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Abstract

This is the protocol for a Campbell review. Amid the cumulative burden of conflict-induced displacement in low- and middle-income countries (LMICs), forcibly displaced persons often experience profound social and material adversity and limited access to mental health care. Life skills education (LSE) and psychosocial interventions may help mitigate anxiety and depression symptoms in low-resource humanitarian settings. Nonetheless, decision makers still require robust evidence on their effectiveness for depression and anxiety outcomes in forcibly displaced populations in LMICs. Our primary research question is: Among forcibly displaced persons in LMICs, what is the effectiveness of life skills education and psychosocial interventions, compared with inactive, usual care, or active control conditions, in reducing symptoms of depression and anxiety? Our secondary research question is: What is the extent and completeness of sex and gender reporting in included studies, including how sex and gender are defined or measured and whether outcomes are reported or analyzed by sex or gender? The review will include refugees, asylum seekers, and internally displaced persons aged 13 years and older and will synthesize evidence from controlled studies.

Keywords

forcibly displaced persons life skills education psychosocial interventions depression anxiety low- and middle-income countries

Background

Forcibly displaced persons (FDPs) frequently experience interrelated socioeconomic and psychological adversities associated with conflict, persecution, violence, or environmental disaster. FDPs in overcrowded camps, informal settlements, or host communities often lack essential resources, including clean water, food, adequate shelter, and accessible healthcare services (Cotroneo, 2017; Roberts et al., 2001). Large influxes of displaced populations can exacerbate difficulties in low- and middle-income countries (LMICs), where primary care and public health systems may already be under-resourced (Langlois et al., 2020). These conditions can contribute to heightened levels of stress, anxiety, and depression, all of which can become chronic if not addressed in a timely, culturally relevant, and contextually appropriate manner (Chiumento et al., 2020; Sudheer & Banerjee, 2021). Restricted mobility, protracted asylum processes, and concerns about personal safety add further distress, as do the uncertainties surrounding livelihood opportunities and longer-term prospects for resettlement or return (Etzold et al., 2022).

According to the United Nations High Commissioner for Refugees (UNHCR), 123.2 million people were forcibly displaced worldwide at the end of 2024, and most were hosted in LMICs (Global Report on Internal Displacement 2025, 2025). Major host countries include Türkiye, Lebanon, the Islamic Republic of Iran, Colombia, Ethiopia, and Uganda, among others (Global Report on Internal Displacement 2025, 2025).

Research examining displaced individuals in these contexts suggests that persistent exposure to traumatic events, loss of social networks, and extended instability frequently contribute to widespread emotional distress (Morina et al., 2018). Some FDPs have endured or witnessed physical violence, human rights violations, torture, or other forms of extreme adversity (Griswold et al., 2021; Steel et al., 2009; Tay et al., 2016). Others suffer from interrupted formal education, depletion of financial resources, and breakdown of familial and communal support systems (Abed Alah, 2024; Sagan & Palombo, 2024; Sengoelge et al., 2020). Over time, these factors may intensify the sense of hopelessness or social isolation, which can fuel negative cycles of mental health deterioration (Singh et al., 2018; Spira et al., 2025; Vidal et al., 2023).

Miller and Rasmussen (2017) argued that displaced individuals’ mental health is influenced not only by their experiences of war but also by various ongoing displacement-related stressors within their social environment. Accordingly, a social ecological framework for understanding refugee distress emphasizes that ongoing stressors within the social environment are equally significant contributors to distress as prior exposure to war-related violence and loss (Miller & Rasmussen, 2017). Thus, it is crucial to assess current environmental challenges and historical experiences of conflict when addressing the mental health needs of displaced populations (Miller & Rasmussen, 2017). Failure to adequately consider post-migration stressors may lead to misattributing distress solely to war exposure, potentially overlooking stressors that could be directly addressed or mitigated (Miller & Rasmussen, 2017).

