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Outcomes of an individual counselling programme in Grozny, Chechnya: a randomised controlled study.

ABSTRACT: OBJECTIVES:To evaluate the effectiveness of individual counselling on functioning of clients participating in a mental health intervention in a humanitarian setting. DESIGN:Randomised controlled trial. SETTING:Mental health programme implemented by Médecins Sans Frontières in Grozny, Republic of Chechnya. PARTICIPANTS:168 eligible clients were randomly assigned to the intervention and waitlisted (2 months) arms between November 2014 and February 2015. INTERVENTION:Individual counselling sessions. MAIN OUTCOME MEASURES:Change in functioning was measured using the Short Form 6 (SF6) and gender-specific locally adapted Chechen functioning instruments in the intervention group at the end of counselling and the waitlisted group after their waitlisted period. Unadjusted differences in gain scores (DGSs) between intervention and waitlisted groups were calculated with effect size (Cohen's d) for both tools. Linear regression compared the mean DGS in both groups. RESULTS:The intervention group (n=78) improved compared with waitlisted controls (n=80) on the SF6 measures with moderate to large effect sizes: general health (DGS 12.14, d=0.52), body pain (DGS 10.26, d=0.35), social support (DGS 16.07, d=0.69) and emotional functioning (DGS 16.87, d=0.91). Similar improvement was seen using the Chechen functioning instrument score (female DGS -0.33, d=0.55; male DGS -0.40, d=0.99). Adjusted analysis showed significant improvement (p<0.05) in the intervention group for all SF6 measures and for the Chechen functioning instrument score in women but not men (p=0.07). CONCLUSIONS:Individual counselling significantly improved participants' ability to function in the intervention group compared with the waitlisted group. Further research is needed to determine whether similar positive results can be shown in other settings and further exploring the impact in male clients' population. TRIAL REGISTRATION NUMBER:NTR4689.

SUBMITTER: Lenglet A

PROVIDER: S-EPMC6112398 | biostudies-literature | 2018 Aug

REPOSITORIES: biostudies-literature

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Outcomes of an individual counselling programme in Grozny, Chechnya: a randomised controlled study.

Lenglet Annick A Lopes-Cardozo Barbara B Shanks Leslie L Blanton Curtis C Feo Concetta C Tsatsaeva Zalina Z Idrisov Kyuri K Bolton Paul A PA Pintaldi Giovanni G

BMJ open 20180823 8

<h4>Objectives</h4>To evaluate the effectiveness of individual counselling on functioning of clients participating in a mental health intervention in a humanitarian setting.<h4>Design</h4>Randomised controlled trial.<h4>Setting</h4>Mental health programme implemented by Médecins Sans Frontières in Grozny, Republic of Chechnya.<h4>Participants</h4>168 eligible clients were randomly assigned to the intervention and waitlisted (2 months) arms between November 2014 and February 2015.<h4>Intervention ...[more]

PMID: 30139892

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Project description:BackgroundCouples HIV testing and counselling (CHTC) is encouraged but is not widely done in sub-Saharan Africa. We aimed to compare two strategies for recruiting male partners for CHTC in Malawi's option B+ prevention of mother-to-child transmission programme: invitation only versus invitation plus tracing and postulated that invitation plus tracing would be more effective.MethodsWe did an unblinded, randomised, controlled trial assessing uptake of CHTC in the antenatal unit at Bwaila District Hospital, a maternity hospital in Lilongwe, Malawi. Women were eligible if they were pregnant, had just tested HIV-positive and therefore could initiate antiretroviral therapy, had not yet had CHTC, were older than 18 years or 16-17 years and married, reported a male sex partner in Lilongwe, and intended to remain in Lilongwe for at least 1 month. Women were randomly assigned (1:1) to either the invitation only group or the invitation plus tracing group with block randomisation (block size=4). In the invitation only group, women were provided with an invitation for male partners to present to the antenatal clinic. In the invitation plus tracing group, women were provided with the same invitation, and partners were traced if they did not present. When couples presented they were offered pregnancy information and CHTC. Women were asked to attend a follow-up visit 1 month after enrolment to assess social harms and sexual behaviour. The primary outcome was the proportion of couples who presented to the clinic together and received CHTC during the study period and was assessed in all randomly assigned participants. This study is registered with ClinicalTrials.gov, number NCT02139176.FindingsBetween March 4, 2014, and Oct 3, 2014, 200 HIV-positive pregnant women were enrolled and randomly assigned to either the invitation only group (n=100) or the invitation plus tracing group (n=100). 74 couples in the invitation plus tracing group and 52 in the invitation only group presented to the clinic and had CHTC (risk difference 22%, 95% CI 9-35; p=0.001) during the 10 month study period. Of 181 women with follow-up data, two reported union dissolution, one reported emotional distress, and none reported intimate partner violence. One male partner, when traced, was confused about which of his sex partners was enrolled in the study. No other adverse events were reported.InterpretationAn invitation plus tracing strategy was highly effective at increasing CHTC uptake. Invitation plus tracing with CHTC could have many substantial benefits if brought to scale.FundingNational Institutes of Health.

