Attachment_3_Clinical_Practitioner_Guide_DJF-18-4210-PR-0008262.pdf

Guideline Development Panel for the Treatment of Posttraumatic Stress Disorder in Adults Adopted as APA Policy February 24, 2017

PTSD

CLINICAL PRACTICE

GUIDELINE

for the Treatment of

Clinical Practice Guideline for the Treatment of Posttraumatic Stress Disorder (PTSD) in Adults

American Psychological Association

Guideline Development Panel for the Treatment of PTSD in Adults

Adopted as APA Policy February 24, 2017

GDP Members:

Christine A. Courtois, Chair

Jeffrey Sonis, Vice-Chair

Laura S. Brown

Joan Cook

John A. Fairbank

Matthew Friedman

Joseph P. Gone

Russell Jones

Annette La Greca

Thomas Mellman

John Roberts

Priscilla Schulz

APA Guidelines Staff:

Lynn F. Bufka

Raquel Halfond

Howard Kurtzman i

Abstract

Description: The American Psychological Association (APA) developed this guideline to provide recommendations on psychological and pharmacological treatments for posttraumatic stress disorder (PTSD) in adults.

Methods: This guideline used methods recommended by the Institute of Medicine report, Clinical Practice Guidelines We Can Trust (IOM, 2011). Those methods are designed to produce guidelines that are based on evidence and patient preferences and are transparent, free of conflict of interest, and worthy of public trust. The guideline used a comprehensive systematic review (Psychological and Pharmacological Treatments for Adults With

Posttraumatic Stress Disorder (PTSD)) conducted by the Research Triangle Institute-University of North Carolina Evidence-based Practice Center as its primary evidence base (Jonas, Cusack, Forneris, Wilkins, Sonis, Middleton, et al., 2013). The systematic review was based on

English-language studies published between 1980 and 2012; complementary and alternative treatments were not included in the systematic review. An updated search was conducted by

APA to identify studies published between 2012 and June 1, 2016, to determine if the recommendations made by the panel based on the systematic review were likely to hold up based on more recent evidence; risk of bias assessment, strength of evidence rating and meta-analyses were not conducted on the studies identified through the updated search.

The guideline development panel (GDP) consisted of health professionals from the disciplines of psychology, psychiatry, social work, and family medicine as well as community members, who self-identified as having had PTSD. The GDP made recommendations based on 1) strength of evidence; 2) treatment outcomes and the balance of benefits vs. harms and burdens of interventions; 3) patient values and preferences; and 4) applicability of the evidence to various treatment populations. PTSD symptom reduction and serious harms were selected by the GDP as critical outcomes for making recommendations. Various other outcomes were ii selected as important, including those related to remission, quality of life, disability, comorbid conditions and adverse events.

The target audience for this guideline includes all clinicians as well as researchers, patients and policy makers.

Recommendations: The panel strongly recommends the use of the following psychotherapies/interventions (all interventions that follow listed in alphabetical order) for adult patients with PTSD: cognitive behavioral therapy (CBT), cognitive processing therapy (CPT), cognitive therapy (CT), and prolonged exposure therapy (PE). The panel suggests the use of brief eclectic psychotherapy (BEP), eye movement desensitization and reprocessing (EMDR), and narrative exposure therapy (NET). There is insufficient evidence to recommend for or against offering Seeking Safety (SS) or relaxation (RLX). For medications, the panel suggests offering the following (in alphabetical order): fluoxetine, paroxetine, sertraline, and venlafaxine.

There is insufficient evidence to recommend for or against offering risperidone and topiramate.

Based on the updated search, the panel concluded that all of its treatment recommendations, except those for EMDR and NET, were unlikely to change. The panel also concluded that, based on studies published between 2012 and June 2016, the recommendations for EMDR and

NET may change from conditional (“the panel suggests”) to strong (“the panel recommends”).

(Note: This abstract was prepared following approval of the guideline document as APA policy by the APA Council of Representatives at its February 2017 meeting.)

