A TALE OF TWO STUDIES

In my previous post[1], I reviewed a study[2] about  acupressure[3]. The researchers attempted to establish acupressure as an effective therapeutic method for the management of psychophysiological insomnia[4]. The study (somehow) concluded acupressure was a “safe, effective and cost-effective therapy,” though the study design didn’t actually test acupressure, or provide a clear, descriptive methodology and data showing the effective management of insomnia in the sample group. The study instead provided presented a causative effect from the research information it collected using the Sea-Band device, even though:

• No research had even established the efficacy of the device as an acupressure therapy (nor had any science-based research established any meaningful therapeutic effects of acupressure)
• The study did not directly test the safety of the device
• The researchers concluded the effectiveness of the device using the presumed authority [5]of a standard sleep study test and quantitative data, in order to dredge for significance across 22 data points from only two data sets, one pre-treatment measurement and one post-“treatment”

The acupressure study left a sour taste in my mouth. It seemed to be an overt attempt to provide legitimacy to Eastern “medicine,” acupressure, and the Sea-Band device by masking a poorly designed, poorly implemented pseudoscientific research study as science-based clinical research.

A 2012 study[6] from the Psychiatria Danubina[7] journal, utilized a similar research design to examine a more established psychological paradigm, Cognitive-Behavioral Therapy (CBT). Researchers from the Department of Psychiatry, at the Medical University of Gdańsk (Poland), studied the effect of CBT treatments on sleep quality and hyperarousal levels in adults diagnosed with primary insomnia. While the research design presents several similar areas of concern, the researches provide a more descriptive and precise methodology, specific and replicable data collection, and a more relevant conclusion.

DIAGNOSTIC DIFFERENCES

The 2013 acupressure and the 2012 CBT study both attempted to examine the effectiveness of their respective therapies in relationship to psychophysiological insomnia[8], the primary type of insomnia and sleep disturbance under care of a psychiatrist or psychologist.

Participants in the CBT study were diagnosed by psychologist with primary insomnia, using clinical criteria from the DSM-IV TR[9] as their diagnostic basis. Psychiatrist from the acupressure study instead utilized the ICSD-2 for diagnosing participants. What the DSM-IV TR refers to as primary insomnia, the ICSM-II manual, and the updated DSM (5)[10], refer to the condition as psychophysiological insomnia. The DSM-5 was released after the publication of the CBT study and more closely resembles the ICSM-II. Despite slight differences in terminology and format, the DSM-IV TR diagnostic criteria was essentially the same.

• A complaint of difficulty in initiating, maintaining sleep or experiencing non-restful sleep for more than one month
• Significant distress or impairment in functioning during waking hours
• Sleep disturbances must exclude known biological disruptions, environmental effects, medical conditions, mental illness, or substance use

COGNITIVE BEHAVIORAL THERAPY AND INSOMNIA

Cognitive Behavioral Therapy (CBT)[11], as a psychotherapy, attempts to relieve maladaptive thinking. These negativethought processes may cause behavioral, emotional, or psychosomatic dysfunctions. CBT presents patients with a logic-based therapy: a CBT therapist:

• assists patients in identifying and assessing thought patterns (cognitions) resulting in the undesired behavior(s)
• addresses misconceptions, regarding the patient’s thoughts or behaviors
• provides patients methods to alter their thought patterns in order to modify the desired behavior.

The Gdańsk study employed an insomnia specific CBT treatment developed by Dr. Michael Perlis[12]. Three key aspects of the therapy are:

1. Sleep Restriction Therapy: the therapist instructs the patient to restrict negative sleep behaviors—such as mid-day napping, and going to bed early—in order to adjust tiredness to the desired time frame
2. Stimulus Control Instruction: the therapist provides “do’s” and “dont’s” for maintaining restful sleep—the therapist and patient examine behaviors, thought patterns prior to attempting sleep, anxieties and other negative cognitions, determining patient specific conditions that may be disrupting sleep
3.  Sleep Hygiene Education: the therapist provides customized alterations to patient specific behaviors, attempting  to produce a guide for sleep, while allowing for the patient’s input and adjustment

Using the Perlis method, therapist also teach patients how to recognize and prevent reocurrences. Unlike acupressure, and Eastern “medicine” techniques, CBT has been well established in the literature, and is endorsed by the National Institute for Health[13].

The Gdańsk CBT study, when compared to the acupressure study, provided a superior attempt utilizing the same basic research design. The Gdańsk study provided relevant targeted behaviors and precise data collection with corresponding qualitative information. However, the study still shared similar design flaws, and failed to present a clear CBT as the specific cause relieving insomnia symptoms.

