Trial design
The present study is designed as a prospective, single-center, assessor-masked, individually randomized, two-group superiority trial. It will compare a 6-session transdiagnostic, low-intensity manualized psychological treatment to a TAU. The treatment group will receive TAU and adapted PM+, the control group will receive TAU only. Both groups will be recruited from a professional mental health treatment wait list . The trail design is depicted in the Consolidated Standards of Reporting Trials (CONSORT) flow chart in Fig.1 (39) and the Standard Protocol Items: Recommendations for Interventional Trials (SPIRIT) participant timeline is shown in Table 1, and the SPIRIT checklist (40) is provided as supplementary material.
Study Setting
The trial setting is the Outpatient Unit for Research, Teaching, and Practice, Faculty of Psychology, University of Vienna. All assessments, in-depth interviews, and treatment sessions will take place in a separate room and only the participant, the psychologist, and the interpreter will be present in the room.
Participants
The study will include help-seeking, Dari-speaking adult Afghan asylum seekers or refugees who fulfil the following inclusion criteria: (a) being on a wait-list for professional mental health treatment in a specialized facility and (b) positive screening on a screening questionnaire for common mental disorders in refugees: a score of 12 or higher on the RHS-15 or a score of 5 or higher on the distress scale of the RHS-15.
Exclusion criteria are: (a) presenting with a current condition requiring other treatment (acute suicidality, severe mental disorder such as psychotic disorders or substance dependence), (b) severe cognitive impairment (e.g. moderate to severe intellectual disability or dementia), based on definitions in the mhGAP Intervention Guide (41), or (c) current trauma-focused treatment.
TIMEPOINT
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-t0
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t1
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t2
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-1 week
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-1 week
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7 weeks
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6 months
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Enrollment
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|
|
|
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Eligibility screening
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X
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|
|
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Informed consent
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X
|
|
|
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Allocation
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|
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X
|
|
|
Interventions
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|
|
|
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Adapted PM+
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|
|
|
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TAU
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|
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|
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Assessments
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|
|
|
|
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Screening for eligibility
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|
|
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Refugee Health Screener (RHS-15)
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X
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|
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Demographic characteristics
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X
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|
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Demographic questions
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X
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Harvard Trauma Questionnaire – Checklist (HTQ)
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X
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Primary endpoint
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General Health Questionnaire-28 (GHQ-28)
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X
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X
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X
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Secondary endpoints
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Post-Migration Living Difficulties Checklist (PMLDC)
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X
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X
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X
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International Trauma Questionnaire (ITQ)
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X
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X
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X
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WHO Quality of Life Questionnaire (WHOQOL-BREF)
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X
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X
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X
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Psychological Outcome Profile (PSYCHLOPS)
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X
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X
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X
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Service and health care use
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X
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X
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X
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Immigrant Integration Index (IPL-12)
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X
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X
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X
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Table 1. Participant timeline for the Standard Protocol Items: Recommendation for Interventional Trials (SPIRIT)
Intervention
The current study uses an adapted version of PM+ in the intervention arm. PM+ (30) is a transdiagnostic, low-intensity psychological treatment for common mental disorders (e.g. depression, anxiety, and stress). It was developed by the WHO as part of its mhGAP Program (42). PM+ was developed to help adults impaired by distress in communities who are exposed to adversity, whether or not exposure to adversity has caused their problems (30). The original PM+ manual comprises four core therapeutic strategies that were chosen based on a strong evidence base and following review by international experts (31). These four core strategies are: “Managing Stress”, “Managing Problems”, “Get Going, Keep Doing”, and “Strengthening Social Support”. Our modification of the treatment protocol includes an additional sixth session, focusing on either anger-regulation or self-efficacy. This extra session is based on the specific needs of treatment-seeking refugees. It was developed by the research team in the initial phase of the study and includes the results from our preliminary study interviewing experts in the field. Participants will decide during the course of the treatment whether they prefer a session on anger-regulation or on self-efficacy, depending on their subjective needs. According to the Austrian law, only medical doctors and mental health specialists (clinical psychologists, psychotherapists) have official approval to treat people with mental disorders. Consequently, the treatment will be implemented by clinical psychologists who have a legal treatment allowance in Austria. Participants have six weekly face-to-face appointments (five from the original protocol and one developed as part of this study); the duration of these sessions is 90 minutes. The sessions will be facilitated with interpreters. The psychologists will be specifically trained by PM+ master trainers. Regular supervision will guarantee therapist adherence to the protocol. Treatment fidelity will be scored using the PM+ Helper´s Self-rating Fidelity Checklist. The checklist records delivery of the intervention, psychosocial communication, and safety management skills. The treatment group will receive TAU and adapted PM+.
