Feasibility and Acceptability of Culturally Adapted, Evidence-Informed Psychological Support on Mental Health Symptoms and Violence for Conflict-Affected Populations in Afghanistan: A Study Protocol
Phase: NA
Conditions: Depression and Suicide Ideation, Anxiety, PTSD
Sponsor: Peace of Mind Association (PoMA)

 
 
 
 
Feasibility and Acceptability of Culturally Adapted, Evidence-Informed 
Psychological Support on Mental Health Symptoms and Violence for Conflict-
Affected Populations in Afghanistan: A Study Protocol 
Lyla Schwartz1, Marit Sijbrandij1, Els van der Ven1, Cansu Alozkan Sever1 
1  Department of Clinical, Neuro- and Developmental Psychology, WHO Collaborating Center for 
Research and Dissemination of Psychological Interventions, Amsterdam Public Health Research 
Institute, Vrije Universiteit Amsterdam (VU Amsterdam), De Boelelaan 1105, 1081 HV Amsterdam  
Keywords: Youth mental health, Afghan, evidenced informed interventions, mental health 
symptoms, psychological experiences, culturally adapted psychological support, implementation 
science 
NCT ID not yet assigned 
30 April 2025 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Abstract 
 

 
 
 
 
Background: A large portion of Afghanistan's population, particularly children, has endured prolonged 
conflict, poverty, and displacement, leading to significant psychological distress. As children grow into 
adolescence and adulthood, this distress often manifests in mental health symptoms and an increased 
likelihood of violent behaviours. With limited mental health professionals and strong stigma around 
mental health in Afghanistan, culturally adapted, evidence-based interventions are needed. 
Objective: The study aims to explore the feasibility and acceptability of culturally adapted mental 
health intervention Problem Management Plus with an additional Emotional Processing module (PM+ 
EP), in reducing psychological distress in young Afghans. The primary objective is to assess the 
feasibility of delivering this intervention in Afghanistan and its acceptability by the target 
communities, and the secondary objective is to assess symptom reduction and behavioural change. 
Methods: This is a pilot Randomized Control Trial (RCT) with participants aged 16 to 30 in Afghanistan. 
Eligible participants, young Afghans with high levels of distress and impaired functioning - measured 
by the Kessler Psychological Distress Scale (K10) -, will be randomized to PM+ EP (n=30) or the waiting 
group (n=30). The participants will be evaluated through self-report questionnaires at three time 
points; baseline (T1), four weeks later immediately post-intervention (T2), and 3 months post-
intervention (T3), and through a qualitative interview (Process Evaluation) at the end of the study. 
Outcomes will include measures of anxiety and depression (HSCL-25), aggressive behaviours (AGQ), 
PTSD symptoms (PCL-5), and daily functioning (WHODAS 2.0). 
Results and Conclusion: This study will assess the feasibility and acceptability of culturally adapted 
PM+ EP in Afghanistan and explore the relationship between mental health symptoms and violence 
among young Afghans. It will be the first to evaluate the feasibility of PM+ EP with this population and 
could pave the way for a large define RCT examining the effectiveness this approach, should the results 
show promise. 
Highlights 
- 
Examine the feasibility and acceptability of culturally adapted PM+ EP among young 
populations with high levels of distress in Afghanistan.  
- 
Assess mental health symptoms reduction and behavioural change among Afghan youth. 
- 
Discuss the process of culturally adapting evidence-informed mental health interventions for 
Afghan populations. 
 
