Feasibility, acceptability and practicality of transcranial stimulation in obsessive compulsive symptoms (FEATSOCS): A randomised controlled crossover trial.

BACKGROUND: Transcranial direct current stimulation (tDCS) is a non-invasive form of neurostimulation with potential for development as a self-administered intervention. It has shown promise as a safe and effective treatment for obsessive compulsive disorder (OCD) in a small number of studies. The two most favourable stimulation targets appear to be the left orbitofrontal cortex (L-OFC) and the supplementary motor area (SMA). We report the first study to test these targets head-to-head within a randomised sham-controlled trial. Our aim was to inform the design of future clinical research studies, by focussing on the acceptability and safety of the intervention, feasibility of recruitment, adherence to and tolerability of tDCS, and the size of any treatment-effect. METHODS: FEATSOCS was a randomised, double-blind, sham-controlled, cross-over, multicentre study. Twenty adults with DSM-5-defined OCD were randomised to treatment, comprising three courses of clinic-based tDCS (SMA, L-OFC, Sham), randomly allocated and delivered in counterbalanced order. Each course comprised four 20-min 2 mA stimulations, delivered over two consecutive days, separated by a 'washout' period of at least four weeks. Assessments were carried out by raters who were blind to stimulation-type. Clinical outcomes were assessed before, during, and up to four weeks after stimulation. Patient representatives with lived experience of OCD were actively involved at all stages. RESULTS: Clinicians showed willingness to recruit participants and recruitment to target was achieved. Adherence to treatment and study interventions was generally good, with only two dropouts. There were no serious adverse events, and adverse effects which did occur were transient and mostly mild in intensity. Yale-Brown Obsessive-Compulsive Scale (Y-BOCS) scores were numerically improved from baseline to 24 h after the final stimulation across all intervention groups but tended to worsen thereafter. The greatest effect size was seen in the L-OFC arm, (Cohen's d = -0.5 [95% CI -1.2 to 0.2] versus Sham), suggesting this stimulation site should be pursued in further studies. Additional significant sham referenced improvements in secondary outcomes occurred in the L-OFC arm, and to a lesser extent with SMA stimulation. CONCLUSIONS: tDCS was acceptable, practicable to apply, well-tolerated and appears a promising potential treatment for OCD. The L-OFC represents the most promising target based on clinical changes, though the effects on OCD symptoms were not statistically significant compared to sham. SMA stimulation showed lesser signs of promise. Further investigation of tDCS in OCD is warranted, to determine the optimal stimulation protocol (current, frequency, duration), longer-term effectiveness and brain-based mechanisms of effect. If efficacy is substantiated, consideration of home-based approaches represents a rational next step. TRIAL REGISTRATION: ISRCTN17937049. https://doi.org/10.1186/ISRCTN17937049.

Repetitive transcranial magnetic stimulation (r-TMS) and selective serotonin reuptake inhibitor-resistance in obsessive-compulsive disorder: A meta-analysis and clinical implications.

