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Evaluation of Drinking Risk Levels as Outcomes in Alcohol Pharmacotherapy Trials: A Secondary Analysis of 3 Randomized Clinical Trials.

Importance: The US Food and Drug Administration recognizes total abstinence and no heavy drinking days as outcomes for pivotal pharmacotherapy trials for alcohol use disorder (AUD). Many patients have difficulty achieving these outcomes, which can discourage seeking treatment and has slowed the development of medications that affect alcohol use. Objective: To compare 2 drinking-reduction outcomes with total abstinence and no heavy drinking outcomes. Design, setting, and participants: Data were obtained from 3 multisite, randomized, placebo-controlled clinical trials of medications for treating alcohol dependence (naltrexone, varenicline, and topiramate) in adults with DSM-IV-categorized alcohol dependence. Main outcomes and measures: Within each trial, the percentage of participants in active and placebo conditions who met responder definitions of abstinence, no heavy drinking days, a WHO 1-level reduction, and a WHO 2-level reduction was computed by month with corresponding effect sizes (Cohen h). Results: Across the 3 trials (N = 1169; mean [SD] age, 45 [10] years; 824 [70.5%] men), the percentage of participants classified as responders during the last 4 weeks of treatment was lowest for abstinence (naltrexone, 34.7% [100 of 288]; varenicline, 7.3% [7 of 96]; topiramate, 11.7% [21 of 179]) followed by no heavy drinking days (naltrexone, 51.0% [147 of 288]; varenicline, 24.0% [23 of 96]; topiramate, 20.7% [37 of 179]), WHO 2-level reduction (naltrexone, 75.0% [216 of 288]; varenicline, 55.2% [53 of 96]; topiramate, 44.7% [80 of 179]), and WHO 1-level reduction (naltrexone, 83.3% [240 of 288]; varenicline, 69.8 [67 of 96]; topiramate, 54.7% [98 of 179]) outcomes. Standardized treatment effects observed for the WHO 2-level reduction outcomes (naltrexone, Cohen h = 0.214 [95% CI, 0.053 -0.375]; varenicline, 0.273 [95% CI, -0.006 to 0.553]; topiramate, 0.230 [95% CI, 0.024-0.435]) and WHO 1-level reduction (naltrexone, Cohen h = 0.116 [95% CI, -0.046 to 0.277]; varenicline, 0.338 [95% CI, 0.058-0.617]; topiramate, 0.014 [95% CI, -0.192 to 0.219]) were comparable with those obtained using abstinence (naltrexone, Cohen h = 0.142 [95% CI, -0.020 to 0.303]; varenicline, 0.146 [95% CI, -0.133 to 0.426]; topiramate, 0.369 [95% CI, 0.163-0.574]) and no heavy drinking days (naltrexone, Cohen h = 0.140 [95% CI, -0.021 to 0.302]; varenicline, 0.232 [95% CI, -0.048 to 0.511]; topiramate, 0.207 [95% CI, 0.002-0.413]). Conclusions and relevance: WHO drinking risk level reductions appear to be worthwhile indicators of treatment outcome in AUD pharmacotherapy trials. These outcomes may align with drinking reduction goals of many patients and capture clinically meaningful improvements experienced by more patients than either abstinence or no heavy drinking days. Trial registration: ClinicalTrials.gov identifiers: NCT00006206; NCT01146613; NCT00210925.

JAMA psychiatry · randomised controlled trial · 98 citationsread the source →

Attention Bias Modification training in individuals with depressive symptoms: A randomized controlled trial.

Background and objectives: Negative attentional biases are often considered to have a causal role in the onset and maintenance of depressive symptoms. This suggests that reduction of such biases may be a plausible strategy in the treatment of depressive symptoms. The present clinical randomized controlled trial examined long-term effects of a computerized attention bias modification (ABM) procedure on individuals with elevated depressive symptoms. Methods: In a double-blind study design, 77 individuals with ongoing mild to severe symptoms of depression were randomly assigned to one of three conditions: 1) ABM training (n = 27); 2) placebo (n = 27); 3) assessment-only (n = 23). In both the ABM and placebo conditions, participants completed 8 sessions of 216-trials (1728 in total) during a 2-week period. Assessments were conducted at pre-training and post-training (0, 2, 4, 8-week, 3, 7-month follow-ups). Change in depressive symptoms and restoration of asymptomatic level were the primary outcome measures. Results: In the ABM, but not the other two conditions, significant reductions in depressive symptoms were found at post-training and maintained during the 3-month follow-up. Importantly, more participants remained asymptomatic in the ABM condition, as compared to the other two conditions, from post-training to 7-month follow-up. ABM also significantly reduced secondary outcome measures including rumination and trait anxiety, and notably, the ABM effect on reducing depressive symptoms was mediated by rumination. Limitation: Generalization of the findings may be limited because the present sample included only college students. Conclusions: The ABM effect on reducing depressive symptoms was maintained for at least 3-month duration in individuals with elevated depressive symptoms, and these results suggest that ABM may be a useful tool for the prevention of depressive symptoms. CLINICALTRIALS.GOV: NCT01628016.

