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

NCT06980441 | Not Yet Recruiting

• 1 other identifier: 1378139
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Depression and Suicide Ideation; Anxiety; PTSD

Keywords

Youth mental health; Afghanistan; Implementation science; Culturally adapted psychological support; Evidence informed interventions; Mental health symptoms; Psychological experiences

Outcome Measures

Primary Outcomes (3)

• Reduction in psychological distress symptoms among participants, as measured by scientific scale HSCL-25.

  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. All participants will complete four surveys for assessment at study points T0, T1, T2 and T3. The Hopkins Symptom Checklist 25 (HSCL-25) is one outcome measure designed to measure for anxiety and depression. 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.

  Pre-intervention until 3 months post-intervention

• Reduction in psychological distress symptoms among participants, as measured by scientific scale DSM-5 (PCL-5).

  The primary outcome of this pilot RCT is to assess the feasibility and acceptability of delivering the PM+ EP intervention in Afghanistan and its potential for safe scale-up and positive impact. All participants will complete four assessments at T0, T1, T2, and T3. PTSD symptoms will be measured using the PTSD Checklist for DSM-5 (PCL-5), a 20-item self-report tool that assesses symptoms over the past month. Each item is scored from 0 (Not at all) to 4 (Extremely), covering four symptom clusters: Re-experiencing, Avoidance, Negative Cognition/Mood, and Hyperarousal. A provisional PTSD diagnosis can be made if participants endorse the minimum number of symptoms in each cluster at a rating of 2 or higher. A total score between 31-33 suggests probable PTSD. This outcome will help determine whether PM+ EP is a feasible and acceptable approach to reducing trauma symptoms among conflict-affected youth in Afghanistan.

  Pre-intervention until 3 months post-intervention

• Reduction in psychological distress symptoms among participants, as measured by scientific scale WHODAS 2.0.

  The primary outcome of this pilot RCT is to assess the feasibility and acceptability of delivering the PM+ EP intervention in Afghanistan, evaluating its potential for safe scale-up and positive outcomes. All participants will complete four assessments at T0, T1, T2, and T3. Functional ability will be measured using the WHO Disability Assessment Schedule 2.0 (WHODAS 2.0), a validated tool developed by WHO to assess health and disability across six domains: cognition, mobility, self-care, getting along, life activities, and participation. Participants report difficulties experienced in the past 30 days on a five-point Likert scale (1 = none to 5 = extreme), with total scores ranging from 12 to 60. Higher scores indicate greater functional impairment. This outcome will inform whether PM+ EP is feasible, acceptable, and functionally beneficial for young Afghans experiencing psychological distress.

  Pre-intervention until 3 months post-intervention

Secondary Outcomes (2)

• Participant-Reported Changes in Attitudes Toward Violence and Perceived Impact of PM+ EP on Mental Health and Behavior.

  3 months post-intervention

• Analysis of relationship between mental health and violence, as measured by scientific scale AGQ.

  Pre-intervention until 3 months post-intervention

Study Arms (2)

Intervention Arm: PM+ EP

EXPERIMENTAL

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.

Behavioral: Problem Management Plus with Emotional Processing module

No Intervention Arm

NO INTERVENTION

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.

Interventions

Problem Management Plus with Emotional Processing module 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.

Intervention Arm: PM+ EP

Eligibility Criteria

• Age: 16 Years - 30 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Peace of Mind Association (PoMA): lead
• VU University of Amsterdam: collaborator

Study Sites (1)

Peace of Mind Association (PoMA)

Kabul, Afghanistan

Location

MeSH Terms

Conditions

Depression; Anxiety Disorders; Stress Disorders, Post-Traumatic

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior; Mental Disorders; Stress Disorders, Traumatic; Trauma and Stressor Related Disorders

Study Officials

• Lyla L Schwartz, Masters

  Peace of Mind Association (PoMA)

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Lyla L Schwartz, Masters

CONTACT

4132973569; lyla@pomaglobal.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Directors of Programs and Psychology

Study Record Dates

• First Submitted: May 1, 2025
• First Posted: May 20, 2025
• Study Start: June 1, 2025
• Primary Completion: December 1, 2025
• Study Completion (Estimated): December 1, 2026
• Last Updated: May 20, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: Data requests can be submitted immediately after article publication and the data will be made accessible for up to 24 months.
• Access Criteria: Access to trial IPD can be requested by qualified researchers engaging in independent scientific research, and will be provided following review and approval of a research proposal and the signing of a Data Sharing Agreement (DSA).

Locations

AF (1)