Project description:BackgroundCommon avoidable factors leading to maternal, perinatal and neonatal deaths include lack of birth planning (and delivery in an inappropriate place) and unmet need for contraception. Progress has been slow because routine antenatal care has focused only on women. Yet, in Uganda, many women first want the approval of their husbands. The World Health Organization recommends postpartum family planning (PPFP) as a critical component of health care. The aim of this trial is to test the feasibility of recruiting and retaining participants in a trial of a complex community-based intervention to provide counselling to antenatal couples in Uganda.MethodsThis is a two-group, non-blinded cluster-randomised controlled feasibility trial of a complex intervention. Primary health centres in Uganda will be randomised to receive the intervention or usual care provided by the Ministry of Health. The intervention consists of training village health teams to provide basic counselling to couples at home, encouraging men to accompany their wives to an antenatal clinic, and secondly of training health workers to provide information and counselling to couples at antenatal clinics, to facilitate shared decision-making on the most appropriate place of delivery, and postpartum contraception. We aim to recruit 2 health centres in each arm, each with 10 village health teams, each of whom will aim to recruit 35 pregnant women (a total of 700 women per arm). The village health teams will follow up and collect data on pregnant women in the community up to 12 months after delivery and will directly enter the data using the COSMOS software on a smartphone.DiscussionThis intervention addresses two key avoidable factors in maternal, perinatal and neonatal deaths (lack of family planning and inappropriate place of delivery). Determining the acceptability and feasibility of antenatal couples' counselling in this study will inform the design of a fully randomised controlled clinical trial. If this trial demonstrates the feasibility of recruitment and delivery, we will seek funding to conduct a fully powered trial of the complex intervention for improving uptake of birth planning and postpartum family planning in Uganda.Trial registrationPan African Clinical Trials Registry PACTR202102794681952 . Approved on 10 February 2021. ISRCTN Registry ISRCTN97229911. Registered on 23 September 2021.

Project description:BackgroundFew studies have investigated the specific effect of single intervention components in randomized controlled trials. The purpose was to investigate the effect of adding group-based diet and exercise counselling to individual life-style counselling on long-term changes in dietary habits.MethodsThe study was a randomized controlled intervention study. From a general Danish population, aged 30 to 60 years (n = 61,301), two random sample were drawn (group A, n = 11,708; group B, n = 1,308). Subjects were invited for a health screening program. Participation rate was 52.5%. All participants received individual life-style counselling. Individuals at high risk of ischemic heart disease in group A were furthermore offered group-based life-style counselling. The intervention was repeated for high-risk individuals after one and three years. At five-year follow-up all participants were invited for a health examination. High risk individuals were included in this study (n = 2 356) and changes in dietary intake were analyzed using multilevel linear regression analyses.ResultsAt one-year follow-up group A had significantly increased the unsaturated/saturated fat ratio compared to group B and in men a significantly greater decrease in saturated fat intake was found in group A compared to group B (net change: -1.13 E%; P = 0.003). No differences were found between group A and B at three-year follow-up. At five-year follow-up group A had significantly increased the unsaturated/saturated fat ratio (net change: 0.09; P = 0.01) and the fish intake compared to group B (net change: 5.4 g/day; P = 0.05). Further, in men a non-significant tendency of a greater decrease was found at five year follow-up in group A compared to group B (net change: -0.68 E%; P = 0.10). The intake of fibre and vegetables increased in both groups, however, no significant difference was found between the groups. No differences between groups were found for saturated fat intake in women.ConclusionOffering group-based counselling in addition to individual counselling resulted in small, but significantly improved dietary habits at five-year follow-up and a tendency of better maintenance, compared to individual counselling alone.Trial registrationThe Inter99 study was approved by the local Ethics Committee (KA 98 155) and is registered with ClinicalTrials.gov (registration number: NCT00289237).