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Table of Contents

Abstract ................................................................................................................................... i

Table of Contents ................................................................................................................... iii

Disclaimer ............................................................................................................................. vii

Executive Summary ............................................................................................................ ES-1

Table 1. Summary of Recommendations

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Table of Contents

v

Table of Contents

Guideline Summary and Future Directions

Conflicts of Interest

Author Disclosure

Developer

Funding Source/Sponsor

Acknowledgments

References vi

Appendices (New Document)

A. Descriptions of Treatments and Strength of Recommendations

B. Treatment Dose, Timing, and Duration as Described in Reviewed Studies

C. Evidence Profiles Prepared for APA by RTI-UNC Scientists

D. Decision Tables

E. Definition of Key Terms

F. Additional Tables and Figure for Updated Evidence (2012-2016)

G. Trials Identified Through Search Update (published 2012-2016) Matching One or More Recommendations

H. Trials Identified Through Search Update (published 2012-2016) Matching One or More Evidence Profiles but Not Matching Any Recommendations

I. Trials Identified Through Search Update (published 2012-2016) That Would Not Have Met Criteria for Inclusion in Systematic Review

J. APA Declarations/COI Form

K. Voting Procedures Established by Advisory Steering Committee (ASC)

L. Strength of Evidence Ratings for Psychotherapies and Medications vii

Disclaimer

This guideline is intended to be aspirational and is not intended to create a requirement for practice. It is not intended to limit scope of practice in licensing laws for psychologists or for other independently licensed professionals, nor limit coverage for reimbursement by third party payers.

The term guideline refers to statements that suggest or recommend specific professional behavior, endeavor, or conduct for psychologists or other independently licensed professionals.

Guidelines differ from standards in that standards are mandatory and may be accompanied by an enforcement mechanism. In contrast, guidelines are aspirational in intent. They are intended to facilitate the continued systematic development of the profession and to help assure a high level of professional practice by psychologists and other professionals. Guidelines are not intended to be mandatory or exhaustive and may not be applicable to every professional and clinical situation. They are not definitive and they are not intended to take precedence over the judgment of psychologists and other professionals. The different types of guidelines produced by the APA were detailed in an association document published in the American Psychologist in

December, 2015 (American Psychological Association, 2015).

The recommendations made by the APA PTSD Guideline Development Panel (GDP) were developed after careful review of the evidence. The GDP endorses the following statement from the British National Institute for Health and Care Excellence (NICE, 2016) “When exercising their judgement, professionals are expected to take this guideline fully into account, alongside the individual needs, preferences and values of their patients or service users. The application of the recommendations in this guideline is not mandatory and the guideline does not override the responsibility of healthcare professionals to make decisions appropriate to the circumstances of the individual patient, in consultation with the patient and/or their carer or guardian,” (p.18).

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Executive Summary

Scope of the Guideline

This guideline is intended to provide treatment recommendations for Posttraumatic

Stress Disorder (PTSD) in adults, based on a systematic review of the evidence for treatment

Psychological and Pharmacological Treatments for Adults With Posttraumatic Stress Disorder

(PTSD) conducted by the Research Triangle Institute- University of North Carolina Evidence-

Based Practice Center (RTI-UNC EPC) (Jonas, Cusack, Forneris, Wilkins, Sonis, Middleton, et al., 2013).The RTI-UNC Systematic Review addressed the following Key Questions:

1. What is the efficacy of psychological and medication treatments for adults with

PTSD, compared to no treatment or to inactive controls?

2. What is their comparative effectiveness (i.e., psychological treatments compared to other psychological treatments, medication treatments compared to other medication treatments, and psychological treatments compared to medication treatments)?

3. Which treatments work best for which patients1? In other words, do patient characteristics or type of trauma modify treatment effects?

4. Do serious harms of treatments or patient preferences influence treatment recommendations?

Although of considerable importance in the treatment of PTSD, this guideline does not address complementary or alternative treatments, assessment and screening of PTSD, subthreshold

PTSD, PTSD prevention, PTSD treatment in children, dose/timing/duration of treatment, or cost.

It is the hope of panel members that future iterations of this guideline include these topics as their evidence base develops.

1 To be consistent with evidence-based clinical practice guidelines in other areas of health care, we use the term patient to refer to the person receiving psychological services. However, we recognize that in many situations there are important and valid reasons for using such terms as client, consumer or person in place of patient to describe the recipients of services.

