Posttraumatic stress disorder intervention for people with severe mental illness in a low-income country primary care setting: a randomized feasibility trial protocol.
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ABSTRACT: Background
In this protocol, we outline a mixed-methods randomized feasibility trial of Brief Relaxation, Education and Trauma Healing (BREATHE) Ethiopia. BREATHE Ethiopia is a culturally and contextually adapted intervention for PTSD in participants with severe mental illness. BREATHE Ethiopia maps onto the World Health Organization's guidelines for posttraumatic stress disorder (PTSD) treatment in low- and middle-income country primary care settings.Methods
Specifically, this study includes a non-randomized pre-pilot (n = 5) and a randomized feasibility trial comparing BREATHE Ethiopia to Treatment as Usual (n = 40) to assess trial procedures, acceptability, and feasibility of intervention delivery, and investigate potential effectiveness and implementation. In a process evaluation, we will collect data that will be critical for a future fully randomized controlled trial, including the numbers of participants who are eligible, who consent, who engage in treatment, and who complete the assessments, as well as the feasibility and acceptability of assessments and the intervention. Qualitative data on facilitators and barriers to intervention delivery and quantitative data on provider fidelity to the intervention and participant and provider satisfaction will also be collected. Quantitative assessments at baseline, post-treatment, 1-month follow-up, and 3-month follow-up will assess change in mental health symptoms and functional impairment and hypothesized intervention mechanisms, including knowledge about PTSD, stigma, trauma-related cognitions, and physiological arousal.Discussion
Findings from this study will inform a future fully-powered randomized controlled trial, and if found to be effective, the intervention has the potential to be integrated into mental healthcare scale-up efforts in other low-resource settings.Trial registration
Registered with ClinicalTrials.gov (NCT04385498) first posted May 13th, 2020; https://www.clinicaltrials.gov/ct2/show/NCT04385498?term=ethiopia&cond=PTSD&draw=2&rank=1 .
SUBMITTER: Ng LC
PROVIDER: S-EPMC8323310 | biostudies-literature |
REPOSITORIES: biostudies-literature
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Project description:BACKGROUND:Peer-delivered services potentially provide broad, multifaceted benefits for persons suffering severe mental illness. Most studies to date have been conducted in countries with well-developed outpatient mental health systems. The objective of this study was to examine the feasibility for developing a community-based peer service in China. METHODS:Thirteen peer service providers and 54 consumers were recruited from four communities in Beijing. We initiated the program in two communities, followed by another two in order to verify and add to our understanding of potential scalable feasibility. Semi-structured face-to-face interviews were conducted 12 month after initiation at each site to measure satisfaction and perceived benefits from perspectives of peer service providers, and consumers and their caregivers. RESULTS:Key stakeholders reported that peer support services were satisfying and beneficial. Eleven of 13 peer service providers were willing to continue in their roles. Ten, 8, and 7 of them perceived improvements in working skills, social communication skills, and mood, respectively. Among consumers, 39 of 54 were satisfied with peer services. Improvements in mood, social communication skills, illness knowledge, and illness stability were detected among 23, 18, 13, and 13 consumers, respectively. For caregivers, 31 of 32 expressed a positive view regarding peer services. Caregivers reported improvement in their own mood, confidence in recovery of their family members, and reduction in caretaker burdens. CONCLUSIONS:The findings highlight that peer-delivered services have promise in China for benefiting persons with severe mental illness and their family caregivers, as well as the peer service providers themselves.
| S-EPMC6854628 | biostudies-literature
Project description:Interventions: We are assessing the impact of the National Bowel Cancer Screening Program (NBCSP) by comparing participation rates of people with and without Severe Mental Illness (SMI) and looking at health outcomes. We will be using data collected from Aug 2006 - latest available.
We are linking data using Commonwealth data (NBCSP, Medicare Benefits Schedule, Pharmaceutical Benefits Scheme, Australian Cancer Database & the National Death Index) to compare bowel cancer screening participation in people with SMI to those from the general population. We will additionally link these to the NSW cancer registry and hospital data to examine care pathways from diagnosis through treatment and end-of-life care.
We will also conduct a consultation with people with experience of SMI and Colorectal cancer and people with SMI in peer support roles who can provide their perspective on the barriers faced by people with SMI to gaining timely screening, diagnosis and optimal care.