• The researchers provided extensive and precise data points for comparing therapeutic effects. The data collected was relevant to testing the hypothesis, but the chosen research design still suffers from inherently  weak internal validity.
• The researchers chose a specific mechanism of effect, an insomnia specific CBT treatment developed by Dr. Michael Perlis, but failed to explain specific methods provided in treatment.
• The study shows a strong correlation between CBT treatment and the relief of insomnia symptoms in participants, but does not provide sufficient data, due to design, to infer CBT as the sole causative factor for the therapeutic effect

AN INTRODUCTION

The Gdańsk study provided a literature review relevant to insomnia and specific to their targeted behaviors. Four behaviors are specified prior to testing the research effectiveness.

1. Sleep onset latency
2. Number of sleep awakenings
3. Sleep Quality
4. Psychophysiological hyperarousal

The study examined the efficacy of CBT treatment for primary—psychophysiological—insomnia though the four specified targets behaviors, and as a secondary objective, explored differences between persons more and less vulnerable to stressors predicting insomnia.

Each targeted behavior of the Gdańsk study was established prior to testing; previous research established these aspects as key factors of psychophysiological insomnia. The researchers provide multiple studies, establishing the four targeted behaviors. DSM provides similar information. By establishing specific points for testing, with established relevance, the researchers prevented issues of data-dredging for significance, a damning weakness of the acupressure study.

For comparison: the acupressure study briefly introduced the idea of insomnia, before diving into an exploration of Eastern “medicine”, and how acupuncture and acupressure restore the flow of energy along human body’s meridians (energy channels). The researchers explained a particular point on the body, the HT-7 point according to “tradition” —FYI > not established by any scientific tradition—seems to have a therapeutic effect in patients with disorders of sleep initiation and maintenance. Regardless of the existence of these meridians on the body, specific points, the Sea-Band doesn’t even claim to utilize that point.

The study aimed to assess the efficacy and safety of the HT-7 point acupressure system—the Sea-Band?— for treating insomnia in adolescents. They specified the use of a polysomnographic evaluation—without specifying which of the 22 data points they would consider relevant to their specific study, and why those points are relevant.

The DSM-IV TR[14] reveals the ineffectiveness of the polysomnography tests in distinguishing persons with insomnia from persons experiencing typical sleep (though the test may show impairments with sleep continuity—specifically sleep onset latency and frequent sleep awakenings).

THE DESIGN

The Gdańsk study recruited 26 individuals, in their early forties—22 women and 4 men. Persons presenting with insomnias other than primary insomnia were excluded from the study. Potential participants evaluated using the Hospital Anxiety and Depression Scale (HADS-M).[15] Individuals with high HADS scores were excluded from the study.

A Ford Insomnia Response to Stress Test (FIRST) was employed to test the secondary objective of the study, and separated participants into two groups-one group with a high vulnerability to stressors resulting in insomnia, the other group with a low vulnerability to stressors resulting in insomnia[16].

The study employed the four primary tests to assess sleep quality and hyperarousal associated with insomnia:

• Athens Insomnia Scale
• Leeds Sleep Evaluation Questionnaire
• Sleep Diary
• Actimetry Test

Treatment consisted of a supervised board certified CBT therapist providing the participants the Perlis CBT program for insomnia. Sessions were 50-minute, weekly, for 8-10 weeks, with one follow-up session at 3 months post-treatment.

RESULTS

The AIS scale was assessed prior to treatment, after treatment, and during the follow-up session. High scores relate to sleep difficulties. The results presented a significant change and a negative trend that continued after treatment, as of the follow-up session.

The AIS scale is a self-assessment test, established as an effective means for research and diagnosis of insomnia. It is a holistic assessment, including questions concerning sleep quality—awakenings, induction, duration—as well as, daily functioning and sleepiness.[17]

The study used the Hyperarousal Scale to determine hyperarousal levels in the participants. A significant statistical decrease was detected in psychophysiological arousal, as measured by the the Hyperarousal Scale.

Hyperarousal—somatic and cognitive arousals, often worrying or ruminating about sleeping or sleep onset—has proven to be a key component disrupting the sleep of persons  with insomnia (Espie et

al. 2006)[18]

The Hyperarousal Scale, another self-report assessment, has been established as a valid assessment of increased behaviors and thought patterns in persons with insomnia, when compared with EEG arousal measures.[19]

The study also used the Leeds Sleep Evaluation Questionnaire (LSEQ) to evaluate sleep quality, improved quality of falling asleep, and decreased morning awakenings.