Because conflict-affected communities often experience higher rates of anxiety and depression than the general population, this emphasizes the need for targeted interventions that address the specific vulnerabilities experienced by forcibly displaced people (Charlson et al., 2019). Besides experiencing mental health problems stemming from trauma, displacement, and limited access to support systems (Charlson et al., 2019; Tol et al., 2011), cultural and language barriers further complicate the delivery of mental health services (Akyeampong et al., 2015; Bhui, 2012; Hwang et al., 2008; Kartal et al., 2019), while stigma may deter individuals from seeking care (Javed et al., 2021; Wachter et al., 2018). This is exacerbated by the low priority often given to mental health services in humanitarian responses, which hampers efforts to adequately support refugees, asylum seekers, and internally displaced persons (IDPs) (Ekezie et al., 2020; Tol et al., 2011). While short-term humanitarian relief efforts typically prioritize immediate material needs, such as food and shelter, mental health and psychosocial support (MHPSS) is often under-resourced and remains difficult to access in conflict-affected populations (Miller & Rasmussen, 2017; Roberts & Fuhr, 2019; Turrini et al., 2019).

Life skills education (LSE) and psychosocial interventions may help strengthen coping, emotion regulation, and related psychosocial capacities among people exposed to armed conflict, violence, and displacement-related adversity, including those experiencing depression, anxiety, or psychological distress in low-resource humanitarian settings (Eboreime et al., 2024; Morrice, 2021; Sherif et al., 2023; Tol et al., 2020; World Health Organization, 1994). Nonetheless, their implementation and scalability remain challenging due to logistical and cultural barriers, as well as under-resourced health systems (Eboreime et al., 2024).

By synthesizing evidence on the effectiveness of these interventions, this review aims to guide policy and practice, thereby promoting the long-term wellbeing and reintegration of displaced populations.

Recent evidence syntheses have examined mental health and psychosocial support (MHPSS) for displaced populations, but important gaps remain for decision-makers who need effectiveness estimates for depression and anxiety outcomes in LMICs. For example, Dickson et al. (2024) synthesized processes, perspectives, and experiences of MHPSS programs for displaced populations in LMICs. That review provides valuable insight into implementation challenges and user perspectives, but did not estimate pooled intervention effects on depression and anxiety symptom outcomes.

In addition, existing effectiveness-focused reviews often combine displaced and non-displaced conflict-affected populations (Bangpan et al., 2019), pool across heterogeneous intervention approaches without a transparent typology of interventions (Nocon et al., 2017), and inconsistently report whether trials were designed and analyzed in sex- and gender-inclusive ways (Heidari et al., 2024). Moreover, in humanitarian mental health evidence, the central challenge is often not heterogeneity alone, but pooled meta-analytic estimates that average across substantially different interventions and populations without a transparent intervention typology and without robustness checks that clarify how decision-relevant the pooled effect is in new settings (Bangpan et al., 2019; Higgins et al., 2003; IntHout et al., 2016). These limitations make it difficult for policymakers and implementers to compare options when selecting which intervention types to fund, adapt, or scale in humanitarian settings (Bangpan et al., 2019; Tol et al., 2011).

In this review, we will address these gaps by conducting an effectiveness-focused systematic review and meta-analysis of LSE and psychosocial interventions for depression and anxiety among forcibly displaced persons in LMICs. We will operationalize LSE and psychosocial interventions using a priori, reproducible coding rules to classify interventions by their active components and delivery format, enabling structured synthesis while acknowledging clinical heterogeneity.

Sex and gender inclusivity are treated as a cross-cutting review priority. Rather than conducting subgroup meta-analyses by sex or gender, which are frequently underpowered and can be vulnerable to ecological bias when based on aggregate study-level information (Berlin et al., 2002; Cuijpers et al., 2021; Lambert et al., 2002), we will extract and report how included studies define and measure sex and gender. We will also describe the extent to which outcome data are presented by sex or gender and whether intervention and trial procedures incorporate sex- and gender-responsive features in their design or delivery.

Consistent with this focus on effectiveness, we will not restrict inclusion by publication year and will include studies published in languages other than English when eligibility criteria are met. By clarifying the level of analysis, this review distinguishes (i) limitations of the existing evidence base for the effectiveness of interventions for depression and anxiety outcomes and (ii) limitations in prior syntheses that have not produced policy-oriented effectiveness estimates for displaced populations in LMICs.

