User-Centered App Adaptation of a Low-Intensity E-Mental Health Intervention for Syrian Refugees

Introduction: The aim of this study is to describe the initial stages of the iterative and user-centered mobile mental health adaptation process of Step-by-Step (SbS), a modularized and originally web-based e-mental health intervention developed by the World Health Organization (WHO). Given the great need for improving the responsiveness and accessibility of health systems in host countries, the EU-funded STRENGTHS consortium studies the adaptation, implementation and scaling-up of SbS for Syrian refugees in Germany, Sweden and Egypt. Using early prototyping, usability testing and identification of barriers to implementation, the study demonstrates a user-centered process of contextual adaptation to the needs and expectations of Syrian refugees.Materials and Methods:N = 128 adult Syrian refugees residing in Germany, Sweden and Egypt took part in qualitative assessments. Access, usage, and potential barriers regarding information and communication technologies (ICTs) were assessed in free list interviews. Interactive prototypes of the app were presented in key informant interviews and evaluated on usability, user experience and dissemination strategies. Focus groups were conducted to verify the results. The interview protocols were analyzed using inductive and deductive thematic analysis.Results: The use of digital technologies was found to be widespread among Syrian refugees. Technical literacy and problems with accessing the internet were common barriers. The majority of the respondents reacted positively to the presented app prototypes, stressing the potential health impact of the intervention (n = 28; 78%), its flexibility and customizability (n = 19; 53%) as well as the easy learnability of the app (n = 12; 33%). Aesthetic components (n = 12; 33%) and the overall length and pace of the intervention sessions (n = 9; 25%) were criticized in regard to their negative impact on user motivation. Acceptability, credibility, and technical requirements were identified as main barriers to implementation.Discussion: The study provided valuable guidance for adapting the app version of SbS and for mobile mental health adaptation in general. The findings underline the value of contextual adaptation with a focus on usability, user experience, and context specific dissemination strategies. Related factors such as access, acceptability and adherence have major implications for scaling-up digital interventions

Improving mental health and psychosocial wellbeing in humanitarian settings: Reflections on research funded through R2HC

From Springer Nature via Jisc Publications RouterMajor knowledge gaps remain concerning the most effective ways to address mental health and psychosocial needs of populations affected by humanitarian crises. The Research for Health in Humanitarian Crisis (R2HC) program aims to strengthen humanitarian health practice and policy through research. As a significant portion of R2HC’s research has focused on mental health and psychosocial support interventions, the program has been interested in strengthening a community of practice in this field. Following a meeting between grantees, we set out to provide an overview of the R2HC portfolio, and draw lessons learned. In this paper, we discuss the mental health and psychosocial support-focused research projects funded by R2HC; review the implications of initial findings from this research portfolio; and highlight four remaining knowledge gaps in this field. Between 2014 and 2019, R2HC funded 18 academic-practitioner partnerships focused on mental health and psychosocial support, comprising 38% of the overall portfolio (18 of 48 projects) at a value of approximately 7.2 million GBP. All projects have focused on evaluating the impact of interventions. In line with consensus-based recommendations to consider a wide range of mental health and psychosocial needs in humanitarian settings, research projects have evaluated diverse interventions. Findings so far have both challenged and confirmed widely-held assumptions about the effectiveness of mental health and psychosocial interventions in humanitarian settings. They point to the importance of building effective, sustained, and diverse partnerships between scholars, humanitarian practitioners, and funders, to ensure long-term program improvements and appropriate evidence-informed decision making. Further research needs to fill knowledge gaps regarding how to: scale-up interventions that have been found to be effective (e.g., questions related to integration across sectors, adaptation of interventions across different contexts, and optimal care systems); address neglected mental health conditions and populations (e.g., elderly, people with disabilities, sexual minorities, people with severe, pre-existing mental disorders); build on available local resources and supports (e.g., how to build on traditional, religious healing and community-wide social support practices); and ensure equity, quality, fidelity, and sustainability for interventions in real-world contexts (e.g., answering questions about how interventions from controlled studies can be transferred to more representative humanitarian contexts).All studies described here were funded by Elrha’s Research for Health in Humanitarian Crises (R2HC) Programme, which aims to improve health outcomes by strengthening the evidence base for public health interventions in humanitarian crises.14pubpu

