An interventional study of Problem Management Plus in Distress, PTSD and Anxiety, sponsored by University of Zurich. Completed at 1 site in Switzerland. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2021-02-08.
Sponsored by University of Zurich · Not applicable, Interventional, and Treatment
The current refugee crisis across the Middle East and Europe has large effects on individual refugees' psychological well-being, as well as on the healthcare systems of countries hosting refugees. For example, in Switzerland patients sometimes have to wait up to 12 months for the specific psychological treatment due to a lack of specialists. To address this problem the WHO has developed Problem Management Plus (PM+), a brief (five sessions), low-intensity psychological intervention, delivered by paraprofessionals, that addresses common mental disorders in people in communities affected by adversity. The feasibility of PM+ has never been examined in Switzerland before, this is the aim of the current pilot study.
Recent crises in the Middle East, most notably in Syria, have resulted in an unprecedented increase in the worldwide number of refugees and asylum seekers. Switzerland (CH) is strongly affected by this crisis too. Eight percent of asylum requests in 2016 were made by people from Syria (2015: 12 %). More than 7'000 asylum seekers from Syria entered CH over the last two years. Due to the ongoing war in this region, it is unlikely that this kind of migration and flight will stop. Notably, 50% of the refugee population are children and adolescents.
Refugees have typically been exposed to multiple stressors related to war and displacement including loss of family members, destruction of homes and livelihoods and human rights violations such as sexual violence or torture. They have often undertaken a risky and stressful flight leaving their homes for an unknown future. Accordingly, studies consistently show that refugees are at considerable risk of developing common mental disorders, including depression, anxiety, posttraumatic stress disorder (PTSD) and related somatic health symptoms. Recent WHO projections suggest that approximately 15-20% of Syrian refugees will develop some type of mental health problem and therefore represent an enormous public mental health challenge.
According to the UNHCR, 86% of all displaced persons remain in conflict or neighboring countries where appropriate health care is mostly not available. But also Western health systems are often unable to appropriately cover the needs of this particularly vulnerable population regarding prevention and treatment of mental health problems. As a response to this situation, the WHO developed the low-intensity Problem Management Plus (PM+) programs, a new generation of shorter, less expensive and trans-diagnostic (i.e., not specifically aimed at treating a certain mental disorder) programs to reduce common mental health symptoms and improve psychosocial functioning. PM+ is based on the WHO treatment guidelines for conditions related to stress. PM+ is a 5-sessions intervention aimed at reducing symptoms of depression, anxiety, PTSD, and related conditions, is delivered by trained non-specialized workers or lay people, and is available in individual and group delivery formats for both children and adults. It comprises evidence-based techniques of (a) problem solving, (b) stress management, (c) behavioral activation, and (d) accessing social support. PM+ has been successfully implemented in Kenya and Pakistan.
The STRENGTHS (Syrian REfuGees MeNTal HealTH Care Systems) study aims at evaluating the effectiveness and implementation of PM+ with Syrian refugees in different settings in low- and high-resource countries. The study consortium includes international experts in the domains of trauma and public mental health as well as representatives of WHO and UNHCR. The Zürich study site has been consigned to examine PM+ with adult refugees in an individual treatment setting in Switzerland. At the same time, similar studies in other countries will be undertaken. Despite the objective of these studies to implement and evaluate the effectiveness of PM+ in refugees, each research institution acts independently. Moreover, the other studies will be completed in different treatment settings - i.e., in children and adolescents (Lebanon), in groups (Turkey and Netherlands), and internet-delivered PM+ (Germany and Egypt).
To date, the feasibility of PM+ has not been investigated in a highly industrialized country, such as Switzerland.
In the present study, the investigators will evaluate the feasibility of PM+ in Syrian refugees in Switzerland.
This research entails single-blind randomized controlled trial.
The amendment was secured by December 2018. Trainers, assessors, supervisors and helpers are already identified, recruited an trained.
After the approval, the first participants will be identified, invited to screening and if they fulfill the criteria they will be invited to participate in the pilot study. The pilot study will end by the end of 2019. After the pilot study the results will be evaluated, analyzed and integrated in the planning of the definitive randomized controlled trial (RCT) (next study, not the part of current registration).