The LSEQ is another self-report, assessed: a person’s quality of sleep, ability to get to sleep, quality of awakenings from sleep, and tiredness following wakening.[20]

The sleep diaries maintained by participants during and after treatment showed a significant decrease in

• Sleep onset latency—from more than 60 minutes, to nearly 20 minutes
• Number of sleep awakenings—from an average of 2, to an average of .04
• Sleep efficiency—77% before treatment, 93% after treatment

While subjective, if effective properly maintained, the sleep diaries provide not just expanded data to assess the process of the the treatment, but a method of self-assessment and potential therapeutic benefit.

The actigraphic test night/day ratio, performed over two seven-day periods—one  prior to treatment, and one following treatment—did not show a significant change in the ratio of night/day time (sleep/wake) time.

Actigraphic testing has shown to be as effective a test as polysomnographic study, neither have proven to be specifically as an identifier of persons with psychophysiological insomnia.[21][22]

Based upon the above findings, the Gdańsk researchers concluded CBT was an effective treatment for primary-psychophysiological-insomnia. Though the above assessments showed no significant relationship between participants with high vulnerability or low vulnerability as determined by the FIRST.

The Gdańsk study, like the acupressure study, employed an inherently weak research design. Both studies utilized a one-group pretest-posttest design[13]. A single group—in the Gdańsk study, adults with insomnia—are tested prior to therapy, provided the therapy, and tested after therapy. The Gdańsk study adds a second posttest, as well as multiple points of data throughout the therapy, via the sleep diary.

Unlike the acupressure study, the Gdańsk study attempts to balance this issue with these expanded data points. Each test is a relative test of hypothesis, and an established standard test within the fields of psychology and sleep medicine.

The Gdańsk study chose the actigraphic test over a polysomnographic test, despite the assertion—non-sequitur assumption?—from the acupressure research team, test results form either test cannot establish a relationship to psychological insomnia symptoms.[23]

Regardless of non-significance, the actigraphic test was assessed over seven days, during both the pretest, and the post test. The seven day test provides adjustments for natural variations in sleep. The test performed by the acupressure, on a single day, once before and after treatment, creates too many variables and cannot be an effective measure of sleep patterns.

The other test, while qualitative by design, have established a qualitative equivalence, or relevance, in assessing the various qualities in sleep affected by insomnia. While, the acupressure study attempts to express the importance of it’s quantitative test, the Gdańsk  study employed qualitative test that may prove more relevant, especially considering the study explored three distinct, established test providing and provided similar results, at three data-intervals—pretest, posttest, and during the 3 month follow-up. These results, in conjunction with the sleep diaries also assessing the study’s four target behaviors, provide significant data in concluding a relationship between CBT to improved sleep quality and diminished hyperarousal.

“Pharmacotherapy remains the most common treatment for insomnia. However, many studies suggest CBT may be a supreme therapeutic approach resulting in better long-term outcome (Morin 2006).”[24]

While several studies have shown CBT to be an effective treatment for insomnia[24] and other disorders—such as anxiety—and may be more effective than medicine for some mental illness. It remains difficult to determine whether simply receiving an attentive psychotherapy treatment for some issues are beneficial and CBT specifically. Current evidence shows CBT to be ineffective in persons with medical illnesses—as chronic fatigue syndrome-and certain mental illness—such as severe depression, bipolar and schizophrenia—and substance abuse issues.[26] 

The study mentioned using a modified mention of the Perlis treatment. Including specific methods employed during CBT therapy would increase the ability to generalize and replicate the study, and the study’s effects.

The Gdańsk study sees the lack of polysomnographic recordings as a serious limitation. However, the lack of a control group and the limited size of the sample provide a greater hit to internal validity. The lack of a control group, and random assignment increase bias for the experimenter and with the test group. The sample, enrolled by the study, hinders external validity and generalization.

While these flaws must be considered when considering the relevance of research, the study provided relevant data for CBT treatments of insomnia, in relation to the targeted behaviors.

The study clearly defines most methods, treatment and targeted behaviors, providing a basis for future research, and replication—though as mentioned above, a greater description of the methods of CBT would increase the ability to generalize the results.

Gdańsk researcher’s concluded the efficacy of the CBT treatment; however, the research design provides too many variables, and prevents causation with any certainty. At best, the research shows a strong relationship—correlation—between CBT treatments and insomnia management.

DISCUSSION

Why do physiological test have a hard time differentiating persons with psychophysiological insomnia from persons with typical, well-adjusted sleep patterns?

