To evaluate the EASE intervention for reducing anxiety and depression among adolescents in Pakistan: a protocol for a mixed methods study, including a cluster-randomised controlled trial

Mar 23, 2025BMJ open

Testing the EASE program to reduce anxiety and depression in Pakistani teenagers using a combined survey and group trial

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Abstract

The EASE intervention aims to address anxiety and depression among adolescents aged 13-19 in Multan, Pakistan.

A cluster randomized control trial will evaluate the effectiveness of the EASE intervention compared to a waitlist control group.
Primary outcomes include reductions in anxiety and depression among participants.
Secondary outcomes will assess impacts on parenting, quality of life, and psychological distress.
Exploratory analyses will investigate how socioeconomic characteristics and parenting skills may influence the intervention's effectiveness.
Qualitative research will gather stakeholder perceptions to understand the intervention's acceptability and feasibility in a Pakistani context.

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INTRODUCTION: The rising prevalence of adolescent anxiety and depression in low- and middle-income countries (LMICs) highlights the urgency for effective interventions. Challenges with standard treatments necessitate exploring accessible strategies. In addition, adapting interventions from high-income countries to LMICs raises concerns about efficiency. The LMIC-tailored Early Adolescent Skills for Emotions (EASE) intervention, integrating cognitive-behavioural principles, group sessions, non-specialist delivery and parental involvement, provides a promising solution. This protocol aims to evaluate the effectiveness, acceptability and feasibility of the intervention in public schools in Multan, Pakistan, for addressing anxiety and depression among adolescents.

METHOD AND ANALYSIS: This proposed study aims to achieve its objectives through a two-phase approach by using a mixed methods experimental design. Primarily, a cluster randomised control trial with a two-arm (intervention and waitlist control) single-blinded design will assess the effectiveness of the EASE intervention in reducing anxiety and depression (primary outcome) and parenting, quality of life and psychological distress (secondary outcome) among adolescents aged 13-19, employing a 1:1 allocation ratio. Subsequently, leveraging effectiveness data, the study will explore moderating (eg, socioeconomic characteristics) and mediating pathways (parenting skills and parents' psychological distress) to enhance our comprehension of the intervention's effectiveness. Lastly, an exploratory descriptive qualitative study will investigate the perceptions of various stakeholders regarding the acceptability and feasibility of the School-Based Mental Health Programme intervention in the Pakistani context. For the trial data, linear mixed models will be used to account for clustering at the school level and adjust for baseline differences. For the qualitative data, content analysis will be conducted to identify stakeholder perceptions about the intervention.

ETHICS AND DISSEMINATION: The study received ethical approval from the Ethics Committee of the School of Nursing and Rehabilitation at Shandong University, Jinan, China (Reference No. 2023-R-024) and Institutional Review Board (Ref: IRB-2019/MASH/Approval-06/March/2023) Mukhtar A Sheikh Hospital, Multan. The findings will be shared through publications in peer-reviewed journals and presentations at national and international conferences.

TRIAL REGISTRATION NUMBER: This trial is registered at ClinicalTrials.gov (ID NCT06155838).

Key numbers

1.3 billion

Adolescents Affected

Global adolescent population aged 10-19.

41.3%

Prevalence of Anxiety

Combined prevalence of anxiety among adolescents in South Asian countries.

449

Participants Planned

Total participants planned for the intervention study.

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To evaluate the EASE intervention for reducing anxiety and depression among adolescents in Pakistan: a protocol for a mixed methods study, including a cluster-randomised controlled trial

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