Project description:INTRODUCTION:In recent years, medical treatment for cancer has improved, thereby increasing the life expectancy of patients with cancer. Hence, the focus in healthcare shifted towards analysing treatments that offer to decrease distress and improve the quality of life of patients with cancer. The psychological burden of patients with cancer originates from all kinds of psychosocial challenges related to diagnosis and treatment. Cancer counselling centres (CCounCs) try to address these concerns. However, the current literature lacks research on the effectiveness of CCounCs. This study aims to assess the effectiveness of CCounCs with regard to distress and other relevant psychosocial variables (quality of life, anxietyand so on). METHODS AND ANALYSIS:This prospective observational study with a non-randomised control group has three measurement points: before the first counselling session (baseline, t0) and at 2?weeks and 3?months after baseline (t1, t2). Patients and their relatives who seek counselling between December 2018 and November 2020 and have sufficient German language skills will be included. The control group will be recruited at clinics and oncological outpatient centres in Hamburg. Propensity scoring will be applied to adjust for differences between the control and intervention groups at baseline. Sociodemographic data, medical data and counselling concerns are measured at baseline. Distress (distress thermometer), quality of life (Short Form-8 Health Survey, European Organization for Research and Treatment of Cancer Core Quality of Life Questionnaire-Core 30), anxiety (Generalized AnxietyDisorder-7), depression (Patient HealthQuestionnaire-9) and further psychosocial variables are assessed at all time points. With a total of 787 participants, differences between the intervention and control groups of a small effect size (f=0.10) can be detected with a power of 80%. ETHICS AND DISSEMINATION:The study was registered prior to data collection with the German Registration of Clinical Trials in September 2018. Ethical approval was received by the local psychological ethical committee of the Center for Psychosocial Medicine at the University Medical Centre Hamburg-Eppendorf in August 2018. The results will be published in peer-reviewed journals. TRIAL REGISTRATION NUMBER:DRKS00015516; Pre-results.

Project description:INTRODUCTION:Residency is a stressful phase associated with high prevalence of mental distress. Besides impaired personal health, mental distress in residents has an impact on the quality of patient care and produces economic costs. Therefore, there is demand for interventions that improve resident physicians' mental health. The aim of the present study is to examine the effects of a mindfulness-based intervention that has been tailored to residents' needs. Specifically, mindfulness has been supplemented by a focus on the concept of Muße. METHODS AND ANALYSIS:This study applies a randomised controlled multimethod design. Residents assigned to the intervention group will participate in an 8-week mindfulness course followed by a 4-month maintenance phase, whereas residents assigned to the control group will read text-based information about mindfulness on a weekly basis for the duration of 8?weeks. The intervention is focussed on a transfer of learnt techniques into the daily routine and is targeted to promote residents' self-care as well as on building empathic relationships. Participants will be assessed before, directly after the intervention, after the maintenance phase as well as at follow-up 6?months after the intervention group completes the intervention. Assessments will consist of self-report measures, physiological data, qualitative interviews, third-party reports as well as implicit and projective measures and will focus on both psychopathology and salutogenesis. The primary outcome will be burnout. Data will be analysed using linear mixed modelling. ETHICS AND DISSEMINATION:The study was approved by the ethics committee of the Medical Center - University of Freiburg and is funded by the German Research Foundation as part of the interdisciplinary Collaborative Research Center 'SFB Muße 1015'. The results of this study will be published in scientific journals and disseminated through the study's website, and conferences. TRIAL REGISTRATION NUMBER:DRKS00014015.

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Project description:BackgroundDepression is a significant cause of morbidity. Many patients have communicated an interest in non-pharmacological therapies to their general practitioners. Systematic reviews of acupuncture and counselling for depression in primary care have identified limited evidence. The aim of this study was to evaluate acupuncture versus usual care and counselling versus usual care for patients who continue to experience depression in primary care.Methods and findingsIn a randomised controlled trial, 755 patients with depression (Beck Depression Inventory BDI-II score ? 20) were recruited from 27 primary care practices in the North of England. Patients were randomised to one of three arms using a ratio of 2.2.1 to acupuncture (302), counselling (302), and usual care alone (151). The primary outcome was the difference in mean Patient Health Questionnaire (PHQ-9) scores at 3 months with secondary analyses over 12 months follow-up. Analysis was by intention-to-treat. PHQ-9 data were available for 614 patients at 3 months and 572 patients at 12 months. Patients attended a mean of ten sessions for acupuncture and nine sessions for counselling. Compared to usual care, there was a statistically significant reduction in mean PHQ-9 depression scores at 3 months for acupuncture (-2.46, 95% CI -3.72 to -1.21) and counselling (-1.73, 95% CI -3.00 to -0.45), and over 12 months for acupuncture (-1.55, 95% CI -2.41 to -0.70) and counselling (-1.50, 95% CI -2.43 to -0.58). Differences between acupuncture and counselling were not significant. In terms of limitations, the trial was not designed to separate out specific from non-specific effects. No serious treatment-related adverse events were reported.ConclusionsIn this randomised controlled trial of acupuncture and counselling for patients presenting with depression, after having consulted their general practitioner in primary care, both interventions were associated with significantly reduced depression at 3 months when compared to usual care alone.Trial registrationControlled-Trials.com ISRCTN63787732 Please see later in the article for the Editors' Summary.

