V Criteria for PTSD

Summary of DSM V Criteria for PTSD31

-The person has been exposed to a traumatic event, their response involves fear, helplessness or horror (this can be actual or threatened death, and can include a witness to such events) -The traumatic event is persistently re-experienced (one of: intrusive memories, dreams, flashbacks, psychological distress or psychological reactivity) - Persistent avoidance of stimuli associated with the trauma and numbing of general responsiveness (three of: avoidance of thoughts, feelings, conversations; avoidance of situations, places, people; amnesia of the event; loss of interest; flattened affect; estrangement from significant others; sense of foreshortened future; persistent negative expectation; persistent self blame or blame of others; inability to experience positive emotion) – Persistent symptoms of increased arousal (two of: sleep problems, anger, poor concentration, hypervigilance, exaggerated startle response) –Duration more than one month – The disturbance causes significant distress or impairment in functioning

Exclusion Criteria

         i.            Participants not fulfilling DSM-V Criteria for PTSD

       ii.            Age above 65 years

      iii.            Concurrent other diagnosed mental illness with psychotic symptoms (Bipolar disorder, Schizophrenia)

Implementation of therapy

        I.            Initiation Phase

      II.            Maintenance Phase

    III.            Final Evaluation

Statistical Analysis

        I.            Sample size

60 subjects fulfilling Diagnostic and Statistical Manual of Mental Disorders Fifth Edition criteria for PTSD.

EXPECTED OUTCOMES

Strategic Outcome Focused Therapy to show high efficacy for the treatment of PTSD compared to placebo.

  

SIGNIFICANCE OF THE RESEARCH

Empirically demonstrate the efficacy of Strategic Outcome Focused Therapy in the treatment of posttraumatic stress disorder.

Improve long term public health costs and outcomes associated with the treatment of PTSD amongst returned war veterans by developing an evidenced based, practical and cost effective treatment program.

Set the groundwork to utlilize Strategic Outcome Focused Therapy in the treatment of PTSD in the general population.

Further scientific knowledge in the area of PTSD.

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