Add-on Sodium Benzoate and N-Acetylcysteine in Patients With Early Schizophrenia Spectrum Disorder: A Multicenter, Double-Blind, Randomized Placebo-Controlled Feasibility Trial.

Background and Hypothesis: Oxidative stress pathways may play a role in schizophrenia through direct neuropathic actions, microglial activation, inflammation, and by interfering with NMDA neurotransmission. N-acetylcysteine (NAC) has been shown to improve negative symptoms of schizophrenia, however, results from trials of other compounds targeting NMDA neurotransmission have been mixed. This may reflect poor target engagement but also that risk mechanisms act in parallel. Sodium Benzoate (NaB) could have an additive with NAC to act on several pathophysiological mechanisms implicated in schizophrenia. Study Design: A multicenter, 12 weeks, 2 × 2 factorial design, randomized double-blind placebo-controlled feasibility trial of NaB and NAC added to standard treatment in 68 adults with early schizophrenia. Primary feasibility outcomes included recruitment, retention, and completion of assessments as well as acceptability of the study interventions. Psychosis symptoms, functioning, and cognitive assessments were also assessed. Study Results: We recruited our desired sample (n = 68) and retained 78% (n = 53) at 12 weeks, supporting the feasibility of recruitment and retention. There were no difficulties in completing clinical outcome schedules. Medications were well tolerated with no dropouts due to side effects. This study was not powered to detect clinical effect and as expected no main effects were found on the majority of clinical outcomes. Conclusions: We demonstrated feasibility of conducting a clinical trial of NaB and NAC. Given the preliminary nature of this study, we cannot draw firm conclusions about the clinical efficacy of either agent, and a large-scale trial is needed to examine if significant differences between treatment groups emerge. Trial Registration: ClinicalTrials.gov: NCT03510741.

Assessing the efficacy of a brief universal family skills programme on child behaviour and family functioning in Gilgit-Baltistan, Pakistan: protocol for a feasibility randomised controlled trial of the Strong Families programme.

PURPOSE: The global burden of mental health difficulties among children underscores the importance of early prevention. This study aims to assess the efficacy, feasibility and acceptability of the Strong Families programme in enhancing child behaviour and family functioning in low-resource settings in Gilgit-Baltistan, Pakistan. METHODS AND ANALYSIS: This is a two-arm, multisite feasibility randomised controlled trial with an embedded process evaluation in three districts of Gilgit-Baltistan, namely Gilgit, Hunza and Skardu. 90 families living in these challenged settings, comprising a female primary caregiver aged 18 or above, and at least one child aged 8-15 years, will participate. Participants will be randomly assigned to either receive the Strong Families programme or to the waitlist group. Strong Families is a 7-hour family skills group intervention programme attended by children and their primary caregivers over 3 weeks. The waitlist group will be offered the intervention after their outcome assessment. Three raters will conduct blind assessments at baseline, 2 and 6 weeks postintervention. The primary outcome measures include the feasibility of Strong Families, as determined by families' recruitment and attendance rates, and programme completeness (mean number of sessions attended, attrition rates). The secondary outcomes include assessment of child behaviour, parenting practices, parental adjustment and child resilience. Purposefully selected participants, including up to five caregivers from each site, researchers and facilitators delivering the intervention, will be interviewed. Descriptive statistics will be used to analyse primary and secondary outcomes. The process evaluation will be conducted in terms of programme context, reach, fidelity, dose delivered and received, implementation, and recruitment. ETHICS AND DISSEMINATION: This study has been approved by the UNODC Drug Prevention and Health Branch in the Headquarters office of Vienna and the National Bioethics Committee of Pakistan. Findings will be disseminated through publication in reputable journals, newsletters and presentations at conferences. TRIAL REGISTRATION NUMBER: NCT05933850.

A culturally adapted manual-assisted problem-solving intervention (CMAP) for adults with a history of self-harm: a multi-centre randomised controlled trial.

