The Effectiveness of Current Treatments
By Jim Gardner, Ph.D.
Introduction
Posttraumatic Stress Disorder (PTSD) is defined in the 4th edition of the Diagnostic and Statistical Manual of Mental Disorder (DSM-IV-TR) as a mental disorder that occurs when, “The person has been exposed to a traumatic event in which both of the following were present: (1) the person experienced, witnessed, or was confronted with an event or events that involved actual or threatened death or serious injury, or a threat to the physical integrity of self or others, and (2) the person’s response involved intense fear, helplessness, or horror.” Several other symptoms are required before one can be diagnosed with PTSD but there are a wide range of events that can lead to this diagnosis including sexual abuse, physical abuse, witnessing violent actions, military combat, rape, and natural disasters such as earthquakes, tsunamis, tornadoes, hurricanes, and flooding.
Posttraumatic Stress Disorder was first recognized as a diagnostic category in 1980 with the development of the DSM III, largely as a result of the number of Vietnam Veterans who were found to have combat-related trauma. It is estimated that 3.1 million personnel served in Southeast Asia during the Vietnam War and that 15% to 30% experienced war-related PTSD in their lifetime (Kulka, R.A., Schlenger, W.E., Fairbank, J.A., Hough, R.L., Jordan, B.K., Marmar, C.R., et al. (1990), Trauma and the Vietnam War generation: Report of findings from the National Vietnam Veterans Readjustment Study. New York: Brunner/Mazel.). For 20 years the Department of Veterans Affairs provided specialized programs for the treatment of PTSD for war veterans but after conducting studies of the efficacy of such treatments they began to withdraw their support for specialized PTSD programs around 2000 due to the cost of these treatments and their perceived lack of efficacy.
In 2010 I attended a workshop on PTSD and Grief that was conducted by a Board Certified Expert in Traumatic Stress who was described as a “national and internationally known author and speaker.” I was particularly interested in this seminar to hear what this expert would say about grief since I was very familiar with the research on this topic and knew that the leading experts agreed that therapy for normal grief was not effective. I spoke with this “expert” personally, who seemed to be a very nice person with Christian values, and found that she was unfamiliar with this research. She expressed her belief to me that grief therapy is effective, even though the research does not support this position.
When this “expert” spoke about treatments for PTSD she made the statement, “SSRIs are very effective in treating PTSD and can heal PTSD.” That statement was so inaccurate that it shocked me into interrupting her by saying, “Excuse me.” She paused and acknowledged me and I tried to carefully select my words so as not to sound offensive. “That statement that SSRIs can heal PTSD sounds a little strong to me. I have worked with many people with PTSD who are on SSRIs and I have never seen any of them “healed” of PTSD. Do you mean by using the term “heal” that they showed some improvement?” I asked. After a few moments to she reconsidered her statement and said, “Yes. That would be a better way of stating it. I should have said that SSRIs can help people with their PTSD symptoms. Thank you.”
The National Academy of Science Opinion
The Department of Veterans Affairs commissioned a committee through the National Academy of Sciences to study the research on the treatment of PTSD and assess the efficacy of current treatment approaches. Their lengthy written opinion was documented in April 2008 in the document, “Treatment of Posttraumatic Stress Disorder” and they summarized their findings before the U.S. House of Representatives on April 1, 2008. With regard to the efficacy of SSRIs one of the committee members stated, “The committee found the evidence for SSRIs inadequate to conclude efficacy.” This means that although there are many researchers who have concluded that some particular form of therapy is effective in treating PTSD, the examination of the major research projects conducted on PTSD over the last 40 years by this unbiased group of scientists led them to conclude that there is weak and “inadequate” evidence for the effectiveness of SSRIs in treating PTSD.
The same committee gave their opinion about the efficacy of psychotherapy treatments for PTSD. “The evidence for all but one of the remaining psychotherapy categories (including the broad “group therapy” category) was inadequate to conclude efficacy. The committee judged the evidence for exposure therapy sufficient to conclude efficacy." In exposure therapy a patient is asked to vividly recall a traumatic event repeatedly until their emotional reaction decreases and they are able to encounter trauma-related stimuli without strong emotional reactions. The committee did not say how effective exposure therapy is but simply stated that it shows some level of efficacy.
I attended another seminar in 2010 that was conducted by three additional “experts” on childhood trauma and PTSD. One of the speakers deplored the “ready willingness among some to use… practices that have no evidence for their efficacy.” In contrast, she strongly advocated the use of “evidence-based practices” and particularly endorsed Trauma-Focused Cognitive-Behavioral Therapy because of its “high level of empirical support.” In the last ten years there has been a concerted effort made by some mental health professionals to require all mental health professional to use only “evidence-based practices,” implying that there are truly effective methods that everyone should be using. The professional opinion given above by the National Academy of Science study, however, was that any therapy that utilized a form of exposure therapy shows some efficacy and other therapies do not. The question that this raises, however, is just how effective are these “efficacious” PTSD treatments?
