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Using one of the largest cross-cultural data sets of the PSYCHLOPS, we demonstrated that using a Western only model of mental distress does not capture important local values. This finding supports the argument that consideration of local priorities and outcomes is important in mental health research and care provision. PGOM could not only be useful in monitoring and evaluation of therapeutic change, as an inlet to therapeutic discussion, but also to inform programme selection and delivery. For example, if one finds that unemployment is a major problem for most of the community prior to running a psychological intervention, the intervention could be tailored to help participants build skills or problem solve in relation to employment or entrepreneurship.

Further research turned to the issue of how adapting an intervention itself can bring added value to its use. The importance of adapting self-help psychological interventions when they are used in diverse cultural settings was demonstrated by the finding that the more an intervention was adapted, the more effective it was. Though the sample size was possibly too small for clear conclusions to be made, nor was the mechanism of this increase in efficacy clear, (e.g., what mediating factors may be at play), we still suggest that cultural adaptation could be very relevant to program managers and treatment providers in diverse settings. Additionally, we call upon

researchers to detail and for publishers to facilitate publishing methods and outputs of cultural adaptation efforts. More research needs to be done directly comparing adapted and unadapted interventions, which could facilitate further meta-analysis of individual participant data, controlling for the number of sessions completed and other potentially mediating variables on the efficacy of adapted interventions. With more information on effects and methods of adaptation, decision makers and clinicians can make informed choices around their investment in adaptation procedures.

The process of designing an intervention for use across cultures and contexts has highlighted that flexibility is key when designing an app-delivered psychological intervention for global use.

Considering diverse contexts from the outset, we hope that scale-up of the Step-by-Step app will be possible with minimal resources, increasing its potential as a public mental health tool. Further testing which is currently ongoing in a number of sites will help estimate the efficacy of Step-by-Step before it can be made available for free.

In adapting Step-by-Step first to the Lebanese context, and then to overseas Pilipino migrant workers in Macau, we learned a number of valuable lessons. Systematically carrying out and fully reporting methods and results of cultural adaptation research is important in itself, given the lack of detailed accounts of this in the literature. Programme managers and care providers should hopefully be able to appreciate the importance of adaptation and replicate or modify our methods for their own adaptation of interventions. Including potential end-users in a bottom-up approach is crucial in ensuring that their views and preferences can increase the relevance, acceptability and

comprehensibility of an intervention. Other stakeholders such as front-line health workers and service managers can also give insight into potential service delivery and acceptability issues.

The feasibility testing of Step-by-Step has provided important research design and intervention revisions ahead of further testing and has proved an indispensable step in the management and planning of further efficacy testing. Though the research had many limitations, the preliminary

196 results reported hint that Step-by-Step could be an effective intervention among people living in Lebanon.

Further, rigorous testing of Step-by-Step is currently underway with the aim to prove its efficacy in two large trials ahead of the release of the product as a global good. Once such an intervention is integrated into a health system, implementation research will be important to understand the real-world considerations and benefits of employing such innovation into mental health treatment services.

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16 Appendices

Appendix 1: List of abbreviations

CI Confidence Interval

EASE Early Adolescent Skills for Emotions ECR Essai Contrôlé Randomisé

EH Eva Heim, Research and Clinical Psychologist at University of Zurich ERC Ethical Review Committee

EVM Ecological Validity Model

GAD-7 Generalised Anxiety and Depression scale, 7 item HIC High Income Countries

I2 Higgins heterogeneity statistic

JAR Jinane Abi Ramia, Project coordinator, Lebanese Ministry of Public Health KC Kenneth Carswell, clinical Psychologist at WHO

LMIC Low and Middle Income Countries MhGAP Mental Health Gap Action Programme MoPH Ministry of Public Health, Lebanon MRC Medical Research Council

MSc Masters of Science degree

OMS Organisation Mondiale de la Santé PGOM Patient Generated Outcome Measure PHCCs Primary Health Care Centres

PHQ-8 Patient Health Questionnaire, 8 item PM+ Problem Management Plus

PSYCHLOPS Psychological Outcome Profile Questionnaire PTSD Post Traumatic Stress Disorder

RCT Randomised Controlled Trial SES Socioeconomic Status SH+ Self-Help Plus

SOPs Standard Operating Procedures WHO World Health Organization

WHO-5 World Health Organization Five wellbeing index

WHODAS World Health Organization Disability Assessment Schedule YLD Years Lived with Disability

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Appendix 2: Adaptation monitoring form (Chapter 6)

This form was used to record both data during qualitative research and to monitor the changed being made to the interventions in the adaptation meetings. These cells were reproduced for each

adaptation.

Stage of adaptation

Original text including document name and page number

Proposed change

Justification to change original text

Notes Change

agreed

 Contextual research

 Translation

 Pre-testing

 Accuracy check

 Adaptation during use

 Not

understandable

 Inappropriate

 Irrelevant

 Other

 Yes

 No

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Appendix 3: Methodological reflections and lessons learned

With the goal of the doctoral programme in Global Health being to bridge the gap between academia and global health, this section of the thesis provides personal reflection on the work completed in order to share lessons learned and practical considerations. Notably, adverse events during the research are summarised.

Chapter 3 methodological reflections: Using PSYCHLOPS in Kenya and Pakistan

The experience of collecting PSYCHLOPS data in Pakistan and Kenya highlighted differences in how the measure was used. It was originally designed as a self-report measure but due to the lower literacy level of the populations studied, it was presented in an interview. The PSYCHLOPS asks for one problem or life limitation in response to its main three questions, and in the peri- and post-intervention versions, asks respondents to reflect back on the problem or limitation they cited pre-intervention. In both settings, enumerators a.) recorded many responses to each question, which were then difficult to code during analysis and, in b.) Kenya, new problems were cited peri-and post-intervention. If PSYCHLOPS is being delivered in an interview, assessors should use an interview schedule with clear instructions. This should include some reassurance of the confidentiality of participant’s responses, as social biasing was found to impact the data gathered. This would help to avoid difficulty in assigning codes and difficulty comparing problems pre- to post-intervention.

Social biasing may have affected the results of this study. The paper (chapter three) details accounts by participants and study staff of instances where this likely occurred. One example is that the enumerators in Kenya were from a local NGO which normally help families to pay for school and school supplies, potentially biasing participant’s problem responses toward being financial in nature.

The process of summarising and translating responses (without them being checked by another bilingual team member as was the case for Kenya) may have diluted or changed responses in some cases, introducing further inaccuracies.

In the Kenya study, there were four serious adverse events at screening stage only (therefore nothing to do with the intervention of the research methods). These persons were not included in the study.

Each case was suicidal intent, two cases of which had been planned and three cases of which were accompanied by malnutrition. The clients were given some food supplies and were referred to the nearest hospital for assessment with a psychiatric nurse and care was transferred to the referral hospital where they received antidepressants and some attended follow up sessions (study staff followed up with the hospital staff for four weeks after the incident and where participants did not attend follow up, study staff tried to make contact). In Pakistan, there was one serious adverse event recorded at the beginning of the study. The person was referred to a psychiatrist who assessed her as having severe depression and suicidal thought and started her on an antidepressant as well as making a suggestion that she admits herself to a psychiatric facility. All travel and treatment costs were borne by the research study.

Chapter 4 methodological reflections: Cultural adaptation of self-help interventions, meta-analysis