BACKGROUND: Self-harm is an important predictor of a suicide death. Culturally appropriate strategies for the prevention of self-harm and suicide are needed but the evidence is very limited from low- and middle-income countries (LMICs). This study aims to investigate the effectiveness of a culturally adapted manual-assisted problem-solving intervention (CMAP) for patients presenting after self-harm. METHODS: This was a rater-blind, multicenter randomised controlled trial. The study sites were all participating emergency departments, medical wards of general hospitals and primary care centres in Karachi, Lahore, Rawalpindi, Peshawar, and Quetta, Pakistan. Patients presenting after a self-harm episode (n = 901) to participating recruitment sites were assessed and randomised (1:1) to one of the two arms; CMAP with enhanced treatment as usual (E-TAU) or E-TAU. The intervention (CMAP) is a manual-assisted, cognitive behaviour therapy (CBT)-informed problem-focused therapy, comprising six one-to-one sessions delivered over three months. Repetition of self-harm at 12-month post-randomisation was the primary outcome and secondary outcomes included suicidal ideation, hopelessness, depression, health-related quality of life (QoL), coping resources, and level of satisfaction with service received, assessed at baseline, 3-, 6-, 9-, and 12-month post-randomisation. The trial is registered on ClinicalTrials.gov. NCT02742922 (April 2016). RESULTS: We screened 3786 patients for eligibility and 901 eligible, consented patients were randomly assigned to the CMAP plus E-TAU arm (n = 440) and E-TAU arm (N = 461). The number of self-harm repetitions for CMAP plus E-TAU was lower (n = 17) compared to the E-TAU arm (n = 23) at 12-month post-randomisation, but the difference was not statistically significant (p = 0.407). There was a statistically and clinically significant reduction in other outcomes including suicidal ideation (- 3.6 (- 4.9, - 2.4)), depression (- 7.1 (- 8.7, - 5.4)), hopelessness (- 2.6 (- 3.4, - 1.8), and improvement in health-related QoL and coping resources after completion of the intervention in the CMAP plus E-TAU arm compared to the E-TAU arm. The effect was sustained at 12-month follow-up for all the outcomes except for suicidal ideation and hopelessness. On suicidal ideation and hopelessness, participants in the intervention arm scored lower compared to the E-TAU arm but the difference was not statistically significant, though the participants in both arms were in low-risk category at 12-month follow-up. The improvement in both arms is explained by the established role of enhanced care in suicide prevention. CONCLUSIONS: Suicidal ideation is considered an important target for the prevention of suicide, therefore, CMAP intervention should be considered for inclusion in the self-harm and suicide prevention guidelines. Given the improvement in the E-TAU arm, the potential use of brief interventions such as regular contact requires further exploration.

Culturally adapted motivational interviewing with cognitive behavior therapy and mindfulness-based relapse prevention for substance use disorder in Pakistan (CAMAIB): protocol for a feasibility factorial randomised controlled trial.

BACKGROUND: The use of psychoactive substances significantly impacts the health, social and economic aspects of families, communities and nations. There is a need to develop and test psychological interventions aimed for individuals with substance use disorder (SUD) in lower- and middle-income countries (LMICs), such as in Pakistan. The aim of this exploratory trial is to test the feasibility and acceptability of two culturally adapted psychological interventions in a factorial randomised controlled trial (RCT). METHODS: The proposed project will be conducted in three phases. The first phase of the study will focus on cultural adaptation of the interventions through qualitative interviews with key stakeholders. The second phase will be to refine and produce manually assisted interventions. Third and last stage would be to assess the feasibility of the culturally adapted interventions through a factorial RCT. The study will be carried out in Karachi, Hyderabad, Peshawar, Lahore and Rawalpindi, Pakistan. Recruitment of participants will take place from primary care and volunteer organisations/drug rehabilitation centres. A total of 260 individuals diagnosed with SUD (n = 65) in each of the four arms will be recruited. The intervention will be delivered weekly over a period of 12 weeks in both individual and group settings. Assessments will be carried out at baseline, at 12th week (after completion of intervention) and 24th week post-randomisation. The analysis will determine the feasibility of recruitment, randomisation, retention and intervention delivery. Acceptability of intervention will be determined in terms of adherence to intervention, i.e. the mean number of sessions attended, number of home assignments completed, attrition rates, as well as through process evaluation to understand the implementation process, context, participants' satisfaction, and impact of the study intervention. The health resource use and impact on the quality of life will be established through health economic data. DISCUSSION: This study will provide evidence for feasibility and acceptability of culturally adapted manually assisted psychological interventions for individuals with SUD in the context of Pakistan. The study will have clinical implications if intervention is proven feasible and acceptable. TRIAL REGISTRATION: Name of the registry: ClinicalTrials.gov, Trial registration number: NCT04885569 , Date of registration: 25th April 2021.

'Care co-ordinator in my pocket': a feasibility study of mobile assessment and therapy for psychosis (TechCare).