Policy Relevance

This review aligns with global and national policies prioritizing mental health in humanitarian contexts. It directly supports Sustainable Development Goal (SDG) 3, which emphasizes mental health and wellbeing, and SDG 10, which focuses on reducing inequalities (United Nations, 2015). The Global Compact on Refugees and the World Health Organization (WHO) Mental Health Action Plan (2013–2030) highlights the importance of accessible, culturally appropriate, and community-based mental health services for populations affected by forced displacement (World Health Organization, 2013).

Within LMIC humanitarian systems, policymakers and implementers face practical decisions about which intervention types to adopt (e.g., skills-based group programs versus individual psychological treatments), how to deliver them (e.g., lay-facilitated, task-shared delivery in community settings versus specialist-led delivery), and how to adapt delivery platforms (for example, in-person, hybrid, or technology-enabled delivery where feasible). They must also prioritize population groups and settings, including refugees, asylum seekers, and IDPs living in camps, informal settlements, and host communities, often under severe resource constraints (Ekezie, 2022; Ekoh et al., 2023; Huq & Miraftab, 2020).

Cornerstone national policies reinforce integration of mental health services within broader humanitarian responses in LMICs. Nigeria’s Mental Health Act of 2021 represents a major policy shift, emphasizing a rights-based approach and embedding mental health services within humanitarian relief frameworks (Ozota et al., 2024; Saied, 2023). Nonetheless, scaling up trauma-related mental health services for IDPs remains challenging, for example, in Northern Nigeria, where systemic barriers to access and implementation persist despite increasing recognition of mental health needs in humanitarian crises (Madaki, 2022).

India’s Mental Healthcare Act of 2017 seeks to expand community-based mental health services and establish legal protections for vulnerable populations, including forcibly displaced persons (Duffy & Kelly, 2019; Malhotra, 2023). Although India has introduced progressive legal and policy frameworks, structural challenges persist, with national and district-level programs struggling to align with rights-based mental health principles (Ranade et al., 2022). The expansion of technology-assisted mental health solutions has been promoted as an innovation in service delivery, but concerns remain regarding accessibility, equity, and the digital divide, particularly in rural and marginalized communities (Ranade et al., 2022).

Kenya’s Mental Health Policy (2015–2030) acknowledges the mental health needs of refugees and IDPs and integrates mental health services into primary healthcare settings (Musyimi et al., 2017; Ndetei et al., 2017). Notwithstanding, challenges remain in ensuring equitable access to mental healthcare, including persistent stigma, coercive treatment practices, and systemic barriers to service delivery (Di Pierdomenico et al., 2024).

In Latin America, Brazil’s Mental Health Law (Lei No. 10.216/2001) and the National Mental Health Policy have contributed to reducing institutionalization and integrating psychosocial support into the country’s broader healthcare system (Amarante & Nunes, 2018; Mari et al., 2024).

Against this policy landscape, the primary audience for this review includes humanitarian health ministries, implementing agencies, and donors that need effectiveness estimates for depression and anxiety to inform intervention selection and scale-up in LMIC displacement settings. The review will synthesize intervention effects on depression and anxiety outcomes and will transparently report the sex- and gender-inclusive features of the evidence base to support equity-oriented interpretation of the findings. The review will not conduct subgroup meta-analyses by sex or gender; instead, sex- and gender-related reporting will be summarized descriptively and used to identify evidence gaps relevant to policy commitments to equitable service delivery.

Objectives

The objective of this systematic review is to assess the effectiveness of LSE and psychosocial interventions in reducing symptoms of depression and anxiety among forcibly displaced persons (including refugees, asylum seekers, and IDPs) living in LMICs. We will also summarize sex and gender reporting in the included studies to inform applicability and evidence gaps, including how sex and gender are defined or measured, sample composition, and whether outcomes are reported or analyzed by sex or gender.

Review Questions

(1) Among forcibly displaced persons in LMICs, what is the effectiveness of LSE and psychosocial interventions, compared with inactive, usual care, or active control conditions, in reducing symptoms of depression and anxiety?

(2) What is the extent and completeness of sex and gender reporting in included studies, including how sex and gender are defined or measured and whether outcomes are reported or analyzed by sex or gender?