 
 
 
 
 
 
 
 
1. Background and Rationale  
 
An estimated 85% of Afghanistan’s population have experienced or witnessed at least one traumatic 
event that has left them in psychological distress, with most averaging four events (Human Rights 

 
 
 
 
Watch, 2018). The psychological disturbance from decades of conflict, is only accentuated by high 
rates of poverty, and the cultural and structural barriers to mental health and health care. Similarly, 
recent assessments have illustrated that more than a third of children in Afghanistan have experienced 
some psychological distress due to loss of loved ones, and the constant threat of death and illness 
around them; oftentimes manifesting into mental health conditions, such as Post-Traumatic Stress 
Disorder (PTSD), anxiety and depression (Qamar et al, 2022). Children and adolescents are more 
vulnerable to developing mental health symptoms due to their ongoing emotional and social 
development (Lewis et al, 2019). In fact, children who are subjected to violence and conflict are at a 
high risk of developing cognitive and social difficulties (Neto et al, 2022). In a study of 1011 adolescents 
in Afghanistan, 22.2% met the criteria for a probable psychiatric disorder and 18.0%, 4.8%, and 23.9% 
met the criteria for emotional concerns, conduct problems, and PTSD, respectively (Panter-Brick et al, 
2019). In another study, it was found younger age was itself a risk factor for developing mental health 
disorders (Alemi et al, 2018). 
Researchers have identified a link between the negative mental health effects caused by a lack of 
social cohesion within Afghanistan's insecure context, and a high level of violence (Abasi, 2008). They 
found mental health problems are a key contributor to violence, in combination with other impacts of 
adversity faced in Afghanistan. Whilst research on child development shows, in turn, experiences of 
violence can lead to mental health issues developing (Shoib et al, 2022). In Afghanistan, children are 
particularly prone to being victimized by persistent violence; one cross-sectional study found 71% of 
children experienced physical violence across 2017 (Shoib et al, 2022). Furthermore, subsequent 
vulnerability, anxiety, and psychological distress all have a detrimental impact on the neurocognitive 
development of children and have resulted in widespread mental health issues in the country (Shoib 
et al, 2022; Kovess-Masfety et al, 2021). Further studies conducted in Afghanistan have found that 
vulnerable youth who experience distressing experiences are more likely to join non-state armed 
groups, and that without effective rehabilitation and mental health support, violence is likely to be a 
reoccurring issue (Schwartz, 2020).  
Children in Afghanistan face numerous obstacles to achieving stable mental health, including poverty, 
lack of stability, and persistent violence. This can in turn contribute to adverse childhood experiences, 
such as difficulty maintaining relationships, difficulty regulating emotions, and difficulty concentrating 
(Jones et al, 2020). Without support to help them regulate their emotions, in an attempt to manage 
high stress levels, some children may resort to unhealthy coping mechanisms, such as being violent, 
withdrawing from society, or taking drugs (Catani, 2018; Hadid et al, 2019). Living in an environment 
where there is a constant state of conflict exacerbates mental health symptoms. This combined with 
the cultural stigma around mental health, lack of inclusion, and lack of mental health literacy, prevents 
enabling environments to form where support is available. 
In Afghanistan, much of the interpersonal violence is concentrated in the most conflict-affected areas 
including Central Highlands, western, and southern regions, where health and justice infrastructure 
are weak (Ferguson, 2018). Such socioeconomic risk factors as poverty, unemployment, lack of 
education, and exposure to violence have also been found somewhat associated with attitudes 
towards violence, with a higher acceptance of violence among populations most affected by adversity 
(Li et al, 2018). Identifying mechanisms that minimise this risk of violence is critical in developing 
violence prevention programs and interventions. One study, designed to analyse the relationship 
between childhood exposure to violence and adolescent conduct, revealed that children who are 

 
 
 
 