These participants will be recruited from New South Wales consumer organisations and organisations with a strong focus on provision of peer support and advocacy. We will use a semi structured group interview schedule to facilitate discussion of a single focus group of 15 people. The group will consist of both people with lived experience who have direct experience of bowel cancer (n=10), as well as other people with lived experience who have supported people in this situation – as peer support workers or in other consumer advocacy/support roles (n=5). We will use this qualitative arm of the study to further develop our understanding of the quantitative findings. The consultation will also develop ideas on how to improve access to care.
Primary outcome(s): Participation rates in the National Bowel Cancer Screening Program assessed using data from the NBCSP.[Person-years will be calculated from entry into the study (2006) (the date of commencement of the NBCSP) or from the year that people become eligible for screening (i.e. age 50), whichever occurs later.. This is a retrospective cohort study, so all of the outcomes have already occurred and were recorded in the administrative data. This will be assessed when we receive the data.];Colonoscopy rates assessed using data from the NBCSP [Person-years will be calculated from entry into the study (2006 the date of commencement of the NBCSP), or from the year that people become eligible for screening (i.e. age 50), whichever occurs later, until colonoscopy. This is a retrospective cohort study, so all of the outcomes have already occurred and have been recorded in the administrative data.];Cancer diagnosis using data from the Australian Cancer Database[Person-years will be calculated from entry into the study (2006 the date of commencement of the NBCSP), or from the year that people become eligible for screening (i.e. age 50), whichever occurs later, until cancer diagnosis. This is a retrospective cohort study, so all of the outcomes have already occurred and have been recorded in the administrative data.]
Study Design: Purpose: Screening;Duration: Longitudinal;Selection: Case control;Timing: Both
| 2470998 | ecrin-mdr-crc
Project description:BACKGROUND:An advance directive is a document specifying a person's preferences for treatment, should he or she lose capacity to make such decisions in the future. They have been used in end-of-life settings to direct care but should be well suited to the mental health setting. OBJECTIVES:To examine the effects of advance treatment directives for people with severe mental illness. SEARCH STRATEGY:We searched the Cochrane Schizophrenia Group's Register (February 2008), the Cochrane Library (Issue 1 2008), BIOSIS (1985 to February 2008), CINAHL (1982 to February 2008), EMBASE (1980 to February 2008), MEDLINE (1966 to February 2008), PsycINFO (1872 to February 2008), as well as SCISEARCH and Google - Internet search engine (February 2008). We inspected relevant references and contacted first authors of included studies. SELECTION CRITERIA:We included all randomised controlled trials (RCTs), involving adults with severe mental illness, comparing any form of advance directive with standard care for health service and clinical outcomes. DATA COLLECTION AND ANALYSIS:We extracted data independently. For homogenous dichotomous data we calculated fixed-effect relative risk (RR) and 95% confidence intervals (CI) on an intention-to-treat basis. For continuous data, we calculated weighted mean differences (WMD) and their 95% confidence interval again using a fixed-effect model. MAIN RESULTS:We were able to include two trials involving 321 people with severe mental illnesses. There was no significant difference in hospital admission (n=160, 1 RCT, RR 0.69 0.5 to 1.0), or number of psychiatric outpatient attendances between participants given advanced treatment directives or usual care. Similarly, no significant differences were found for compliance with treatment, self harm or number of arrests. Participants given advanced treatment directives needed less use of social workers time (n=160, 1 RCT, WMD -106.00 CI -156.2 to -55.8) than the usual care group, and violent acts were also lower in the advanced directives group (n=160, 1 RCT, RR 0.27 CI 0.1 to 0.9, NNT 8 CI 6 to 92). The number of people leaving the study early were not different between groups (n=321, 2 RCTs, RR 0.92 CI 0.6 to 1.6). AUTHORS' CONCLUSIONS:There are too few data available to make definitive recommendations. More intensive forms of advance directive appear to show promise, but currently practice must be guided by evidence other than that derived from randomised trials. More trials are indicated to determine whether higher intensity interventions, such as joint crisis planning, have an effect on outcomes of clinical relevance.
