Guided digital health intervention for depression in Lebanon: randomised trial

Background Most people with mental disorders in communities exposed to adversity in low-income and middle-income countries (LMICs) do not receive effective care. Digital mental health interventions are scalable when digital access is adequate, and can be safely delivered during the COVID-19 pandemic. Objective To examine the effects of a new WHO-guided digital mental health intervention, Step-by-Step, supported by a non-specialist helper in Lebanon, in the context of concurring economic, humanitarian and political crises, a large industrial disaster and the COVID-19 pandemic. Methods We conducted a single-blind, two-arm pragmatic randomised trial, comparing guided Step-by-Step with enhanced care as usual (ECAU) among people suffering from depression and impaired functioning. Primary outcomes were depression (Patient Health Questionnaire 9 (PHQ-9)) and impaired functioning (WHO Disability Assessment Schedule-12 (WHODAS)) at post-treatment. Findings 680 people with depression (PHQ-9>10) and impaired functioning (WHODAS>16) were randomised to Step-by-Step or ECAU. Intention-to-treat analyses showed effects on depression (standardised mean differences, SMD: 0.71; 95% CI: 0.45 to 0.97), impaired functioning (SMD: 0.43; 95% CI: 0.21 to 0.65), post-traumatic stress (SMD: 0.53; 95% CI: 0.27 to 0.79), anxiety (SMD: 0.74; 95% CI: 0.49 to 0.99), subjective well-being (SMD: 0.37; 95% CI: 0.12 to 0.62) and self-identified personal problems (SMD: 0.56; 95% CI 0.29 to 0.83). Significant effects on all outcomes were retained at 3-month follow-up. Conclusions Guided digital mental health interventions can be effective in the treatment of depression in communities exposed to adversities in LMICs, although some uncertainty remains because of high attrition

Step-by-step: Feasibility randomised controlled trial of a mobile-based intervention for depression among populations affected by adversity in Lebanon

Background: E-mental health interventions may help to bridge the mental health treatment gap. Evidence on their effectiveness is compelling in high-income countries. Not enough evidence has been generated on their use with communities affected by adversity in low- and middle-income countries. The World Health Organization (WHO), the National Mental Health Programme (NMMP) at Ministry of Public Health (MoPH) in Lebanon and other partners have adapted a WHO intervention called Step-by-Step for use with Lebanese and displaced people living in Lebanon. Step-by-Step is a minimally guided, internet-based intervention for adults with depression. In this study, a feasibility randomised controlled trial (RCT) and a qualitative process evaluation were conducted to explore the feasibility and the acceptability of the research methods, and the intervention, in preparation for two fully powered trials to assess the effectiveness and cost-effectiveness of Step-by-Step in Lebanon. Method: Participants were recruited through social media. Inclusion criteria were: being able to understand and speak Arabic or English; access to an internet connected device; aged over 18; living in Lebanon; scores above cut-off on the Patient Health Questionnaire and the WHO Disability Assessment Schedule 2.0. Participants were randomly assigned to the intervention or enhanced care as usual. They completed post-assessments eight weeks after baseline, and follow-up assessments another three months later. Primary outcomes were depression and level of functioning, secondary outcomes were anxiety, post-traumatic stress, and well-being. Qualitative interviews were conducted to evaluate the feasibility and acceptability of the research procedures and the intervention. Results: A total of N = 138 participants, including 33 Syrians, were recruited and randomised into two equal groups. The dropout rate was higher in the control group (73% post- and 82% follow-up assessment) than in the intervention group (63% post- and 72% follow-up assessment). The intervention was perceived as relevant, acceptable and beneficial to those who completed it. Suggestions were made to further adapt the content and to make the intervention more engaging. Statistical analyses were conducted despite the small sample size. Complete cases analysis showed a statistically significant symptom reduction in depression, anxiety, disability, and post-traumatic stress, and statistically significant improvement in well-being and functioning. Intention-to-treat analysis revealed non-significant effects. Conclusion: The research design, methods and procedures are feasible and acceptable in the context of Lebanon and can be applied in the RCTs. Preliminary findings suggest that Step-by-Step may be effective in reducing symptoms of depression and anxiety and improving functioning and well-being

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

Feasibility and uptake of a digital mental health intervention for depression among Lebanese and Syrian displaced people in Lebanon: a qualitative study