exposed to violence and victimization before the age of ten have an increased risk of enacting violent 
behaviours, and that exposure to violence is a demonstrated predictor of violence in adolescents 
(Weaver et al, 2011). Further research indicates that persistent violence in Afghanistan is both a 
catalyst and a consequence of mental health disorders (Nascimento et al, 2022). Thus, by better 
understanding this relationship between mental health symptoms and violence, we can support the 
development of preventative interventions that work to effectively prevent and mitigate violence for 
this particular population. 
Afghanistan’s mental health system has been historically weak, with decades of underinvestment, 
limited specialist availability, and a fragmented approach to care (Rahimi-Movaghar et al, 2014). In 
response to these challenges, the Basic Package of Health Services (BPHS), introduced in 2003, sought 
to integrate mental health into primary healthcare, aiming to improve accessibility in a country where 
psychiatric services were previously centralized in just a few urban centers (Trani et al, 2010). This 
integration marked a significant step forward, ensuring that mental health care was included in public 
health facilities nationwide. However, despite its ambitious goals, the BPHS faced several obstacles. 
While it expanded the availability of psychological support within primary healthcare facilities, the 
actual implementation remained inconsistent, largely due to inadequate funding, a shortage of 
trained mental health professionals, and competing healthcare priorities (Ventevogel et al, 2013). 
Many BPHS clinics lacked the resources and staffing to provide meaningful psychological 
interventions, often reducing mental health care to the prescription of psychotropic medications by 
undertrained general practitioners (Scholte et al, 2004). Additionally, stigma and cultural 
misconceptions surrounding mental illness limited community engagement, preventing many from 
seeking available services (Rahimi-Movaghar et al, 2014). The collapse of international funding 
following the Taliban takeover in 2021 further weakened the system, leaving mental health services 
even more under-resourced (HRW, 2022). Given these limitations, the need for alternative, 
community-based, and culturally adapted mental health interventions is clear. Programs that train lay 
health workers in structured, evidence-based approaches - such as Problem Management Plus (PM+) 
- offer a feasible way to bridge the current service gaps. PM+ is an evidence-based low intensity 
psychological intervention developed by the World Health Organization (WHO), designed for adults 
impaired by distress due to exposure to conflict and adversity. The intervention seeks to introduce 
strategies to help people problem solve, manage stress, build resilience, and reflect on behaviors and 
actions in real time. It has been tested with favorable outcomes amongst refugee and LMIC 
populations (Schafer et al, 2023). ‘Emotional Processing’ (EP) is a newly developed component 
introduced in session 3 that helps participants process significant life memories—two positive and one 
distressing—by discussing the emotions, thoughts, and future perspectives associated with them, 
using a jigsaw puzzle metaphor. Its goal is to reduce emotional intensity around these memories 
through structured reflection and emotional expression (Alozkan Sever et al, 2021). This pilot study 
will analyse the applicability of PM+ EP in a country of origin, in this case, Afghanistan. By providing 
interventions that align with local cultural frameworks and strengthening community engagement, 
these programs have the potential to address both psychological distress and associated risk factors 
for violence among young people in Afghanistan (Alem et al, 2008). 
This pilot study will assess the feasibility, acceptability, and safety of implementing the culturally 
adapted PM+ EP among a novice population in Afghanistan. The study will examine the process of 
cultural adaptation and implementation, evaluating whether these interventions are practical and 
well-received by the target population. As a secondary objective, the study will explore the association 

 
 
 
 
between mental health symptoms—such as depression, anxiety, aggression, and impaired 
functioning—and experiences of violence among young people in Afghanistan. Using our chosen 
instruments, we can examine key factors contributing to violence at baseline and explore how 
differences in mental health outcomes relate to behavioural change. Ultimately, the findings may 
inform the development of scalable mental health interventions that support improved mental health 
outcomes, daily functioning, and a reduction in violence. 
 