Journal of behavior therapy and experimental psychiatry · randomised controlled trial · 91 citationsread the source →

The effect of neck-specific exercise with or without a behavioral approach on psychological factors in chronic whiplash-associated disorders: A randomized controlled trial with a 2-year follow-up.

Background: To investigate the effect of neck-specific exercise with (NSEB) or without (NSE) a behavioural approach and prescribed physical activity (PPA) on general pain disability and psychological factors in chronic whiplash-associated disorders (WAD), grade 2 and 3, with a 2-year follow-up. Methods: A randomized controlled multi-centre study of 3 exercise interventions (NSE, NSEB or PPA) including a 2-year follow-up. A total of 216 volunteers with chronic WAD were recruited and 194 were analyzed, mean age 40.4 (Standard Deviation [SD] 11.4). Measures of general pain disability, pain catastrophizing, anxiety and depression, and kinesiophobia were evaluated at baseline, and 3, 6, 12 and 24 months with linear mixed models. Results: General pain disability decreased by 28% in the NSEB group from baseline to 3 months (P < 0.001) and the improvements in disability were maintained over time (6, 12 and 24 months P < 0.01) compared to the NSE (P > 0.42) and PPA groups (P > 0.43). Pain catastrophizing decreased in the NSE group from baseline to 6 and 12 months (P < 0.01) and in the NSEB group from baseline to 3 and 24 months (P < 0.01) compared to the PPA group (P > 0.82) that showed no change over time. The NSE group improved in kinesiophobia over time from baseline to12 months (P < 0.01) compared to the NSEB (P = 0.052) and the PPA groups (P > 0.74). Anxiety decreased over time from baseline to 12 and 24 months in the NSE group (P > 0.02), but not in the NSEB (P > 0.25) or the PPA (P > 0.50) groups. The PPA had no effect on general disability or any of the measured psychological factors. Conclusion: This randomised controlled trial with a 2-year follow-up shows that physiotherapist-led neck-specific exercise with or without the addition of a behavioural approach had superior outcome on general disability and most psychological factors compared to the mere prescription of physical activity.

Medicine · randomised controlled trial · 32 citationsread the source →

SARS-CoV-2 in Spanish Intensive Care Units: Early experience with 15-day survival in Vitoria.

Purpose: Community transmission of SARS-CoV-2 was detected in Spain in February 2020, with 216% intensive care unit (ICU) capacity expanded in Vitoria by March 18th, 2020. Methods: We identified patients from the two public hospitals in Vitoria who were admitted to ICU with confirmed infection by SARS-CoV-2. Data reported here were available in April 6th, 2020. Mortality was assessed in those who completed 15-days of ICU stay. Results: We identified 48 patients (27 males) with confirmed SARS-CoV-2. Median [interquartile range (IQR)] age of patients was 63 [51-75] years. Symptoms began a median of 7 [5-12] days before ICU admission. The most common comorbidities identified were obesity (48%), arterial hypertension (44%) and chronic lung disease (37%). All patients were admitted by hypoxemic respiratory failure and none received non-invasive mechanical ventilation. Forty-five (94%) underwent intubation, 3 (6%) high flow nasal therapy (HFNT), 1 (2%) extracorporeal membrane oxygenation (ECMO) and 22 (46%) required prone position. After 15 days, 14/45 (31%) intubated patients died (13% within one week), 10/45 (22%) were extubated, and 21/45 (47%) underwent mechanical ventilation. Six patients had documented super-infection. Procalcitonin plasma above 0.5μg/L was associated with 16% vs. 19% (p=0.78) risk of death after 7 days. Conclusion: This early experience with SARS-CoV-2 in Spain suggests that a strategy of right oxygenation avoiding non-invasive mechanical ventilation was life-saving. Seven-day mortality in SARS-CoV-2 requiring intubation was lower than 15%, with 80% of patients still requiring mechanical ventilation. After 15 days of ICU admission, half of patients remained intubated, whereas one third died.

Anaesthesia, critical care & pain medicine · cohort or longitudinal · 156 citationsread the source →

Components of Successful Spiritual Care.