Does CBT offer an effective therapy, or has the current consensus of effectiveness within psychology/psychiatry provided CBT a better mask than acupressure, alternative therapies, or other psychotherapies?

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NEUROPSYCHIATRIC PSEUDOSCIENCE ATTEMPTS TO LEGITIMIZE ACUPRESSURE AND THE SEA-BAND TREATMENT

Insomnia is a disruptive and sometimes debilitating condition. Nearly 30% of adults report experiencing at least one symptom of insomnia^[1]. Though many of us experience situational insomnia to a degree—especially as a grad student—only about 6% of people experience insomnia severe enough to meet clinical criteria.

There are several types of sleep disruptions classified as insomnia. Psychological research of insomnia often focuses on psychophysiological insomnia.^[2]  To be classified as psychophysiological insomnia, the sleep disruption cannot be due to substance use, mental illness, or medical conditions. Diagnosis by the DSM-5^[3] must include dissatisfied sleep and at least one of the following criteria: sleep latency—difficulty initiating sleep; frequent nocturnal waking—difficulty maintaining sleep; prolonged periods of wakefulness; or undesired early waking. The sleep disturbance must also cause significant distress and dysfunction during non-sleep activity, and must occur for at least three nights a week over the course of three months.

A new study^[4] published in the Journal of Neuropsychiatric Disease and Treatment^[5] presents a suspect treatment for psychophysiological insomnia in adolescents. Researchers at the Clinic of Child and Adolescent Neuropsychiatry in Naples, recently concluded acupressure^[6] to be an effective therapy for managing insomnia in adolescents.

How? Unfortunately, I don’t know how. I have read the article a dozen times, and the science and research design are deeply flawed. 

I believe the study intentionally attempted to provide an unsubstantiated legitimacy to acupressure as an alternative therapy^[7]—specifically assisting the interests of the manufacturer of the Sea-Band device used within the study. The researchers used pseudo-scientific conventions to convey the pretense of scientifically valid clinical research. 

I fail to see how how the authors could present the data in the study as research. It is ill structured, even to infer a loose correlation, let alone conclude significance and effect—especially when considering:

• The study employed a flawed research design, vague data collection, and data-dredging^[8] to infer statistical significance.
• The researchers did not clearly define the mechanism of effect for the therapy.
• The study is full of logical fallacies^[9], further compromising the internal validity of the study and contributing to reader confusion.

THE STUDY DESIGN

The researchers explicitly described the study as an assessment of the efficacy and safety of an HT-7 point acupressure system when used to treat insomnia in adolescents. Yet, the study more accurately assessed the Sea-Band device, and does not conclusively treat insomnia.

The study did not examine or reference any established efficacy of Sea-Band as a treatment for insomnia, nor did it provide evidence for the efficacy of Sea-Band device as an acupressure device.

Further, the study inferred—relied on—acupressure as established therapy. Yet it did not provide a clear method of effect for either acupressure or the Sea-Band device.

“Insomnia can be treated with medication, herbal therapy, and psychologic or physical therapy. Commonly used medications include hypnotic/sedative drugs, but may have adverse effects, including impairment of memory, drug resistance, dependency, and addiction. Among the nondrug therapies for insomnia, acupressure, a method used for over 5000 years in Eastern medicine, is becoming increasingly popular worldwide.”

To establish acupressure as a potential therapy for insomnia, the author referred to a single study^[14]. That study reviewed meta-analysis of various studies combining acupuncture, acupressure, and reflexology; it concluded there was no evidence supporting any of these therapies as an effective treatment for insomnia.

Even presuming acupressure is a potential therapy, and stimulating the HT-7 point is the mechanism of effect, the author does not give clear cause for the premise that use of the Sea-Band is acupressure. In fact, while providing not further exploration into how they work, the Sea-Band website FAQ^[15] states the band exerts pressure and stimulates the P6 acupressure point, not the HT-7.

It is also not clear whether the devices were given to subjects with the pretense of improvement, or as a test for therapeutic effect, but the author specifically stated:

“The Sea-Band device was given to the patients in order to improve their symptoms related to difficulty falling asleep.”

This might convey to a potential participant—or an unsuspecting reader of the study—an unwarranted assumption of the established therapeutic ability of the Sea-Band device to diminish insomnia, and may also the confirmation bias of the research team.  

Researchers recruited 25 adolescents affected by psychophysiological insomnia. Subjects were caucasian from a middle-class socioeconomic background. Initial screenings and preliminary diagnoses were made by a neuropsychiatrist, utilizing criteria from the International Classification of Sleep Disorders (ICSD-2)^[10]—criteria from the ICSD-2 closely resembles the above DSM-5 criteria. 