Methods

This protocol adheres to the Methodological Expectations of Campbell Collaboration Intervention Reviews (MECCIR) conduct standards, as recommended by the Methods Group of the Campbell Collaboration (Aloe et al., 2024). The proposed review will be conducted as an effectiveness-focused systematic review and meta-analysis, following procedures consistent with the Campbell and Cochrane guidance for intervention reviews. Where relevant, we will draw on Joanna Briggs Institute (JBI) guidance for effectiveness reviews to inform practical steps in review conduct (Aromataris et al., 2024), aiming to identify and synthesize available evidence on the extent to which an intervention, when used appropriately, achieves the intended effect. In addition, this protocol complies with the PRISMA-P (Preferred Reporting Items for Systematic Review and Meta-Analysis Protocols) 2015 guidelines (PRISMA-P Group et al., 2015; Shamseer et al., 2015). In accordance with the guidelines, our systematic review protocol was registered on the International Platform of Registered Systematic Review and Meta-Analysis Protocols (INPLASY) on December 13, 2024 (registration number INPLASY2024120057), and was subsequently updated and reregistered with the Campbell Collaboration on February 12, 2025 (registration number cl2.20250025). The Campbell Standards Checklist is provided in Supporting Information S1: I.

Inclusion Criteria

This systematic review will outline studies’ eligibility using a structured inclusion criterion informed by the Population, Intervention, Comparison, Outcome, and Study design (PICOS) framework.

Types of Interventions

Eligible interventions are non-pharmacological psychosocial or psychological interventions intended to prevent, reduce, or treat symptoms of depression and/or anxiety among forcibly displaced persons in LMICs. Interventions may be delivered individually or in groups, across community, school, primary care, camp, or other humanitarian service settings, and may be provided by specialists or non-specialists (via task-sharing), or delivered digitally.

For the purposes of this review, we define LSE as interventions that include an explicit, taught set of cognitive, behavioral, and socio-emotional skills delivered through structured sessions with skill practice. This definition is based on the WHO’s description of life skills as abilities for adaptive and positive behavior that enable individuals to deal effectively with the demands and challenges of everyday life (Life Skills Education for Children and Adolescents in Schools. Pt. 1, Introduction to Life Skills for Psychosocial Competence. Pt. 2, Guidelines to Facilitate the Development and Implementation of Life Skills Programmes, 1994), including core skills such as decision making, problem solving, effective communication, interpersonal skills, self-awareness, empathy, critical and creative thinking, and coping with stress and emotions (Lakshmi, 2024). Interventions will be coded as LSE only if materials explicitly describe active skills training with guided practice (e.g., role-play, rehearsal, homework, behavioral exercises, or coached in-session practice); psychoeducation or information-only approaches without structured skills practice will not be coded as LSE.

We define psychosocial interventions as structured psychological or psychosocial interventions with specified therapeutic content intended to prevent, reduce, or treat symptoms of depression, anxiety, or both. Examples include brief transdiagnostic interventions that teach and rehearse skills relevant to common mental disorders and distress in adversity settings, including Self-Help Plus and Problem Management Plus (Epping-Jordan et al., 2016; PROBLEM MANAGEMENT PLUS (PM+) Individual Psychological Help for Adults Impaired by Distress in Communities Exposed to Adversity, 2018).

We will include technology-enabled delivery (e.g., mobile, web-based, telehealth, or virtual reality) (Philippe et al., 2022; Seegan et al., 2023; Virk et al., 2025) when the intervention content meets the definitions above and the outcomes include depression, anxiety, or both.

We will not treat spirituality or religion as a standalone intervention category. This approach is consistent with established humanitarian MHPSS frameworks, which recognize cultural, religious, and spiritual supports as part of broader psychosocial support systems (Inter-Agency Standing Committee, 2007). Interventions will be included when spiritual or religious content is incorporated as an adjunct component within an otherwise eligible psychosocial intervention and eligible depression and/or anxiety outcomes are reported.

We will exclude interventions that are exclusively pharmacological, exclusively economic or livelihood programs without an explicit psychological or psychosocial skills component, unstructured social support or case management without specified therapeutic content, and general community mental health service strengthening initiatives that do not include a defined participant-level intervention with eligible outcomes.

Types of Studies

We will include randomized controlled trials (including cluster-randomized trials), quasi-experimental studies with a concurrent comparison group (e.g., non-randomized controlled trials or controlled before-and-after studies), and other controlled quantitative designs that allow estimation of the intervention effects on depression and/or anxiety outcomes.