2. Methods  
2.1 Design and Setting 
The study is a stand-alone project, culturally adapting the existing World Health Organization (WHO) 
PM+ programme and trialling it with a new subject population - Afghan youth. This pilot RCT will be 
conducted in a community setting in Afghanistan and the research team will be a mix of researchers 
attached to the Vrije Universiteit (VU) Amsterdam, and field researchers in Afghanistan working with 
non-profit Peace of Mind Association (PoMA). 
This study is a pilot randomized controlled trial (RCT) which involves assessing the feasibility and 
acceptability of culturally adapted PM+ with an Emotional Processing (EP) module (PM+ EP), and 
exploring the relationship between mental health symptoms and behavioural change. Self-report 
assessments will be conducted at three points during the study; prior to delivering the intervention 
(T1), directly post-intervention (T2), and 3 months-post intervention (T3), and through a qualitative 
interview conducted at the end of the study.  
2.2 Participants 
Participants for this study will be recruited through health-related entry pathways, such as health 
clinics, gender-focused support services, community hubs, and ministries and stakeholders working 
within the mental health sector in Afghanistan. Participants will be men and women between the ages 
of 16 and 30 residing in Afghanistan, who experience psychological distress. Eligible participants will 
have elevated levels of psychological distress measured by the Kessler-10 Psychological Distress Scale 
(K10 > 15) (Andrews, 2001). They should also meet the inclusion criteria of having the ability to read 
and write in Dari. Those who present as an imminent suicide risk, with psychosis, or those with 
neurological or cognitive disabilities, will be excluded. Potential participants will be asked to provide 
their contact information and will be invited to complete the K10 self-report assessment, to measure 
their level of psychological distress. Once determined as having elevated levels of psychological 
distress, 60 eligible participants will be invited to partake in the study. Participants will be assigned a 
case number, to protect their identity and provide anonymity. Participants will be asked to provide 
written consent in Dutch/English and/or Dari and be made aware that they are permitted to withdraw 
from the study at any point.  
2.2.2 Sample Size 
Since this is a pilot RCT no power calculations have been carried out. The total sample size will be 60 
persons, with half of the participants receiving PM+ EP (N=30) and half assigned to the waiting group 
(n=30). Randomization will be carried out using a random numbers table generated by computerised 
software. Those participants in the waiting group will be offered the chance to receive the intervention 

 
 
 
 
post-study. The total number included in the study allows us to evaluate the feasibility and 
acceptability of the intervention and allow for drop-out rates and incomplete data to be omitted. For 
the Process Evaluation, a non-random sample size of ten people will be interviewed. 
2.3 Procedure 
Participants receiving PM+ EP will meet their facilitator individually, someone of the same gender, and 
receive the intervention through sessions conducted over Zoom or a similar platform; mitigating the 
difficulties around accessing psychological support, and the risks associated with safety of participants 
and stigma around mental health. Participants will receive six individual sessions of PM+ EP over the 
period of one calendar month.  
All participants will complete four surveys for assessment at study points T1, T2 and T3; The Hopkins 
Symptom Checklist 25 (HSCL-25) to measure for anxiety and depression (Mollica et al, 1987), The 
Aggression Questionnaire (AGQ) to measure violent behaviours (Buss and Perry, 1992), The Post 
Traumatic Stress Disorder (PTSD) Checklist for DSM-5 (PCL-5) will screen participants for symptoms of 
PTSD (Weathers et al, 2013), and cognitive ability and overall ability to function will be measured by 
WHO Disability Assessment Schedule 2.0 (WHODAS 2.0) (WHO, 2012). The latter has been used in 
studies looking at PTSD and other trauma-symptoms in low-resource settings, to assess the 
communities’ impaired daily functioning (Hamdani et al., 2020). After the final assessment has been 
complete, a non-random sample of participants will be invited to partake in an interview – the Process 
Evaluation -, to gather qualitative data to assess the feasibility and acceptability of the program. 
The timeline and frequency at which the instruments that will be used for screening, baseline and post 
intervention are listed in the table below. Some of the listed instruments have translations in Dari or 
Farsi (Afghan Persian/Iranian Persian). In case there is no translation, the instrument will be translated 
and back translated by the research team.   
Table 1. Measure Overview and Timeline 
 
2.3.1 Facilitators 
The PM+ EP intervention will be delivered by facilitators who are Afghan and speak the Dari language. 
Future adaptations may allow for a wider variety of Afghan languages. Facilitators will be trained to 

 
 