| S-EPMC4161493 | biostudies-other
Project description:PurposePeople with severe mental illness (SMI) experience poor physical health and premature mortality, contributed significantly by modifiable lifestyle risk factors such as poor nutrition, low cardiorespiratory fitness, and physical inactivity. Lifestyle interventions can reduce cardiometabolic risk and confer a range of other positive mental and physical health benefits. We assessed the feasibility, acceptability, safety, and preliminary effectiveness of a lifestyle (combined dietary and exercise) intervention lead by senior exercise and dietetics students in a residential mental health rehabilitation setting.DesignSingle arm, prospective study evaluating outcomes pre and post a 10-week dietary and exercise intervention.MethodPeople with SMI from three residential rehabilitation units participated in a mixed aerobic and resistance training exercise intervention three times per week that was combined with a dietary intervention (six individual and group sessions). Primary outcome considerations were feasibility (recruitment, retention, and participation rates), acceptability, and adverse events. Secondary outcomes were preliminary effectiveness; (functional exercise capacity, volume of exercise, and metabolic markers), psychiatric symptoms, quality of life, and attitudes to exercise.ResultsForty-two participants were recruited (92% primary diagnosis of schizophrenia). Intervention feasibility was supported by high levels of recruitment (68%), retention (77%), and participation (70% exercise, 65% diet sessions); and the absence of serious adverse events. Significant improvements in functional exercise capacity, volume of exercise, general psychiatric symptoms, and negative psychotic symptoms occurred. Anthropometric and metabolic blood markers did not change. While the intervention was acceptable to participants, motivation for and perceived value of exercise reduced over 10 weeks.ConclusionsA brief pragmatic student-led lifestyle intervention integrated into usual mental health care was feasible, acceptable, safe, and scalable across two additional mental health residential rehabilitation sites, and resulted in physical and mental health improvements. Increased frequency of dietary sessions and length of dietary intervention may improve metabolic outcomes in the future. People with SMI living in residential rehabilitation units should have access to lifestyle programs to address modifiable lifestyle risk factors. While this brief intervention was feasible and acceptable, this study highlights some of the challenges associated with maintaining motivation for healthy lifestyles for people with SMI. Longer term investigation of real-world lifestyle interventions is warranted, together with additional interventions that may support people with SMI to sustain motivation to address lifestyle factors.Clinical trial registrationThe trial was registered with the Australian New Zealand Clinical Trials Registry (ANZCTR), Unique Identifier: ACTRN 12618000478213, http://www.anzctr.org.au Universal trial number (UTN)-U1111-1211-4009.
| S-EPMC7198865 | biostudies-literature
Project description:BackgroundResearch consistently reports elevated rates of exposure to traumatic events and post-traumatic stress disorder (PTSD) in people with severe mental illness (SMI). PTSD may be adequately managed with psychotherapy; however, there is a gap when it comes to management in culturally diverse settings like Botswana. This paper describes a study protocol whose aim is to culturally adapt the BREATHE intervention, a brief psychological intervention for people living with comorbid PTSD and SMI that was developed and tested in the USA; assess the feasibility and acceptability of the adapted BREATHE intervention and explore its efficacy.MethodsThe study will be conducted in three phases using a mixed methods approach. The first phase will identify and describe the most common traumatic experiences and responses to traumatic experiences, amongst patients with SMI, and patients' and mental health care providers' perceptions about suitable PTSD interventions for Botswana. The second phase will entail cultural adaption of the intervention using findings from phase 1, and the third phase will be a pilot trial to assess the feasibility and acceptability of the culturally adapted intervention and explore its efficacy. Quantitative and qualitative data will be analysed using basic descriptive statistics and thematic analysis, respectively.DiscussionLiterature highlights cultural variations in the expression and management of mental illness suggesting the need for culturally adapted interventions. The findings of this feasibility study will be used to inform the design of a larger trial to assess the efficacy of an adapted brief intervention for PTSD in patients with SMI in Botswana.Trial registrationClinicaltrials.gov registration: NCT04426448 . Date of registration: June 7, 2020.