8,057 studies on the registry are indexed under Depression; 1,641 are open to participants now.
This study's enrollment of 59 is below the median of 84 across 6,720 interventional studies indexed under Depression.
Browse Depression studies →University of Zurich is the lead sponsor of 1,030 studies on the registry; 130 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
The control group will receive enhanced treatment as usual (ETAU). ETAU means that the research team will advise the participants to contact their doctor in case of physical or mental health problems. Moreover, the research team will hand over the list with the general practitioners (GP) in the neighborhood of the participant and the written information (official booklet) about the operating of the Swiss health care system. Adequate treatment will be provided by this physician, usually, a general practitioner who acts as a gate-keeper (an asylum seeker or refugee has to go first to his/her assigned GP in order to get access to the health care system).
PM+ is a new, brief, psychological intervention program based on Cognitive Behaviour Therapy (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.
Behavioral: Problem Management Plus
PM+ is a new, 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.
Verification procedure to the measurement in psychological distress at baseline assessment
measured by the Hopkins Symptom Checklist (HSCL-25)
Time frame: baseline assessment (before PM+)
Verification procedure to the measurement in psychological distress after PM+ intervention or ETAU
measured by the Hopkins Symptom Checklist (HSCL-25)
Time frame: post-assessment baseline (after PM+/ETAU)
Verification procedure to the measurement in psychological distress 3 months after PM+ intervention or ETAU
measured by the Hopkins Symptom Checklist (HSCL-25)
Time frame: 3-months follow-up (after PM+/ETAU)
Verification procedure to the measurement of symptoms of posttraumatic stress disorder at baseline assessment
measured using the PTSD Checklist for Diagnostic and Statistical Manual of Mental Disorders (DSM-5) (PCL-5)
Time frame: baseline assessment (before PM+)
Verification procedure to the measurement of symptoms of posttraumatic stress disorder after PM+ intervention or ETAU
measured using the PTSD Checklist for Diagnostic and Statistical Manual of Mental Disorders (DSM-5) (PCL-5)
Time frame: post-assessment baseline (after PM+/ETAU)
Verification procedure to the measurement of symptoms of posttraumatic stress disorder 3 months after PM+ intervention or ETAU
measured using the PTSD Checklist for Diagnostic and Statistical Manual of Mental Disorders (DSM-5) (PCL-5)
Time frame: 3-months follow-up (after PM+/ETAU)
Verification procedure to the measurement of functional disability at screening
assessed by the WHODAS 2.0 (WHO Disability Assessment Schedule 2.0)
Time frame: screening (before PM+)
Verification procedure to the measurement of functional disability after PM+ intervention or ETAU
assessed by the WHODAS 2.0 (WHO Disability Assessment Schedule 2.0)
Time frame: post-assessment baseline (after PM+/ETAU)
Verification procedure to the measurement of functional disability 3 months after PM+ intervention or ETAU
assessed by the WHODAS 2.0 (WHO Disability Assessment Schedule 2.0)
Time frame: 3-months follow-up (after PM+/ETAU)
Feasibility of PM+ by the number of dropouts
Monitoring of the dropouts by number of patients
Time frame: screening (before PM+)
Feasibility of PM+ by the number of dropouts
Monitoring of the dropouts by number of patients
Time frame: baseline assessment (before PM+)
Feasibility of PM+ by the number of dropouts
Monitoring of the dropouts by number of patients
Time frame: post-assessment baseline (after PM+/ETAU)
Feasibility of PM+ by the number of dropouts
Monitoring of the dropouts by number of patients
Time frame: 3-months follow-up (after PM+/ETAU)
Feasibility of PM+ by feedbacks regarding the understanding of intervention and measurements instruments
Monitoring of wrong understanding or wrong translation (by number of patients and the scope of the feedback)
Time frame: screening (before PM+)
Feasibility of PM+ by feedbacks regarding the understanding of intervention and measurements instruments
Monitoring of wrong understanding or wrong translation (by number of patients and the scope of the feedback)
Time frame: baseline assessment (before PM+)
Feasibility of PM+ by feedbacks regarding the understanding of intervention and measurements instruments