IntroductionDigital interventions are increasingly regarded as a potential solution for the inaccessibility of mental health treatment across low-and-middle-income settings, especially for common mental disorders. Step-by-Step (SbS) is a digital, guided self-help intervention for depression found effective in two Randomized Controlled Trials (RCTs) in Lebanon. For research implementation and further scale-up, this paper reports the results of a qualitative evaluation of SbS among the Lebanese and others and displaced Syrians in Lebanon.MethodsThirty-four Key Informant Interviews (KIIs) were executed with participants of the RCTs, SbS staff members, and external stakeholders. Questions garnered feedback about the feasibility, acceptability, enabling factors, and barriers to adhering to the research, implementation, and the SbS intervention. A thematic analysis was conducted using NVivo, and key themes, topics, and recommendations, on research methods and the intervention itself, were generated and reported.ResultsResults showed a high level of acceptability of SbS among Lebanese and Syrians and identified sub-groups for whom acceptance or use might be lower, such as older adults and people with limited access to the internet or smartphones. Furthermore, interviews identified the main enabling factors and barriers to adherence related to the research design, content, and delivery approach. Barriers related to feasibility included lengthy assessments as part of the RCTs, and mistrust related to delays in study compensations. Other common challenges were forgetting login credentials, poor internet connection, being busy and competing needs. Enabling factors and best practices included motivating participants to use the intervention through the weekly support provided by helpers, setting an oral contract for commitment, and dividing the compensations into several installments as part of the RCTs. Recommendations regarding sustainability were given.DiscussionThe findings show that overall, SbS is feasible, acceptable, and much needed in Lebanon among the Lebanese and Syrians. This assessment identifies reasons for low adherence to the research and the intervention and presents improvement solutions. Recommendations generated in this paper inform the upscale of SbS and the planning, design, and implementation of future digital interventions in research and service provision settings in the mental health field

The effectiveness of problem solving therapy in deprived South African communities: results from a pilot study

<p>Abstract</p> <p>Background</p> <p>The majority of South Africans with a DSM-IV diagnosis receive no treatment for their mental health problems. There is a move to simplify treatment for common mental disorders (CMDs) in order to ease access. Brief problem solving therapy (PST) might fill the treatment gap for CMD's in deprived communities in South Africa. This pilot study evaluates the feasibility, acceptability and effectiveness of this PST program for CMD's in deprived communities around Cape Town.</p> <p>Methods</p> <p>A Dutch problem solving program was adapted and translated into English, Xhosa and Afrikaans and thereafter implemented in townships around Cape Town. An initial attempt to recruit participants for online PST proved difficult, and so the program was adapted to a booklet format. Volunteers experiencing psychological distress were invited to participate in the either individually or group delivered 5-week during self-help program. To evaluate the effectiveness, psychological distress was administered through self-report questionnaires. After completion of the intervention participants also rated the program on various acceptability aspects.</p> <p>Results</p> <p>Of 103 participants, 73 completed 5 weeks of brief PST in a booklet/workshop format. There were significantly more dropouts in those who used the booklet individually than in the group. Psychological distress measured on the K-10 and SRQ fell significantly and the program was evaluated positively.</p> <p>Conclusions</p> <p>The results suggest that brief problem solving in a booklet/workshop format may be an effective, feasible and acceptable short-term treatment for people with CMD's in deprived communities. In this setting, group delivery of PST had lower drop-out rates than individual delivery, and was more feasible and acceptable. Randomized controlled trials are needed to evaluate the effect of brief self-help PST more rigorously.</p

Step-by-Step: a new WHO digital mental health intervention for depression

The World Health Organization is developing a range of interventions, including technology supported interventions, to help address the mental health treatment gap, particularly in low and middle-income countries. One of these, Step-by-Step, is a guided, technology supported, intervention for depression. It provides psychoeducation and training in behavioural activation through an illustrated narrative with additional therapeutic techniques such as stress management (slow breathing), identifying strengths, positive self-talk, increasing social support and relapse prevention. Step-by-Step has been designed so that it can be adapted for use in settings with different cultural contexts and resource availability and to be meaningful in communities affected by adversity. This paper describes the process of developing Step-by-Step and highlights particular design features aimed at increasing feasibility of implementation in a wide variety of settings

Effectiveness of Group Problem Management plus (Group-PM+) for adults affected by humanitarian crises in Nepal:Study protocol for a cluster randomized controlled trial

© 2020 The Author(s). Background: Globally, the lack of availability of psychological services for people exposed to adversities has led to the development of a range of scalable psychological interventions with features that enable better scale-up. Problem Management Plus (PM+) is a brief intervention of five sessions that can be delivered by non-specialists. It is designed for people in communities in low- and middle-income countries (LMIC) affected by any kind of adversity. Two recent randomized controlled trials in Pakistan and Kenya demonstrated the effectiveness of individually delivered PM+. A group version of PM+ has been developed to make the intervention more scalable and acceptable. This paper describes the protocol for a cluster randomized controlled trial (c-RCT) on locally adapted Group PM+ in Nepal. Methods/design: This c-RCT will compare Group PM+ to enhanced usual care (EUC) in participants with high levels of psychological distress recruited from the community. The study is designed as a two-arm, single-blind c-RCT that will be conducted in a community-based setting in Morang, a flood affected district in Eastern Nepal. Randomization will occur at ward level, the smallest administrative level in Nepal, with 72 enrolled wards allocated to Group PM+ or to EUC (ratio 1:1). Group PM+ consists of five approximately 2.5-h sessions, in which participants are taught techniques to manage their stressors and problems, and is delivered by trained and supervised community psychosocial workers (CPSWs). EUC consists of a family meeting with (a) basic information on adversity and mental health, (b) benefits of getting support, (c) information on seeking services from local health facilities with mhGAP-trained staff. The primary outcome measure is levels of individual psychological distress at endline (equivalent to 20 ± 1 weeks after baseline), measured by the General Health Questionnaire (GHQ-12). Secondary outcome measures include levels of functioning, depressive symptoms, post-traumatic stress disorder symptoms, levels of social support, somatic symptoms, and ways of coping. We hypothesize that skills acquired will mediate any impact of the intervention. Discussion: This c-RCT will contribute to the growing evidence-base for transdiagnostic psychological interventions delivered by non-specialists for people in communities affected by adversity. If Group PM+ is proven effective, the intervention manual will be released for use, giving the opportunity for further adaptation and implementation of the intervention in diverse settings with communities that require better access to psychological interventions. Trial registration: ClinicalTrials.gov, NCT03747055