OBJECTIVES: The aim of the project was to examine the acceptability and feasibility of a mobile phone application-based intervention 'TechCare', for individuals with psychosis in the North West of England. The main objectives were to determine whether appropriate individuals could be identified and recruited to the study and whether the TechCare App would be an acceptable intervention for individuals with psychosis. METHODS: This was a mixed methods feasibility study, consisting of a test-run and feasibility evaluation of the TechCare App intervention. SETTING: Early Intervention Services (EIS) for psychosis, within an NHS Trust in the North West of England. PARTICIPANTS: Sixteen participants (test-run n=4, feasibility study n=12) aged between 18 and 65 years recruited from the East, Central and North Lancashire EIS. INTERVENTION: A 6-week intervention, with the TechCare App assessing participants' symptoms and responses in real-time and providing a personalised-guided self-help-based psychological intervention based on the principles of Cognitive Behaviorual Therapy (CBT). RESULTS: A total of 83.33% (n=10) of participants completed the 6-week feasibility study, with 70% of completers achieving the set compliance threshold of ≥33% engagement with the TechCare App system. Analysis of the qualitative data suggested that participants held the view that the TechCare was both an acceptable and feasible means of delivering interventions in real-time. CONCLUSION: Innovative digital clinical technologies, such as the TechCare App, have the potential to increase access to psychological interventions, reduce health inequality and promote self-management with a real-time intervention, through enabling access to mental health resources in a stigma-free, evidence-based and time-independent manner. TRIAL REGISTRATION NUMBER: ClinicalTrials.gov Identifier: NCT02439619.

mHealth based interventions for the assessment and treatment of psychotic disorders: a systematic review.

The relative burden of mental health disorders is increasing globally, in terms of prevalence and disability. There is limited data available to guide treatment choices for clinicians in low resourced settings, with mHealth technologies being a potentially beneficial avenue to bridging the large mental health treatment gap globally. The aim of the review was to search the literature systematically for studies of mHealth interventions for psychosis globally, and to examine whether mHealth for psychosis has been investigated. A systematic literature search was completed in Embase, Medline, PsychINFO and Evidence Based Medicine Reviews databases from inception to May 2016. Only studies with a randomised controlled trial design that investigated an mHealth intervention for psychosis were included. A total of 5690 records were identified with 7 studies meeting the inclusion criteria. The majority of included studies, were conducted across Europe and the United Sates with one being conducted in China. The 7 included studies examined different parameters, such as Experiential Sampling Methodology (ESM), medication adherence, cognitive impairment, social functioning and suicidal ideation in veterans with schizophrenia. Considering the increasing access to mobile devices globally, mHealth may potentially increase access to appropriate mental health care. The results of this review show promise in bridging the global mental health treatment gap, by enabling individuals to receive treatment via their mobile phones, particularly for those individuals who live in remote or rural areas, areas of high deprivation and for those from low resourced settings.

An acute in-patient psychiatric service for 16- to 17-year-old adolescents in the UK: a descriptive evaluation.

Aims and method The need for an age-appropriate in-patient service for 16- to 17-year-olds led to the development of a 6-bed acute admissions unit in a non-metropolitan county in the UK. We provide a descriptive evaluation of the first 2 years of its operation. All admissions from April 2010 to March 2012 were reviewed, clinical details systematically recorded and descriptively analysed. Results Ninety-seven young people were admitted during this period (a third were compulsorily detained under the Mental Health Act 1983). The average length of stay was 3-4 weeks. The most common presenting complaints were self-harm and low mood, usually in the context of life events and childhood adversity. Nearly half had substance misuse and other risk-taking behaviours. A third presented with psychotic symptoms. Adjustment and anxiety disorders were most common, followed by alcohol/substance use disorders, depressive illnesses and psychotic illnesses. Comorbidity was the rule rather than the exception. Most patients improved by the time of discharge. Clinical implications The unit provides an accessible and effective age-appropriate service and is likely to constitute an important component of the comprehensive child and adolescent mental health service strategy in the county.

Mental health services in Libya.

Despite all the internal and external criticisms of mental health services in Libya, they remain underdeveloped across the country. The World Health Organization has made efforts to improve the country's mental health services; however, until a stable government is formed, patients with mental illness will continue to be deprived of their basic needs.

Antidepressant and group psychosocial treatment for depression: a rater blind exploratory RCT from a low income country.