INTRODUCTION: Despite promising results from several randomized controlled trials (RCTs) and meta-analyses, the efficacy of r-TMS as a treatment for OCD remains controversial, at least in part owing to inconsistency in the trial methodologies and heterogeneity in the trial outcomes. This meta-analysis attempts to explain some of this heterogeneity by comparing the efficacy of r-TMS in patients with or without resistance to treatment with selective serotonin reuptake inhibitors (SSRI), defined using standardized criteria. METHODS: We conducted a pre-registered (PROSPERO ID: 241381) systematic review and meta-analysis. English language articles reporting blinded RCTs were retrieved from searches using MEDLINE, PsycINFO, and Cochrane Library databases. Studies were subjected to subgroup analysis based on four stages of treatment resistance, defined using an adaptation of published criteria (1 = not treatment resistant, 2 = one SSRI trial failed, 3 = two SSRI trials failed, 4 = two SSRI trials failed plus one or more CBT trial failed). Meta-regression analyses investigated patient and methodological factors (age, duration of OCD, illness severity, stage of treatment-resistance, or researcher allegiance) as possible moderators of effect size. RESULTS: Twenty-five independent comparisons (23 studies) were included. Overall, r-TMS showed a medium-sized reduction of Yale-Brown Obsessive-Compulsive Scale (Y-BOCS) scores (Hedge's g: -0.47; 95%CI: - 0.67 to -0.27) with moderate heterogeneity (I2 = 39.8%). Assessment of publication bias using Trim and Fill analysis suggested a reduced effect size that remained significant (g: -0.29; 95%CI: -0.51 to -0.07). Subgroup analysis found that those studies including patients non-resistant to SSRI (stage 1) (g: -0.65; 95%CI: -1.05 to -0.25, k = 7) or with low SSRI-resistance (stage 2) (g:-0.47; 95%CI: -0.86 to -0.09, k = 6) produced statistically significant results with low heterogeneity, while studies including more highly resistant patients at stage 3 (g: -0.39; 95%CI: -0.90 to 0.11, k = 4) and stage 4 (g: -0.36; 95%CI: -0.75 to 0.03, k = 8) did not. Intriguingly, the only significant moderator of the effect size found by meta-regression was the severity of baseline depressive symptoms. All trials showed evidence of researcher allegiance in favour of the intervention and therefore caution is required in interpreting the reported effect sizes. CONCLUSION: This meta-analysis shows that r-TMS is an effective treatment for OCD, but largely for those not resistant to SSRI or failing to respond to only one SSRI trial. As a consequence, r-TMS may be best implemented earlier in the care pathway. These findings would have major implications for clinical service development, but further well-powered RCTs, which eliminate bias from researcher allegiance, are needed before definitive conclusions can be drawn.

New challenges in facing cyberchondria during the coronavirus disease pandemic.

Cyberchondria (CYB) is characterized by excessive online searching for medical information and is associated with increasing levels of distress, anxiety, and interference with daily activities. As the use of digital devices and the Internet as a source of everyday information has increased, particularly during the current coronavirus disease (COVID-19) pandemic, so has CYB, becoming an object of interest to clinicians and researchers. The present review will provide an overview of the latest updates in CYB research. Emerging evidence draws attention to various vulnerability factors for developing CYB, including personal characteristics such as female gender, younger age, or a history of mental disorder, as well as engagement in particular forms of online behavior, such as increased use of social media, increased acceptance of online information, and information overload. Additionally, recent studies suggest that CYB may itself act as a mediating factor for increased COVID-19-related psychological burden. However, the data are still very sparse. Knowledge gaps include a universally accepted definition of CYB, severity thresholds to help differentiate nonpathological online health searches from CYB, as well as robustly evidence-based interventions.

Education and training in psychiatry in South Asian countries.

"Show me a sane man and I will cure him for you."-Carl Jung. Essentially, Jung was saying that a sane man does not exist. Emotional problems and difficulties are present in a benign form in the vast majority of people. Therefore, psychiatric education should focus on the very common nature of mental and emotional problems. Training of psychiatrists to provide the best quality care and conduct the highest quality research continues to remain a priority across the globe. The treatment and training gaps in many countries continue despite the sustained efforts at improving these, especially in low- and middle-income (LAMI) countries. Although many LAMI countries have improved curricula for undergraduate and postgraduate training, yet the treatment and training gap continues. This article will look to explore education and training in psychiatry in some of the South Asian countries with a special focus on India.

Feasibility and acceptability of transcranial stimulation in obsessive-compulsive symptoms (FEATSOCS): study protocol for a randomised controlled trial of transcranial direct current stimulation (tDCS) in obsessive-compulsive disorder (OCD).