Improving mental health and psychosocial wellbeing in humanitarian settings: reflections on research funded through R2HC

Major knowledge gaps remain concerning the most effective ways to address mental health and psychosocial needs of populations affected by humanitarian crises. The Research for Health in Humanitarian Crisis (R2HC) program aims to strengthen humanitarian health practice and policy through research. As a significant portion of R2HC’s research has focused on mental health and psychosocial support interventions, the program has been interested in strengthening a community of practice in this field. Following a meeting between grantees, we set out to provide an overview of the R2HC portfolio, and draw lessons learned. In this paper, we discuss the mental health and psychosocial support-focused research projects funded by R2HC; review the implications of initial findings from this research portfolio; and highlight four remaining knowledge gaps in this field. Between 2014 and 2019, R2HC funded 18 academic-practitioner partnerships focused on mental health and psychosocial support, comprising 38% of the overall portfolio (18 of 48 projects) at a value of approximately 7.2 million GBP. All projects have focused on evaluating the impact of interventions. In line with consensus-based recommendations to consider a wide range of mental health and psychosocial needs in humanitarian settings, research projects have evaluated diverse interventions. Findings so far have both challenged and confirmed widely-held assumptions about the effectiveness of mental health and psychosocial interventions in humanitarian settings. They point to the importance of building effective, sustained, and diverse partnerships between scholars, humanitarian practitioners, and funders, to ensure long-term program improvements and appropriate evidence-informed decision making. Further research needs to fill knowledge gaps regarding how to: scale-up interventions that have been found to be effective (e.g., questions related to integration across sectors, adaptation of interventions across different contexts, and optimal care systems); address neglected mental health conditions and populations (e.g., elderly, people with disabilities, sexual minorities, people with severe, pre-existing mental disorders); build on available local resources and supports (e.g., how to build on traditional, religious healing and community-wide social support practices); and ensure equity, quality, fidelity, and sustainability for interventions in real-world contexts (e.g., answering questions about how interventions from controlled studies can be transferred to more representative humanitarian contexts)

3 years of liraglutide versus placebo for type 2 diabetes risk reduction and weight management in individuals with prediabetes: a randomised, double-blind trial