Eligible comparators include waitlist controls, usual care, minimal attention controls, active comparators (e.g., alternative psychosocial programs), and placebo or sham controls, where relevant. Studies without a concurrent comparison group will be excluded from the effectiveness synthesis.

If observational studies are included, they must have a clearly defined comparison group and use an analytic approach to address confounding (e.g., matching, inverse probability weighting, regression adjustment with prespecified covariates). We anticipate that most included studies will be randomized or quasi-experimental.

Qualitative studies, standalone process evaluations, and studies without quantitative outcomes for depression or anxiety will be excluded, as this review is limited to evidence of effectiveness.

Types of Participants

Participants will be forcibly displaced persons living in LMICs, including refugees, asylum seekers, and IDPs, as defined by the study authors or relevant legal or administrative status. We will prioritize these population groups because they are explicitly targeted in humanitarian mental health policy and programming (Inter-Agency Standing Committee Task Force on Mental Health et al., 2007), and because their service access and exposure profiles differ from those of non-displaced conflict-affected populations (Refugee and Migrant Mental Health (Fact Sheet), 2025). Reasons for displacement may include persecution, armed conflict, generalized violence, human rights violations, or other events that result in forced displacement (Lischer, 2007; Mitchell & Pizzi, 2021). Studies that include mixed samples (e.g., displaced and non-displaced conflict-affected participants) will be included only if results for forcibly displaced participants are reported separately, or if the displaced majority is clearly documented and sensitivity analyses can assess the impact of mixed samples. Eligible participants are 13 years of age or older. Age categories include adolescents (13–17 years) and adults (18 years and older) due to differing mental health needs and vulnerabilities (Charlson et al., 2019; Tol et al., 2011).

Types of Outcome Measures

Primary outcomes are symptoms of depression and symptoms of anxiety measured using psychometric instruments reported at post-intervention and, where available, at follow-up. We anticipate that included studies will use instruments such as the Patient Health Questionnaire (PHQ-9) and the Generalized Anxiety Disorder scale (GAD-7) (Kroenke et al., 2001; Spitzer et al., 2006), as well as other widely used symptom scales (e.g., HSCL-25) (Derogatis et al., 1974; Ventevogel et al., 2007).

To balance rigor with the realities of displacement and LMIC contexts, we will include outcomes measured using instruments that are either (i) validated in any population with documented measurement properties, including translated or culturally adapted versions, or (ii) locally developed or locally adapted measures that are clearly described and provide some evidence of reliability or validity (for example, internal consistency, test-retest reliability, or documented development and adaptation procedures).

Secondary outcomes, when reported, will be extracted and synthesized narratively. Secondary outcomes may include functioning, well being, or quality of life, coping, social support, and adverse events. Secondary outcomes will not be meta-analyzed unless sufficient studies use comparable measures and the data are judged sufficiently homogeneous.

Electronic Searches

A comprehensive electronic search strategy will be employed to identify relevant studies. The search strategies will be developed by the review team in consultation with an experienced librarian or information specialist, and the primary database strategy will be peer reviewed using the PRESS (Peer Review of Electronic Search Strategies) checklist before final execution (McGowan et al., 2016; Rethlefsen et al., 2015).

The following databases will be searched: PubMed, PsycINFO, EMBASE (Ovid), MEDLINE (Ovid), Global Health Database, Global Health Data Exchange (GHDx), Web of Science, Scopus, the Cochrane Library, the Joanna Briggs Institute (JBI) Evidence Synthesis Database, and the Centre for Reviews and Dissemination Database.

The search will be conducted using combinations of key terms related to anxiety, depression, forcibly displaced persons, life skills education, psychosocial interventions, and low- and middle-income countries (LMICs).

The search strategy will incorporate controlled vocabulary and free-text terms specific to each database, and no restrictions will be placed on language or publication date.

The tentative search strategy for PubMed is as follows:

PubMed Search Strategy.