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Recommendations

Following its detailed review and independent analysis of the findings of the systematic review, the APA Guideline Development Panel (GDP) strongly recommends the use of the following psychotherapies/interventions (all interventions that follow listed in alphabetical order) for adult patients with PTSD: cognitive behavioral therapy (CBT)2, cognitive processing therapy

(CPT), cognitive therapy (CT), and prolonged exposure therapy (PE). The panel suggests the use of brief eclectic psychotherapy (BEP), eye movement desensitization and reprocessing

(EMDR), and narrative exposure therapy (NET). There is insufficient evidence to recommend for or against offering Seeking Safety (SS) or relaxation (RLX). For medications, the panel suggests offering the following (in alphabetical order): fluoxetine, paroxetine, sertraline, and venlafaxine. There is insufficient evidence to recommend for or against offering risperidone and topiramate.

Impact of New Trials on Recommendations

The systematic review that was used as the evidence base for this guideline included trials that had been published prior to May 24, 2012. To determine whether the panel recommendations based on that evidence would hold up in the face of new evidence published since that time, the panel conducted a revised search, to identify trials published between May

25, 2012 and June 1, 2016. The panel concluded that, based on the new trials, its recommendations for all of the interventions except two (EMDR and NET) were unlikely to change; there was insufficient evidence to determine whether the conditional recommendations for EMDR and NET3 would change to strong.

2 The systematic review did not evaluate trauma-focused CBT separately from CBT that was not trauma-focused.

Accordingly, the panel’s recommendations are based on CBT as a category that encompasses all types of CBT and are not limited to trauma-focused CBT.

3 As we discuss later in this report, the panel acknowledges uncertainty in the stability of our conditional recommendations for EMDR and NET on the basis of more recent evidence that could result in an upgraded recommendation pending future meta-analyses.

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Introduction

Trauma involves events that pose significant threat (physical, emotional, or psychological) to the safety of the victim or loved ones/friends and are overwhelming and shocking. Many individuals exposed to traumatic events experience a range of posttraumatic psychophysiological reactions though most of these reactions remit spontaneously within approximately the first month of occurrence (Rothbaum, Foa, Riggs, Murdock, & Walsh, 1992;

Nugent, Saunders, Williams, Hanson, Smith, & Fitzgerald, 2009; Orcutt, Erickson, & Wolfe, 2004). A number of risk and resilience factors (such as age, severity, duration, and availability of support) may affect whether the reactions remit. If they persist, they might meet criteria for one or more posttraumatic diagnoses such as Acute Stress Disorder (ASD) or Posttraumatic Stress

Disorder (PTSD).The 5th edition of the Diagnostic and Statistical Manual of Mental Disorders, DSM-5, (American Psychiatric Association, 2013), defines PTSD as comprised of four clusters of symptoms including intrusive and recurrent memories of the trauma, avoidance of trauma-related stimuli, numbing and/or negative changes in mood or cognitions pertaining to the trauma, and changes in reactivity and arousal. The DSM-IV-TR (American Psychiatric

Association, 2000) previously defined PTSD as being comprised of three symptom clusters including avoidance and numbing, re-experiencing, and hyperarousal. Of note, all of the studies included in the RTI-UNC systematic review that served as the evidence base for that report used DSM-IV-TR or earlier DSM criteria and are those discussed throughout this guideline.

Furthermore, PTSD can range from relatively mild to totally debilitating and has also been found to create vulnerability for revictimization and retraumatization (see Duckworth and

Follette, 2012) for a comprehensive overview). Some individuals and populations are especially at risk and co-morbidities such as substance use and abuse, depression, anxiety, dissociation and dissociative disorders, personality disorders, psychosis, cognitive impairment, violence towards self and others, increased risk of non-suicidal self-injury and of suicide, are common to the diagnosis. Psychosocial impacts can include homelessness, poverty, and incarceration. All

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of these factors make PTSD a complicated and challenging psychophysiological and psychosocial disorder to treat and suggest the need for further guidance to indicate which treatments are effective and for whom.

Currently, numerous guidelines from various agencies and professional organizations recommend several trauma-focused psychological interventions for treating PTSD and most acknowledge some benefit of several medication treatments as well. The present guideline differs from other guidelines in several ways. It fully follows and builds upon the standards set forth by the Institute of Medicine (IOM) (now the National Academy of Medicine) of the National

Academies of Sciences, Engineering, and Medicine standards for developing high-quality, independent, and reliable practice guidelines (IOM, 2011a & 2011b). Its recommendations and suggestions for treatment are based on an analysis of a comprehensive independent systematic review of the literature for treatment of PTSD in adults. Further, panel members who worked on the present guideline document were an interdisciplinary group from professions including psychology, social work, primary care, and psychiatry--and included consumer members as well. Finally, the present guideline includes attention to potential and actual harms and burdens of PTSD treatments and patient preferences as part of the process.

