Nepal is a low-income country with a history of internal conflict, political instability, and natural disasters. In 2015, an earthquake resulted in injuries, deaths and displacement. 34.3% and 33.8% of participants in an earthquake affected district scored above the validated cut-off scores for depression and anxiety respectively (32). The country reports that there are 0.52 psychologists and 0.36 psychiatrists for every 100,000 people, mostly working in larger cities and are not easily accessible to those in rural areas (33). The lack of trained specialists and their limited reach to populations around the country makes an intervention with non-specialists a practical and important solution to consider. To date, there have been minimal efforts to adapt EBTs in the Nepal (34). Group PM+ was considered an appropriate intervention to test in this setting due to its scalability and task-sharing approach.
The Group PM+ intervention’s adaptation process and feasibility trial was conducted in Sindhuli district, which was heavily impacted by the 2015 earthquake (35,36). Two Village Development Committees (VDCs) were selected for the adaptation process and the feasibility trial to follow. There were no specialized mental health treatment facilities in the district and the closest psychiatric services were approximately six-hours away from the study site. For this reason, local health posts were the first portal of care and the referral sites for program participants. The adaptation process and implementation of the trial was conducted by the staff of Transcultural Psychosocial Organization (TPO) Nepal based in Kathmandu, Nepal. TPO Nepal was established in 2005 and is a leading mental health service delivery, training, and research organization (37).
A study was conducted to demonstrate the feasibility and acceptability of Group PM+ in Nepal (36). The pilot feasibility study was registered on ClinicalTrials.gov (NCT03359486). A ten-step adaptation model was followed in preparation for a feasibility and acceptability trial. After the feasibility trial, qualitative interviews were conducted with program stakeholders to gather data on the acceptability and scalability of the adaptations (35). After making improvements to the adaptations, a definitive Group PM+ trial will be conducted in a flood-affected area of Nepal to test the effectiveness of the program and the adaptations made to support it (38).
Ecological Validity Model (EVM)
We used the Ecological Validity Model (EVM) to guide our adaptation of the Group PM+ intervention (39,40). The EVM framework was selected because it allows the treatment to keep its core principles and directs focus to the periphery, but equally important, aspects of the intervention (40). This framework is based on the view that individuals must be understood within their cultural, social, and political environment. Their personal motivations, attitudes, beliefs, and goals must also align with the intervention. The EVM framework serves to “culturally center” an intervention through eight dimensions that must be incorporated for an intervention to have ecological validity and be embedded within the cultural context (41). These dimensions include language, persons, metaphors, content, concepts, goals, methods, and context (see Table 1).
Overview of Cultural Adaptation and Contextualization Methodology
The adaptation process was an ongoing, iterative process and some of the steps overlapped with one another. Questions addressed in each step were based on what was or was not answered in the prior steps and the iterative process of this methodology more easily allowed for finding a balance between fidelity versus fit. The format of this methodology was participatory and involved a high level of engagement with the communities where the intervention was delivered. For this reason, the methodology was helpful in ensuring that adaptations were made not only to the clinical treatment material but also the scalability and implementation of the intervention.
A detailed data collection process and documentation system allowed us to ensure that each adaptation made was based on evidence. We created a matrix before the start of the adaptation process based on the FRAME approach for documentation (42): 1) the eight broad dimensions from EVM, 2) implementation strategy (what exactly should be changed in the intervention material), 3) rationale for change (description of why it should be changed and what it would accomplish for the intervention), and 4) evidence for change (which adaptation step(s) the change was a result of). All changes and adaptations were listed in the EVM matrix during the length of the process (see supplemental online material).
The following approach charts the cultural adaptation process from the preparation phase before the feasibility trial, through the trial, and any changes after the trial (see Table 2).
- Identify the key mechanisms of action
The mechanisms of action are theorized process by which a psychological intervention alleviates distress and supports behavioral change (43). Cognitive-behavioral therapies are built upon a theoretical framework that changes in cognition will precede emotional and behavioral changes. Four types of interpersonal distress are theorized as the cause of depression in interpersonal psychotherapy. Behavioral reinforcement cycles of avoidance and distress are targeted in behavioral activation therapy. The specific mechanisms of action for Group PM+ were identified by reading literature of the same intervention conducted in different contexts and discussing with experts that have developed and implemented the intervention (27,28,31), (see Table 3).
- In-depth Literature Review (and consulting with experts)
A systematic review of existing literature on mental health interventions in Nepal was conducted to extract data on: mechanisms of action, delivery agents, trainings, supervision methods, process measures, outcome measures, psychoeducation method, integration into health systems, and cultural/ethno-psychology elements. Databases such as PubMed, PsychInfo and PsychiatryOnline were searched as well as grey literature from policy briefs and annual reports of local NGOs. Though not a formal part of the literature review, interviews were also conducted with staff from leading mental health organizations in Nepal to identify issues for community engagement and implementation related to mental health research and service delivery in Nepal. Data were summarized for key findings, gaps in research and methodology, and recommendations for Group PM+ adaptation in Nepal.