The quantifiable health benefits of spiritual practice and religious community have inspired a movement toward addressing religion within health care and medical education, yet biomedical professionals still often avoid this topic (Giordano and Engebretson in Explore 2(3):216--225, 2006; Post et al. in Ann Intern Med 132(7):578, 2000). This is largely due to a lack of clarity on how to ethically engage with diverse spiritual practices and maintain professional boundaries regarding spiritual care. However, a majority of patients desire increased incorporation of spirituality in medical discussions, indicating a deficit in care that must be addressed (Best et al. in Patient Educ Couns 98(11):1320-1328, 2015; Zaidi in AMA J Ethics 20(7), 2018). In this article, I clarify what constitutes successful spiritual care by identifying its key components and major challenges. I then make recommendations for ethically mindful, comprehensive spiritual care and consider potential next steps including structural changes that prioritize compassion and empathy in medicine.

Journal of religion and health · 9 citationsread the source →

Prevalence and management of chronic insomnia in Swiss primary care: Cross-sectional data from the "Sentinella" practice-based research network.

We investigated the prevalence and treatment of patients with chronic insomnia presenting to Swiss primary care physicians (PCPs) part of "Sentinella", a nationwide practice-based research network. Each PCP consecutively asked 40 patients if they had sleep complaints, documented frequency, duration, comorbidities, and reported ongoing treatment. We analysed data of 63% (83/132) of the PCPs invited. The PCPs asked 76% (2,432/3,216) of included patients about their sleep (51% female); 31% (761/2,432) of these had had insomnia symptoms; 36% (875/2,432) had current insomnia symptoms; 11% (269/2,432) met the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) criteria for chronic insomnia (61% female). In all, 75% (201/269) of patients with chronic insomnia had comorbidities, with 49% (99/201) reporting depression. Chronic insomnia was treated in 78% (209/269); 70% (188/268) took medication, 38% (102/268) benzodiazepines or benzodiazepine receptor agonists, 32% (86/268) took antidepressants. Only 1% (three of 268) had been treated with cognitive behavioural therapy for insomnia (CBT-I). A third of patients presenting for a non-urgent visit in Swiss primary care reported insomnia symptoms and 11% met the DSM-5 criteria for chronic insomnia. Hypnotics were the most common treatment, but almost no patients received first-line CBT-I. Reducing the burden of insomnia depends on disseminating knowledge about and access to CBT-I, and encouraging PCPs to discuss it with and offer it as a first-line treatment to patients with chronic insomnia.

Journal of sleep research · 30 citationsread the source →

Estimating the effect of palliative care interventions and advance care planning on ICU utilization: a systematic review.

Objective: We conducted a systematic review to answer three questions: 1) Do advance care planning and palliative care interventions lead to a reduction in ICU admissions for adult patients with life-limiting illnesses? 2) Do these interventions reduce ICU length of stay? and 3) Is it possible to provide estimates of the magnitude of these effects? Data sources: We searched MEDLINE, EMBASE, Cochrane Controlled Clinical Trials, and Cumulative Index to Nursing and Allied Health Literature databases from 1995 through March 2014. Study selection: We included studies that reported controlled trials (randomized and nonrandomized) assessing the impact of advance care planning and both primary and specialty palliative care interventions on ICU admissions and ICU length of stay for critically ill adult patients. Data extraction: Nine randomized controlled trials and 13 nonrandomized controlled trials were selected from 216 references. Data synthesis: Nineteen of these studies were used to provide estimates of the magnitude of effect of palliative care interventions and advance care planning on ICU admission and length of stay. Three studies reporting on ICU admissions suggest that advance care planning interventions reduce the relative risk of ICU admission for patients at high risk of death by 37% (SD, 23%). For trials evaluating palliative care interventions in the ICU setting, we found a 26% (SD, 23%) relative risk reduction in length of stay with these interventions. Conclusions: Despite wide variation in study type and quality, patients who received advance care planning or palliative care interventions consistently showed a pattern toward decreased ICU admissions and reduced ICU length of stay. Although SDs are wide and study quality varied, the magnitude of the effect is possible to estimate and provides a basis for modeling impact on healthcare costs.

Critical care medicine · systematic review · 219 citationsread the source →

Comparing the Effects of Mindfulness-Based Cognitive Therapy and Sleep Psycho-Education with Exercise on Chronic Insomnia: A Randomised Controlled Trial.

