Culturally Adapted Psychological Support for Conflict-Affected Afghans: Study Protocol on Mental Health & Violence

NCT ID: NCT06980441

Last Updated: 2025-05-20

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-06-30
• Study Completion Date: 2026-12-31

Brief Summary

This pilot study examines the feasibility and acceptability of a culturally adapted psychological intervention-Problem Management Plus with Emotional Processing (PM+ EP)-for young Afghans aged 16-30 experiencing high psychological distress. Through a pilot randomized control trial and qualitative interviews, the study explores whether PM+ EP can reduce symptoms of anxiety, depression, PTSD, and aggression, and improve daily functioning. Findings will inform the potential for a larger trial and address critical mental health and violence prevention needs in conflict-affected Afghan communities.

Detailed Description

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).

Analysis: 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.

Conditions

Depression and Suicide Ideation; Anxiety; PTSD

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: SINGLE

Study Groups

Intervention Arm: PM+ EP

Participants in this group will receive a culturally adapted version of the World Health Organization's Problem Management Plus (PM+) program, with an added Emotional Processing (EP) module. The intervention will be delivered through six individual sessions over one month by trained Afghan facilitators of the same gender as the participant. Sessions will focus on managing distress, solving problems, building social support, and processing difficult emotions.

Group Type: EXPERIMENTAL

Problem Management Plus with Emotional Processing module

Intervention Type: BEHAVIORAL

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.

No Intervention Arm

Participants in this group will not receive the intervention during the study period but will complete the same assessments as the intervention group. After the study concludes, they will be offered the opportunity to receive the PM+ EP sessions.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Problem Management Plus with Emotional Processing 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.

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• Psychological Distress, measured at >15 on the Kessler Psychological Distress Scale (K10)
• Afghan nationality
• Age between 16 and 30
• Ability to read and write in Dari

Exclusion Criteria

• Imminent suicide risk
• Experiencing psychosis
• Neurological or cognitive disabilities

• Minimum Eligible Age: 16 Years
• Maximum Eligible Age: 30 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

VU University of Amsterdam

OTHER

Sponsor Role: collaborator

Peace of Mind Association (PoMA)

OTHER

Sponsor Role: lead

Responsible Party

Lyla Schwartz

Directors of Programs and Psychology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Lyla L Schwartz, Masters

Role: PRINCIPAL_INVESTIGATOR

Peace of Mind Association (PoMA)

Locations

Peace of Mind Association (PoMA)

Kabul, , Afghanistan

Countries

Afghanistan

Central Contacts

Lyla L Schwartz, Masters

Role: CONTACT

lyla@pomaglobal.org

4132973569

Provided Documents

Document Type: Study Protocol

View Document

Other Identifiers

1378139

Identifier Type: -

Identifier Source: org_study_id