In addition to these strengths, the guideline also has some limitations. Gaps in the current empirical literature regarding treatment comparisons, evaluation of moderators of treatment effects, inclusion of participants with comorbidities, measurement of potential side effects and harms, and assessment of important outcomes and the timing of their assessment all need to be addressed to answer important clinical questions. Additionally, methodological improvements that minimize attrition/dropout, decrease missing data and ensure sufficient power will improve the quality of the findings and hence the possible conclusions that can be drawn. Finally, the panel did not have data on which to make recommendations for some treatments in use because they arise from traditions with non-RCT research practices or the

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quality of the research base has not been subjected to the level of critical appraisal of systematic review.

It was the panel’s goal in the development of this guideline to render a collective judgment and decision-making process that is transparent so that interested readers might appropriately appreciate the rationale for the recommendations made in response to the evidence in the systematic review. It is also recognized that this guideline may provide a foundation for developing key questions for future systematic reviews leading to updated recommendations regarding effective treatments for PTSD. Finally, it should be reiterated that a clinical practice guideline is based on the best available evidence at the time and should not be construed as a standard of care or prescribing a specific course of treatment.

Process and Method

At the outset, panel members discussed a range of relevant outcomes and determined which were most critical for deciding whether to recommend or not recommend a treatment through a modified Delphi survey. The panel decided that PTSD symptom reduction and serious harms/adverse events were the most critical outcomes and that remission (no longer having symptoms), loss of PTSD diagnosis, quality of life, disability or functional impairment, prevention or reduction of comorbid medical or psychiatric conditions, adverse events leading to withdrawals (treatment discontinuation), and other adverse events, and burdens were important though not critical.

The primary evidence base for the present guideline was the systematic review, Psychological and Pharmacological Treatments for Adults With Posttraumatic Stress Disorder

(PTSD) (Jonas et al., 2013) produced by the Research Triangle International- University of

North Carolina Evidence Based Practice Center (RTI-UNC EPC) which followed the protocol set forth by the Institute of Medicine (2011b) for conducting systematic reviews. The comprehensive and transparent systematic review addressed psychological and pharmacological treatments for

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PTSD. The trials included in the systematic review included samples that, as a whole, were broadly diverse in terms of gender, race, ethnicity and type of trauma.

APA’s Advisory Steering Committee for Development of Clinical Practice Guidelines

(ASC) issued a call for panel member nominations (including self-nominations) for individuals from a variety of backgrounds (consumer, psychology, social work, psychiatry, general medicine) with content and treatment knowledge or methodological expertise. Conflicts of interest (financial and non-financial) were considered and managed both during panel member selection and throughout the guideline development process. Panel members were asked to complete a COI form (see Appendix J) and that was reviewed by APA staff and ASC members before members were appointed to the GDP. Additionally, they were asked to present the details of their forms to other members in the first face to face meeting and to update their COI’s yearly or on an as-needed basis and to submit it to staff for review.

The panel considered four factors as it drafted recommendations: 1) overall strength of the evidence; 2) the balance of benefits vs. harms/burdens; 3) patient values and preferences;

and 4) applicability. Based on the combination of these factors, the panel made a strong or conditional recommendation for or against each particular treatment or made a statement that there was insufficient evidence to be able to make a recommendation for or against. The panel used a tool called a decision table to document its decision-making process for each recommendation. Copies of the decision tables are available in Appendix D.

Discussion

For treating PTSD in adults, the present guideline strongly recommends cognitive behavioral therapy (CBT), cognitive processing therapy (CPT), cognitive therapy (CT), and prolonged exposure therapy (PE) and suggests the use of brief eclectic psychotherapy (BEP), eye movement desensitization and reprocessing (EMDR), and narrative exposure therapy