Definitions of “Effectiveness”
In August of 2006, researchers Agnes van Minnen and Edna B. Foa authored a study entitled, “The Effect of Imaginal Exposure Length on Outcome of Treatment for PTSD” (Journal of Traumatic Stress, Vol. 19, No.4, August 2006, pp. 427-438). They began their article with the statement, “Several controlled studies have demonstrated the efficacy of prolonged exposure (PE) in ameliorating posttraumatic stress disorder (PTSD) and related psychopathology.” What does it tell us about a treatment modality when researchers tell us it is effective? What measurements and standards are these researchers using and just how effective are the current recommended treatments for PTSD?
Using prolonged exposure techniques Minnen and Foa compared the use of 30-minute with 60-minute “Imaginal Exposure” sessions to determine whether there was a difference in effectiveness and conclude that both are equally effective. Sixty patients received 60-minute imaginal exposure sessions and 32 patients received 30-minute imaginal exposure sessions, for a total of 10 weekly sessions. Throughout the imaginal exposure process, anxiety levels were monitored using a 10-point likert scale called SUDS (Subjective Units of Distress) and all patients were assessed prior to each session and at the end of the study with the PTSD Symptom Scale Self-Report (PSS-SR). The PSS-SR provides a rating from 0-3 on each of the 17 DSM-IV criteria for PTSD with a total score ranging from 0 to 51. The findings were that patients from both groups showed a significant decrease in symptoms from the beginning to the end of treatment, but the two groups did not differ in the amount of decrease.
On the face of it, this study sounds conclusive but a closer examination reveals some significant limitations of the study. This study reported both 30-minute and 60-minute sessions to be equally “effective” in reducing PTSD symptoms using Imaginal Exposure in treating patients over a 10-week period. However, 21% of the initial patients dropped out, 63% of the patients had experienced a single traumatic event, PSS-SR scores dropped an average of 12 points on a 51-point scale, and about 41% of the patients achieved a PSS-SR score of 20 or less. SUDS scores dropped only 2 points on average, from initial ratings of 8 to final ratings of 6 on a 10-point scale of emotional distress. Most potential patients would not be enamored by such results but researchers call such treatments “effective” and urge all clinicians to use such“empirically-supported” methods.
Results of Other PTSD Studies
Other studies of “effective” PTSD treatments are similar. These studies indicate that they have good “efficacy” but this means that the patients show an “improvement” but nothing close to a complete remission or remediation of PTSD symptoms. In a study published in 1999 by seven researchers, both Cognitive Therapy and Imaginal Exposure were declared to be “equally effective” in treating chronic PTSD (Journal of Consulting and Clinical Psychology, V.67, 13-18, 1999). The treatment involved 16 weeks of treatment over 6 months, only 50% of all study participants “improved,” and researchers admitted that neither therapy was sufficient alone to completely remediate chronic PTSD.
In the October 2005 issue of the Journal of Traumatic Stress (Vol.18, No.5, pp. 425-436) authors Joseph Spinazzola, Margaret Laustein, and Bessel A. van der Kolk published an article entitled, “Posttraumatic Stress Disorder Treatment Outcome Research: The Study of Unrepresentative Samples?” In this article, the authors stated that “Several empirically supported.. interventions have been … tested.. and replication studies have established their efficacy in treatment of PTSD.” The authors examined 34 recent studies that met the Practice Guidelines for the Effective Treatment of PTSD established by the International Society for Traumatic Stress Studies (ISTSS) in 2000. Of these 34 studies, it was found that of the studies that reported pretreatment enrollment data, “21% of the participants dropped out prior to starting treatment, and an additional 16% were eliminated at baseline due to the presence of exclusionary criteria.” Thus, only 63% of the initial study participants were included in the study, and only 53% of the initial study participants actually completed treatment.
Recommendations for Efficacy Studies
The authors of the 2005 study cited above made a number of significant recommendations in their report. Four of their recommendations were as follows:
1. Studies should always include precise participant enrollment data and drop-out rates so that the actual number of participants are known.
2. PTSD efficacy studies should attempt to include diverse samples so that they can be better generalized to broad populations of persons with PTSD, and to better assess the ability of PTSD treatments to reduce symptoms of highly impaired trauma survivors.
3. “Investigators should develop and evaluate innovative treatments designed to address more complex symptom presentations.” Innovative treatments should receive higher prioritization by funding sources for development and evaluation, including those that attempt to treat PTSD symptoms in persons with addictive behaviors and disorders.
4. “Journals should publish negative findings,” so that “studies evaluating the efficacy of empirically untested psychotherapeutic interventions, or medications yet unapproved for PTSD” can be publicized for the benefit of other researchers who are searching for innovative approaches for treating PTSD.