| S-EPMC8414703 | biostudies-literature
Project description:BackgroundSeveral interventions have been developed to improve physical health and lifestyle behaviour of people with a severe mental illness (SMI). Recently, we conducted a pragmatic cluster-randomised controlled trial which evaluated the effects of the one-year Severe Mental Illness Lifestyle Evaluation (SMILE) lifestyle intervention compared with usual care in clients with SMI. The SMILE intervention is a 12-month group-based lifestyle intervention with a focus on increased physical activity and healthy food intake. The aim of the current study was to explore the experiences of people with SMI and healthcare professionals (HCPs) regarding implementation feasibility of the SMILE intervention and the fidelity to the SMILE intervention.MethodsA process evaluation was conducted alongside the pragmatic randomized controlled trial. The experiences of clients and HCPs in the lifestyle intervention group were studied. First, descriptive data on the implementation of the intervention were collected. Next, semi-structured interviews with clients (n = 15) and HCPs (n = 13) were performed. Interviews were audiotaped and transcribed verbatim. A thematic analysis of the interview data was performed using MAXQDA software. In addition, observations of group sessions were performed to determine the fidelity to the SMILE intervention using a standardised form.ResultsTen out of 26 HCPs who conducted the group sessions discontinued their involvement with the intervention, primarily due to changing jobs. 98% of all planned group sessions were performed. Four main themes emerged from the interviews: 1) Positive appraisal of the SMILE intervention, 2) Suggestions for improvement of the SMILE intervention 3) Facilitators of implementation and 4) Barriers of implementation. Both clients and HCPs had positive experiences regarding the SMILE intervention. Clients found the intervention useful and informative. The intervention was found suitable and interesting for all people with SMI, though HCPs sometimes had to tailor the intervention to individual characteristics of patients (e.g., with respect to cognitive functioning). The handbook of the SMILE intervention was perceived as user-friendly and helpful by HCPs. Combining SMILE with daily tasks, no support from other team members, and lack of staff and time were experienced as barriers for the delivery of the intervention.ConclusionThe SMILE intervention was feasible and well-perceived by clients and HCPs. However, we also identified some aspects that may have hindered effective implementation and needs to be considered when implementing the SMILE intervention in daily practice.
| S-EPMC8729040 | biostudies-literature
Project description:INTRODUCTION:The construct of recovery was conceptualised in high-income countries and its applicability in low-income and middle- income countries is underexplored. A scoping review is proposed to synthesise knowledge, review conceptual overlap and map key elements of recovery from severe mental illness in low-income and middle-income countries. We aim to appraise the literature so as to inform future recovery-oriented services that consider the cultural and contextual influences on recovery from severe mental illness. METHODS AND ANALYSIS:The following electronic databases: MEDLINE via PubMed, SCOPUS (which included contents of Embase), PsycINFO, CINAHL, Africa-Wide Information, PsycARTICLES, Health source: Nursing/Academic Edition, Academic Search Premier and SocINDEX all via the EBSCOHOST platform, the Latin American and Caribbean Health Sciences Literature, the Cochrane Centre Register of Controlled Trials) and grey literature sources will be searched between May and December 2019. Eligible studies will be independently screened for inclusion and exclusion by two reviewers using a checklist developed for this purpose. Studies published between January 1993 and November 2019 that focus on recovery from severe mental illness in a low-income and middle-income country will be included. Findings will be compared and discrepancies will be discussed. Unresolved discrepancies will be referred to a third reviewer. All bibliographic data and study characteristics will be extracted and thematically analysed using a tool developed through an iterative process by the research team. Indicators will be classified according to a predefined conceptual framework and categorised and described using qualitative content analysis. ETHICS AND DISSEMINATION:The review aims to synthesise information from available publications, hence it does not require ethical approval. The results will be disseminated through publications, conference presentations and future workshops with stakeholders involved within the recovery paradigm of mental health policy and practice. The scoping review title is registered with the Joanna Briggs Institute.
| S-EPMC7044907 | biostudies-literature
Project description:ObjectiveTo examine the literature on how recovery of people with severe mental illness (SMI) is conceptualised in low/middle-income countries (LMICs), and in particular what factors are thought to facilitate recovery.DesignScoping review.Data sources and eligibilityWe searched 14 electronic databases, hand searched citations and consulted with experts during the period May-December 2019. Eligible studies were independently screened for inclusion and exclusion by two reviewers. Unresolved discrepancies were referred to a third reviewer.Data extraction and synthesisAll bibliographical data and study characteristics were extracted using a data charting form. Selected studies were analysed through a thematic analysis emerging from extracted data.ResultsThe Preferred Reporting Items for Systematic Reviews and Meta-Analyses flow diagram offers a summary of the results: 4201 titles, 1530 abstracts and 109 full-text articles were screened. Ten articles were selected for inclusion: two from Turkey, two from India, and one each from China, Swaziland, Indonesia, Egypt, South Africa and Vietnam. Although most studies used qualitative methods, data collection and sampling methods were heterogeneous. One study reported on service provider perspectives while the rest provided perspectives from a combination of service users and caregivers. Three themes emerged from the data analysis. First, studies frame recovery as a personal journey occurring along a continuum. Second, there was an emphasis on social relationships as a facilitator of recovery. Third, spirituality emerged as both a facilitator and an indicator of recovery. These themes were not mutually exclusive and some overlap exists.ConclusionAlthough there were commonalities with how high-income countries describe recovery, we also found differences in conceptualisation. These differences in how recovery was understood reflect the importance of framing the personal recovery concept in relation to local needs and contextual issues found in LMICs. This review highlighted the current sparse evidence base and the need to better understand recovery from SMI in LMICs.