Background: Mindfulness-based cognitive therapy (MBCT) is a potential treatment for chronic insomnia. We evaluated the efficacy of MBCT for insomnia (MBCT-I) by comparing it with a sleep psycho-education with exercise control (PEEC) group. Methods: Adults with chronic primary insomnia (n = 216) were randomly allocated to the MBCT-I or PEEC group. The MBCT-I included mindfulness and psycho-education with cognitive and behavioural components under cognitive behavioural therapy for insomnia. PEEC included psycho-education of sleep hygiene and stimulus control, and exercises. Any change in insomnia severity was measured by the Insomnia Severity Index (ISI). Secondary outcomes included sleep parameters measured by a sleep diary, health service utilisation, absence from work and mindfulness measured by the Five Facet Mindfulness Questionnaire. Results: The ISI score significantly decreased in the MBCT-I group compared with the PEEC group at 2 months (i.e., post-intervention) (p = 0.023, effect size [95% CI] -0.360 [-0.675, -0.046]) but not at 5 or 8 months. Treatment response rates and remission rates based on the ISI cut-off scores were not significantly different between groups. Wake time after sleep onset (WASO) was less in the MBCT-I group at 2 and 5 months. At 8 months, both groups showed a reduced ISI score, sleep onset latency and WASO, and increased sleep efficiency and total sleep time; however, no group differences were seen. Other outcome measures did not significantly improve in either group. Conclusions: Long-term benefits were not seen in MBCT-I when compared with PEEC, although short-term benefits were seen.

Psychotherapy and psychosomatics · randomised controlled trial · 49 citationsread the source →

The Pittsburgh Sleep Quality Index in older primary care patients with generalized anxiety disorder: psychometrics and outcomes following cognitive behavioral therapy.

The Pittsburgh Sleep Quality Index (PSQI) is a widely used, comprehensive self-report measure of sleep quality and impairment, which has demonstrated good psychometric properties within various populations, including older adults. However, the psychometric properties of the PSQI and its component scores have not been evaluated for older adults with generalized anxiety disorder (GAD). Additionally, changes in PSQI global or component scores have not been reported following cognitive-behavioral treatment (CBT) of late-life GAD. This study examined (1) the psychometric properties of the PSQI within a sample of 216 elderly primary care patients age 60 or older with GAD who were referred for treatment of worry and/or anxiety; as well as (2) response to CBT, relative to usual care, for 134 patients with principal or coprincipal GAD. The PSQI demonstrated good internal consistency reliability and adequate evidence of construct validity. Those receiving CBT experienced greater reductions in PSQI global scores at post-treatment, relative to those receiving usual care. Further, PSQI global and component scores pertaining to sleep quality and difficulties falling asleep (i.e., sleep latency and sleep disturbances) demonstrated response to treatment over a 12-month follow-up period. Overall, results highlight the usefulness of the PSQI global and component scores for use in older adults with GAD.

Psychiatry research · randomised controlled trial · 54 citationsread the source →

The impact of substance use, sexual trauma, and intimate partner violence on sexual risk intervention outcomes in couples: a randomized trial.

Background: Few HIV prevention interventions focus on sexual risk reduction as mutual process determined by couple members, though risk behaviors are inter-dependent. Purpose: This trial examined the impact of substance use, history of sexual trauma, and intimate partner violence on sexual risk associated with participation in a risk reduction intervention. Methods: HIV seroconcordant and serodiscordant multicultural couples in Miami, Florida (n = 216) were randomized to group (n = 112) or individual (n = 104) couple-based interventions. Results: Group intervention participants increased condom use in couples in which women had a history of sexual trauma [F(2,221) = 3.39, p = 0.036] and by partners of alcohol users. History of sexual trauma was a determinant of conflict resolution, predicting negative communication and intimate partner violence. Conclusions: Results emphasize the need for group sexual risk reduction interventions targeting sexual trauma, partner violence, and substance use among HIV seroconcordant and serodiscordant couples.

Annals of behavioral medicine : a publication of the Society of Behavioral Medicine · randomised controlled trial · 17 citationsread the source →

A health survey of a colonia located on the west Texas, US/Mexico border.

Little is known about how health disparities affect the health status and general health perceptions of Hispanics living in Texas colonias. The purpose of this study was to conduct a health survey of residents (n = 216) of a colonia community on the border between El Paso, Texas and Juarez, Mexico. Instruments used in this study included a researcher developed demographic questionnaire, the Short Acculturation Scale for Hispanics (SASH), Cutting down, Annoyance by criticism, Guilty feeling and Eye-openers (CAGE) for alcohol consumption, and the Short Form version 2 (SF36v2) health survey. Study findings show the average participant was approximately 42 years old, attained an average of 9.6 years of education, earned an average annual household income of $17,575 and had an average SASH score of 25.4. SASH scores range from 12 to 60, with higher scores suggesting higher levels of American acculturation. Findings from this health survey suggest the average resident of the colonia may have health disadvantages when compared to residents from other parts of El Paso and Texas. Binge drinking was self-reported by 13.4% of all participants; with 5.6% having a CAGE score greater than 2 (indicating an increased propensity towards problems with alcohol). The self-report rates of diabetes, depression and anxiety were 15.3%, 20.4% and 16.7% respectively. The SF36v2 composite functional health status scores mirrored the national norms.