Full-Remission Studies
The Journal of the American Medical Association (JAMA. 2007; 297:820-830) published an article entitled “Cognitive Behavioral Therapy for Posttraumatic Stress Disorder in Women” in 2007. The authors reported that “prior research suggests that cognitive behavioral therapy is a particularly effective treatment for PTSD.” They included 284 female veterans in this study and 141 of them were randomly assigned to receive prolonged exposure therapy (PE), while 143 of them were randomly assigned to receive present-centered therapy (PCT) in 10 weekly 90-minute sessions. They reported that the prolonged exposure therapy was more effective, had more patients who no longer met PTSD diagnostic criteria, and more who achieved “total remission” which was defined as a CAPS score of less than 20 points.
A closer examination of the study reveals that 53 of the 141 women assigned to PE dropped out (38%) and 30 of the 143 women assigned to PCT dropped out (21%), 61% to 71% of the participants were taking psychotropic medications during the study, the average PTSD Checklist score at the end of the study was 41.6 for the women who received PE and 48.9 for those who received PCT (with a maximum score of 51). They reported that “total remission” was achieved (a CAPS score less than 20) by 15.2% of the 87 women receiving PE and 6.9% of the 112 women receiving PCT. Most of the women were treated for sexual trauma that had occurred 20 years earlier so these results are probably not generalizable to male PTSD patients. Although roughly two-thirds of the patients had a “clinically meaningful improvement, only 62% of the initial PE patients completed the treatment so 66% of 62% (41%) actually improved from the PE treatment.
Other studies have begun using the term “full remission” as a measurement term but none of them refers to the total elimination of subjective emotional distress. They refer to a pre-established cutoff criteria or goal for the treatment, which is frequently a CAPS score of less than 20. In the Archives of General Psychiatry (Vo. 65, No. 6, June 2008) in a study titled, “Treatment of Acute Stress Disorder” the authors report in the abstract of the report that patients who underwent exposure therapy were more likely to “achieve full remission” (47% vs. 13%) but this term was never defined in the study. Based upon other studies that used this terminology it probably indicates that 47% of the patients received a CAPS score of less than 20 at the end of the study period. However, the use of such terminology is very misleading.
SUDS Scores
The 2006 study done by Minnen and Foa on, “The Effect of Imaginal Exposure Length on Outcome of Treatment for PTSD” (Journal of Traumatic Stress, Vol. 19, No.4, August 2006, pp. 427-438) used multiple measurement tools, including the PSS-SR and the SUDS measure of subjective distress given by patients who rated their distress on a 10-point scale. This is a common-sense measure that can be easily understood by the average person. Both the 30-minute and the 60-minute treatments showed a significant improvement in scores on the PSS-SR from pre- to post-treatment and a significant “effect size” for both treatments, but there were no significant differences between the two treatments. The SUDS measures likewise demonstrated a significant improvement in patient measures from pre- to post-treatment, but no differences between the two groups. The average improvement on SUDS scores from pre- to post- treatment was 2.2 units on the 60-minute group and 2.1 on the 30-minute treatment group.
Since the SUDS scores showed comparable results to the PSS-SR scores it is puzzling that researchers continue to prefer using instruments like the PSS-SR and CAPS rather than the more simple and intuitively understandable CAPS scores. When using an instrument like the PSS-SR or CAPS researchers can report “significant findings” and even report “full remission” when there is very little clinical significance to the findings. Likewise, when the results of the study are given in terms of effect size, this may sound impressive but may have no clinical significance and it is not easily understood by the lay person or the average mental health practitioner. On the other hand, use of the SUDS scoring technique makes the results easily understood to the lay person and to the typical therapist. A decrease in average SUDS scores from 10 to 8 means simply that their subjective distress when thinking about the traumatic event has decreased slightly but is certainly not “in full remission.”
Measures of Effectiveness
Two researchers from Emory University, Drew Westen and Rebekah Bradley, wrote a challenging critique of evidence-based practices in “Current Directions in Psychological Science” (2005, Vol.14, No.5, 266-271). While applauding the efforts of researchers to evaluate the empirical evidence for efficacy of treatments, they expose the limitations of the most common measures of effectiveness.
Effect Size. The standard measurements used by researchers to evaluate treatment efficacy leave a lot of room for confusion. The criteria used most frequently by researchers to determine treatment efficacy is the “effect size,” which numerically describes the magnitude of the effect that the average patient can expect to receive relative to a control group. These measurements are meaningless to the layperson, however, and may indicate a “large effect size” for a treatment when, in fact, there is not a clinically significant effect or the effect is obtained with just a small percentage of clients. Westen and Bradley stated that “On average, roughly half of patients who complete treatments in such trials improve” and they wrote, “We suspect most patients would be chagrined to learn that what is widely described in the research literature as the treatment of choice for their disorder gives them a 1 in 3 chance of recovery.”