(1) (“forcibly displaced person*” OR “internally displaced person*” OR refugee* OR migrant* OR displacement OR IDP OR FDP OR refugee OR migrant)

(2) (“life skills education” [All Fields] OR “psychosocial intervention*” [All Fields] OR psychotherapy [MeSH Terms] OR psychotherapy [All Fields] OR counseling [MeSH Terms] OR counseling [All Fields] OR “psychological intervention*” OR “mental health intervention*” OR “psychosocial support” [All Fields] OR “community-based intervention*” OR “group therapy” [All Fields] OR “individual therapy” [All Fields] OR “cultural healing practice*” OR “traditional support system*”)

(3) (anxiety OR depression OR “mental health outcomes” OR “psychological distress” [All Fields] OR “psychological wellbeing” [All Fields] OR anxious OR depressive OR “psychological distress” [All Fields])

(4) (“low- and middle-income countr*” OR LMIC* OR “developing countr*” OR “low-income countr*” OR “middle-income countr*” OR “resource-limited setting*” OR “resource-constrained setting*” OR Africa OR Asia OR “Latin America”)

(5) (“randomized controlled trial” [pt] OR “controlled clinical trial” [pt] OR randomized OR randomized OR “RCT” OR “controlled trial” [All Fields] OR “intervention study” [All Fields])

(6) #1 AND #2 AND #3 AND #4 AND #5

Searching Other Resources

We will conduct additional searches for relevant gray literature (Hopewell et al., 2007), including reports from international humanitarian agencies (e.g., UNHCR and WHO), academic dissertations, conference abstracts, and the reference lists of included studies and relevant systematic reviews.

We will also perform forward and backward citation tracking for the key included studies and related reviews (e.g. (Dickson et al., 2024)). Backward citation tracking will involve screening reference lists. Forward citation tracking will be conducted using Google Scholar and CitationChaser (or equivalent software) to identify newer studies citing key articles (Haddaway et al., 2022; Hirt et al., 2023).

Trial registries such as ClinicalTrials.gov, the WHO International Clinical Trials Registry Platform, the Pan African Clinical Trials Registry (PACTR), the International Standard Randomised Controlled Trial Number (ISRCTN) Registry, the European Union (EU) Clinical Trials Register, and the Australian New Zealand Clinical Trials Registry (ANZCTR) will be reviewed to identify ongoing or unpublished studies.

Data Collection and Analysis

Description of Methods Used in Primary Research

Eligible studies will be critically appraised based on detailed descriptions of their methodological approaches. This will encompass study designs, sampling strategies, intervention characteristics, comparison conditions, outcome assessments, and statistical analyses applied to control for potential biases.

Selection of Studies

Two independent reviewers will screen titles and abstracts against predefined eligibility criteria. Both reviewers will then independently screen full texts of potentially eligible studies. Discrepancies will be resolved through structured discussions, with arbitration by a third reviewer if consensus cannot be reached. A pilot screening will be conducted to ensure consistent application of the eligibility criteria. Inter-rater reliability will be assessed using percent agreement and Cohen’s kappa to quantify reviewer agreement (McHugh, 2012; Park & Kim, 2015). The study selection process will be documented in a PRISMA flow diagram (Page et al., 2021), and screening decisions will be managed in Covidence to ensure transparency and reproducibility (McKeown & Mir, 2021).

Data Extraction and Management

Two independent reviewers will extract data using a standardized data extraction form developed specifically for this review. Discrepancies will be resolved by consensus or by involving a third reviewer. Extracted study characteristics will include authors, year, country, and setting (for example, camp, informal settlement, urban or rural host community), study design, sample size, displacement status (refugee, asylum seeker, internally displaced person), recruitment context, and follow-up timing.

Participant characteristics will include age (mean and range), sex and gender reporting (definitions used, distribution, and whether outcomes are reported or analyzed by sex or gender), and other key sociodemographic variables reported by the study (for example, education, marital status, and baseline symptom severity).

Intervention characteristics will include intervention type classification (based on a priori coding rules described in this protocol), delivery format (group or individual), delivery agent (specialist or non-specialist), delivery platform (in-person or technology-enabled), intensity and duration, and comparator description.

Outcome data will include depression and anxiety measures, time points (post-intervention and follow-up), and all information required to compute standardized mean differences (for example, means, standard deviations, change scores, or other effect estimates with standard errors). Secondary outcomes and adverse events will be extracted when reported.