| S-EPMC7993175 | biostudies-literature
Project description:ImportancePeople with a severe mental illness (SMI) have a life expectancy reduced by 10 to 20 years compared with the general population, primarily attributable to cardiometabolic disorders. Lifestyle interventions for people with SMI can improve health and reduce cardiometabolic risk.ObjectiveTo evaluate the effectiveness of a group-based lifestyle intervention among people with SMI in outpatient treatment settings compared with treatment as usual (TAU).Design, setting, and participantsThe Severe Mental Illness Lifestyle Evaluation (SMILE) study is a pragmatic cluster randomized clinical trial performed in 8 mental health care centers with 21 flexible assertive community treatment teams in the Netherlands. Inclusion criteria were SMI, age of 18 years or older, and body mass index (calculated as weight in kilograms divided by height in meters squared) of 27 or greater. Data were collected from January 2018 to February 2020, and data were analyzed from September 2020 to February 2023.InterventionsWeekly 2-hour group sessions for 6 months followed by monthly 2-hour group sessions for another 6 months, delivered by trained mental health care workers. The intervention targeted overall lifestyle changes, emphasizing establishing a healthy diet and promoting physical activity. TAU (control) did not include structured interventions or advice on lifestyle.Main outcomes and measuresCrude and adjusted linear mixed models and multivariable logistic regression analyses were performed. The main outcome was body weight change. Secondary outcomes included changes in body mass index, blood pressure, lipid profiles, fasting glucose level, quality of life, self-management ability, and lifestyle behaviors (physical activity and health, mental health, nutrition, and sleep).ResultsThe study population included 11 lifestyle intervention teams (126 participants) and 10 TAU teams (98 participants). Of 224 included patients, 137 (61.2%) were female, and the mean (SD) age was 47.6 (11.1) years. From baseline to 12 months, participants in the lifestyle intervention group lost 3.3 kg (95% CI, -6.2 to -0.4) more than those in the control group. In the lifestyle intervention group, people with high attendance rates lost more weight than participants with medium and low rates (mean [SD] weight loss: high, -4.9 [8.1] kg; medium, -0.2 [7.8] kg; low, 0.8 [8.3] kg). Only small or no changes were found for secondary outcomes.Conclusions and relevanceIn this trial, the lifestyle intervention significantly reduced weight from baseline to 12 months in overweight and obese adults with SMI. Tailoring lifestyle interventions and increasing attendance rates might be beneficial for people with SMI.Trial registrationNetherlands Trial Register Identifier: NTR6837.
| S-EPMC10285675 | biostudies-literature
Project description:ObjectiveTo determine the most effective way of helping people with severe mental illness to obtain competitive employment-that is, a job paid at the market rate, and for which anyone can apply.DesignSystematic review.ParticipantsEligible studies were randomised controlled trials comparing prevocational training or supported employment (for people with severe mental illness) with each other or with standard community care.Outcome measuresThe primary outcome was number of subjects in competitive employment. Secondary outcomes were other employment outcomes, clinical outcomes, and costs.ResultsEleven trials met the inclusion criteria. Five (1204 subjects) compared prevocational training with standard community care, one (256 subjects) compared supported employment with standard community care, and five (484 subjects) compared supported employment with prevocational training. Subjects in supported employment were more likely to be in competitive employment than those who received prevocational training at 4, 6, 9, 12, 15, and 18 months (for example, 34% v 12% at 12 months; number needed to treat 4.45, 95% confidence interval 3.37 to 6.59). This effect was still present, although at a reduced level, after a sensitivity analysis that retained only the highest quality trials (31% v 12%; 5.3, 3.6 to 10.4). People in supported employment earned more and worked more hours per month than those who had had prevocational training.ConclusionSupported employment is more effective than prevocational training at helping people with severe mental illness obtain competitive employment.
| S-EPMC26585 | biostudies-literature