BACKGROUND: Research in the West shows that group psychological intervention together with an antidepressant treatment leads to more effective treatment of a depressive disorder. There are no treatment trials from low income countries comparing the efficacy of antidepressant treatment with a group psychological intervention. AIM: To conduct a feasibility trial to compare the efficacy of an antidepressant to a group psychosocial intervention, for low income women attending primary health care in Karachi, Pakistan. METHOD: This was a preliminary RCT in an urban primary health care clinic in Karachi, Pakistan. Consecutive eligible women scoring >12 on the CIS-R and >18 on Hamilton Depression Rating Scale (HDRS) (n = 66) were randomly assigned to antidepressants or a psychosocial treatment in group settings. The primary outcome measure was HDRS score; secondary outcome measures were disability and quality of life. RESULTS: More than half of the patients in both groups improved (50% reduction in HDRS scores); at end of therapy at 3 months 19 (59.4%) vs 18 (56.2%), and at 6-month follow-up 21(67.7%) vs 20(62.5%) for antidepressants and psychosocial intervention respectively. Although HDRS, BDQ and EQ5-D scores all improved considerably in both groups from start to end of treatment, and these improvements were largely maintained after a further 3 months, the differences between the two treatments were not statistically significant. CONCLUSION: Psychosocial intervention was as effective as antidepressants in reducing depression and in improving quality of life and disability at the end of therapy. However, these findings need further exploration through a larger trial.

Which antidepressant would psychiatrists and nurses from a developing country choose for themselves?

OBJECTIVE: To determine the prescribing preference of mental health professionals in a developing country for antidepressants if they themselves developed a depressive illness. METHODS: A specifically designed self reporting questionnaire was used to investigate which antidepressant was the preferred choice of psychiatrists and nurses and the factors which influenced their decision making. RESULTS: Fluoxetine was the antidepressant most likely to be chosen by psychiatrists for themselves, followed by escitalopram and tricyclic antidepressant. A total of 21 (27.6%) nurses said that they did not know which antidepressant they would prefer for themselves and 22 (29%) said that they would choose a benzodiazepine. Majority of the psychiatrists (71.9%) had more experience with SSRIs, 26.6% with tricyclic antidepressants and only about 1.5% had used venlafaxine and mirtazapine. Efficacy and safety of antidepressants were the two most important factors in selecting an antidepressant. CONCLUSIONS: SSRIs are the preferred antidepressants of Pakistani psychiatrists and nurses for their patients and for themselves. Efficacy and safety of a drug are likely to play a greater role in drug choice than cost of the drug.

Medically unexplained symptoms--a perspective from general practitioners in the developing world.

OBJECTIVES: In this study, we explored the attitudes toward Medically Unexplained Symptoms (MUS) of 500 general practitioners (GPs) in Karachi, Pakistan. Using a questionnaire previously developed by Reid et al. (2001), we aimed to investigate whether GPs' attitudes toward medically unexplained symptoms are similar to those of GPs in the developed world. METHODS: Five hundred GPs on the database of primary care centers at the Pakistan Institute of Learning and Living in Karachi were all sent a covering letter explaining the purpose of the survey with a case vignette, a questionnaire, and a stamped addressed envelope. One month later, non-respondents received a telephone call from an investigator to remind them of the study. RESULTS: Of the 429 respondents, 68.5% (294) were male and 31.5% (135) female. Although 80.2% of respondents felt that the main role of GPs was to provide support and reassurance, 76.9% of respondents also agreed that GPs had a role in referring patients with MUS for further investigations to identify a cause. Two hundred and four (47.55%) respondents agreed that somatization was useful concept, only 146 (34.03%) felt that there was effective treatment for it. CONCLUSION: For the most part, Pakistani GPs' attitudes toward MUS are not very different to those of their counterparts in the West. Both agree that the GP has an important role in providing reassurance and counseling. However, our survey also shows that Pakistani GPs are less likely to place emphasis on an underlying psychiatric diagnosis and tend to focus on looking for an underlying physical cause.

A survey of British senior psychiatry trainees' ethnocultural personal values.

OBJECTIVE: The authors explored the ethnocultural values of a group of senior psychiatry trainees in the northwest region of England. METHODS: The authors surveyed senior psychiatry trainees using the Personal Values Questionnaire and analyzed responses under the headings of ethnic stereotypes, ethnocultural service issues, and perceptions of racism. They also explored training requirements on cultural issues in a subsample of trainees. RESULTS: The majority of the trainees disagreed with certain commonly held ethnic stereotypes and acknowledged the role of culture in mental health. However, they had contrasting views on the need for culture-specific services and on perceptions of racism. They expressed interest in training programs on cultural issues in psychiatric practice. CONCLUSION: In multicultural settings, personal beliefs, perceptions, and values are likely to influence psychiatric practice. A training program on cultural aspects of mental health could help improve awareness and sensitivity of these issues and the quality of care.