Journal of immigrant and minority health · cohort or longitudinal · 18 citationsread the source →

The effect of sperm DNA fragmentation index on assisted reproductive technology outcomes and its relationship with semen parameters and lifestyle.

Background: The sperm DNA fragmentation index (DFI) is widely regarded as a key measure for assessing male fertility, but the predictive value of the DFI for outcomes of assisted reproductive technology (ART) remains under debate. In this study, we used a large sample to analyze the effect of sperm DFI on pregnancy outcomes following ART and its relationship with oocyte fertilization and embryo development in in vitro fertilization (IVF)/intracytoplasmic sperm injection (ICSI). We also explore the value of sperm DNA fragmentation (SDF) and its associated factors in assessing male fertility. Methods: The relationship between the DFI measured with the sperm chromatin structure assay (SCSA) and pregnancy outcomes following ART were retrospectively analyzed in 2,622 ART treatment cycles, of which 1,185 were intrauterine insemination (IUI) cycles, 1,221 were IVF cycles and 216 were ICSI cycles. Rates of pregnancy, early abortion, oocyte fertilization and good quality embryos from IVF and ICSI cycles were compared between the groups of low DFI (DFI ≤15%), medium DFI (15%< DFI <30%) and high DFI (DFI ≥30%). Additionally, the relationships between sperm DFI and male lifestyle variables such as age, body mass index, smoking, and alcohol consumption, as well as routine semen parameters, were analyzed. Results: Clinical pregnancy rates following IUI among high, medium, and low sperm DFI groups were 12.5% (11/88), 14.3% (48/336), and 13.4% (102/761), respectively, with no statistical difference between the groups (P=0.88); however, early abortion rates among these groups were 27.3% (3/11), 14.6% (7/48), and 4.9% (5/102), respectively, and the difference was statistically significant (P=0.02). No significant differences in the rates of clinical pregnancy, early abortion, oocyte fertilization, or good quality embryos in IVF or ICSI cycles were detected among different DFI groups (P<0.05). Sperm DFI was negatively associated with sperm density, vitality and normal morphology; It was positively correlated with age, abstinence time and unhealthy lifestyles. Conclusions: As an increasingly common technique for reproductive testing, sperm DFI has proven to be very valuable in male fertility evaluation, but its significance as a predictor of pregnancy outcomes following ART requires further investigation.

Translational andrology and urology · 101 citationsread the source →

The Burden of Bereavement: Early-Onset Depression and Impairment in Youths Bereaved by Sudden Parental Death in a 7-Year Prospective Study.

Objective: The authors sought to determine the long-term impact of sudden parental death on youths and pathways between youth bereavement and impairment. Methods: Youths (N=216) who lost a parent to suicide, accident, or sudden natural death and nonbereaved youths (N=172) were followed periodically for up to 7 years. The incidence and prevalence of disorder and of functional impairment, as well as pathways to impairment, were assessed using Cox and mixed-effects logistic regression and structural equation modeling. Results: Prior to parental death, bereaved youths had higher rates of psychiatric disorder, parental psychiatric disorder, and maltreatment. Even after adjustment for predeath risk factors, bereavement was associated with an increased incidence of depression, posttraumatic stress disorder, and functional impairment. The peak incidence of depression was in the first 2 years postbereavement, with incident depression occurring mainly in those who lost a parent at age 12 or younger. Youths bereaved by all three causes of death showed higher rates of impairment at all time points. Structural equation modeling found that bereavement had a direct effect on impairment and was also linked to impairment via its effects on early and later depression and through negative life events. Child psychiatric disorder prior to parental loss also contributed to functional impairment. Conclusions: Parental death increased the incidence of depression in offspring early in the course of bereavement. Early identification and treatment of depression in bereaved youths and augmentation of family resilience may protect against later sequelae of functional impairment.