Control condition
This study uses a control arm to control for possible spontaneous remission and other uncontrolled factors. The control arm will be assessed at the same time points as the treatment arm but will not receive any treatment by the research team. During the period between pre-assessment and follow-up assessment, participants from this arm will receive TAU in their daily living conditions. We expect that the control arm in this study will receive treatments that are commonly implemented in the Austrian medical settings, this includes any contact to medical and mental health professionals or pharmacological therapy; receiving psychopharmacological or psychological treatment is considered as TAU and does not preclude a person from the control arm.
Outcome measures
Primary outcome
The primary outcome is the general health assessed with the General Health Quenstionnaire-28 (GHQ-28; 43), which is a 28-items self-report questionnaire assessing somatic symptoms, anxiety and insomnia, social dysfunction, and severe depression. The GHQ-28 is widely used in research across different cultural settings and has good psychometric properties (44). The GHQ-28 will be assessed by investigators blind to treatment allocation at baseline, 7-week follow-up, and at the 6-month follow-up. We will use the German and Dari versions of the questionnaire.
Secondary outcomes
We will also use several secondary endpoints: An adapted Version of the Post-Migration Living Difficulties Checklist (PMLDC; 44), the International Trauma Questionnaire (ITQ; 46), the WHO Quality of Life Questionnaire (WHOQOL-BREF; 45), the Psychological Outcome Profile (PSYCHLOPS; 47) and the Immigrant Integration Index (IPL-12).
The PMLDC is a self-evaluated checklist used to assess the frequency of recent adverse life experiences typical of migration (5). The checklist was adapted to the study population. The final version include 26 items measured on a 5-point Likert scale. In addition, the associated degree of distress is assessed on a 10-pont Likert scale. The ITQ is an instrument designed to assess ICD-11 PTSD and Complex PTSD. The ITQ includes six items for PTSD, six items for Complex PTSD, and two times three items for functional impairment by symptoms of PTSD and Complex PTSD (48). The ITQ has shown good psychometric properties in initial validations (49). The WHOQOL-BREF is a cross-culturally comparable instrument to assess the quality of life. It consists of 26 items measured on a 5-point Likert scale. It is divided into four domains: physical health, psychological health, social relationships, and environment. The PSYCHLOPS promotes a patient-centered definition of therapy outcome and contains questions on problems, function, and well-being. Participants are asked to describe their main problem or problems and how they affect them (function) with five questions. The Immigration Integration Index, short version (IPL-12; 45) is a pragmatic and multidimensional measure of immigrant integration. It consists 12 items and captures six dimensions of integration: psychological, social, economic, political, linguistic, and navigational. We are using the available Dari and German versions and translating the remaining Questionnaires.
Additional measures
Traumatic experiences will be assess with an adapted version of the Trauma Checklist of the Harvard Trauma Questionnaire (51), Dari and German version. The Service Use Questionnaire (CSRI) is used to collect data about the health care contacts.
Sample size
Studies using the original PM+ manual so far have found small to large effects compared to TAU at six months post-treatment. Assuming an α error probability of .05 and a power (1-β error probability) of .80, we need a total sample size of 90 persons (45 persons per group) when testing for a medium effect (f = 0.3). We chose the more conservative approach and assumed only small effects of the treatment and thus aim to include 90 persons in the analysis. We expect a dropout rate of 25%. Taking this into account, we aim to include a total of N = 120 participants in our study that will be randomly assigned to either the intervention arm (n = 60) or the TAU arm (n = 60). A subgroup of the intervention arm (n = 20) will be invited for in-depth interviews.
