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

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

• Ages 16 to 30 years
• All sexes
• No healthy volunteers
• Child, Adult

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

About this study

Official title: 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

Conditions

Depression and Suicide Ideation, Anxiety, PTSD

Being tested

Problem Management Plus with Emotional Processing module

Keywords

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

Medical subject headings

Depression, Anxiety Disorders, Stress Disorders, Post-Traumatic

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

• Problem Management Plus with Emotional Processing moduleBehavioural

  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.

What is being measured

The primary outcome is the main question the study is designed to answer.

1. 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.

   Measured: Pre-intervention until 3 months post-intervention

2. 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.

   Measured: Pre-intervention until 3 months post-intervention

3. 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.

   Measured: Pre-intervention until 3 months post-intervention

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1. First posted20 May 2025
2. Study startJun 2025 (estimated)
3. Primary completionDec 2025 (estimated)
4. Study completionDec 2026 (estimated)

Resources

• Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
• Other trials for Depression and Suicide IdeationStudies of the same condition, open and under way.
• What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.