(NET). These recommendations are largely but not entirely consistent with those of various other organizations. The present guideline also suggests the use of fluoxetine, paroxetine, ES-7 sertraline, and venlafaxine. These recommendations add to the pharmacotherapy recommendations of other organizations. Although some psychotherapies (CBT, CPT, CT, PE) received strong recommendations but no medications did, the panel does not make recommendations of psychotherapy before or instead of medications or use the term “first-line” treatment because there was insufficient evidence from the systematic review on direct comparisons between psychotherapy and medications for PTSD. The implications of this distinction are that efficacy inferences for psychotherapies and those for pharmacotherapies may not be truly comparable across these classes of treatment owing to the differential stringency of these typical control conditions. The strength of the panel’s recommendations for all interventions depended, to some extent, on the magnitude of the beneficial effect (i.e., the effect size). But the effect size magnitude in a trial can be influenced by the type of the comparator in the trial. Since all of the medication trials used placebo comparators while the psychotherapy did not (and could not …) and there was insufficient evidence on direct comparison of the two types of treatments, the panel did not make any recommendations about psychotherapy versus medication treatment. Clinical judgment and patient preferences (as well as patient response to psychotherapy or psychopharmacology) are all important factors in deciding the course of treatment for PTSD.

Treatment effect heterogeneity (sub-group effects) was evaluated in the RTI-UNC

Systematic Review. Its authors concluded that the research evidence was insufficient to determine treatment effect heterogeneity by many of the subgroups that were examined.

Members of the current guideline development panel agreed that the randomized trials included in the review do not sufficiently address the important issue of which treatments are best for which patients and constitutes an important future research need.

Generalizability (applicability) of systematic review findings to an external population means that the magnitude and direction of an intervention effect, based on included trials, is

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similar to the magnitude and direction of intervention effect that would be expected in that external population. Absence of generalizability occurs when there is heterogeneity of treatment effects (e.g., by gender, ethnicity, trauma type or other significant factors) and when there are differences between the distribution of those characteristics in the samples included in a systematic review and the external population. The authors of the RTI-UNC Systematic Review concluded that there was insufficient evidence “to determine whether the findings are applicable to all those with PTSD or whether they are applicable only to certain groups” and insufficient evidence about whether there were subgroup effects. Based in part on this conclusion, members of the APA panel did not reach consensus about the generalizability of the systematic review’s findings, reflecting differences of opinion found in the literature about conditions required to demonstrate generalizability (Post, de Beer, & Guyatt, 2013; Rothwell, 2005). Some panel members think that lack of generalizability to all subgroups should be assumed in the face of insufficient evidence about generalizability. Others on the panel believe that, in the face of insufficient evidence about generalizability or strong theoretical rationale to suggest treatment effect heterogeneity, generalizability to most subgroups should be assumed. Panel members agree however that examination of treatment effect heterogeneity with diverse samples should be prioritized for future research.

Community members on the GDP shared what they considered to be important patient values and preferences for PTSD treatment. These included such things as having a psychotherapist who is aware of and knowledgeable about trauma, who offers information about treatment, teaches coping skills, works from a personalized approach, and is sensitive to cultural and socio-demographic differences. Likewise, clinicians on the panel shared their views of general patient values and preferences gained from their experience providing treatment.

They found variation in patient preferences for trauma-focused therapies, preference for psychotherapy over medication in many cases (though a minority prefers medication) and some who prefer no treatment whatsoever. Many seek short-term treatment and want to experience

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significant symptom relief and alleviation of their suffering. Clinicians and community members also reported that patients want information about treatment, value culturally sensitive therapists, and have various preferences regarding intensity and pace of treatment. An open question is whether patient preference for specific treatment varies by treating provider such that patients choose professionals able to provide preferred treatment or identify a treatment as preferred on the basis of what the provider is able to offer.

In order to implement interventions effectively a number of considerations are relevant, including informed consent and the role of patient and relationship factors in treatment. Informed consent includes providing patients with information about potential available treatments before treatment commences and to aid in decision making. Informed consent includes discussion and can include written material about the process and procedures involved, effectiveness and risks-benefits, and associated emotional and practical demands. Second, there is a body of literature that has shown an association between patient and patient-therapist factors (sometimes referred to as “common factors”), relationship factors, and treatment outcomes. These factors include such things as patient coping style, expectation for change, and therapist empathy and collaboration. Clinicians are encouraged to bear these factors in mind when implementing recommended treatments.

Other treatment considerations include the therapist working from a trauma-informed4 approach and attending to the role of socio-economic, cultural or other diversity or contextual issues. These may facilitate whether patients find therapist actions and recommendations intelligible, useful, and worthwhile. They may also have a direct impact on the treatment application. Finally, while monitoring PTSD symptoms during treatment can provide insight into progress and treatment targets and guidance when adjusting treatment seems necessary, it is unclear as of yet whether this treatment monitoring improves patient outcomes.