Recruitment
We will collaborate with NGOs and outpatient treatment centres in Vienna, Austria, that provide psychological and psychiatric help for treatment-seeking asylum seekers and refugees. These partners have agreed to inform help-seeking Afghan asylum seekers and refugees about our study as part of their initial contact with them giving them our contact information. Participants´ travel costs will be refunded for each assessment and treatment session. Each participant will receive monetary compensation for their involvement (€10; handed out at the 6-months follow-up assessment). As all participants are on a waiting list for professional mental health treatment, it is possible that some might receive treatment during the period of their study participation, i.e. before their 6-month follow up assessment. As this is considered as part of their usual treatment, we do not exclude participants if they receive additional treatment; however, based on the average waiting time of more than a year, we do not expect this in many cases. Information regarding received medical attention and mental health treatment will be gathered during follow-up assessments for both groups.
Group allocation and blinding
The allocation ratio will be 1:1 with 60 participants per group (total N = 120). Participants will be randomized to either one group with random allocation software after the baseline assessment. The random numbers will be generated by an assistant who will not be involved in the assessments nor in the treatment. The participants will be informed after the baseline assessment. The study will be conducted assessor-blind, i.e. the psychologist conducting the baseline and follow-up assessments will be masked with regard to the allocated treatment arm (adapted PM+ vs. TAU).
Data collection and data management
Self-report questionnaires will be offered in Dari and German and will be completed in a face-to-face fully-structured interview with a trained psychologist and an interpreter. All instruments will be delivered in interview format because some participants are expected to be illiterate. The assessment will take approximately 90 minutes per time point (baseline, 7-week follow-up, 6-month follow-up), i.e. three times 90 minutes in total for each participant. The in-depth interviews will be conducted by a trained psychologist and an interpreter. They will take approximately 60 minutes and will be audio-recorded.
Computer assisted data assessment will reduce possible data entry errors and increase data quality. All identifying information will be recorded with a participant number to secure participant privacy, and personal identity-related information will be entered into the electronic database containing the assessment information. The key connecting the participant numbers and names (as well as contact and tracking information) will be kept in a separate data file. The electronic files will be saved to an encrypted hard drive with a password lock. Only members of the research team will have access to the respective files. All other papers with identifying information (i.e., signed informed consent forms) will be stored in a separate locked cabinet.
Statistical analyses
Firstly, we will compare baseline scores between the treatment group and TAU group on all primary and secondary outcome measurements, using Chi-squared tests and 2-sample t-tests, for categorical and continuous variables, respectively. In order to estimate significant changes over time as a result of the intervention for all primary and secondary outcome measures, we will employ hierarchical linear modelling (HLM). Analyses will be based on an intent-to-treat population, where critically, HLM allows the number of observations to vary between participants and effectively handles missing data by calculating estimates of trajectories using maximum likelihood estimation. Time (linear and quadratic), treatment condition, and their interaction will be included in the models, where we will also examine how covariate factors such as age, biological sex, education level, and asylum status explain variance within the data. Here, similar models will be employed for the primary and secondary outcome measures, where we will conservatively correct for multiple comparisons where appropriate. Specifically, the Level 1 model will characterize within-patient change over time, and the Level 2 model will predict variation of within-patient change over time and between-patient variables.
We will also examine if treatment success can be predicted from baseline clinical measures and individual differences using machine learning methods, including non-linear random forest regressions and linear ordinary least squares model with lasso regularization (OLS-LASSO).
Regarding qualitative data, interviews of the sub-sample will be transcribed verbatim and will be analyzed using thematic analysis (46). The thematic analysis approach is a method for identifying, analyzing, and reporting themes within data. The in-depth interviews will be analyzed independently by two researchers and interrater-reliability will be calculated. The results from the interviews following the online training tool will be analyzed with the same methodological approach.
Data monitoring
All serious adverse events (SAEs) that are reported spontaneously by the participants or observed by the investigators during the trial will be recorded by the research team and will be reported to the independent advisory board (47). The chair of the advisory board will review SAEs within 72 hours and the research team will review all AEs regularly, where necessary respond appropriately. The consent process includes informing participants about whom they can contact if they experience adverse reactions (i.e., Kriseninterventionszentrum Wien [Crisis intervention centre Vienna]). Depending on the nature of the adverse event, follow-up may require additional tests or medical procedures as indicated, and/or referral to a general physician or medical specialist. All adverse events will be followed until specialist care (including referrals, additional tests or medical procedures) is in place for the client, or until a stable situation has been reached.