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:
- 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
- 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
- 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.
- Sleep onset latency
- Number of sleep awakenings
- Sleep Quality
- 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
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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[1]An Inaccurate Account of Acupressure’s Effect on Insomnia http://mgn1.me/16oB1fW [2] Carotenuto, M., et. al. (2013). Acupressure therapy for insomnia in adolescents: a polysomnographic study.Neuropsychiatric Disease and Treatment, 9(1), 157-162. http://europepmc.org/articles/PMC3559075/reload=0;jsessionid=HkcC9YFQkApU1TPB74cz.40 [3] Acupressure http://en.wikipedia.org/wiki/Acupressure [4] Sleep Disorders http://yoursleep.aasmnet.org/Disorder.aspx?id=42 [5] Logical Fallacy: Argument from Authority http://www.theskepticsguide.org/resources/logical-fallacies?wlfrom=%2Fresources [6] Gałuszko-Węgielnik M., Jakuszkowiak-Wojten K., Wiglusz M.S., Cubała, W.J., & Landowski J. (2012). The efficacy of cognitive-behavioural therapy (cbt) as related to sleep quality and hyperarousal level in treatment of primary insomnia. Psychiatria Danubina, 24(S1), 51-55.http://www.hdbp.org/psychiatria_danubina/pdf/dnb_vol24_sup1/dnb_vol24_sup1_51.pdf [7] Psychiatria Danubia http://www.hdbp.org/psychiatria_danubina/ [8] Sleep Disorders http://yoursleep.aasmnet.org/Disorder.aspx?id=42 [9] American Psychiatric Association. (2000). Sleep Disorders. Diagnostic and Statistical Manual of Mental Disorders (4th ed., tex rev.). Washington, DC: Author. [10] American Psychiatric Association. (2013). Section II: diagnostic criteria and codes, sleep-wake disorders. Diagnostic and Statistical Manual of Mental Disorders (5th ed.). DOI: 10.1176/appi.books.9780890425596.685034 [11] Cognitive Behavioral Therapy http://en.wikipedia.org/wiki/Cognitive_behavioral_therapy [12]Michael Perlis http://www.med.upenn.edu/bsm/faculty_perlis.html [13]Insomnia [NIH] http://www.nhlbi.nih.gov/health/health-topics/topics/inso/treatment.html [14] American Psychiatric Association. (2013). Section II: diagnostic criteria and codes, sleep-wake disorders. Diagnostic and Statistical Manual of Mental Disorders (5th ed.). DOI: 10.1176/appi.books.9780890425596.685034 [15] Hospital Anxiety and Depression Scale http://en.wikipedia.org/wiki/Hospital_Anxiety_and_Depression_Scale [16] Ford Insomnia Response to Stress Test (First) http://termwiki.com/EN:ford_insomnia_response_to_stress_test_(FIRST) [17] Athens Insomnia Scale http://www.ncbi.nlm.nih.gov/pubmed/11033374 [18] Espie, C.A., Broomfield, N.M, MacMahon, K.M.A., Macphee, L.M., Taylor, L.M. (2006). The attention–intention–effort pathway in the development of psychophysiologic insomnia: a theoretical review. Sleep Medicine Review, 10(4),215-245.http://www.sciencedirect.com/science/article/pii/S1087079206000219 [19] Pavlova, et al. (2001). Self-reported hyperarousal traits among insomnia patients. Journal of Psychosom Res, 51(2), 435-441. [20] LSEQ example http://www.nps.org.au/publications/health-professional/nps-radar/2010/may-2010/melatonin/melatonin-web-extra [21] American Psychiatric Association. (2013). Section II: diagnostic criteria and codes, sleep-wake disorders. Diagnostic and Statistical Manual of Mental Disorders (5th ed.). DOI: 10.1176/appi.books.9780890425596.685034 [22] Polalck C.P., Tyron, W.W., Nagaraja, H., & Dzwoncyk, R. (2001). SLEEP, 24(8), 957-965. http://www.journalsleep.org/Articles/240811.pdf [23] American Psychiatric Association. (2013). Section II: diagnostic criteria and codes, sleep-wake disorders. Diagnostic and Statistical Manual of Mental Disorders (5th ed.). DOI: 10.1176/appi.books.9780890425596.685034 [24][25] Morin, C.M. (2006): Combined therapeutics for insomnia: should our first approach be behavioral or pharmacological? SLEEP, 7, S15-19. http://www.ncbi.nlm.nih.gov/pubmed/16702028 [26]Hofmann, S.G., Asnaani, A., et al. (2012). The efficacy of cognitive behavioral therapy: a review of meta-analyses. Cognitive Ther Res, 38(5), 427-440. http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3584580/
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