- Training of Trainers (ToT)
Clinical Supervisors and supporting counselors were given a 10-day training by a Group PM+ trainer from a previous study site. This training focused on how to train facilitators in delivering Group PM+. The participants of this ToT identified overlap of approach with preexisting practices in the program site and suggested culturally fit adaptations to intervention content. The Group PM+ Clinical Supervisors gathered the adaptations suggested by the trainees and reviewed them before finalization. Suggestions that modified the mechanisms of action were rejected. Other suggestions that adapted peripheral aspects of the intervention, such as the language or metaphors, were documented, accepted and finalized into the manual by the Clinical Supervisors.
- Translation of Manual
Clinical supervisors incorporated initial changes into the English manual which was then translated to Nepali by a professional translator. During the translation process, clinical supervisors regularly reviewed the translator’s progress to ensure that the manual would be translated into lay Nepali and could be understood by non-specialist delivery agents. After completing the translation of the manual, the Clinical Supervisors reviewed it fully for any additional changes in language. This was an ongoing process and focused on language rather than the content of the manual. Study staff without a clinical background also reviewed the manual to ensure its comprehensibility for lay persons.
- Expert read-through
Experienced bilingual Nepali psychosocial counselors read through the Nepali language intervention manual and suggested changes in language and content to fit into the cultural context during a one-day workshop. The main objective of this step was to gain additional perspective from persons experienced in the program’s mental health context on the intervention’s content, language, and applicability.
- Formative qualitative study
Based on gaps identified in prior steps, a formative qualitative study was conducted at the proposed study site to gather data on implementation, such as the community’s awareness of mental health, identification of pre-existing community resources and identification of practical problems faced by community members. Local stakeholders such as female community health volunteers (FCHVs), key leaders, health workers, and community members were identified for Key Informant Interviews (KIIs) (n=18) and Focus Group Discussions (FGDs) (n=2). Interviews were then coded by two coders (MS and RG) using deductive analysis and key findings related to program implementation and cultural ethno-psychological elements were summarized to be applied to the manual and program implementation strategy, which included community sensitization programs, recruitment, family meetings, referral pathways, and follow-up with participants.
- Practice rounds
Clinical supervisors conducted Group PM+ practice rounds to gain experience delivering the 5-session intervention, gather feedback from the participants on their comprehension and relatability of the intervention, and apply any further changes to the manual and implementation strategy. Practice rounds were conducted with one female group from a nearby community organization and one male group. During these practice rounds, the facilitators (clinical supervisors) noted if adaptations already made in the manual were feasible and acceptable among participants and if further adaptations were necessary to improve the participants’ engagement and understanding of the material. After each session, the participants were encouraged to give feedback to the facilitators on content, language, materials and methods used, and facilitation skills. This information was collected through informal interviews with the participants and noted down by the Clinical Supervisors.
- Team adaptation workshop
A team workshop with the study Principal Investigators, Program and Research Coordinators, and Clinical Supervisors was conducted to summarize all intervention adaptations listed to date on the EVM matrix. Certain adaptations were accepted or rejected based on if and to what degree they brought changes to the core mechanisms of action. Once all adaptations were thoroughly discussed, Clinical Supervisors made final changes to the manual before the start of the trial. Program staff also modified competency and quality monitoring procedures. Because of the iterative nature of this methodology, most large-scale changes, such as the delivery agents, delivery location, and target population, had been discussed with the team and integrated into the manual and into the delivery of the intervention prior to the workshop.
- Implementation and Supervision
Lay Nepali community members were recruited to deliver Group PM+ to their communities as part of the feasibility trial (35,36). Regarding the trial procedures, Enhanced Usual Care (EUC) was compared to Group PM+ intervention. We employed a randomized control trial (RCT) design where the two chosen VDCs in Sindhuli district were randomly assigned to EUC or PM+. Approximately 60 participants, that were similar in population size, ethnic demographics, and access to health facilities, were recruited for each arm. During the Group PM+ training, the facilitators (n=4) were encouraged to suggest changes in the manual’s language and feasibility and acceptability of the proposed implementation strategy. These changes were further incorporated into the manual and other program documentation. Cultural adaptation was an iterative process throughout the feasibility trial. All staff recorded notes about first-hand experiences working on program recruitment, delivery, and engagement with the community, and shared these experiences with their supervisors. Some changes were made in real-time while others required further discussion at the end of the trial.
- Review through Process Evaluation
After completing the intervention, qualitative interviews were conducted with field staff, intervention participants, participants’ families, and other key community stakeholders to gain perspective on the successes and challenges of varying adaptation and implementation strategies. Questions for these stakeholders were related to feasibility and acceptability of various cultural adaptions, feedback on the implementation strategies, program fidelity, and overall challenges. A total of 31 Key Informant Interviews (KIIs) and 6 Focus Group Discussions (FGDs) were conducted with stakeholders and then analyzed by the Program Coordinator and Clinical Supervisor. A deductive data analysis process was used; key themes were identified prior to analysis and a codebook with themes related to feasibility and acceptability of the manual content and implementation was developed (35). Interviews were coded using NVivo software and the two coders (MS and RG) established an acceptable inter-reliability rate (IRR) (IRR = 0.8) during the coding process. Once analyzed, key changes and their rationale were discussed within the core team and implemented further to the intervention before the definitive trial.