 
 
deliver the PM+ EP program sessions to participants, by a PM+ Training expert, in addition to carrying 
out consent and screening procedures. The facilitators will be recruited based on their qualifications 
and experience and receive a three-day training on delivering the culturally adapted PM+ EP, 
psychological first aid (PFA), selfcare techniques, and ethics in research. Following training, facilitators 
will be required to role play practice cases using case studies provided by the research team and will 
receive bi-weekly supervision throughout the program by a PM+ supervisor, alternating between 
group supervision and individual supervision; allowing facilitators to learn from peers and from their 
supervisor. Facilitators must be fluent in Dari and preferably have a good knowledge of English. 
2.3.2 Process Evaluation 
After the study, participants will be approached for the Process Evaluation; sampling five people 
ensuring variance on gender, age, and completion of the program (drop out/completed), to partake 
in a qualitative interview. Five mental health providers who delivered the intervention PM+ EP will 
also be approached to participate in the qualitative interviews. The objective of this process is to 
understand the perspectives of those who received the intervention and those who delivered the 
intervention, on the feasibility and acceptability of the program among their own communities and in 
their country, and the perceived change in mental health symptom and behavioural change for 
themselves or the participants. This will provide insight into the possibility of scaling the study and 
providing the intervention on a wider scale. The Process Evaluation will use a semi-structured 
interview script to collect qualitative data, and participants will be asked about their experiences with 
the intervention, ease of adherence to the intervention, thoughts on the recruitment process, the 
PM+ EP facilitators and their approach, and whether the program could be effectively integrated into 
health systems in Afghanistan. 
2.3.3 Outcomes 
In this pilot RCT, the primary outcome is to explore the feasibility and acceptability of delivering the 
PM+ EP intervention in Afghanistan. The study serves to demonstrate whether such interventions 
could be safety scaled and produce positive outcomes for the target population. The study’s secondary 
outcome is to analyse the relationship between mental health and violence, and to discuss the 
potential for impact of culturally adapted mental health programming on symptom-change and 
behavioral change, in particular in reducing violence, and to illustrate the context-specific linkages 
between mental health and violence. Through this research, we can examine the mental health 
symptoms, risk factors, and functional impairment, caused by ongoing exposure to conflict or 
adversity, and advocate for scaling-up adaptation and implementation of evidence-informed mental 
health interventions in countries such as Afghanistan. 
 
2.4 Intervention: Program Management Plus (PM+) with Emotional Processing (EP) Module  
PM+ EP comprises of Problem Management Plus, an evidence-based low intensity psychological 
intervention developed by the World Health Organization (WHO), with an additional Emotional 
Processing module specifically to address psychological distress related to trauma exposure. The core 
of the intervention is designed for adults impaired by distress in communities exposed to conflict and 
adversity; it consists of CBT techniques that have been adapted for communities that do not have 
good availability of specialist care. The additional module was developed by researchers treating 

 
 
 
 