The American journal of psychiatry · 75 citationsread the source →

Problematic Internet use: an overview

The “global village”, a metaphor used to describe how the Internet has shortened distances and facilitated the flow of information, has grown to over one billion users 1. Statistics from across the world highlight its reach and penetrance: 90% of South Korean households connect to high-speed, inexpensive broadband 2; Londoners spend an average of 45 days a year online, more than they spend watching TV 3; and the rate of increase in the number of Internet users in Africa and the Middle East exceeded 1,300% between 2000 and 2009 4. For the majority of Internet users, the World Wide Web represents a tremendous wellspring of opportunity that enhances well-being. For others, however, it can lead to a state that appears to meet the DSM definition of a mental disorder, described as a “clinically significant behavioral or psychological syndrome…that is associated with present distress… or with a significantly increased risk of suffering death, pain, disability, or an important loss of freedom” 5. Scientific understanding of that state has lagged behind media attention 6, in part because of inconsistency in defining the problem 7, disagreement about its very existence 8, and the variable research methodology used in studying it. Still, a body of data by scientists from the East and West (with the East increasingly leading the way) tells a cautionary tale about the Internet's potential to bring about psychological harm. In 1996, the psychologist K. Young became the first to publish a detailed case report of problematic Internet use 9. Her “patient zero” was a non-technologically oriented 43-year-old homemaker with a “content home life and no prior addiction or psychiatric history”, who, within three months of discovering chat rooms, was spending up to 60 hours per week online. She reported feeling excited in front of the computer, and depressed, anxious, and irritable when she would log off. She described having an addiction to the medium “like one would to alcohol”. Within one year of purchasing her home computer, she was ignoring household chores, had quit social activities she used to enjoy, and had become estranged from her two teenage daughters and her husband of 17 years. Based on this and other patients she interviewed, Young proposed the first set of diagnostic criteria for what she termed “Internet addiction”. She modeled them on the DSM-IV definition for substance dependence because of similarities she observed with the states of tolerance (needing more of the substance to achieve the same effect) and withdrawal (psychological and physical discomfort upon reducing or stopping the substance) 9. Others conceptualized problematic Internet use as a behavioral addiction not involving an intoxicant 10, and Young subsequently updated her definition, adapting the DSM-IV criteria for pathological gambling, an impulse control disorder often described as a behavioral addiction, into her Diagnostic Questionnaire 11 (Table 1). The questionnaire, which required at least five of the eight criteria be met for the Internet addiction diagnosis, has not received adequate psychometric testing. Shapira et al 12 proposed five years later a more inclusive diagnostic schema in the general style of the impulse control disorders. They argued that definitions based solely on substance dependence or pathological gambling were too narrow to capture the population of problematic Internet users and could lead to premature conclusions about the new disorder and the patients. They eschewed the “Internet addiction” label for lack of scientific proof for true addiction and favored the less controversial “problematic Internet use”, defining it as: a) maladaptive preoccupation with Internet use, experienced as irresistible use for periods of time longer than intended; b) significant distress or impairment resulting from the behavior; and c) the absence of other Axis I pathology that might explain the behavior, such as mania or hypomania. To date, only two studies have attempted to develop diagnostic criteria empirically by testing them against the diagnosis made on the basis of a systematic psychiatric interview. Ko et al 13 tested a set of criteria in 468 Taiwanese high school students. Starting with 13 candidate criteria, they eliminated those with low diagnostic accuracy, and determined that a cutoff of six out of the nine remaining criteria had the best diagnostic accuracy while maintaining high specificity (97.1%) and acceptable sensitivity (87.5%). The criterion for functional impairment was listed separately as criterion B and was required for the diagnosis (Table 2). In a second study, Ko et al 14 confirmed the diagnostic accuracy of their criteria in an older cohort of 216 Taiwanese college students. However, the relatively small size of both studies and the non-representative nature of the groups studied limit the applicability of the proposed criteria to the general population. Several assessment scales have been proposed to screen for, and help diagnose, problematic Internet use. As a group, these instruments show no consensus on the underlying dimensions that constitute the condition 6,15. In addition to Young's Diagnostic Questionnaire, two are in relatively common use in research and/or clinical settings: Young's Internet Addiction Test 16 and the Chen Internet Addiction Scale 17. Young's Internet Addiction Test 16 consists of 20 “how-often” questions, each rated on a scale of 1 to 5 (1=rarely; 2=occasionally; 3=frequently; 4=often; 5=always.) A score of 80 or above is consistent with problematic use (Table 3). The psychometric properties of the instrument were studied in 86 subjects 18. Six factors were extracted from the questionnaire: salience, excessive use, neglect of work, anticipation, lack of control, and neglect of social life. These factors showed good concurrent validity and internal consistency. Salience explained most of the variance and was also found to be the most reliable as indicated by its Cronbach's alpha. However, the selection bias introduced by online recruitment and the small size of the study limit its value. The Chen Internet Addiction Scale 17 is a self-report instrument composed of 26 items rated on a 4-point Likert scale (adapted in