BACKGROUND: Obsessive-compulsive disorder (OCD) is a neuropsychiatric disorder which often proves refractory to current treatment approaches. Transcranial direct current stimulation (tDCS), a noninvasive form of neurostimulation, with potential for development as a self-administered intervention, has shown potential as a safe and efficacious treatment for OCD in a small number of trials. The two most promising stimulation sites are located above the orbitofrontal cortex (OFC) and the supplementary motor area (SMA). METHODS: The aim of this feasibility study is to inform the development of a definitive trial, focussing on the acceptability, safety of the intervention, feasibility of recruitment, adherence and tolerability to tDCS and study assessments and the size of the treatment effect. To this end, we will deliver a double-blind, sham-controlled, crossover randomised multicentre study in 25 adults with OCD. Each participant will receive three courses of tDCS (SMA, OFC and sham), randomly allocated and given in counterbalanced order. Each course comprises four 20-min stimulations, delivered over two consecutive days, separated by at least 4 weeks' washout period. We will collect information about recruitment, study conduct and tDCS delivery. Blinded raters will assess clinical outcomes before, during and up to 4 weeks after stimulation using validated scales. We will include relevant objective neurocognitive tasks, testing cognitive flexibility, motor disinhibition, cooperation and habit learning. DISCUSSION: We will analyse the magnitude of the effect of the interventions on OCD symptoms alongside the standard deviation of the outcome measure, to estimate effect size and determine the optimal stimulation target. We will also measure the duration of the effect of stimulation, to provide information on spacing treatments efficiently. We will evaluate the usefulness and limitations of specific neurocognitive tests to determine a definitive test battery. Additionally, qualitative data will be collected from participants to better understand their experience of taking part in a tDCS intervention, as well as the impact on their overall quality of life. These clinical outcomes will enable the project team to further refine the methodology to ensure optimal efficiency in terms of both delivering and assessing the treatment in a full-scale trial. TRIAL REGISTRATION: ISRCTN17937049 . (date applied 08/07/2019). Recruitment (ongoing) began 23rd July 2019 and is anticipated to complete 30th April 2021.

Approach to Informed Consent in Telepsychiatric Service: Indian Perspective.

Consent is an essential and important medico-legal prerequisite for a patient's treatment. This necessitates the service provider to participate in the informed consent process and discuss the risk-benefit of the proposed treatment, the best available treatment, engage in shared decision-making process, opportunity to convey their view and thereby limit chances of legal liability for all parties. The clinician should have ample knowledge and skill pertaining to the informed consent process and also have adequate understanding of medical ethics and law. This article provides an overview on informed consent pertaining to telepsychiatric services in India.

Making the most of Mental Healthcare Act 2017: Practitioners' perspective.

The Mental Healthcare Act (MHCA) 2017, after parliamentary approval in 2017, came into effect from May 29, 2018. It is rights-based and empowers the patients to make their own choices unless they become incapacitous due to mental illness. There is much emphasis on the protection of human rights of persons with mental illness. The act provides a framework and regulation on how a person with mental illness should be treated. The experts, on multiple occasions, have debated on whether the act is a boon or a bane for the practitioners in India. The MHCA 2017 brings about more impetus on documentation, unlike the previous acts. With the act in place, clear documentation with reasons for decisions made and care given are important for good practice. Although this may potentially raise the cost of care, this will ensure a safer practice of psychiatry and will prove beneficial for the patients and the psychiatrists. To comply with the provisions of the act, one will have to modify the manner in which one carries out the day-to-day practice. Regular training through workshops is required to understand the practical implications of different provisions of the act. Furthermore, regular peer group meetings may give a sense of support and an opportunity to learn from one another and help find solutions to difficult aspects. Overall, following this and adapting to the new act may bring uniformity in practice. This article aims to explore ways to leverage the MHCA 2017 from the practitioner's perspective.

Is it the right time to implement Community Treatment Order in India?

India enacted the Mental Healthcare Act, 2017 (MHCA 2017) on April 7, 2017 to align and harmonize with United Nations Convention on Persons with Disabilities and the principles of prioritizing human rights protection. While MHCA 2017 is oriented toward the rights of the patients, the rights of the family members and professionals delivering treatment, care, and support to persons with severe mental disorder (SMD) often suffer. MHCA 2017 mandates discharge planning in consultation with the patients for admitted patients and makes the service providers responsible for ensuring continuity of care in the community. The concerns surrounding the chances of relapse and recurrence when a person with a SMD stops medications continue to remain largely unaddressed. The rights-based MHCA 2017 makes it difficult for the prevailing practices of surreptitious treatment by the family/caregiver and proxy consultations on behalf of the patients. This will, in turn, lead to increased chances of relapse, risk of violence, homelessness, stigma, and suicide in persons with SMDs in the community, largely due to noncompliance to treatment. This will also result in increased caregiver burden and burnouts and may also cause disruptions in the family and the community. To strike a balance over the current MHCA 2017, there is a need to amend or bring-forth a new law rooted in the principles of community treatment order.