Background Liraglutide 3\ub70 mg was shown to reduce bodyweight and improve glucose metabolism after the 56-week period of this trial, one of four trials in the SCALE programme. In the 3-year assessment of the SCALE Obesity and Prediabetes trial we aimed to evaluate the proportion of individuals with prediabetes who were diagnosed with type 2 diabetes. Methods In this randomised, double-blind, placebo-controlled trial, adults with prediabetes and a body-mass index of at least 30 kg/m2, or at least 27 kg/m2 with comorbidities, were randomised 2:1, using a telephone or web-based system, to once-daily subcutaneous liraglutide 3\ub70 mg or matched placebo, as an adjunct to a reduced-calorie diet and increased physical activity. Time to diabetes onset by 160 weeks was the primary outcome, evaluated in all randomised treated individuals with at least one post-baseline assessment. The trial was conducted at 191 clinical research sites in 27 countries and is registered with ClinicalTrials.gov, number NCT01272219. Findings The study ran between June 1, 2011, and March 2, 2015. We randomly assigned 2254 patients to receive liraglutide (n=1505) or placebo (n=749). 1128 (50%) participants completed the study up to week 160, after withdrawal of 714 (47%) participants in the liraglutide group and 412 (55%) participants in the placebo group. By week 160, 26 (2%) of 1472 individuals in the liraglutide group versus 46 (6%) of 738 in the placebo group were diagnosed with diabetes while on treatment. The mean time from randomisation to diagnosis was 99 (SD 47) weeks for the 26 individuals in the liraglutide group versus 87 (47) weeks for the 46 individuals in the placebo group. Taking the different diagnosis frequencies between the treatment groups into account, the time to onset of diabetes over 160 weeks among all randomised individuals was 2\ub77 times longer with liraglutide than with placebo (95% CI 1\ub79 to 3\ub79, p<0\ub70001), corresponding with a hazard ratio of 0\ub721 (95% CI 0\ub713\u20130\ub734). Liraglutide induced greater weight loss than placebo at week 160 (\u20136\ub71 [SD 7\ub73] vs 121\ub79% [6\ub73]; estimated treatment difference 124\ub73%, 95% CI 124\ub79 to 123\ub77, p<0\ub70001). Serious adverse events were reported by 227 (15%) of 1501 randomised treated individuals in the liraglutide group versus 96 (13%) of 747 individuals in the placebo group. Interpretation In this trial, we provide results for 3 years of treatment, with the limitation that withdrawn individuals were not followed up after discontinuation. Liraglutide 3\ub70 mg might provide health benefits in terms of reduced risk of diabetes in individuals with obesity and prediabetes. Funding Novo Nordisk, Denmark

A randomized, controlled trial of 3.0 mg of liraglutide in weight management

BACKGROUND Obesity is a chronic disease with serious health consequences, but weight loss is difficult to maintain through lifestyle intervention alone. Liraglutide, a glucagonlike peptide-1 analogue, has been shown to have potential benefit for weight management at a once-daily dose of 3.0 mg, injected subcutaneously. METHODS We conducted a 56-week, double-blind trial involving 3731 patients who did not have type 2 diabetes and who had a body-mass index (BMI; the weight in kilograms divided by the square of the height in meters) of at least 30 or a BMI of at least 27 if they had treated or untreated dyslipidemia or hypertension. We randomly assigned patients in a 2:1 ratio to receive once-daily subcutaneous injections of liraglutide at a dose of 3.0 mg (2487 patients) or placebo (1244 patients); both groups received counseling on lifestyle modification. The coprimary end points were the change in body weight and the proportions of patients losing at least 5% and more than 10% of their initial body weight. RESULTS At baseline, the mean (±SD) age of the patients was 45.1±12.0 years, the mean weight was 106.2±21.4 kg, and the mean BMI was 38.3±6.4; a total of 78.5% of the patients were women and 61.2% had prediabetes. At week 56, patients in the liraglutide group had lost a mean of 8.4±7.3 kg of body weight, and those in the placebo group had lost a mean of 2.8±6.5 kg (a difference of -5.6 kg; 95% confidence interval, -6.0 to -5.1; P&lt;0.001, with last-observation-carried-forward imputation). A total of 63.2% of the patients in the liraglutide group as compared with 27.1% in the placebo group lost at least 5% of their body weight (P&lt;0.001), and 33.1% and 10.6%, respectively, lost more than 10% of their body weight (P&lt;0.001). The most frequently reported adverse events with liraglutide were mild or moderate nausea and diarrhea. Serious events occurred in 6.2% of the patients in the liraglutide group and in 5.0% of the patients in the placebo group. CONCLUSIONS In this study, 3.0 mg of liraglutide, as an adjunct to diet and exercise, was associated with reduced body weight and improved metabolic control. (Funded by Novo Nordisk; SCALE Obesity and Prediabetes NN8022-1839 ClinicalTrials.gov number, NCT01272219.)

