CHAPTER ONE
Introduction
Major depressive disorder (MDD) is one of the most prevalent psychiatric disorders (Kessler et al, 2003) and foremost public health threats of the 21st century (Judd, 2000). Current estimates suggest MDD affects 151 million individuals worldwide, with a 16.2 % lifetime prevalence (Reinhold, 2008). According to the American Psychiatric Association (APA), depressed mood is central to the diagnosis of MDD. This neuropsychiatric disease is characterized by a complex constellation of cognitive, behavioral, and physical symptoms that can impair normal and instrumental activities of daily living. The cardinal symptoms are depressed mood, sadness, hopelessness, sleep disturbance, changes in appetite and weight, loss of interest, guilt, difficulty concentrating and suicidal ideation (Reinhold, 2008). According to Rubio et al. (2011), MDD carries a burden that creates a need to understand the condition and areas of alleviating its symptoms. Major depressive disorder manifests most commonly as a disturbance in emotion (depressed mood) with a ratio of high negative and low positive emotions. With its chronic nature and propensity to remit and relapse depending on life circumstances and treatment, MDD results in functional impairment in numerous life domains and is a leading predictor of increased morbidity and mortality (Rubio et al, 2011).
Electroconvulsive therapy (ECT) is a neurostimulation therapeutic intervention that is highly effective and most often used to treat certain psychiatric conditions, in particular MDD (Trevino, McClintock & Husain, 2010). However, it has been and remains a controversial method of treatment. The clinical literature establishing the efficacy of ECT in specific neuropsychiatric disorders is among the most substantial for any medical treatment. Various sources of evidence support the efficacy of ECT in the treatment of MDD. The decision to recommend the use of ECT derives from a risk/benefit analysis for the specific patient. This analysis takes into consideration the diagnosis of the patient, severity of the presenting illness, the patient’s treatment history, medical risks and anticipated adverse effects, and the likely speed of action, efficacy, and safety of alternative treatments (Fink, 2001).
Electroconvulsive therapy is considered a first-line treatment when medical or psychiatric factors require a rapid and robust clinical response, when ECT poses less risk to a patient than medication (e.g., during pregnancy or in elderly patients), when there is a clear history of medication resistance or a history of favorable response to ECT, or when the patient prefers ECT to other psychotropic treatments. The intervention involves the application of a mild electrical current in specific neurocortical areas for the purpose of inducing a therapeutic generalized seizure. Commonly, ECT is administered two to three times per week, with an electrode configuration of right unilateral placement and an ultra-brief pulse width (Lisanby, 2007).
To determine the impact of ECT treatment, it is necessary to evaluate outcome in terms of change in depressive symptoms. The growing importance of symptom reduction in managing MDD has been recognized for several years (Rush et al, 2003). Although the effectiveness of ECT for patients with MDD has been controversial (Lisanby, Pallanti, et al., 2009), there is a need to better understand how many treatments and which electrode configuration (right unilateral, bitemporal, bifrontal) would be most effective and efficient for patients with MDD. Thus, the current study proposes to use the 16 item-Quick Inventory of Depressive Symptomatology –Self Report (QIDS-SR16) (Rush, Trivedi, Ibrahim, et al. 2003) to exam the effectiveness of ECT.
The QIDS-SR16 is a brief reliable valid measure of the DSM-IV-TR symptom criteria for MDD (Rush, Trivedi, Ibrahim, et al. 2003).
. The QIDS-SR16 was created to match the symptom profile construction included in the DSM-IV-TR and to provide a measure of depression severity that could be completed in a time efficient manner (Rush, Trivedi, Ibrahim, et al. 2003).
The purpose of this study is to contribute to the outcome studies in ECT for MDD, and specifically, for the first time use a patient self-report instrument (i.e., QIDS-SR16) to determine treatment related outcome. Although, ECT has gained popularity for the treatment for MDD, to our knowledge, there have been little to no studies that examined its effectiveness per a self-report depression severity measure. In this study we want to examine those depressive symptoms that are codified in the DSM-IV-TR. Shared decision making between the patient and clinicians that has been advocated in the medical community is important since clinicians rely on patient’s self report of their symptoms to inform the proper treatment course. The rationale for using QIDS-SR16 is that self report scales are free of clinician bias and are therefore free from clinician over estimation of patient improvement (Zimmerman, 2012); the measurement includes all nine DSM-IV-TR criterion for depression. And it has been translated into multiple languages and gained international respect that furthers its utility. The researchers will examine the differences between pre- and post- treatment scores on the QIDS-SR16 in a clinical cohort of patients with MDD treated with ECT. Given the findings from previous studies (Husain, McClintock, Rush, et al., 2008); (Lisanby, 2007); (Husain, Rush, Fink, et al., 2004) and (Trevino, McClintock, & Husain, 2010), the researchers hypothesized that depressive symptoms in people with a diagnosis of MDD will lessen over an acute ECT course.