Monitoring of wrong understanding or wrong translation (by number of patients and the scope of the feedback)
Time frame: post-assessment baseline (after PM+/ETAU)
Feasibility of PM+ by feedbacks regarding the understanding of intervention and measurements instruments
Monitoring of wrong understanding or wrong translation (by number of patients and the scope of the feedback)
Time frame: 3-months follow-up (after PM+/ETAU)
Verification procedure to the measurement of change in response to therapy at baseline
patient-generated outcome measure by the Psychological Outcomes Profiles (PSYCHLOPS) scale \[PSYCHLOPS has questions on Problems, Function and Wellbeing. Participants are asked to describe their main Problem or Problems and how this affects them (Function). Responses to all questions are scored \[likert-scale 0 to 5 from "severely affected" to "not at all affected"); it is a highly sensitive measure of change during the course of psychotherapeutic interventions.\]
Time frame: baseline assessment (before PM+)
Verification procedure to the measurement of change in response to therapy at post-assessment
patient-generated outcome measure by the Psychological Outcomes Profiles (PSYCHLOPS) scale \[PSYCHLOPS has questions on Problems, Function and Wellbeing. Participants are asked to describe their main Problem or Problems and how this affects them (Function). Responses to all questions are scored \[likert-scale 0 to 5 from "severely affected" to "not at all affected"); it is a highly sensitive measure of change during the course of psychotherapeutic interventions.\]
Time frame: post-assessment baseline (after PM+/ETAU)
Verification procedure to the measurement of change in response to therapy 3 months after
patient-generated outcome measure by the Psychological Outcomes Profiles (PSYCHLOPS) scale \[PSYCHLOPS has questions on Problems, Function and Wellbeing. Participants are asked to describe their main Problem or Problems and how this affects them (Function). Responses to all questions are scored \[likert-scale 0 to 5 from "severely affected" to "not at all affected"); it is a highly sensitive measure of change during the course of psychotherapeutic interventions.\]
Time frame: 3-months follow-up (after PM+/ETAU)
Post-migration stressors at baseline
will be assessed using a version of the Post-Migration Living Difficulties Checklist (PMLDC)
Time frame: baseline assessment (before PM+)
Post-migration stressors at post-assessment
will be assessed using a version of the Post-Migration Living Difficulties Checklist (PMLDC)
Time frame: post-assessment baseline (after PM+/ETAU)
Post-migration stressors 3 months after
will be assessed using a version of the Post-Migration Living Difficulties Checklist (PMLDC)
Time frame: 3-months follow-up (after PM+/ETAU)
Previous exposure to traumatic events
assessed using the Traumatic Events (TE) - a combination of two standardized questionnaires, namely the Life Events Checklist (LEC) (Weathers et al., 2013) and the Harvard Trauma Questionnaire (HTQ) (Mollica et al., 1992). HTQ consists of 3 sections with 48 questions. LEC consists of 17 question. Single questions from HTQ (Section 1) and LEC are summarized to the sequence of 27 questions (about experienced trauma or adversities with yes/no answer format). The number of positive answers is the outcome value.
Time frame: baseline
Access to Health Care Services (AHCS)
The set of question regarding previous contact with the mental health care services and the previous experiences regarding the utilization of any forms of mental support
Time frame: baseline assessment (before PM+)
Medical service utilization of people with mental disorders at baseline
accessed using the Client Service Receipt Inventory (CSRI) as the basis for calculating the costs of care for mental health cost-effectiveness research
Time frame: baseline assessment (before PM+)
Medical service utilization of people with mental disorders at post-assessment
accessed using the Client Service Receipt Inventory (CSRI) as the basis for calculating the costs of care for mental health cost-effectiveness research
Time frame: post-assessment baseline (after PM+/ETAU)
Medical service utilization of people with mental disorders at post-assessment 3 months after
accessed using the Client Service Receipt Inventory (CSRI) as the basis for calculating the costs of care for mental health cost-effectiveness research
Time frame: 3-months follow-up (after PM+/ETAU)
Plan to share: Undecided
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University of Zurich