Mental Healthcare Act, 2017 and homeless persons with mental illness in India.

Homeless persons with mental illness (HPMI) suffer indignities due to shirking of all obligations by the society. In addition, the HPMI is denied all rights available to citizens, such as confidentiality, privacy, safety, right to practice religion, health, and the right to not suffer from inhuman treatment. In this context, the new Mental Healthcare Act (MHCA), 2017 has brought in a list of rights for HPMI, and this is a welcome sign. The MHCA has also taken away the mandated involvement of judiciary to provide care for the HPMI. However, the ground realities in terms of the systems and the existent infrastructure are far from satisfactory to handle the issue in India. The onus of providing care for the HPMI has shifted to the state, and the public agencies are responsible for ensuring the same. The article aims to look at various sections of the MHCA relevant in regard to providing care for the HPMI.

Psychiatrist in Court: Indian Scenario.

The impetus for practical exposure to legalities that arise in the context of psychiatry and law is minimal in postgraduate training in psychiatry and curriculum. Those who choose to get trained often do not get first-hand exposure to court proceedings. Law and psychiatry often come into each other's interface, and psychiatry is regulated by the legal system more often than the other specialties in medicine. This article is an attempt to equip the psychiatrist in dealing with instances where they will present themselves in court.

Cost estimation for the implementation of the Mental Healthcare Act 2017.

The Mental Healthcare Act, 2017 (MHCA) was a step that was essential, once the Government of India ratified the United Nations Convention on the Rights of Persons with Disabilities in 2007. The MHCA looks to protect, promote, and fulfill the rights of persons with mental illness (PMI) as stated in the preamble of the Act. Further, there is an onus on the state to provide affordable mental health care to its citizens. In India, mental health has always been a lesser priority for lawmakers and citizens alike. The rights-based MHCA looks to overhaul the existing system by giving prominence to autonomy, protecting the rights of the mentally ill individuals, and making the State responsible for the care. The decision to make all this happen is commendable. The annual health expenditure of India is 1.15% of the gross domestic product, and the mental health budget is <1% of India's total health budget. This article systematically analyses and describes the cost estimation of the implementation of MHCA 2017, and it is not an estimation of mental health economics. The conservative annual estimated cost on the government to implement MHCA, 2017 would be 94,073 crore rupees. The present study estimation depicts that investing in the implementation of MHCA, 2017 by the government will yield 6.5 times the return on investment analysis benefit. If the State is not proactive in taking measures to implement the MHCA, the rights promised under this legislation will remain aspirational.

Sale of medicines by Registered Medical Practitioners at their clinics: Legal and ethical issues.

In India, manufacturing, storing, transportation, distribution, and dispensing of drugs are licensed and regulated under the drugs and cosmetic act, 1940; Indian Medical Council Act, 1956; the Pharmacy Act, 1948; and the Narcotic Drugs and Psychotropic Substances Act, 1985. Prescribing and dispensing medicines at the same time to their patients by registered medical practitioners (RMPs) is a well-known practice in all systems of medicine across the country. Further, the kind of branded medicines a patient gets from the clinics will come wrapped in a huge profit margin for RMPs, and this has been an alternative source of income to them. Dispensing and selling of medicines by RMPs at their clinics to their patients may represent a significant potential conflict of interest with the medical ethical principles, namely autonomy, beneficence, and non-maleficence and it raises various ethical and legal challenges. This article focuses on the ethical and legal issues of this practice and emphasizes the need for a proactive and dynamic approach to meet the rising demand for quality healthcare in India.