CHAPTER TWO
Review of the Literature
MAJOR DEPRESSIVE DISORDER
Major Depressive Disorder (MDD)
Major Depressive Disorder (MDD) is a common, typically recurrent, often chronic, and very disabling disorder affecting approximately 14 million adults in the United States (US) each year. When left untreated or inadequately treated, there is substantial societal cost and personal morbidity. Society as a whole is heavily burdened by depressive illness. The annual financial cost of effective illness has been estimated at 44 billion dollars in total costs (Reddy, 2010). The World Health Organization (WHO) estimates that at its current rate, MDD will be the second only to ischemic heart disease with regard to the most common cause of disability worldwide by 2020. Major depressive disorder has a lifetime prevalence of 4.9-16.2%. Severe depression can impair the quality of life and lead to death by suicide. Indeed, the lifetime risk of suicide among patients with affective disorders is 6 to 15% (Lisanby, 2007).
Epidemiology
Usually, MDD is an episodic disorder with on average one episode every five years (Rush et al., 2004). Of persons with MDD in the US, 20-35% experience a chronic unremitting course (Rush, et al., 2004). Long episodes of MDD appear to be more difficult to treat (Rush et al, 2004). Major depressive disorder occurs more frequently among young and elderly adults and those with general medical conditions. Depressed adults have nearly twice the annual health care costs of those without depression (Reddy, 2010).
Epidemiological studies related to MDD found that women have greater prevalence of MDD compared to men, which has been a conclusive finding over time since 1977 to the present (Romans, Tyas, Cohen, & Silverstone, 2007). Despite the conclusive nature of this finding, researchers and clinicians have yet to explain the reason for the gender disparity. Romans et al. (2007), post several probable reasons gained from literature synthesis including differences in social roles, artifacts derived from measurements, and biological differences.
A recent research study qualifying the gender differences was by Lai (2011) through 16-item Quick Inventory of Depressive Symptomatology-Self Report (QIDS-SR16), Integral Inventory for Depression (IID), and EuroQol life quality scale, showed that female participants had higher scores on the three scales. Significant gender differences of sadness, sleep, appetite, painful symptoms, and sexual functioning were observed. The MDD episodes were related to the EuroQol life quality scale and the SDS. Interepisode years were associated with the IID. The Sheehan disability scale used in the study was correlated with QIDS-SR16 with statistical significance. In conclusion, patients with MDD showed a correlation between symptoms and functional impairment. Female patients might be more sexually impaired, more vegetative, more depressed, and experiencing more sadness and physical pain (Lai, 2011).
Epidemiological studies (Rubio et al., 2011) estimate 12-month and lifetime prevalence for MDD in the United States to be 5.3% and 13.2%, respectively. According to Rubio et al (2011), studies of clinical samples suggest that 10-30% of individuals with MDD develop a chronic course despite adequate treatment, indicating that MDD is a major public health problem. When the lifetime risk of MDD was examined across sociodemographic population subgroups, significant higher rates of MDD were found among women. And among race and ethnic groups, the odds of MDD were higher in Native Americans and significantly lower among Asians, Hispanics, and African Americans compared to Caucasians. Respondents who were middle aged (45 to 64 years of age) or widowed, separated, or divorced than those that were married or cohabitating, and those in lower income levels had higher rates of MDD. For each successively lower category of income, risk of MDD weakly increased, although only the lowest category (<$19,999/y) differed significantly from the highest. Risk of MDD did not differ by urbanicity, region, or education (Rubio et al, 2011).