Project description:BackgroundThere is a lack of evidence on the effectiveness of livelihood interventions amongst people with disabilities. In many countries, self-employment or microentrepreneurship is a dominant source of livelihoods for people with disabilities and their caregivers. However, this group may face heightened barriers to successful microentrepreneurship, including discrimination, exclusion from training or inaccessible transport, infrastructure and communication systems. The InBusiness programme is a livelihoods programme targeted to microentrepeneurs with disabilities or their caregivers delivered by a consortium of non-governmental organisations. The programme focuses on improving the skills, practices and opportunities of microentrepreneurs while linking them with procurement opportunities with private and public institutions. This protocol describes a randomised controlled trial of the InBusiness programme in eight counties of Kenya.MethodsThe randomised controlled trial will involve 495 microentrepreneurs who have been verified as eligible for InBusiness by programme implementers. Individuals will be randomised within counties, either being invited to enrol in InBusiness in March 2023 or allocated to a control group. Participants in the control arm will receive information about compliance with business-related laws and available social protection programmes. The trial will assess the impact of InBusiness on household consumption and individual economic empowerment (primary outcomes) as well as food security, well-being, social attitudes, unmet need for disability-related services and microenterprise profits (secondary outcomes). Baseline was conducted in March 2023, and follow-up will be 24 months from baseline (12 months from completion of the programme). Analysis will be through intention to treat. A process evaluation will explore fidelity, mechanisms of impact and the role of context, and complementary qualitative research with participants will be used to triangulate findings across the trial.DiscussionThis study will provide evidence on the impact of a large-scale disability-targeted livelihood programme on household and individual financial security and well-being. Currently, there is a lack of evidence on the effectiveness of livelihood programmes amongst people with disabilities, and so this trial can help inform the design and delivery of InBusiness as well as other livelihood programmes targeted to people with disabilities.Trial registrationClinicalTrials.gov ISRCTN13693137. Registered on April 24, 2023.

Project description:BackgroundNutrition in the first 1,000 days of life (during pregnancy and the first two years) is critical for child growth and survival. Poor maternal, infant and young child nutrition (MIYCN) practices are widely documented in Kenya, with potential detrimental effects on child growth and survival. This is particularly a problem in slums, where most urban residents live. For example, exclusive breastfeeding for the first six months is only about two per cent. Innovative strategies to reach slum residents are therefore needed. Strategies like the Baby Friendly Hospital Initiative have proven effective in some settings but their effectiveness in resource-limited settings, including slums where many women do not deliver in hospital, is questionable. We propose to test the effectiveness of a home-based intervention on infant feeding practices, nutrition and health outcomes of infants born in two slums in Nairobi, Kenya.Methods/designThe study, employing a cluster-randomised study design, will be conducted in two slums in Nairobi: Korogocho and Viwandani where 14 community units (defined by the Government's health care system) will form the unit of randomization. A total of 780 pregnant women and their respective child will be recruited into the study. The mother-child pair will be followed up until the child is one year old. Recruitment will last approximately one year and three months from September 2012 to December 2013. The mothers will receive regular, personalised, home-based counselling by trained Community Health Workers on MIYCN. Regular assessment of knowledge, attitudes and practices on MIYCN will be done, coupled with assessments of nutritional status of the mother-child pairs and diarrhea morbidity for the children. Statistical methods will include analysis of covariance and multinomial logistic regression. Additionally, cost-effectiveness analysis will be done. The study is funded by the Wellcome Trust and will run from March 2012 to February 2015.DiscussionInterventions aimed at promoting optimal breastfeeding and complementary feeding practices are considered to have high impact and could prevent a fifth of the under-five deaths in countries with high mortality rates. This study will inform policy and practice in Kenya and similar settings regarding delivery mechanisms for such high-impact interventions, particularly among urban poor populations.Trial registrationISRCTN83692672.

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Outcomes of an individual counselling programme in Grozny, Chechnya: a randomised controlled study.

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Outcomes of an individual counselling programme in Grozny, Chechnya: a randomised controlled study.

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