4 Treatment approaches that directly focus on the details of trauma event(s)/experience(s) in order to assist the patient to process the cognitions, emotions, somatic reactions, and/or memories associated with the trauma. The theory is that once these are processed sufficiently to arrive at a point of resolution, completion, or a change of perspective, trauma symptoms should decline or remit.

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Although the research evidence is strong for the efficacy of particular psychotherapy and pharmacological treatments for adults with PTSD, many other treatments are being used or are under development and there are still significant gaps in the literature. These include the lack of

RCTs for newer treatments, the comparative effectiveness of psychological and pharmacological treatments and combinations of treatments, subgroup effects, applicability of findings to patients with comorbidities and PTSD, patient preferences for care, and impact of treatments on important patient-oriented outcomes such as quality of life, long-term treatment effects, adverse effects and harms, along with other outcomes that are not so easily quantifiable such as moral injury, emotional regulation, identity and sense of self, and ability to form intimate relationships.

In addition to the research gaps noted, there are other methodological concerns with many of the current PTSD treatment trials that should be addressed in future trials. Specifically, the panel recommends that investigators design trials to minimize attrition, identify reasons for attrition/dropout, decrease missing data, and incorporate rigorous methods of handling missing data such as multiple imputation or maximum likelihood. Future trials should report the recency of trauma, address the potential for researcher allegiance effects, provide long term evaluation of outcomes (PTSD symptoms and other outcomes), and include samples large enough to minimize the potential for covariate imbalance. Future trials should also retain rigorous methodologic features that have been commonly used in previous research, such as assessment of treatment fidelity.

The panel members applaud treatment developers and national and international professional organizations for their efforts in designing and implementing PTSD treatment research studies. The panel also supports the continuing efforts to research trauma process and outcome both generally and more specifically to individuals who have experienced trauma. It is also the hope of members of this panel that suggested methodological improvements will serve

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to enhance future iterations of the present guideline and continue to alleviate the suffering of individuals with PTSD.

This document will be reviewed within five years following adoption as policy. A decision to sunset, update or revise the document will be made at that time.

See in Appendix E for definitions of terms used in this guideline.

Clinical Practice Guideline for the Treatment of Posttraumatic Stress Disorder (PTSD) in Adults

American Psychological Association

Guideline Development Panel for the Treatment of PTSD in Adults

Scope of the Document: What the Guideline Addresses and What It Does Not

The purpose of this guideline is to provide recommendations on the treatment of posttraumatic stress disorder (PTSD) in adults. This guideline is based on a systematic review of the evidence on treatment of PTSD Psychological and Pharmacological Treatments for

Adults With Posttraumatic Stress Disorder (PTSD), sponsored by the Agency for Health Care

Research and Quality (AHRQ)5 and conducted by the Research Triangle Institute-University of

North Carolina Evidence-Based Practice Center (RTI-UNC EPC) (Jonas, Cusack, Forneris, Wilkins, Sonis, Middleton, et al., 2013). The intended users include psychologists, other health and mental health professionals, consumers, families of consumers, students/training programs, policy makers, and the public.

The guideline addresses the following Key Questions:

1. What is the efficacy of psychological and medication treatments for adults with PTSD, compared to no treatment or to inactive treatments?

2. What is their comparative effectiveness (i.e., psychological treatments compared to other psychological treatments, medication treatments compared other medication treatments, and psychological treatments compared to medication treatments)?

3. Which treatments work best for which patients? In other words, do patient characteristics or type of trauma modify treatment effects?

5 The Agency for Healthcare Research and Quality's (AHRQ) mission is to produce evidence to make health care safer, higher quality, more accessible, equitable, and affordable, and to work within the U.S. Department of Health and Human Services and with other partners to make sure that the evidence is understood and used.

4. Do serious harms of treatments or patient preferences influence treatment recommendations?

The guideline does not address any of the following:

1. Complementary or alternative treatments, such as yoga or acupuncture. Because the systematic review that served as the evidence base for the guideline excluded studies that focused exclusively on complementary and alternative approaches, treatment of

PTSD with those types of interventions is beyond the scope of this guideline.

2. Screening for exposure to psychological trauma, screening for and assessment of PTSD, assessment of associated conditions (e.g., suicidal ideation, intent, or actions, monitoring response to treatment, follow-up after treatment, or locus of care. These are all key elements in the care of patients exposed to trauma or diagnosed with PTSD, but they are beyond the scope of this guideline.