Symptoms and Treatments
Major Depressive Disorder is the fourth most disabling medical condition worldwide based on disability-adjusted life years (years of life lost due to premature death and years lived with a disability of specified severity and duration) (Grosse, Lollar, Campbell, & Chamie, 2009). During a major depressive episode (MDE), normal mood usually changes to depressed or anhedonic, which is reflected in all areas including family, social, and work. The definition of MDD according to the Diagnostic and Statistical Manual of Mental Disorders Fourth Edition Text Revised (DSM-IV-TR), states that a person must have depressed mood or anhedonia, and at least five other depressive symptoms present during the same 2-week period that represents a change from prior function. At least one of the symptoms is either depressed mood or loss of interest or pleasure.
The nine symptom criteria are:
1. depressed mood most of the day, nearly every day, as indicated by either subjective report (e.g., feels sad or empty) or observation made by others (e.g., appears tearful);
2. markedly diminished interest or pleasure in all or almost all, activities most of the day, nearly every day, (as indicated by either subjective account or observation made by others);
3. significant weight loss when not dieting or weight gain (e.g., a change in more than 5% of the body weight in a month), or a decrease or increase in appetite nearly every day;
4. insomnia or hypersomnia nearly every day;
5. psychomotor agitation or retardation nearly every day (observable by others, not merely subjective feelings of restlessness or being slowed down);
6. fatigue or loss of energy nearly every day;
7. feelings of worthlessness or excessive or inappropriate guilt (which may be delusional) nearly every day (not merely self-reproach or guilt about being sick);
8. diminished ability to think or concentrate, or indecisiveness, nearly every day (either by subjective account or as observed by others) and;
9. recurrent thoughts of death (not just a fear of dying), recurrent suicidal ideation without a specific plan, or a suicide attempt or a specific plan for committing suicide.
Per the DSM-IVTR criteria, for depressive episodes to qualify as MDEs they cannot be better accounted for by schizophrenic, delusional, or psychotic disorders. Also, the depressive symptoms cannot meet criteria for a mixed episode and are not due to the direct physiological effects of a substance or general medical condition. MDD has been found to be comorbid with nicotine dependence (Fink, 2001), alcoholism (Reinhold, 2008), anxiety (Judd et al., 2000), and other psychological illnesses. Those diagnosed with MDD may suffer from the disease throughout their lifetime.
Major Depressive Disorder is a complex and heterogeneous disorder that is comprised of three broad domains of clinical symptoms: mood, cognitive function, and neurovegetative symptoms. The cause of depression is thought to be complex, including various genetic, developmental, and environmental factors (Lisanby, 2007). It is distinct from normal sadness by its persistence for longer than 2 weeks and concordance with other depressive symptoms (Howland, 2008).
There are several approaches to diagnosing MDD that rely on various neuropsychiatric diagnostic instruments (Kessler et al., 2003). The relationship between MDD and increased disability and reduced quality of life is well established in the literature (Langlieb & Guico-Pabia, 2010). Even with systematic antidepressant strategies, MDD is a debilitating disease that is difficult to treat (McClintock, Husain, Wisniewski, et al., 2011). Severe depression can be a life threatening illness and is associated with a high suicide rate.
Early symptomatic remission is the aim of antidepressant treatment. For optimal treatment planning, clinicians, patients and their families need to know the probability and time to onset of a clinically meaningful benefit, defined as a sustained response (i.e., a clinically important reduction in the severity of baseline symptoms that persists) or remission (i.e., a symptom-free state) (Husain et al, 2004). There are many antidepressant strategies available for the treatment of MDD. Psychotropic medications are a common first line treatment. Earlier psychotropic agents included tricyclic antidepressants, monoamine oxides inhibitors, and lithium. Newer agents have expanded treatment options in order to reduce side effects. Despite the availability of these better tolerated antidepressant medications, only 50% of patients with MDD evidence a sustained response with any single antidepressant medicine, and only about one third attain full symptom remission in 8-week medication monotherapy trials (Husain et al, 2004). About 50% of depression cases recur after the first episode, with recurrence rates increasing to 70% after the second episode and 90% after the third episode (Department of Veterans Affairs & Department of Defense, 2009). The more chronic forms of depression may not respond to medication until after eight to ten weeks of psychotropic treatment, and for many of these patients, remission may not occur until sometime during continuation-phase treatment (Husain et al, 2004).
Electroconvulsive Therapy
Electroconvulsive therapy (ECT) is a highly effective treatment for patients with severe or medication-resistant depression (Lisanby, 2007). Per the APA, ECT is a third tier treatment option that may be useful in those cases where the MDE was resistant to psychotherapy and medication (NIMH, 2011c). For example, the Sequenced Treatment Alternatives to Relieve Depression (STAR*D) trial showed MDD in a majority of the patients was unresponsive to treatment with single or combined psychotropic medications. Further, clinical outcomes of treatment with antidepressant medications in the elderly may be suboptimal in part because of intolerance or side effects to antidepressant agents (Rush, 2006). These provide examples of where ECT may have a role in treating depression.
History of Electroconvulsive Therapy
The use of electricity as a treatment for medical disorders has a long and enduring history (Abrams, 2002). Historical accounts estimate the use of electricity dates back to at least 1470 (Endler and Persad, 1988). Before electric generators were developed in the 18th century, electric eels or electric catfish were sometimes applied to the head to treat psychiatric illness. One such report indicated that such treatment could cure psychogenic blindness (Endler and Persad, 1988). The use of electricity to treat medical disorders during the 18th century was short-lived though due to the underdevelopment and lack of available electrical devices (Gangadhar, 1997).
Medical interest was renewed beginning in the middle of the 19th century due to advances in technology that produced devices with newer technical parameters (Endler & Persad, 1988). In 1868, a two volume work titled Elektrotherapie (Benedikt, 1868) on electrical treatment for medical disorders was published. Elektrotherapie provided physicians with instructions for treating various illnesses. There was recommendation to discontinue the use of electricity for treating neurological conditions because of its transient nature and because patients’ treatment responses to electricity varied greatly, attesting to a lack of credible evidence to continue the practice (Fink, 2001).
Evolution of Electroconvulsive Therapy
When ECT was first introduced in the 1930s as a treatment for neuropsychiatric disorders, early experience with the treatment raised concerns about serious side effects, including fractures (before the use of neuromuscular blocking agents) and cognitive impairment (in part related to the dose and technique).. Consequently, the use of ECT declined due to its adverse effects and the introduction of antidepressant pharmacologic agents. In recent decades though, further research and methodological advances have led to renewed interest in the role of ECT for the treatment MDD. Its main use is in the treatment of treatment-resistant MDD or in conditions related to severe depression such as catatonia, emerging suicidal lethality, and psychosis
The second edition of the guidelines of the American Psychiatric Association (APA) Task Force on Electroconvulsive Therapy, which was published in 2001, includes a complete description of the current clinical use of ECT. Briefly, the primary indications for ECT include a MDE that is unresponsive or intolerant to antidepressant treatment, good response to prior ECT, and the need for a rapid clinical response. The decision to use ECT depends on several factors, including the severity and chronicity of the MDE, the likelihood that alternative treatments would be effective, the treatment team and patient preferences, and a weighing of the risks and benefits.
The administration of ECT has significantly changed since its first introduction. In the last 35 years, refinements of ECT instruments and procedures have decreased many of the side effects believed to be associated with memory loss while increasing the efficacy of ECT (Lisanby, 2007). The administration of ECT was improved by use of the constant medical monitoring (e.g., EKG and EEG monitoring) (Lisanby, 2007) and muscle relaxants and short-acting anesthesia. Regarding the ECT technique, current standards recommend the use of brief or ultra-brief pulse wave forms, empirical dose titration, and unilateral electrode configuration (Kellner, 2010). Given the many refinements to the administration of ECT, some (Prudic et al., 1996) have suggested earlier clinical trials did not accurately depict its efficacy and incidence of cognitive side effects.
Electroconvulsive Therapy Procedure
Modern ECT includes the routine use of oxygenation, anesthesia, and continuous physiologic monitoring. These advancements have made ECT more effective and much safer than in the past. There are no absolute contraindications to ECT, but factors that have been associated with reduced efficacy including a prolonged MDE, lack of response to medication, and coexisting psychiatric diagnoses such as a personality disorder. Persons with unstable cardiac disease such as ischemia or arrhythmias, cerebrovascular disease such as recent cerebral hemorrhage or stroke, or increased intracranial pressure may be at increased risk for ECT associated complications. Practically speaking cerebral aneurism or related conditions might reduce risk/benefit. When considering the risk/benefit it is the patient’s decision as well as the treatment team. The pre-ECT workup therefore should include a complete medical and neurological evaluation to detect and manage such conditions (Husain, 2004). For at-risk populations such as elderly adults, persons with cardiac problems, and pregnant women, ECT can be a safe and effective treatment.
