Refugees and asylum seekers (RAS) face numerous stressors and adversities which put them at risk for developing mental health problems. However, access to adequate mental health care in host countries is limited. To address this problem, the World Health Organization (WHO) introduced Problem Management Plus (PM+), a short, low-intensity psychological intervention administered by non-professionals, aiming to alleviate common mental disorders among crisis-affected communities. The present study aims at expanding the existing PM+ intervention by providing additional booster sessions and homework reminders while evaluating its effectiveness and implementation in the public health system.
Refugees and asylum seekers (RAS) are often exposed not only to potentially traumatic events before and during migration but also to significant post-migration stressors. Due to this combined burden, RAS are at increased risk for developing mental health problems. In accessing mental health care in the host countries, however, they face several barriers including waitlists, stigma and communication difficulties. Consequently, RAS are frequently underdiagnosed and often do not receive adequate medical treatment despite an urgent need. To improve the access to evidence-based psychological interventions, the WHO developed a series of scalable interventions. One of these is Problem Management Plus (PM+), a brief, low-intensity psychological intervention, delivered by paraprofessionals, that addresses common mental disorders in people affected by adversity. PM+ consists of 5 sessions that comprise evidence-based techniques of (a) problem solving, (b) stress management, (c) behavioral activation, and (d) accessing social support. The present study aims at expanding the existing PM+ intervention by providing additional booster sessions and homework reminders. PM+ has been proven to be an effective method for reducing mental health problems and improving the psychosocial functioning of people in crisis in various countries and contexts, including Switzerland. Despite its effectiveness, far too little attention has been paid to the successful implementation of such low-intensity psychological interventions into real-world health care systems. To address this gap, the present study aims to evaluate the effectiveness of augmented PM+ on mental health outcomes over 3 months under usual practice conditions and its implementation in the public health care system by using a pragmatic randomized clinical trial design.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
2,000
Problem Management Plus (PM+) is a brief, psychological intervention program based on CBT techniques that are empirically supported and formally recommended by the WHO. The full protocol was developed by the WHO and the University of New South Wales, Australia. The manual involves the following empirically supported elements: problem solving plus stress management, behavioural activation, facing fears, and accessing social support. These elements have been recommended in recent WHO guidelines. Additionally, the original five PM+ sessions will be augmented in two ways. First, the participants will receive three 30-45-minutes telephone booster sessions 10, 22, and 34 weeks after the final original PM+ session. The second augmentation strategy involves handouts and homework reminders.
Klinik für Konsiliarpsychiatrie und Psychosomatik
Zurich, Switzerland
RECRUITINGChange in psychological distress
Change in psychological distress will be measured with the Hopkins Symptom Checklist (HSCL-25). Items are rated on a scale from 1 to 4. Higher scores indicate more pronounced symptom severity.
Time frame: Baseline assessment, 3 month FU assessment (3 months after baseline)
Change in psychological distress
Change in psychological distress will be measured with the Hopkins Symptom Checklist (HSCL-25). Items are rated on a scale from 1 to 4. Higher scores indicate more pronounced symptom severity.
Time frame: 6 month FU assessment (6 months after baseline), 12 months FU assessment (12 months after baseline), 24 month FU assessment (24 months after b.), 36 months FU (36 months after b.)
Change in posttraumatic stress disorder symptoms
Change in posttraumatic stress disorder symptoms will be assessed using the 4-item short form of the PCL-5. Items are rated on a scale from 0 to 4 with higher scores indicating more pronounced symptom severity.
Time frame: Baseline assessment, 3 month FU assessment (3 months after baseline), 6 month FU assessment (6 months after baseline), 12 months FU assessment (12 months after b.), 24 month FU assessment (24 months after b.), 36 months FU (36 months after b.)
General psychological distress
General psychological distress will be measured with the Kessler Psychological Distress Scale (K10), a brief screening questionnaire assessing general psychological distress in the past 30 days. It consists of ten items (e.g., "During the last 30 days, about how often did you feel tired out for no good reason?") rated on a 5-point Likert scale (1 = "none of the time" to 5 = "all of the time"), before summation (range 10-50).
Time frame: Screening, 3 month FU assessment (3 months after baseline), 6 month FU assessment (6 months after baseline), 12 months FU assessment (12 months after baseline)
Somatic symptoms
Somatic symptoms will be assessed using the Somatic Symptom Scale (SSS-8). Items are rated on a scale from 0 to 4 with higher scores indicating higher symptom severity.
Time frame: Baseline assessment, 3 month FU assessment (3 months after baseline), 6 month FU assessment (6 months after baseline), 12 months FU assessment (12 months after b.), 24 month FU assessment (24 months after b.), 36 months FU (36 months after b.)
Reduction of post-migration stressors
Changes in post-migration stressors will be assessed using a 9-item version of the Post Migration Living Difficulties Checklist (PMLDC). Items are rated on a scale from 0 to 4 with lower scores representing fewer post-migration stressors.