refugee youth (Alozkan Sever et al, 2021). For this study, PM+ EP will be a six-session individual and 
guided support program. The original sections of PM+ are available in many languages including Farsi, 
and the additional EP module will be translated by PoMA’s Afghan translator. The sessions cover the 
topics of managing stress, strengthening social support, staying well and persevering. PM+ includes 
the strategies problem solving, stress management, behavioural activation and accessing social 
supports. The additional EP module aims to address negative emotions related to memories of adverse 
and potentially traumatic events, which are common amongst much of the population in Afghanistan 
and so particularly relevant to recovery and healing. The module consists of guiding participants to 
recall and explore both adverse and positive autobiographical memories—conceptualized as ‘puzzle 
pieces’—which they symbolically assemble like a jigsaw to facilitate emotional integration; the module 
concludes with a positive imagery exercise where participants envision an ideal future, fostering 
resilience and goal-oriented thinking PM+ EP works not only to treat the symptom in the immediate, 
but to help build resilience in participants and help them feel prepared for any future traumatic 
events. The intervention provides adaptive skills to participants that help them improve or cope with 
the mental health symptoms they experience. 
Initially, our research team will engage with the target population and conduct in-depth qualitative 
interviews with a variety of persons through key-informant interviews (KIIs). These will cover a broad 
range of questions related to cultural perceptions towards mental health, violence, and the 
relationship between the two. The team seeks to gather information on the target population’s mental 
health needs, where they seek help, and how cultural context and stigma around mental health 
impacts them; to inform on the adaptation process of the PM+ EP intervention. Cultural adaptation of 
PM+ EP should consider adapting the intervention's language, visuals, cultural concepts of mental 
health, treatment goals, and incorporating culturally sensitive and de-stigmatizing delivery methods, 
in such a way, that it is compatible with the client’s "cultural patterns, meanings, and values" (Bernal 
and Rodriguez, 2009). Heim's new framework for cultural adaptation focuses on three main possible 
aspects for adaptation; cultural concepts of distress, treatment components, and treatment delivery 
(Heim and Kohrt, 2019).Following adaptation of PM+ EP, facilitators will be trained to provide the 
intervention, and a pilot randomized control trial (RCT) will test the adapted PM+ EP with this 
population. 
2.5 Study Instruments 
2.5.1 Screening Measures 
K-10 
Kessler-10 Psychological Distress Scale is a 10 item self-report questionnaire used for determining 
whether someone, and to what extent, experiences psychological distress (Kessler et al, 2002). The 
questions in the instrument are rated on 1 to 5 Likert type scale (from none of the time to all of the 
time), higher scores representing higher levels of stress the individual experienced in the last thirty 
days. There is no standard cut-off score; for this study we will use a score of >15 to align it with the 
previous similar research that was carried out with Syrian refugees (de Graaff et al, 2020). The K10 is 
available in Dari by the Transcultural Mental Health Centre (THMC).1 
 
1 Kessler Psychological Distress Scale in Dari language, https://www.dhi.health.nsw.gov.au/transcultural-
mental-health-centre-tmhc/resources/multilingual-resources-by-title/kessler-10 

 
 
 
 
2.5.2 Feasibility Measures 
The primary outcome of this study is to assess the feasibility and acceptability of PM+ EP among young 
populations in Afghanistan. Feasibility will be evaluated based on participant retention rates, 
intervention and assessment completion rates, and the frequency of engagement with provided 
resources. Acceptability will be assessed through participant feedback and dropout rates. Additionally, 
qualitative data from process evaluation interviews will provide further insights into feasibility and 
acceptability by exploring participants’ perceptions of the intervention and their willingness to engage 
in future studies.  
2.5.3 Other Measures 
HSCL-25 
Hopkins Symptom Checklist-25 (HSCL-25) is a 25 item self-report questionnaire assessing symptoms 
of psychological distress; 10 items for anxiety symptoms and 15 items for depression symptoms (2 of 
which identify somatic symptoms) (Mollica et al, 1987). The items are rated on a 4-point Likert scale, 
ranging from 1 (never) to 4 (always) with the anxiety scale ranging from 10-40 and the depression 
scale from 15-60. The total scale (range 25-100) represents psychological distress. It has been 
translated to several languages and validated among culturally diverse refugee adolescent population. 
Researchers who have gathered data from Afghan unaccompanied asylum seekers recommended a 
cut-off of 69.00 for total score, 20.00 for anxiety, and 33.21 for depression (Bronstein et al, 2013). The 
HSCL-25 is available in Dari, created by researchers Kenneth E Miller et al.2 
The Aggression Questionnaire (AGQ)  
The Aggression Questionnaire (AGQ) is a 29-item self-report questionnaire that measures both acts of 
aggression and traits that indicate a temperament to be aggressive or violent. The questionnaire 
covers four major components of aggression; physical aggression, verbal aggression, anger and 
hostility. Participants are asked to rate statements based on how characteristic they are of them. 
Answers are rated on a seven-point Likert scale ranging from 1 (Extremely uncharacteristic of me) to 
7 (Extremely characteristic of me) with the total score ranging between 29 and 203.  (Buss and Perry, 
1992). The AGQ scale will be translated by PoMA’s Afghan translator and checked for correct clinical 
terminology by a clinical team member. 
The PTSD Checklist for DSM-5 (PCL-5) 
The PTSD Checklist for DSM-5 (PCL-5) is a 20 item self-report measure that measures symptoms of 
PTSD. All questions follow the same structure of "In the past month, how much were you bothered 
by...". Each question is scored from 0 (Not at all) to 4 (Extremely). Consistent with the DSM-5, the four 
symptom clusters are represented in the PCL-5 by the following subscales; Re-experiencing (Criterion 
B), Avoidance (Criterion C), Negative Alterations in Cognition and Mood (Criterion D), and Hyperarousal 
(Criterion E). Given the PCL-5 questions closely reassembled the diagnostic criteria in the DSM-5-TR, a 
provisional PTSD diagnosis can be made based on the following rule. The DSM-5 diagnostic criteria 
requires at least: 1 Criterion B item (questions 1-5), 1 Criterion C item (questions 6-7), 2 Criterion D 
items (questions 8-14), and 2 Criterion E items (questions 15-20). A score of 2 (Moderately on the likert 
scale) or higher is an endorsed symptom.  Initial research suggests that a PCL-5 cutoff score between 
 