The small sample size and the common locality of the sample subjects might present some concern—and were the only limitations of the study admitted to provided by the researchers—however, the sample size and criteria for diagnosis are not dissimilar to other sleep studies, and seem practical for an initial therapeutic investigation.

Subjects must have reported experiencing at least two of the following symptoms for at least two years prior to the study: fragmented sleep, frequent awakenings, early morning awakenings, or feeling tired due to poor sleep quality. They were given two Sea-Bands devices, to be worn bilaterally on the wrist at the Shen Men point on the wrists during normal bedtime hours.

Two sets of two polysomnographic sleep studies^[11] were performed. The first set established a baseline before acupressure “therapy,” and the second set to establish the effects after six-months of acupressure “therapy.” Researchers did not evaluate the first night of the sleep studies, from each set, in order to remove the first night effect^[12] known to produce unrepresentative sleep data.

The basic research design of the study is weak, and presents more questions than answers.

The study utilized a one-group pretest-posttest design^[13]. A single group—in this case adolescents with insomnia—are tested prior to therapy, provided the therapy, and tested after therapy. This design is generally referred to as a pre-experimental or quasi-experimental design. The internal validity of this type of test is compromised, due to the lack of a control group, and difficulty accounting for the impact of extraneous variables.

The addition of a control group—perhaps wearing a device similar in appearance to the Sea-Band—would have strengthen the validity of the research design.

Further, only two data points were used. A more effective study might have examined the subjects for multiple days during the pretest and posttest, and might have utilized sleep journals during the intervening therapeutic period.

DATA, DATA, EVERYWHERE

The research team collected and analyzed twenty-two separate criteria from sleep studies. Criteria included: Time in bed, total sleep time, sleep latency, percentage of time in specific sleep stages, sleep efficiency percentage (sleep time/time in bed * 100), etc. The team analyzed each data point using an analysis of variance test, and significance at the P value of < 0.05. They found a “significant” change in about half of the values. The significant results included: Increased time in bed, increased total sleep time, and reduced sleep onset latency.

“A strength of the the gold standard polysomnography for assessment of sleep alterations in order to circumvent subjective reporting by patients.”

The data does not support the explicit  hypothesis and relies on non-sequiturs to infer significance.

The researchers data-dredged. There hypothesis was vague, and they did not clearly state what and how they determine a change in sleep difficulty. By examining all 22 categories, the researchers presented a ripe opportunity for false pattern-recognition. This undermines the internal validity of the study—whatever internal validity remained—and severely muddies the conclusions of the study.

The researchers presumed the the device lessened sleep difficulties due to significant differences in only 11 of the 22 categories. They completely failed to acknowledge the p-values of criteria not supporting their hypothesis and the variability within their selected sample. Persons with insomnia do not have to experience all the symptoms to meet the clinical threshold—Instead:

• The study should have provided all clear changes in data values.
• The researchers should have predetermined data criteria, and established the importance of specific criteria for improving sleep quality.
• The researchers might have Instead examined only common values experienced by subjects.

The author used a non-sequitur argument to dismiss qualitative data and increase the perceived value of their quantitative data—researchers could have utilized a well designed qualitative survey to determine treatment efficacy, especially considering the initial criteria for diagnosis of insomnia is a dissatisfaction with sleep quality and an impairment of daily function due to lack of sleep. The change in the data provided presumes the therapy manages insomnia, without explaining how the data translates to insomnia relief, or whether subjects experienced a relief from their symptoms

CONCLUSIONS

“Acupuncture and acupressure are believed to restore equilibrium. Acupressure involves using the fingers, thumbs, palms, heels of the hand, and elbows to apply pressure and stimulate specific points along the meridians (or energy channels) of the body.”

The study concluded that acupressure could be a “safe, effective, and cost-effective therapy for the management of psychophysiological insomnia.” My conclusion: The researchers cherry picked data. The data’s support of hypothesis is vague and not clearly tested by the parameters of the study. Providing such a definitive conclusion, with such shoddy science, leads me to believe the researchers initiated the study with a pre-existing agenda, and intentional fraud, providing a disservice by further adding to public confusion and concern surrounding psychological research.

If a person with insomnia is concerned about the risks associated with sleep-aid medications, alternative therapies, like acupressure, provides a risk free alternative, also free of definitive results. But,

STAY-TUNED — My next post will examine the effectiveness of Cognitive Behavioral Therapy for psychophysiological insomnia.

STAY TUNED! Look for NEW posts every MONDAY! For updates, follow GETPSYCHED@getpsychedblog or on google+!

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