3 years of liraglutide versus placebo for type 2 diabetes risk reduction and weight management in individuals with prediabetes: a randomised, double-blind trial

Background: Liraglutide 3·0 mg was shown to reduce bodyweight and improve glucose metabolism after the 56-week period of this trial, one of four trials in the SCALE programme. In the 3-year assessment of the SCALE Obesity and Prediabetes trial we aimed to evaluate the proportion of individuals with prediabetes who were diagnosed with type 2 diabetes. Methods: In this randomised, double-blind, placebo-controlled trial, adults with prediabetes and a body-mass index of at least 30 kg/m2, or at least 27 kg/m2 with comorbidities, were randomised 2:1, using a telephone or web-based system, to once-daily subcutaneous liraglutide 3·0 mg or matched placebo, as an adjunct to a reduced-calorie diet and increased physical activity. Time to diabetes onset by 160 weeks was the primary outcome, evaluated in all randomised treated individuals with at least one post-baseline assessment. The trial was conducted at 191 clinical research sites in 27 countries and is registered with ClinicalTrials.gov, number NCT01272219. Findings: The study ran between June 1, 2011, and March 2, 2015. We randomly assigned 2254 patients to receive liraglutide (n=1505) or placebo (n=749). 1128 (50%) participants completed the study up to week 160, after withdrawal of 714 (47%) participants in the liraglutide group and 412 (55%) participants in the placebo group. By week 160, 26 (2%) of 1472 individuals in the liraglutide group versus 46 (6%) of 738 in the placebo group were diagnosed with diabetes while on treatment. The mean time from randomisation to diagnosis was 99 (SD 47) weeks for the 26 individuals in the liraglutide group versus 87 (47) weeks for the 46 individuals in the placebo group. Taking the different diagnosis frequencies between the treatment groups into account, the time to onset of diabetes over 160 weeks among all randomised individuals was 2·7 times longer with liraglutide than with placebo (95% CI 1·9 to 3·9, p&lt;0·0001), corresponding with a hazard ratio of 0·21 (95% CI 0·13–0·34). Liraglutide induced greater weight loss than placebo at week 160 (–6·1 [SD 7·3] vs −1·9% [6·3]; estimated treatment difference −4·3%, 95% CI −4·9 to −3·7, p&lt;0·0001). Serious adverse events were reported by 227 (15%) of 1501 randomised treated individuals in the liraglutide group versus 96 (13%) of 747 individuals in the placebo group. Interpretation: In this trial, we provide results for 3 years of treatment, with the limitation that withdrawn individuals were not followed up after discontinuation. Liraglutide 3·0 mg might provide health benefits in terms of reduced risk of diabetes in individuals with obesity and prediabetes. Funding: Novo Nordisk, Denmark

Design and cultural adaptation of an e-mental health intervention for depression

This thesis employs mixed methodologies, including systematic review and meta-analysis, qualitative research and pre-post design empirical testing. It comprises the in-depth formative work for designing and testing the Step-by-Step e-mental health intervention for depression. We found that a Western only model of mental distress does not capture important local features relevant to informing the design and conduction of efficacy studies of interventions for common mental disorders. We also found that local adaption of self-help psychological interventions can contribute to increased intervention efficacy. Systematically carrying out cultural adaptation of Step-by-Step with local actors was crucial. The feasibility testing of Step-by-Step provided valuable information to inform the design of future large-scale efficacy testing and hinted that Step-by-Step is a potentially promising intervention for reducing the symptoms of depression. An adapted, minimally guided, internet-delivered intervention like Step-by-Step could help close the treatment gap for depression if integrated responsibly into an existing care system

The cultural adaptation of a scalable WHO eMental Health program for overseas Filipino workers