Table 4). It assesses five domains of Internet-related problems: compulsive use, withdrawal, tolerance, interpersonal and health consequences, and time management difficulties. Scores range from 26 to 104. In a study of 454 Taiwanese adolescents who completed the scale and received a structured diagnostic interview, a cutoff of 64 was shown to have high diagnostic accuracy and specificity (88% and 92.6%, respectively) 19. The internal reliability of the scale and subscales in the original study ranged from 0.79 to 0.93 17. Due to the lack of consensus on diagnostic criteria and the dearth of large epidemiological studies, the prevalence of problematic Internet use in the general population has not been established. Overall, prevalence surveys conducted in various countries fall into two main categories, online vs. offline studies, with the former typically yielding higher rates, most likely because of inherent selection bias 20. Only two epidemiological studies exploring the prevalence of problematic Internet use in the general population have been published. One was conducted in the US, the other in Norway 20,21. The US study used random-digit telephone dialing (cellular phone numbers were not included) to interview 2,513 adults taken from all 50 states in a manner proportional to the population in each state 20. More than half of the people reached agreed to be interviewed. Participants’ average age was 48, and 51% fell in the middle class socioeconomic stratum. 68.9% were regular Internet users. The authors’ diagnostic definition, based on published criteria and on similarities with impulse control disorders, substance dependence and obsessive-compulsive disorder, required: a) Internet use that interferes in personal relationships; b) preoccupation with the Internet when offline; c) unsuccessful attempts at quitting or cutting down; and d) staying online longer than intended. This definition yielded a point prevalence of 0.7%. Less stringent definitions yielded higher prevalence rates, and individual features consistent with problematic Internet use were endorsed by as many as 13.7% (respondents who found it hard to stay offline for days in a row). In the second study, Bakken et al 21 mailed Young's Diagnostic Questionnaire to 10,000 inhabitants of Norway, randomly selected from a database of the entire population. 3,399 completed questionnaires were returned (a somewhat lower response rate than the US study). Recipients of the mailed questionnaire also had the option of completing it online. Among respondents, 87% were Internet users. The prevalence of “addicted Internet use” (≥5 questions answered “yes”) was calculated to be 1%, whereas the prevalence of “at risk” Internet use (3–4 questions answered “yes”) was 5.2%. Multivariate analysis showed young age, male gender, higher educational achievement, and financial stress to be positively associated with “problematic Internet use” (defined by the authors to include both “Internet addicts” and “at risk” respondents). Prevalence rates among adolescents have been researched more extensively, perhaps because the so-called “digital natives” grew up incorporating the Internet in many aspects of life and as a result are perceived to be at higher risk. However, even when online-based surveys are excluded, the results can vary widely and are difficult to compare, due to differences in Internet access, recruitment methodology, the exact age bracket studied, and the definitions utilized. Considering only relatively large and offline studies, research from China 22, South Korea 23,24, Greece 25, Norway 26, and Iran 27 has yielded prevalence estimates ranging between 2% and 11%. Problematic Internet use has not been incorporated into large-scale epidemiological studies aimed at estimating the relative prevalence of mental disorders. Still, a review of published studies reveals that the presence of other psychiatric conditions in patients with problematic Internet use is the rule rather than the exception 6. The studies, however, were not designed or statistically powered to detect the nature of the association (cause, effect, or independent). In Bakken's general-population study 21, based on subjects’ self-report, 41.4% of Internet “addicts” reported feelings of depression in the 12-month period prior to the study, compared to 15.8% of non-problematic users. Sleep disturbances, anxious feelings, and alcohol and substance abuse were also more common (38.6% vs. 26.4%, 36.4% vs. 5%, and 13.6% vs. 1.1%, respectively). However, the questions used to assess co-occurring psychological impairment were not based on established criteria for mood, sleep, anxiety, or substance use disorders. Two US case series involved face-to-face interviews of adult patients with problematic Internet use. Black et al 28 assessed 21 subjects with the Diagnostic Interview Schedule and found the lifetime prevalence of mood disorders and major depression to be 33% and 15%, respectively. Further, 38% had a lifetime substance use disorder and 19% had a lifetime diagnosis of anxiety disorder. In a case series that included 20 patients, Shapira et al 29 found a very high (70%) lifetime prevalence for bipolar affective disorder, type I or II, compared with 15% for major depression. Fifty-five percent had a lifetime prevalence of substance abuse, and 45% met criteria for social anxiety disorder. Fifty percent of subjects had a lifetime diagnosis of an impulse control disorder. The authors highlight their observation that patients’ Internet-related symptoms were more impulsive and egosyntonic than compulsive and egodystonic, concluding that problematic Internet use resembles the DSM-IV definition of an impulse control disorder more closely than that of obsessive-compulsive disorder. Our clinical experience supports this conclusion. As a group, surveys conducted among high school and college students show similarly high comorbidity rates with mood and anxiety disorders, but a link between attention-deficit/hyperactivity disorder (ADHD) and problematic Internet use seems more obvious than among adults. One study in 752 South Korean elementary students found that 33% of those with ADHD also met criteria for problematic Internet use 30. Another study in 216 Taiwanese college students showed that 32% subjects with problematic Internet use also had