Problem Management Plus With Emotional Processing (PM+EP) for Forcibly Displaced Youth

NCT06878092 | Recruiting

• 1 other identifier: 2024-05883-02
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this feasibility randomized controlled trial is to learn about the feasibility and acceptability of scalable psychological interventions in Sweden. It will also allow for a preliminary exploration of a novel modular addition targeting traumatic stress to Problem Management Plus (PM+), an evidence-based transdiagnostic psychological intervention for psychological distress. The main question it aims to answer is whether PM+ and PM+ Emotion Processing (PM+EP) feasible and acceptable among forcibly displaced youth in Sweden? Participants will be randomized to receive PM+, PM+EP, or treatment as usual. The two intervention arms consist of a weekly session for six weeks. Assessments will collect data on a variety of psychological symptoms, wellbeing, and service use throughout the duration of the study. Assessments will take place at baseline, 1-week post-intervention, and 3-weeks post-intervention.

Conditions

Psychological Distress; Traumatic Stress

Keywords

psychological distress; scalable psychological interventions; forcibly displaced; common mental disorders

Outcome Measures

Primary Outcomes (1)

• Feasibility and acceptability

  * 70% recruitment and consent rate * 70% attendance of sessions and assessments * 75% protocol adherence * Maximum 10% presence of adverse events and no serious adverse events * Fewer than 15% missing items on assessments

  From enrollment to the end of assessment prior (18 weeks)

Secondary Outcomes (9)

• WHO Disability Assessment Schedule (WHODAS 2.0)

  From enrollment to the end of assessment prior (18 weeks)

• Hopkins Symptom Checklist-25 (HSCL-25)

  From enrollment to the end of assessment prior (18 weeks)

• PTSD Checklist for DSM-5 (PCL-5)

  From enrollment to the end of assessment prior (18 weeks)

• Self-identified problems (PSYCHLOPS)

  From enrollment to the end of assessment prior (18 weeks)

• Client Service Receipt Inventory

  From enrollment to the end of assessment prior (18 weeks)

Study Arms (3)

Problem Management Plus with Emotional Processing (PM+EP)

EXPERIMENTAL

Behavioral: Problem Management Plus with Emotional Processing Module (PM+EP)

Problem Management Plus

ACTIVE COMPARATOR

Behavioral: Problem Management Plus (PM+)

Treatment as Usual

OTHER

Other: Care as usual

Interventions

Problem Management Plus (PM+) BEHAVIORAL

Problem Management Plus is a brief, potentially scalable psychological intervention developed by the World Health Organization and is delivered by non-specialised helpers. In brief, the intervention is based on cognitive behavioural therapy (CBT) techniques and typically consists of five weekly, ninety-minute sessions. Participants are taught the following techniques during the sessions: stress management, problem-solving, behavioural activation, and accessing social support. The effectiveness of both the individual and group formats of the PM+ intervention have been shown in a number of large definitive RCTs. For the purposes of this study, an adapted version of PM+ will be used to match the exposure between the two active intervention arms. There will be six, weekly seventy-five-minute sessions

Problem Management Plus

Problem Management Plus with Emotional Processing Module (PM+EP) BEHAVIORAL

To more directly address symptoms of traumatic stress, an adapted version of PM+ containing Emotional Processing module will be trialed in this study. The PM+ strategies discussed above are identical across both interventions apart from the additional module. The Emotional Processing module aims to provide a safe environment for participants to engage in the emotional processing of both positive and negative memories. During the additional session, participants will be asked to imagine significant memories as pieces of a jigsaw puzzle; participants will be asked to illicit three memories, two positive/pleasurable and one negative/frightening. Participants will be assisted in processing these memories through discussing the puzzle pieces, the thoughts and emotions that come with the memory, and future perspectives. Participants will be asked to rate the intensity of emotions before and after they talk about their memories each time they are brought up.

Problem Management Plus with Emotional Processing (PM+EP)

Care as usual OTHER

The comparison group will receive care as usual (CAU) only. CAU for forcibly displaced youth (under 18) in Sweden corresponds to primary health care, education, social protection services, and specialized psychological treatment programs. However, adults are only able to access care that cannot be deferred. Once the individual has received their residence permit, they are able to access all healthcare. Upon first arriving in Sweden, refugees are referred to a municipality by the Swedish Board of Migration (Migrationsverket) until they have their residence permit. The municipality is responsible for education and social services while the regions are responsible for health care. In the regions, primary care is responsible for the first line of treatment but can also refer to the child and adolescent mental health services (CAMHS) if needed. Unaccompanied children might either be placed in families or in residential facilities and benefit from the same systems as accompanied children.

Treatment as Usual

Eligibility Criteria

• Age: 16 Years - 25 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• to 25 year old youth who arrived in Sweden in 2015 or later due to being forcibly displaced;
• Elevated levels of psychological distress as determined through the Kessler-10 psychological distress scale (K10; K10 \> 15);
• Reduced levels of psychosocial functioning as measured by the WHO Disability Assessment Schedule (WHODAS 2.0; WHODAS 2.0 \> 16);
• Assessment and manual are available in their preferred language, including Swedish.

You may not qualify if:

• An acute medical condition;
• Imminent suicide risk;
• Indication of psychotic disorders and substance-dependence;
• Indication of severe cognitive or neurological impairment;
• Receiving specialized mental health treatment;
• In case of current psychotropic medication used: change in dosage during the past two months.

Sponsors & Collaborators

• Karolinska Institutet: lead
• Rädda Barnen: collaborator

Study Sites (1)

Centrum för stöd och behandling

Stockholm, 10788, Sweden

RECRUITING

Related Publications (1)

• Mattelin E, Alozkan-Sever C, Shahnavaz S, Sijbrandij M, Mittendorfer-Rutz E, Akhtar A. Study Protocol of a feasibility and acceptability trial of Problem Management Plus with Emotional Processing (PM+EP) for forcibly displaced youth living in Sweden. BMJ Open. 2025 Oct 28;15(10):e104845. doi: 10.1136/bmjopen-2025-104845.

  PMID: 41151965 DERIVED

Central Study Contacts

Aemal Akhtar, PhD

CONTACT

+46852483224; aemal.akhtar@ki.se

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: March 10, 2025
• First Posted: March 14, 2025
• Study Start: June 1, 2024
• Primary Completion: October 1, 2025
• Study Completion: October 1, 2025
• Last Updated: July 1, 2025

Record last verified: 2025-03

Locations

SE (1)