Common electrode positions include bitemporal, right unilateral, and bifrontal. Right unilateral and bifrontal placements may be selected to reduce the burden of side effects, whereas bitemporal placement may be selected if the other electrode configurations are unlikely to be effective (e.g., in patients in whom previous ECT treatment with the latter positions has failed) (The UK ECT Review Group, 2003).
Electroconvulsive therapy has a range of effects on the neurobiological features of depression. According to Lisanby (2007), ECT increases cortical y-aminobutyric acid (GABA) concentrations and enhances serotonergic function that may influence neurocortical processes and lead to decreased MDD. Indeed, the Consortium for Research in ECT (CORE) trial reported a 75% remission rate among 217 patients who completed a short course of ECT during an acute episode of depression (Kellner et al., 2006). The number of sessions of ECT will depend on the severity of the MDE and the clinical response during the course of treatment. ECT is accomplished by placing an electrode(s) on the forehead, temporal region, or crown of the head of an individual, depending on employed ECT method. Specific and controlled amounts of electricity are then administered to the brain (Fink, 2001). Seizures are hypermetabolic states accomplished by a large group of neurons firing at once. As a result of the seizure, marked transformations occur in cerebral blood flow, cerebral oxygen consumption, and cerebral metabolic rate (Sackeim et al., 2001). Concluding the seizure, neuronal firing and cerebral blood flow drop below normal levels due to its natural inclination to return to homeostasis. Research also suggests seizures alter biochemical compounds in the brain such as enzymes, proteins, and neurotransmitters, thus resulting in reduced depressive symptoms (Kellner, 2011). The electroencephalogram is monitored during ECT to confirm seizure activity and to document seizure duration. In addition, the medical team monitors seizure motor activity. This technique involves the placement of a tourniquet around an ankle before the administration of the muscle relaxant so that there is maintenance of the potential for muscle contraction in the foot. Oxygen saturation and cardiac rhythm are monitored during the procedure.
Effectiveness of Electroconvulsive Therapy
Agreement on the effectiveness of ECT in treating MDD is undisputed; however, controversies exist on administration of treatment especially on electrode placement specifically the anatomic location of the stimulus electrodes on the individual scalp (Kellner, et al., 2010). The contention in ECT is on the balance of antidepressant efficacy of treatment compared to its cognitive effect on the patient. ECT course is assigned through bifrontal, bitemporal, and right unilateral electrode placement, and as shown in findings by Kellner et al. (2010), these have different efficacies. Bifrontal placement is to one and a half times seizure threshold, while bitemporal is similar, and unilateral is at six times seizure threshold. Seizure threshold is a measure of the minimum electrical energy necessary to induce a generalized seizure (Fink, Petrides, Kellner, et al., 2008). The findings show that bitemporal placement has greater efficacy with more rapid symptom reduction and could be the better placement for urgent clinical situations. Other findings have shown that right unilateral ECT placement is less effective compared to bitemporal ECT and could be a cause for fewer cognitive effects. However, a recent study suggested that right unilateral electrode placement must be delivered at multiples of seizure threshold to be maximally effective resulting in the same cognitive effects as bifrontal and bitemporal electrode placement (Kellner, Tobias and Wiegand, 2010). Other studies have tried multiple placements of electrodes in unilateral, finding that multiple placements have greater efficacy compared to the traditional placements. The bifrontal placement has been reported to have similar efficacy to the bitemporal placement although it has fewer cognitive effects. Despite the controversies in electrode placement, the use of ECT in alleviating the depilating effects of MDD remains an attractive option in using the treatment. Sackeim et al (2008) found ultra-brief bitemporal ECT to have markedly inferior antidepressant efficacy than ultra-brief unilateral ECT. However, the Sienaert et al (2009) study reported an advantage to the use of ultra brief unilateral ECT, when speed of response is concerned. The found patients that were treated with unilateral ECT met response criteria after a significantly lower number of treatment sessions. Furthermore, the estimated odds of achieving response and remission criteria were higher for patients receiving unilateral ECT as compared to patients receiving bifrontal.Electroconvulsive Therapy Dosage
The efficacy of ECT is highly dependent on technique, with remission rates ranging between 20% and 80%, depending on how the treatment is performed (Lisanby, 2007). Double-blind, randomized, controlled clinical investigations have shown interactions between electrode placement and dosage (relative to seizure threshold) in the efficacy and side effects of ECT (Lisanby, 2007). In a review of 22 trials that involved 1408 patients, the United Kingdom ECT Review Group (Lisanby, 2007) reported that bilateral electrode placement was moderately more effective than right unilateral placement, but the efficacy of right unilateral ECT was dose-sensitive, and several of the included trials in that analysis may have used insufficient doses. Several studies have not shown a difference in efficacy between high-dose right unilateral and bilateral ECT, and these studies (Sackeim, Prudic, Devanand, et al., 2000); (McCall, Reboussin, Weiner, & Sackeim, 2000) have indicated that unilateral electrode placement on the right side was associated with a lower incidence of memory loss, especially at long-term follow-up.
The ECT dose is measured in millicoulombs of charge delivered and the dose administered must be sufficient to induce seizure activity. One approach, called the empirical seizure-threshold titration, involves giving progressively higher doses during the initial ECT session until the seizure threshold is reached, and then selecting a dose at various percentages above the seizure threshold during subsequent treatment sessions. Another accepted approach involves the use of an age-based or half-age based dosing algorithm, although this technique has some limitations, since age accounts for only a small percentage of the variance in the seizure threshold (Husain et al, 2004).
The existent ECT literature provides numerous possible explanations to describe how ECT results in therapeutic benefits. Biological explanations contend the brain has a natural proclivity to return to a normal state of balance inside the body, where the body systems work together to keep it functioning in a normal state (Sackeim, et al., 2001). Nonetheless, it remains unclear how ECT provides therapeutic benefit (Fink, 2001).
The results of studies that compared different schedules of ECT administration suggested that, for patients in whom ECT was indicated, a three times a week ECT conferred greater antidepressant effect than one time a week ECT. Furthermore, there was consistent evidence that the two times a week and three times a week ECT schedules were comparable in antidepressant efficacy. However, the results were conflicting in the speed of antidepressant effect. Although Gangadhar et al (1982) reported no advantage for the three times a week ECT, Kellner et al (2010) and Sackeim et al (2000) showed that the three times a week schedule was associated with faster clinical response. However, the three times a week schedule also resulted in increased cognitive impairment that subsided one month after treatment.
Overall, it seems that for treating depression on an outpatient or inpatient basis, a typical course of ECT involves between six and twelve treatments, depending on the severity of the depressive symptoms and the rapidity of the response. Electroconvulsive therapy is generally administered three times per week. Psychotropic medication may be instituted for the purpose of continuation treatment to maintain the ECT clinical response. Since premature discontinuation of ECT can predispose the patient to relapse of depressive symptoms, it is important to monitor the efficacy of the treatment in a systematic fashion. Some patients may need maintenance ECT to avoid relapse. Maintenance ECT is administered generally at a rate of one treatment weekly then reduced to bi-weekly to monthly for up to one year (National Institute of Mental Health, 2003). Efficacy can be monitored by using standardized rating scales for depression or by keeping track of the severity of selected targeted symptoms. Importantly, the medical team should track the side effects that emerge during treatment, such as amnesia, with the use of rating scales of cognitive performance and memory.
Review of the 16-item Quick Inventory of Depressive Symptomatology –Self-Report (QIDS-SR16)
The QIDS-SR16 (Rush, Trivedi, Ibrahim, Carmody, & Arnow, 2003) is a 5-7 minute self-report measure that assesses symptom severity and symptomatic change. The item content was designed to cover all “diagnostic criteria for major depressive disorder” outlined by the DSM-IV-TR (APA, 2010).
Self-report measures have an advantage over clinician-rated instruments in medical settings because they do not require staff time or training to administer, and can be completed in the waiting room by patient. In research settings self-report measures are free from clinician over estimation of patient improvement, which might occur when there are some incentives to document treatment success (Zimmerman, 2012). The measurement is a cost-effective option because it is inexpensive in terms of professional time needed for administration. In the Greenberg et al (1992) study the authors stated that clinicians involved in placebo-controlled medication random controlled trials may detect subtle cues, “knowing” which patients were on active medication (Hughes & Krahn, 1985; Rabkin et al, 1986). They support this finding by the fact in other studies only the clinician report, but not the self report, distinguished active medication from placebos (Edwards et al, 1984; Lambert et al, 1986). These findings suggest self report measures could be more valid than clinician report measures.