Assessment of Risk of Bias in Included Studies

Risk of bias will be assessed using validated tools selected based on the study design. The Cochrane Risk of Bias Tool 2.0 (RoB 2.0) will be used for randomized controlled trials (Higgins et al., 2019; Ma et al., 2020).

The Risk of Bias in Non-randomized Studies of Interventions (ROBINS-I) tool will be applied to nonrandomized or quasi-experimental studies with a concurrent comparison group (Ma et al., 2020; Sterne et al., 2016).

Measures of Treatment Effect

Treatment effects will be presented using standardized mean differences (SMDs) for continuous outcomes and risk ratios or odds ratios for dichotomous outcomes. Confidence intervals will be reported at 95%.

Unit of Analysis Issues

Where studies report clustered designs or repeated measures, we will adjust analyses to address potential unit-of-analysis errors using appropriate statistical methods, such as cluster-adjusted standard errors.

Criteria for the Determination of Independent Findings

When multiple reports describe the same study, we will link records and use a single study identifier. We will designate a primary report for each study based on the report that provides the most complete outcome data for the primary outcomes (depression and anxiety), has the largest sample size, and includes the most relevant follow-up time points. Additional reports will be used to supplement missing information.

For studies with multiple intervention arms compared with a shared control group, we will avoid double-counting by combining intervention arms when clinically appropriate or by splitting the control group sample size across comparisons, consistent with Cochrane guidance. The choice will be documented a priori at extraction and applied consistently.

For studies reporting multiple eligible outcome measures for the same construct at the same time point (e.g., two depression scales), we will prioritize the measure specified by the study authors as the primary outcome. If no primary measure is specified, we will prioritize measures most commonly used across the evidence base to improve comparability in sensitivity analyses, while the main meta-analysis will use standardized mean differences to pool across measures. Only one effect estimate per construct per time point will be included in any single meta-analysis.

For studies reporting multiple time points, the primary analysis will use the immediate post- intervention assessment. Follow-up effects will be summarized separately and meta-analyzed only when sufficient comparable data are available.

Dealing With Missing Data

We will contact the authors of the included studies to obtain missing information (Li et al., 2019). Sensitivity analyses will assess the potential impact of missing data, primarily through intention-to-treat (ITT) analyses (Deeks et al., 2019; White et al., 2012) and, where applicable, by imputing missing values (White et al., 2011).

Assessment of Heterogeneity

Statistical heterogeneity among included studies will be assessed using multiple complementary methods (Bailar, 1997; Cordero & Dans, 2021). We will evaluate evidence of between-study variability using the standard chi-square test for heterogeneity and quantify its magnitude using the I² statistic (Borenstein, 2024; Huedo-Medina et al., 2006). An I² statistic exceeding 50% will indicate substantial heterogeneity, prompting additional examination of potential sources such as participant characteristics, intervention types, or methodological differences (Higgins et al., 2019; Huedo-Medina et al., 2006).

The extent of variability across true effect sizes will also be measured using tau-squared (τ²) (Borenstein, 2024). When sufficient data are available, the prediction interval will be calculated to estimate the range within which true effects are likely to fall in comparable populations.

However, given that prediction intervals derived from a small number of studies may be overly wide due to uncertainty, their interpretation will explicitly acknowledge this limitation when applicable (Borenstein, 2024).

Assessment of Reporting Biases

Reporting biases, including publication bias, will be visually inspected using funnel plots and statistically assessed using Egger’s test (Egger et al., 1997) where sufficient studies are available to conduct a meta-analysis (Aromataris et al., 2024; Tawfik et al., 2019; Zaccagnini & Li, 2023).

Data Synthesis

We will synthesize quantitative effectiveness evidence for the primary outcomes of depression and anxiety. Where at least two studies report sufficiently comparable data, we will conduct random-effects meta-analysis using standardized mean differences (SMDs) with 95% confidence intervals, consistent with Cochrane methods. Random-effects models will be estimated using restricted maximum likelihood (REML). Primary meta-analyses will pool effect estimates across all eligible measures for each outcome (for example, depression and anxiety). We will use the immediate post-intervention assessment as the primary time point. Follow-up time points will be summarized separately and meta-analyzed only if sufficient comparable data are available. Heterogeneity will be quantified using the Tau-squared and I-squared statistics, and prediction intervals will be reported to describe the expected range of effects in new settings. Influence diagnostics will be conducted using leave-one-out analyses.