Background: Electronic mental (e-mental) health interventions can address mental health needs of different populations. Cultural adaptation of these interventions is crucial to establish a better fit with the cultural group and to achieve better treatment outcomes. Objective: This study aimed to describe the cultural adaptation of the World Health Organization\u27s e-mental health program Step-by-Step for overseas Filipino workers. We used a framework which posits that cultural adaptation should enhance (1) relevance, wherein the cultural group can relate with the content; (2) acceptability, where the cultural group will not find any element offensive; (3) comprehensibility, where the program is understandable; and (4) completeness, wherein the adapted version covers the same concepts and constructs as the original program. We aimed to have English and Filipino and male and female versions. Methods: Overall, 3 experienced Filipino psychologists provided their perspectives on the program and how it might be adapted for overseas Filipino workers. We then adapted the program and obtained feedback from 28 overseas Filipino workers from diverse industries through focus group discussions. We conducted 7 and 9 focus group discussions with male and female participants, respectively. Per discussion, cognitive interviewing was used to probe for relevance, acceptability, comprehensibility, and completeness of illustrations and text. Participant feedback guided iterative program adaptations, which were again shown to participants for validation and improvement. Results: Several issues were raised by participants about the generic version of Step-by-Step. There were elements deemed irrelevant, like unfitting characters, lack of Filipino values, and unsuitable problems and activities. There were unacceptable components that were stigmatizing, political, inappropriate to context or subgroups, and too feminine for male users. Some elements were incomprehensible, unclear, or complicated. To address these issues, we made key adaptations. To enhance relevance, we adapted the narrative to match the experiences of overseas Filipino workers, incorporated Filipino values, and illustrated familiar problems and activities. To increase acceptability, our main characters were changed to wise elders rather than health professionals (reducing mental health and help-seeking stigma), political or unacceptable content was removed, and the program was made suitable for overseas Filipino workers from different sectors. To increase comprehension, we used English and Filipino languages, simplified the text to ease interpretation of abstract terms, and ensured that text and illustrations matched. We also used Taglish (ie, merged English and Filipino) when participants deemed pure Filipino translations sounded odd or incomprehensible. Finally, we retained the core elements and concepts included in the original Step-by-Step program to maintain completeness. Conclusions: This study showed the utility of a 4-point framework that focuses on acceptance, relevance, comprehensibility, and completeness in cultural adaptation. Moreover, we achieved a culturally appropriate adapted version of the Step-by-Step program for overseas Filipino workers. We discuss lessons learned in the process to guide future cultural adaptation projects of e-mental health interventions

Cultural Adaptation of Minimally Guided Interventions for Common Mental Disorders: A Systematic Review and Meta-Analysis.

BACKGROUND Cultural adaptation of mental health care interventions is key, particularly when there is little or no therapist interaction. There is little published information on the methods of adaptation of bibliotherapy and e-mental health interventions. OBJECTIVE To systematically search for evidence of the effectiveness of minimally guided interventions for the treatment of common mental disorders among culturally diverse people with common mental disorders; to analyze the extent and effects of cultural adaptation of minimally guided interventions for the treatment of common mental disorders. METHODS We searched Embase, PubMed, the Cochrane Library, and PsycINFO for randomized controlled trials that tested the efficacy of minimally guided or self-help interventions for depression or anxiety among culturally diverse populations. We calculated pooled standardized mean differences using a random-effects model. In addition, we administered a questionnaire to the authors of primary studies to assess the cultural adaptation methods used in the included primary studies. We entered this information into a meta-regression to investigate effects of the extent of adaptation on intervention efficacy. RESULTS We included eight randomized controlled trials (RCTs) out of the 4911 potentially eligible records identified by the search: four on e-mental health and four on bibliotherapy. The extent of cultural adaptation varied across the studies, with language translation and use of metaphors being the most frequently applied elements of adaptation. The pooled standardized mean difference for primary outcome measures of depression and anxiety was -0.81 (95% CI -0.10 to -0.62). Higher cultural adaptation scores were significantly associated with greater effect sizes (P=.04). CONCLUSIONS Our results support the results of previous systematic reviews on the cultural adaptation of face-to-face interventions: the extent of cultural adaptation has an effect on intervention efficacy. More research is warranted to explore how cultural adaptation may contribute to improve the acceptability and effectiveness of minimally guided psychological interventions for common mental disorders