ADHD compared to only 8% of regular Internet users 31. Whether Web-based activities appeal to the short attention span of ADHD sufferers or whether excessive Internet use may cause inattention remains to be elucidated. The clinical evaluation of the patient with problematic Internet use should include a careful assessment of the comorbid conditions frequently present. Those should then be treated according to established treatment guidelines. To the extent that the Internet-related problem may stem from another diagnosis (e.g., a patient with severe social anxiety who starts leading a “virtual” life at the expense of offline interactions), it might improve as the primary condition is addressed. Pharmacotherapeutic and psychotherapeutic interventions specific to problematic Internet use have not yet received adequate testing in large, rigorous studies. Pharmacotherapy often begins with selective serotonin reuptake inhibitors (SSRIs). However, while effective in treating obsessive-compulsive disorder, SSRIs have shown mixed results in impulse control disorders 32,33,34,35–36. In light of the greater similarity between problematic Internet use and impulse control disorders compared to obsessive-compulsive disorder 29, it is unclear whether SSRIs will ultimately prove beneficial, and no double-blind placebo-controlled studies have been published so far. One discontinuation study tested escitalopram, 20 mg/day, in 19 subjects with problematic Internet use 37. During the 10-week open-label phase, subjects showed significant decreases in weekly hours spent online (from a mean of 36.8 hours to 16.5 hours) and improvement in global functioning. At the end of the 10 weeks, subjects were blindly randomized to either continued escitalopram treatment or to placebo. Beyond that, they were followed for 9 weeks. No significant difference was seen between the two groups at the end of the second phase, as gains achieved at week 10 were maintained in both treatment groups. The authors speculate that nine weeks may have not been sufficient for the effect to be lost in the placebo group or for additional gains to be made in the escitalopram group, but do not rule out the possibility that the improvement seen in the open-label phase may have been a placebo response. One case study reported successful treatment with naltrexone 38, a drug that has shown benefit in other impulse control disorders 39,40. The patient was a 31 year old male with compulsive cybersexual behavior who had failed antidepressants, group and individual psychotherapy, Sexual Addicts Anonymous, and pastoral counseling. Naltrexone (150 mg/day), gradually added to a stable dose of sertraline which on its own had been ineffective in treating his problematic Internet use, helped induce a three-year remission. The authors hypothesize that, by blocking the capacity of endogenous opioids to trigger dopamine release in response to reward, naltrexone may block the reinforcing nature of compulsive Internet sexual activity. Another case study reported the successful use of an atypical antipsychotic, quetiapine, 200 mg/day, gradually added to citalopram, in a 23 year old subject with problematic Internet use 41. The improvement was maintained at four-month follow-up. More recently, a study tested methylphenidate in 62 children with ADHD who were Internet video game players 42. Participants’ average age was around 9. After 8 weeks of treatment (average dose 30.5 mg/day), Internet usage decreased significantly and correlated with reduction in ADHD symptoms. The authors cautiously suggest that methylphenidate might be beneficial as a treatment for problematic Internet use, especially when co-occurring with ADHD. Of the psychotherapy approaches used, cognitive behavioral therapy (CBT) has received the most empiric investigation. The largest study enrolled 114 adult subjects and employed CBT interventions including: keeping a daily log of Internet activity, teaching time management skills, and confronting cognitive distortions and rationalizations frequently used by patients to justify continued Internet usage, such as “just a few more minutes won't hurt” 43. Most subjects were able to control their symptoms by the eighth session, and improvement was sustained over a 6-month follow-up. For children and adolescents, family-based interventions that improve communication and teach family monitoring of Internet use can be helpful 44. However, the intensive (and typically very expensive) residential treatment options that have received much media attention have undergone little empiric investigation to warrant a strong recommendation 2,45. The same applies to online treatment websites that encourage the person with problematic Internet use to “click here if you are addicted to the Internet”. For a medium that has so radically changed the way we conduct our lives, the Internet's effects on our psychological health remain understudied. Simply stating that similar fears were raised when the radio, movies and early video games were introduced is not sufficient: the immersive and interactive qualities of the virtual world, and its sheer penetrance, make it potentially more serious. Also deserving of exploration are the more subtle psychological changes that occur in the virtual world, such as online disinhibition and increased risk-taking 46. Those changes are not necessarily evidence of “Internet addiction”, and may not be pathological, but, as important features of the new virtual psychology, should also be studied. As our field continues to debate whether their condition belongs in the next edition of the DSM 47, patients continue to present with symptoms born out of the digital age, and their symptoms are changing as the technology evolves from browsers, to “crackberries”, to “smart phones” that combine texting, talking, video games, and browsing in one device that to many is like a new appendage. Even the “problematic Internet use” designation now seems outdated, which is why some have wisely opted for “pathological use of electronic media”, instead 47. Technology, like media outlets, remains far ahead of scientific investigation. Given the dramatic changes that our society is undergoing as a result of the Internet revolution, it behooves us to try to bridge the gap.

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