Percent Improved. Westen and Bradley identified “percent recovered” and “percent improved” as two other measures that are often used and stated that these measures are helpful at times, but that it is important to know how many patients dropped out of the treatment and to include them in these statistics. Most studies have exclusion and inclusion criteria that can limit the effectiveness of the treatment, such as the exclusion of individuals who are thinking about suicide from studies of depression. This obviously provides over estimations of the efficacy of treatments for depression and these researchers recommend using only “those exclusion criteria in randomized controlled trials that a sensible clinician would impose in everyday practice (e.g., psychosis or severe brain damage in treating depression).
Post-treatment Symptomatology . In addition, they stated that a treatment may lead to some improvement but leave the patients with strong symptoms afterwards and so some researchers use “residual post-treatment symptomatology” measures. If a study indicates that a particular treatment has a strong effect size and 48% of the patients improved significantly after 16 weeks of therapy, it still does not tell us how many of the patients remain symptomatic and how many have achieved total remission. Some measure of post-treatment symptomatology would provide us this information.
So, in order to understand how effective a treatment is in a particular study it is important to identify many factors. We should know the number and types of people who were excluded from the study initially, the number of people who dropped out of the study, the length of the treatment involved in the study, the number who experienced clinically significant improvement, and the number who achieved true remission of symptoms and not just “total remission” by an arbitrarily established cut-off point. Measurement tools that are understood only by researchers should be avoided and tools such as SUDS scores should be used that are relatively simple and intuitively meaningful to patients, therapists, and researchers.
The authors point out that psychotherapy treatments emerge from clinical practice, not from a laboratory as with pharmaceutical trials. Eliminating the use of all clinical practices other than “evidence-based practices” would prevent the development of more effective techniques when the current practices are still very ineffective for the majority of patients. They recommend identifying promising treatment approaches by using clinical practice as a natural laboratory and looking at the “results obtained by experienced clinicians, some percent of whom, either by chance, trial and error, or creativity, experimentation, and experience, are likely to have happened upon something more effective” (p. 270). This corroborates the opinion of researchers Spinazzolla, Laustein, and Kolk (2005) cited earlier that, “Investigators should develop and evaluate innovative treatments designed to address more complex symptom presentations” and that “ Innovative treatments should receive higher prioritization by funding sources for development and evaluation, including those that attempt to treat PTSD symptoms in persons with addictive behaviors and disorders.”
Best Current Treatment Efficacy Facts
The current “evidence-based treatments” recommended to clinicians are only partially effective and their limitations should be clearly stated when being recommended for use. The following are examples of some of the best-available current “evidence-based treatments.”
A. Depression: One in four depressed patients treated with cognitive behavior therapy for 16 weeks recovers and remains recovered two years later, when individuals who are having suicidal thoughts are excluded from treatment (Westen & Bradley, 2005, p. 270).
B. Bulimia Nervosa: Forty percent of patients who enter treatment, and 50% who complete it, no longer binge and purge at the end of 20 weeks of treatment, while the remaining 60% binge once or twice per week and purge two or three times per week on average (Westen & Bradley, 2005, p. 270).
C. Imaginal Exposure for Posttraumatic Stress Disorder: Patients who completed 10 weeks of 30-minute or 60-minute Imaginal Exposure sessions achieved an average symptom reduction of 12 points on a 51-point PTSD scale (41% achieved a final score of 20 or less) and rated their distress 2 points lower on a 10-point SUDS scale. 63% of these patients had experienced a single traumatic event and 21% of the initial patients dropped out of the study due to finding it too stressful (Minnen & Foa, 2006, p. 427-438).
D. Prolonged Exposure Therapy for Posttraumatic Stress Disorder: Women who were treated with 90-minute sessions for 10 weeks lowered their average score from 48 to 41 on a 51-point PTSD scale and 15% of them achieved a final score less than 20. 38% of the initial patients dropped out of the study due to finding it too stressful and 61% of them remained on psychotropic drugs during the study.
Most of the women were treated for sexual trauma that had occurred 20 years earlier (JAMA. 2007; 297:820-830, “Cognitive Behavioral Therapy for Posttraumatic Stress Disorder in Women.”
E. Complicated Grief Therapy for Complicated Grief: Half of the patients who completed 16 weeks of therapy indicated that they felt much better after treatment, while 25% of them dropped out of the study.
Although these are “evidence-based” treatments, there is much room for improvement and it is important that therapist have the freedom to continue searching for more effective treatments. This is why many researchers are recommending that “Innovative treatments should receive higher prioritization by funding sources for development and evaluation” until the mental health profession discovers truly effective ways of helping those with serious mental health disorders. Such “innovative treatments” should include faith-based approaches that may be far more effective than the current treatments being used by mental health professionals.