2 HSCL-25 scale in Dari, (PDF) Hopkins Symptom Checklist 25-Dari 

 
 
 
 
31-33 is indicative of probable PTSD across samples (Weathers et al, 2013). The PTSD Checklist for DSM-
5 (PCL-5) is available in Persian (Farsi), created by researchers Homeria Varmaghani et al.3 
 
WHODAS 2.0 
WHO Disability Assessment Schedule (WHODAS 2.0) is an assessment tool developed by the World 
Health Organization (WHO) to measure health and disability for both research and clinical purposes 
(WHO, 2012). The instrument captures the functionality on six domains which are; 1) Cognition, 2) 
Mobility, 3) Self-care, 4) Getting along, 5) Life activities, and 6) Participation. The questions inquire 
about the experiences of difficulties in the specific domains of functionality within the last thirty days. 
Difficulties are scored on a five-point Likert scale ranging from 1 (none) to 5 (extreme), before 
summation (range 12-60). Higher scores indicate worse functional impairment. WHODAS 2.0 is 
available in Persian (Farsi), shared by the World Health Organization (WHO).4 
2.5.6 Fidelity Assessment 
Protocol adherence will be evaluated through two methods. First, helpers will complete a session-by-
session checklist after each session, indicating which core components of PM+ EP were delivered. 
Second, with informed consent, sessions will be audio-recorded, and approximately 10% of these 
recordings will be analyzed alongside the checklists to assess fidelity. 
2.5.7 Adverse Event Reporting 
Adverse events (AE) can be defined as any undesirable event that occurs to a participant or facilitator 
during the study. A serious adverse event (SAE) refers to any event that causes a serious medical 
emergency. Any AE or SAE will be reported promptly by the investigator to the ethics board (WCG 
Clinical).5 Any serious adverse events, such as incidents that are life threatening, require 
hospitalization for an ongoing duration, result in significant disability, or surgical intervention, may 
result in the study being temporarily paused while the situation is reviewed and necessary safety 
measures are addressed. 
 
3. Analysis 
To evaluate the feasibility and acceptability of the intervention, qualitative analysis will be conducted 
through interviews with participants and facilitators, in addition, quantitative data will be gathered on 
mental health symptoms and behavioral outcomes. Qualitative data will be analyzed using ATLAS.ti to 
explore participant experiences and inform future intervention development. Interview transcripts 
will be imported into the software for systematic coding. An initial coding framework will be 
developed both deductively, based on study objectives, and inductively, based on emerging data. Two 
researchers will independently code a subset of transcripts, refining the codebook through consensus 
discussions to ensure consistency. All transcripts will then be fully coded, and thematic analysis will 
be conducted to identify key patterns and relationships. Findings will be used to complement 
 
3 DSM-5 (PCL-5) in Persian, Psychometric Properties of the Persian Version of the Posttraumatic Stress Disorder 
Checklist for DSM-5 (PCL-5) 
4 
5 WCG Clinical Services: Improving Clinical Trial Quality & Efficiency 

 
 
 
 
quantitative outcomes, providing a deeper understanding of feasibility, acceptability, and potential 
mechanisms of change within the intervention. To analyse quantitative data, mean differences in 
subscale scores and total scores between baseline (T1) and follow-up assessments (T2 and T3) will be 
determined. Linear mixed models will be employed to analyze feasibility and acceptability data, with 
treatment as a fixed effect, baseline endpoint measurements as covariates, and subjects as a random 
effect. This approach will allow for the assessment of trends in participant retention, session 
attendance, and intervention adherence over time while accounting for individual variability. 
Feasibility will be assessed through intervention-specific metrics, including recruitment and consent 
rates, session attendance, assessment completion, protocol adherence, and occurrences of adverse 
events. Qualitative data collected through Process Evaluation interviews will complement these 
findings, providing contextual insights and a deeper understanding of the feasibility and acceptability 
of the program.  
 
4. Ethics Approval 
The study has received IRB ethics approval for this study from the Ministry of Public Health (MoPH) in 
Afghanistan and from WCG Clinical in the US (International approval). Both MoPH and WCG reviewed 
our study protocols, the Principal Investigator, and materials such as the data collection tools and 
consent forms, and provided approval to implement the pilot RCT, collect personal data from 
participants, and publish our findings.  
 
5. Discussion 
This study aims to evaluate the feasibility and acceptability of PM+ EP for young people between 16 
and 30 within Afghanistan. By implementing this intervention, we seek to understand its potential for 
impact, to improve mental health symptoms and psychological distress for youth living in adversity, 
through understanding how feasible it would be to implement in Afghanistan and how accepted it 
would be by target communities. Furthermore, this study will provide critical insights into trial 
procedures, informing the cultural adaptation of further trials and the implementation of mental 
health interventions in Afghanistan. 
Previous research has demonstrated the efficacy of PM+ in low-resource and humanitarian settings 
(Alem et al, 2008). However, this study represents one of the first efforts to assess PM+ EP with the 
additional module, and in Afghanistan. Given the existing barriers to accessing mental health services 
in Afghanistan, such as a lack of psychologists and mental health professionals in the country, and 
social and cultural restrictions to seeking mental health support, this remote-delivery intervention 
could serve as a more accessible and scalable option for addressing mental health needs. 
The findings from this study will contribute to ongoing efforts to integrate evidence-based, scalable 
psychological interventions within community settings in Afghanistan. If the intervention is found to 
be feasible and acceptable, the results can support further implementation efforts, policy 
recommendations, and capacity building for mental health providers. Additionally, findings regarding 

 
 
 
 
cultural adaptation will provide valuable information on the feasibility of delivering evidence-based 
interventions created for populations in the Global North, in this context. 
Further research is necessary to assess the effectiveness and impact of culturally adapted 
interventions and integration strategies within existing service structures. By addressing these gaps, 
future studies can refine intervention models and maximize their impact on mental health outcomes 
in Afghanistan. 
 
6. Data Availability Statement 
Since this manuscript describes a protocol, there is currently no data available to share. Once the trial 
data has been collected, it will be available upon request from the Principal Investigator, with all data 
anonymized if shared. 
 
7. Disclosure Statement 
No potential conflict of interest has been reported by the author. 
 
8. Funding Information 
The funding for this study will be provided by the non-profit organization Peace of Mind Association 
(PoMA). The study is a joint project between Vrije University of Amsterdam and PoMA, with Principal 
Investigator Lyla Schwartz being a PhD student at the first, and the Director of Programs and 
Psychology at the latter. This joint venture will be led by Ms Schwartz, and supported by professors at 
the university and researchers at PoMA. 
 
 
 
 
 
 
 
 
 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
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