3. Subthreshold PTSD. Studies that did not require a formal diagnosis of PTSD for participant inclusion were not included in the RTI-UNC Systematic Review.

4. Prevention of PTSD. Effectiveness of interventions, such as debriefing, that are designed to reduce the risk of development of PTSD, among persons exposed to trauma but who have not been diagnosed with PTSD have not been evaluated. The RTI-UNC EPC did perform a separate systematic review on prevention of PTSD among persons exposed to trauma but the current guideline, devoted to treatment but not prevention, was not based on findings from that systematic review.

5. Treatment of PTSD in children. The panel considered creating a separate guideline for treatment of PTSD among children. The RTI-UNC EPC performed two systematic reviews on treatment of conditions related to trauma in children (birth to 14 years of age).

One review focused on interventions for treatment of conditions related to maltreatment and family violence (including child abuse) and the other review focused on interventions for treatment of conditions related to trauma other than maltreatment and family violence.

The panel decided not to include treatment of PTSD among children in the current report or to issue a separate guideline for treatment of PTSD among children because the vast majority of intervention trials were rated low or insufficient/very low strength of evidence.

As noted in one of the reviews, “Our main finding was that the literature in this field is strikingly limited due to numerous substantive and methodological gaps.” Panel members decided it would be unwise to develop a guideline that would not involve substantive recommendations for most of the interventions due to insufficient evidence.

6. Dose, timing or duration of treatments for adults with PTSD. All of those elements can be related to outcome of treatment but the systematic review that constituted the evidence base for this guideline did not provide sufficient information to make evidence-based recommendations on those factors. Included in this document however, is a table

(Appendix B) that shows the range of the dose and the timing and duration of the treatments used in the randomized trials that were included in the systematic review for which the panel makes recommendations.

7. Costs of treatments. Treatment costs were not considered in the formulation of the panel’s recommendations.

Below in Table 1 is a summary of recommendations. More detailed recommendations are provided in Table 5.

Table 1. Summary of Recommendations of the APA Guideline Development Panel for the Treatment of PTSD

Psychotherapy Strength of

Recommen dation

For adult patients with PTSD, the panel strongly recommends that clinicians offer one of the following psychotherapies/interventions (listed alphabetically):

• cognitive behavioral therapy- (CBT)6

• cognitive processing therapy (CPT)

• cognitive therapy (CT)

• prolonged exposure therapy (PE)

Strong For

For adult patients with PTSD, the panel suggests that clinicians offer one of the following psychotherapies/interventions (listed alphabetically):

• brief eclectic psychotherapy (BEP)

• eye movement desensitization and reprocessing therapy (EMDR)

• narrative exposure therapy (NET)

Conditional

For adult patients with PTSD, there is insufficient evidence to recommend for or against clinicians offering the following psychotherapies/interventions (listed alphabetically):

• relaxation (RX)

• Seeking Safety (SS)

Insufficient

Pharmacotherapy

For adult patients with PTSD, the panel suggests that clinicians offer one of the following (listed alphabetically):

• fluoxetine

• paroxetine

• sertraline

• venlafaxine

Conditional

There is insufficient evidence to recommend for or against clinicians offering the following medications (listed alphabetically) for treatment of adults with PTSD.

• risperidone

• topiramate

Comparative Effectiveness

For adult patients with PTSD, the panel recommends clinicians offer either prolonged exposure or prolonged exposure plus cognitive restructuring when both are being considered.

Strong For

For adult patients with PTSD, the panel recommends clinicians offering either venlafaxine ER or sertraline when both are being considered.7 Strong For

6 The RTI UNC review refers to this as CBT-mixed therapy. CBT-Mixed is a category that includes interventions using aspects of CBT that do not fit neatly into the other CBT categories. It will be referred to in the present document as CBT.

For adult patients with PTSD, the panel suggests clinicians offer CBT rather than relaxation when both CBT and relaxation are being considered.

Conditional For

For adult patients with PTSD, the panel suggests clinicians offer prolonged exposure therapy rather than relaxation when both prolonged exposure therapy and relaxation are being considered.

Conditional For

For adult patients with PTSD, the panel concludes that the evidence is insufficient to recommend for or against clinicians offering Seeking Safety versus active controls.

These recommendations and this clinical practice guideline is not intended to set a standard of care but rather to be a general guide to best practices. A clinical practice guideline can facilitate decision making for both provider and patient.