We will conduct prespecified sensitivity analyses to assess robustness to key analytic decisions. For depression, we will examine (i) the main model including all measures, (ii) a sensitivity analysis excluding multi-arm comparisons from the same trial when relevant, and (iii) a sensitivity analysis excluding less common measurement instruments. We will also conduct separate meta-analyses by outcome measure group (e.g., PHQ-9, HSCL-25, and other instruments). For anxiety, we will follow an analogous approach, including sensitivity analyses that exclude influential studies and analyses restricted to the most common instrument group (e.g., HSCL-25).

Secondary outcomes (e.g., functioning, well-being, quality of life, coping, social support, and adverse events) will be extracted from all included studies but will not be meta-analyzed. Instead, we will synthesize secondary outcomes using the structured synthesis without meta- analysis (SWiM) approach, consistent with SWiM guidance (Campbell et al., 2020). We will present results separately for the immediate post-intervention assessment and, where reported, follow-up time points in structured tables, with clear reporting of effect direction and magnitude based on the available data.

Subgroup Analysis and Investigation of Heterogeneity

If sufficient studies are available, we will explore sources of heterogeneity using prespecified subgroup analyses based on (i) intervention type classification (for example, skills-based LSE- focused programs versus other psychosocial interventions), (ii) population group (internally displaced persons, refugees, asylum seekers), and (iii) setting (camp or settlement versus host community).

We will not conduct subgroup meta-analyses by sex or gender because these analyses are often underpowered and vulnerable to ecological bias. Instead, sex- and gender-related reporting and inclusivity characteristics will be summarized descriptively within the evidence profile.

Additional analyses by outcome measurement group (e.g., PHQ-9, HSCL-25, others) will be treated as sensitivity analyses to assess robustness to measurement choice.

Treatment of Qualitative Research

This review is limited to evidence of effectiveness and will not synthesize qualitative studies. Process evaluations and qualitative findings identified during screening will be documented as excluded study types and may be summarized descriptively as contextual background, but they will not be included in the effectiveness synthesis.

Summary of Findings and Assessment of the Certainty of the Evidence

The Grading of Recommendations Assessment, Development, and Evaluation (GRADE) approach will be used to assess the overall certainty of the evidence (Andrews et al., 2013). Summary tables will present the main findings and certainty ratings (Guyatt, Oxman, et al., 2013; Guyatt, Thorlund, et al., 2013).

Supplemental Material

Supplemental Material - PROTOCOL: Life Skills Education and Psychosocial Interventions for Anxiety and Depression in Forcibly Displaced Persons in LMICs: A Systematic Review

Supplemental Material for PROTOCOL: Life Skills Education and Psychosocial Interventions for Anxiety and Depression in Forcibly Displaced Persons in LMICs: A Systematic Review by Andem Duke, Bala Harri, Raquel Crider, Linda Liebenberg, Rita Orji, Ejemai Eboreime in Campbell Systematic Reviews

Footnotes

Author Contributions

Content: AEED, RC, LL RO, EE, Systematic review methods: AEED, RC, EE. Statistical analysis: AEED, RC. Information retrieval: AEED, RC, BIH. Conceptualization: AEED, EE. Funding acquisition: EE. Investigation: AEED, RO, EE. Methodology: AEED. Project administration: AEED, EE. Resources: EE. Supervision: RO, EE. Writing - original draft: AEED. Writing - review & editing: AEED, EE. Writing – final draft: AEED.

Funding

The authors disclosed receipt of the following financial support for the research, authorship, and/or publication of this article: This work was supported by Grand Challenges [grant number R-HGC-POC-2408-67370] and the Government of Canada, Canadian Institutes of Health Research, Institute of Population and Public Health [grant number PAA-192178].

ORCID iD

Andem Effiong Etim Duke

Declaration of Conflicting Interests

The authors declared no potential conflicts of interest with respect to the research, authorship, and/or publication of this article.

Preliminary Timeframe

If the protocol is not submitted within six months, and the full review is not completed within 18 months of title registration, the topic may become available to other research groups.

Supplemental Material

Supplemental material for this article is available online.

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