A qualitative evaluation of a brief multicomponent intervention provided by lay health workers for women affected by adversity in urban Kenya

Background: Problem Management Plus (PM+) is a brief multicomponent intervention incorporating behavioral strategies delivered by lay health workers. The effectiveness of PM+ has been evaluated in randomized controlled trials in Kenya and Pakistan. When developing interventions for large-scale implementation it is considered essential to evaluate their feasibility and acceptability in addition to their efficacy. This paper discusses a qualitative evaluation of PM+ for women affected by adversity in Kenya. Methods: Qualitative interviews were conducted with 27 key informants from peri-urban Nairobi, Kenya, where PM+ was tested. Interview participants included six women who completed PM+, six community health volunteers (CHVs) who delivered the intervention, seven people with local decision making power, and eight project staff involved in the PM+ trial. Results: Key informants generally noted positive experiences with PM+. Participants and CHVs reported the positive impact PM+ had made on their lives. Nonetheless, potential structural and psychological barriers to scale up were identified. The sustainability of CHVs as unsalaried, volunteer providers was mentioned by most interviewees as the main barrier to scaling up the intervention. Conclusions: The findings across diverse stakeholders show that PM+ is largely acceptable in this Kenyan setting. The results indicated that when further implemented, PM+ could be of great value to people in communities exposed to adversities such as interpersonal violence and chronic poverty. Barriers to large-scale implementation were identified, of which the sustainability of the non-specialist health workforce was the most important one

Effects of a WHO-guided digital health intervention for depression in Syrian refugees in Lebanon: A randomized controlled trial

BACKGROUND: Most displaced people with mental disorders in low- and middle-income countries do not receive effective care, and their access to care has deteriorated during the Coronavirus Disease 2019 (COVID-19) pandemic. Digital mental health interventions are scalable when digital access is adequate, and they can be safely delivered during the COVID-19 pandemic. We examined whether a new WHO-guided digital mental health intervention, Step-by-Step, in which participants were supported by a nonspecialist helper, was effective in reducing depression among displaced people in Lebanon. METHODS AND FINDINGS: We conducted a single-blind, 2-arm pragmatic randomized clinical trial, comparing guided Step-by-Step with enhanced care as usual (ECAU) among displaced Syrians suffering from depression and impaired functioning in Lebanon. Primary outcomes were depression (Patient Health Questionnaire, PHQ-9) and impaired functioning (WHO Disability Assessment Schedule-12, WHODAS) at posttreatment. Secondary outcomes included subjective well-being, anxiety, post-traumatic stress, and self-described problems. A total of 569 displaced people from Syria with depression (PHQ-9 ≥ 10) and impaired functioning (WHODAS > 16) were randomized to Step-by-Step (N = 283; lost to follow-up: N = 167) or ECAU (N = 286; lost to follow-up: 133). Participants were considered to be lost to follow-up when they did not fill in the outcome measures at posttest or follow-up. Recruitment started on December 9, 2019 and was completed on July 9, 2020. The last follow-up assessments were collected in December 2020. The study team had access to the online platform, where they could see treatment arm assignment for each participant. All questionnaires were completed by participants online. Intention-to-treat (ITT) analyses showed intervention effects on depression (standardized mean differences [SMDs]: 0.48; 95% CI: 0.26; 0.70; p < 0.001), impaired functioning (SMD: 0.35; 95% CI: 0.14; 0.56; p < 0.001), post-traumatic stress (SMD: 0.36; 95% CI: 0.16; 0.56; p < 0.001), anxiety (SMD: 0.46; 95% CI: 0.24; 0.68; p < 0.001), subjective well-being (SMD: 0.47; 95% CI: 0.26; 0.68; p < 0.001), and self-identified personal problems (SMD: 0.49; 95% CI 0.28; 0.70; p < 0.001). Significant effects on all outcomes were maintained at 3 months follow-up. During the trial, one serious adverse event occurred, unrelated to the intervention. The main limitation of the current trial is the high dropout rate. CONCLUSIONS: In this study, we found that a guided, digital intervention was effective in reducing depression in displaced people in Lebanon. The guided WHO Step-by-Step intervention we examined should be made available to communities of displaced people that have digital access. TRIAL REGISTRATION: ClinicalTrials.gov NCT03720769