7 The recommendation for the comparison between venlafaxine ER vs sertraline is different than the recommendation for Seeking Safety vs active controls, even though there is moderate evidence of no difference between the two treatments being compared for both comparisons (i.e., venalfaxine ER vs sertraline and Seeking Safety vs active controls). The reason the recommendations are different for venlafaxine ER vs sertraline than for Seeking Safety vs active controls is that the panel made a conditional recommendation for venlafaxine compared to no intervention and a conditional recommendation for sertraline compared to no intervention but did not make any recommendations for Seeking Safety compared to no intervention or active controls compared to no intervention because there was insufficient/very low evidence. In other words, the panel believed that because there was evidence that both venlafaxine and sertraline had demonstrated efficacy compared to inactive intervention, it was reasonable to recommend either treatment when both are being considered.

However, because neither Seeking Safety nor active controls had demonstrated efficacy compared to no intervention, the panel concluded that evidence was insufficient to recommend for or against either treatment.

Introduction to the Topic

Background and Justification: The Scope of the Problem

Defining Trauma. According to the 5th edition of the Diagnostic and Statistical Manual of

Mental Disorders, DSM-5, (American Psychiatric Association, 2013), exposure to traumatic events can occur in one (or more) ways: 1) direct experiencing; 2) witnessing, in person; 3) learning that the traumatic event(s) occurred to a family member, or someone else in close relationship; 4) experiencing repeated or extreme exposure to aversive details of the traumatic event(s) (common in first responders and emergency personnel). Trauma refers to events or experiences that are shocking and overwhelming, typically involving major threat to the physical, emotional, or psychological safety and well-being of the individual victim(s) and loved ones and friends (as well as to others). Its original occurrence is usually sudden and unexpected and it may be a one-time event. In some cases, after the first incident, it may recur on either a short-term or intermittent basis or it may occur on a regular or prolonged basis to the point of becoming continuous and chronic. Examples of traumatic events include: military combat, acts of terror; motor vehicle and other accidents; natural or human-caused disasters and accidents, sudden or violent death of loved ones; interpersonal violence, such as mass shootings, assaults, and physical, sexual, and emotional abuse; traumatic separations and other significant losses (including neglect and abandonment); hostage-taking; torture; slavery; and certain types of disability, illness, and medical treatment, especially for life-threatening conditions. The definition of psychological trauma has been widely debated and the delineation of a traumatic event in DSM (known as Criterion A) has gone through numerous revisions (Weathers & Keane, 2007). Due to the varying magnitude, complexity, intensity, frequency and duration of potential stressors, mental health experts have grappled to create an all-encompassing definition of trauma.

Epidemiological research has demonstrated that traumatic events are common and thus most humans will experience a potentially traumatic event at some point in their lifetime

(Breslau & Kessler, 2001; Copeland, Keeler, Angold, & Costello, 2007; Kessler, Sonnega, Bromet, Hughes, & Nelson, 1995; McLaughlin, Koenen, Hill, Petukhova, Sampson, Zaslavsky &

Kessler, 2013). At the time of occurrence or shortly thereafter, trauma generally causes physiological and psychological stress responses that are overwhelming and exceed or greatly challenge the affected individual’s capacity to cope. Individuals’ post-trauma reactions show great variability, ranging from those that are highly resilient--with little or no emotional distress--to those that are relatively mild and short-term, to those that are major, chronic, and highly debilitating. Disorders of medical or mental health may or may not follow (Bonanno, 2004).

Trauma can also impact others besides the primary victim(s), for example, relatives/loved ones, first responders, therapists and other helpers, and others who can be affected vicariously

(Badger, Royse, & Craig, 2008; Hojat, 2007; Hojat, Gonnella, Nasca, Mangione, Vergare, &

Magee, 2002; Huddleston, Paton, & Stephens, 2006; McLean, Wade, & Encel, 2003; Pearlman

& Saakvitne, 1995; Schauben & Frazier, 1995). Thus, the toll of trauma can be wide ranging and quite uneven.

Posttraumatic Reactions and Diagnoses. The vast majority of individuals exposed to potentially traumatic events experience posttraumatic reactions, such as intrusive memories of the event or autonomic arousal (e.g., difficulty concentrating, hyper-alertness, increased physiological activation and reactivity) within hours or days of the traumatic event.