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

ConditionsPsychological Distress Traumatic Stress

Trial statusRecruiting

Trial phaseNot applicable

Trial typeInterventional

Biological sexAll

Age16-25

SponsorKarolinska Institutet

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

16 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.

Disqualifiers

An acute medical condition;

Imminent suicide risk;

Indication of psychotic disorders and substance-dependence;

Indication of severe cognitive or neurological impairment;

Trial design

Design model

Parallel

Treatments tested in this trial

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 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.
Care as usual
Other intervention
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 groups

60 Participants

are divided into 3 treatment groups

Group A: Problem Management Plus with Emotional Processing (PM+EP)Experimental treatment 1 intervention

Group B: Problem Management PlusActive comparator 1 intervention

Group C: Treatment as UsualOther 1 intervention

Trial outcomes

Primary outcomes

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

Time frame