To reduce the time needed to appraise depressive symptom severity, the 16-item Quick Inventory of Depressive Symptomatology (QIDS16) was developed (Rush et al 2003; Trivedi et al 2004b) in both a clinician-rated (QIDS-CR16) and self-report (QIDS-SR16) version to improve on the available clinician and patient ratings by providing equivalent weightings (range 0-3) for each symptom item along with provide clearly stated anchors that estimate the frequency and severity of symptoms. The QIDS-SR16 scales are based on the 16 QIDS items that convert responses and obtain ratings (range 0–3) concerning all nine criterion symptom domains (Rush et al 2003; Trivedi et al 2004b). The questions are identical for the QIDS-C16 and the QIDS-SR16. For both versions of the QIDS, four items are used to assess the sleep domain (initial, middle, and late insomnia, as well as hypersomnia). Two items are used to gauge psychomotor activity (agitation and retardation). Four items assess the appetite/weight domain (i.e., appetite increase and decrease, weight increase and decrease). For each of these three domains, the highest rating on any one relevant item is used to score the domain (range 0 –3). Only one item is used to score the remaining six criterion domains (each rated 0 –3) (sad mood, concentration, energy, interest, guilt, suicidal ideation/plans).
The QIDS-SR16 has been shown to have a sensitivity to change and is capable of rapidly and reliably defining response and remission. It closely parallels results obtained with the longer commonly used clinician ratings such as the Hamilton Rating Scale for Depression (HRSD) (Hamilton, 1960;1967) and the Montgomery-Asberg Depression Rating Scale (MADRS) (Montgomery & Asberg, 1979) in outpatients treated for chronic, nonpsychotic major depressive disorder (Rush et al, 2004). These clinician rating scales do not specifically identify and weigh equally each of the diagnostic criterion symptoms specified by DSM-IV-TR. Rush et al (2006) suggests that common symptoms (e.g. sad mood) should contribute to a greater degree to the total severity. Self report versions of the clinician rating scales mentioned above are available. However, the inherent limitations in the original clinician ratings likely apply to the self report versions (Rush et al, 1996). The authors suggest that the QIDS-SR16 may be helpful in monitoring symptom outcome changes during treatment for patients and for health care systems (Rush, et al., 2004).
In studies (Rush et al., 2004) comparing the QIDS-SR16 with the HRSD17 in a group of depressed outpatients, the QIDS-SR16 had acceptable test homogeneity at exit. The QIDS-SR16 seemed to measure a single construct more effectively than the HRSD17 in the study, this may have been due to the fact that the QIDS-SR16 measures only the nine core DSM-IV-TR diagnostic criteria and therefore, adheres more closely to the central concept of depression whereas, the HRSD17 includes anxiety items. The QIDS-SR16 may show greater sensitivity to remitting depression in patients than does the HRSD17. Thus, the QIDS-SR16 seems to be an acceptable tool for the evaluation of depressive symptoms and for monitoring of depressive response to treatment in patients.
In a study conducted through Sequenced Treatment Alternatives to Relieve Depression (STAR*D), Howland (2008) compared the efficacy and tolerability of various antidepressant therapies in four sequential levels of treatment. While the study focused on pharmacological treatment, it provides justification to use self report measures as a primary outcome and predictor measure. Among the measures used to access secondary outcomes the QIDS-SR16 score was obtained at baseline and during each treatment visit. To further understand the development and application of the QIDS-SR16, an exploration of the QIDS-SR16 was developed and evaluated is important.
The QIDS-SR16 has been used in a variety of research and clinical settings, including inpatient and outpatient psychiatric clinics and primary care settings. Rush, et al. (2006) states that clinical practice and clinical trial research would benefit greatly if a self-report rating of depression severity and specific depressive symptoms could be found that reasonably reflects findings obtained from more time-consuming clinician ratings.
Several types of validity and reliability have been established for the QIDS-SR16 (Rush, 2004). Information regarding internal consistency and validity of this measure has been gathered. The QIDS-SR16 scores were compared to depression diagnoses in participants’ medical charts as an external criterion. For construct validity, the QIDS-SR16 scores were compared to the scores on the Veteran’s Rand 36-Item Health Survey (VR-36). Internal consistencies ranged from 0.81 to 0.94 for QIDS-SR16 (Trivedi, et al., 2004). Therefore, the QIDS-SR16 was found to have good reliability and impressive construct validity. Strong psychometric properties of this brief self report format and its sensitivity to treatment change suggest that the QIDS-SR16 is a valuable clinical tool (Brown, et al., 2007).
CHAPTER THREE
Methodology
Participants
Participants were those patients treated with ECT on an inpatient or outpatient basis at the University Hospital (UH). One hundred participants were selected for the current study. The UH ECT unit follows the APA ECT guidelines (2001). Consent was obtained prior to treatment and the informed consent process is continued across the complete ECT course. In order to receive ECT at UH, the patient needs to have a psychiatric diagnosis of mood disorder, the most typical being MDD. The patient has to be cleared by the medical and anesthesiology team prior to beginning ECT. The standard procedure for ECT is Right Unilateral (RUL) electrode configuration, ultra-brief pulse-width, and use of the empirical titration method for establishing the dose. The initial treatment is the titration session and subsequent treatments are provided at six times the seizure threshold. The electrode configuration is switched to Bitemporal (BT) around the eighth treatment if there is no clinical response. Treatments are typically administered three times a week for inpatients and two times a week for outpatients. However, variances in the outpatient frequency occurred.
Electroconvulsive Therapy Procedure
Once a patient has been cleared to receive ECT, the procedure begins with monitoring sensors being placed on the patient’s head and other parts of the body. A blood pressure cuff is placed on one of his/her limbs to monitor blood pressure, brain waves and the heart. After the patient is under anesthesia, a controlled amount of electricity is passed between two electrodes that have been placed on the patient’s scalp. Typically the dose used is 1.5 to 2.5 times the seizure threshold for BT ECT, and six times the seizure threshold for RUL. A therapeutic, generalized seizure is generated in the brain. The device used at ZLUH is the Mecta SPECTRUM. Upon completion of treatment, the patient is taken to a recovery room and is monitored until he/she leaves the ECT area.
QIDS-SR16 Procedure
The QIDS-SR16 is administered by a medical student or resident in the morning before the patient’s ECT treatment.
Instruments
Medical Chart
The medical chart was utilized to obtain the total and item domain QIDS-SR16 scores and demographic information. Specifically, this study included the variables of psychiatric diagnosis, age and gender.
QIDS-SR16 Score and Rating
The total score was obtained by adding scores for each of the nine domains. Scores were classified as the following: scores between 0-5 were considered normal; 6-10 were considered mild; 11- 15 were classified as moderate; 16-20 were considered moderate to severe; and 21+were classified as severely depressed.
Data Analysis
SPSS-19 will be used for data analysis.
Descriptive Data Analysis
All demographic data and testing scores will be reported. Continuous/scale data will be analyzed for mean and standard deviations. Nominal/categorical data will be analyzed for frequency, and by chi square. Demographic variables include group placement (i.e. electrode configuration (right unilateral electrode placement or bitemporal electrode placement)), age, gender, diagnosis, and length of treatment (i.e. how many ECT treatments).
Primary Data Analysis
A paired t-test analysis will be applied to the total sample to determine if there is a significant improvement between pre and post treatment scores on the QIDS-SR16 total score. Apaied t-test analysis will be applied to determine the different effect sizes of the sad mood and suicidal ideation domains. The rejection level for all analyses will be set at α =.05. The analyses will be applied in the following:
For total sample:
Testing pre-and-post immediate treatment effects:
Overall immediate effects of receiving ECT using paired t-test of the total QIDS-SR16 pre and post treatment scores.The effect sizes of the sad mood and suicidal ideation domains using t-test of the item domain scores of the QIDS-SR16 pre and post treatment scores.
The researchers expect that the post- ECT treatment scores to move from severe depression symptoms and move toward minor symptoms and that the post- ECT treatment scores across will show more improved depression symptoms from patients that received right unilateral than bitemporal ECT. Also, the researchers expect the effect size of the sad mood and suicidal ideation domains to be greater than the remaining seven symptom domains.
Research Hypotheses
Specifically, the present study hypothesized that:
For total sample:
1. Participants who receive ECT will show improved depression symptoms after treatment as measured on the QIDS-SR16.
2. The effect size of the sad mood domain will be greater than the other symptom domains as measured on the QIDS-SR 16.
3. The effect size of the suicidal ideation domain will be greater than the other symptom domains as measured on the QIDS-SR16.
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