Time frame: Baseline assessment, 3 month FU assessment (3 months after baseline), 6 month FU assessment (6 months after baseline), 12 months FU assessment (12 months after b.), 24 month FU assessment (24 months after b.), 36 months FU (36 months after b.)
Exposure to potentially traumatic events
Exposure to potentially traumatic events is indexed using a list of seven traumatic experiences. Overall trauma exposure is represented by a count of the number of traumatic event types (ranging from 0 to 7) experienced by each participant; higher scores indicate experience of more forms of traumatic events.
Time frame: Baseline assessment
Level of integration
Level of integration will be measured using the Immigration Policy Lab Integration Index (IPL-24).
Time frame: Baseline assessment, 6 month FU assessment (6 months after baseline), 12 months FU assessment (12 months after b.), 24 month FU assessment (24 months after b.), 36 months FU (36 months after b.)
Suicidal Ideation
Suicidal Ideation is measured using the Suicidal Ideation Attribution Scale (SIDAS), a brief measure of severity of suicidal ideation assessing frequency, controllability, closeness to attempt, level of distress associated with the thoughts and impact on daily functioning. It consists of five items rated on a 11-point scale (0 = "Never" to 10 = "Always").
Time frame: Screening, 6 month follow-up assessment (6 months after baseline), 36 month follow-up assessment (36 months after baseline)
Self-efficacy
Self-efficacy is assessed using a subscale of the Compound Psychological Capital Scale (CPS). This subscale consists of three items (e.g., "I can solve most problems if I invest the necessary effort") of the General Self-Efficacy Scale (GSE). Each item is rated on a 6-point Likert type scale ranging from 1 = "strongly disagree" to 6 = "strongly agree".
Time frame: Baseline assessment, 3 month FU assessment (3 months after baseline), 6 month FU assessment (6 months after baseline), 12 months FU assessment (12 months after baseline)
Prolonged Grief
Prolonged Grief will be assessed using a slightly adapted version of the Prolonged Grief Disorder Scale (PG-13). The items are rated on a scale from 1 to 5 with higher scores more pronounced symptom severity.
Time frame: Baseline assessment, 3 month FU assessment (3 months after baseline), 6 month FU assessment (6 months after baseline), 12 months FU assessment (12 months after baseline)
Assessing the extent to which the strategies taught in PM+ are used before and after the study participation with the Reducing Tension Checklist
The outcome is measured with a nine-item scale that was developed to assess the extent to which the participants perceives that they use the specific strategies, which are trained during the study intervention. The items are rated on a scale from 0 to 4. Higher scores represent greater usage of the strategies.
Time frame: Baseline assessment, 3 month FU assessment (3 months after baseline), 6 month FU assessment (6 months after baseline), 12 months FU assessment (12 months after baseline)
Anger
Anger will be assessed using the Dimensions of Anger Reactions Questionnaire (DAR-5). The 5 items are rated on scale from 1 to 5 with higher scores indicating worse symptomatology.
Time frame: Baseline assessment, 3 month FU assessment (3 months after baseline), 6 month FU assessment (6 months after baseline), 12 months FU assessment (12 months after baseline), 24 month FU assessment (24 months after b.), 36 months FU (36 months after b.)]
Time and risk preferences
Time and risk preferences are assessed using five questions of the Global Preference Survey (GPS), an experimentally validated survey measure. It consists of one self-assessment question (rated on a scale from 0 to 10 with higher scores indicating a greater preference) and a 4-item series of interdependent binary choices between immediate and delayed financial rewards, a format commonly referred to as a "staircase" procedure. In each of the binary choice question, participants must decide between receiving a payment today or a larger payment in twelve months (time preference) or between a sure choice and a lottery (risk preference).
Time frame: Baseline assessment, 3 month FU assessment (3 months after baseline)
Facial Expression
After responding to questions about positive / negative past and imagined future experiences, participants are asked to rate the emotionality of the experience they had during the speech on a 10-point scale (1 = not at all distressing, 10 = extremely distressing). Analyses will be conducted to calculate facial actions, acoustic quality, and speech content using the OpenDBM software.
Time frame: Baseline assessment, 3 month FU assessment (3 months after baseline)
Assessment of Coping Strategies
Participants will also be asked about current life stressors and how they cope with these stressors. Analyses will be conducted to calculate facial actions, acoustic quality, and speech content using the OpenDBM software.
Time frame: Baseline assessment, 3 month FU assessment (3 months after baseline)
Counterfactual Comparisons
To assess counterfactual comparisons regarding well-being, two items of the Comparison Standards Scale for Well-being (CSS-W) will be used. The two items of the CSS-W ask about frequency of well-being comparisons in the past three weeks on six-point Likert scales (0 = not at all to 5 = very often).
Time frame: Baseline assessment, 3 month FU assessment (3 months after baseline)
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