Clinical trial NCT06980441: Culturally Adapted Psychological Support for Conflict-Affected Afghans: Study Protocol on Mental Health & Violence
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
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
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
Lead sponsor: Peace of Mind Association (PoMA)
Sponsor class: OTHER
Collaborators: name: VU University of Amsterdam
First posted: 2025-05-20
Enrollment: 60
Sex: ALL
Minimum age (years): 16
Maximum age (years): 30
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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.

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

Primary outcomes:
measure: Reduction in psychological distress symptoms among participants, as measured by scientific scale HSCL-25.
timeFrame: Pre-intervention until 3 months post-intervention
measure: Reduction in psychological distress symptoms among participants, as measured by scientific scale DSM-5 (PCL-5).
timeFrame: Pre-intervention until 3 months post-intervention
measure: Reduction in psychological distress symptoms among participants, as measured by scientific scale WHODAS 2.0.
timeFrame: Pre-intervention until 3 months post-intervention
Secondary outcomes:
measure: Participant-Reported Changes in Attitudes Toward Violence and Perceived Impact of PM+ EP on Mental Health and Behavior.
timeFrame: 3 months post-intervention
measure: Analysis of relationship between mental health and violence, as measured by scientific scale AGQ.
timeFrame: Pre-intervention until 3 months post-intervention
Other outcomes:
Locations:
city: Kabul
country: Afghanistan
facility: Peace of Mind Association (PoMA)
Study officials:
affiliation: Peace of Mind Association (PoMA)
name: Lyla L Schwartz, Masters
role: PRINCIPAL_INVESTIGATOR
References: