psychological symptoms of anxiety, depression and (posttraumatic) stress anxiety depression distress Psychological symptoms
Conditions
Interventions
Participants will be randomized into a treatment and a comparison group.
- All participants (in both the treatment and comparison groups) will receive
Psychological First Aid (PFA) and CAU.
- In ad
Sponsors
Vrije Universiteit
Eligibility
Age
18 Years to 64 Years
Inclusion criteria
Inclusion criteria: Participants will be eligible to participate in the study (phase 2 (and 3)) if they meet all of the following criteria: - 18 years or older; - Living in the Netherlands as labour migrant - Having elevated levels of psychological distress (Kessler Psychological Distress Scale (K10) >15.9). - Sufficient mastery (written and spoken) of one of the languages the DWM/PM+ intervention is being delivered in (e.g. English, Polish, Romanian). - Having access to an electronic device with internet access and webcam to follow the intervention - Oral and written informed consent before entering the study.
Exclusion criteria
Exclusion criteria: Potential participants who meet the inclusion criteria will be excluded from participation in this study (phase 2 (and 3)) if they meet any of the following criteria: - Planning to move abroad, e.g. back to their home country or to another country, before the last quantitative assessment at 2 months after PM+; - Having acute medical conditions (requiring hospitalisation); - Imminent suicide risk, or expressed acute needs or protection risks that require immediate follow-up; - Having a severe mental disorder (e.g. psychotic disorders, substance-dependence); - Having severe cognitive impairment (e.g. severe intellectual disability or dementia); - Currently receiving specialised psychological treatment (e.g. EMDR, CBT); - In case of current psychotropic medication use: being on an unstable dose for at least 2 months.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Study Phase 2: The primary outcome will be the decrease in symptoms of anxiety and depression from baseline to two-month follow-up (week 20), measured through the sum score of the Patient Health Questionnaire (PHQ-9) and General Anxiety Disorder-7 (GAD-7), i.e. the PHQ-Anxiety and Depression Score (PHQ-ADS). We expect to detect a Cohen*s d effect size of 0.3 in the PM+ group at 2 months post-treatment (week 20). | — |
Secondary
| Measure | Time frame |
|---|---|
| Study phase 2: Secundary outcomes include level of anxiety (GAD-7) and depression (PHQ-9), symptoms of posttraumatic stress disorder (PCL-5), resilience (Mainz Inventory of MIcrostressors, MIMIS, Positive Appraisal Style Scale - content focused, PASSc), quality of life (EQ-5D-5L), and costs of care (CSRI). Additional study parameters will include demographic data, traumatic and COVID-19 related (exposure) variables (Brief Trauma Questionnaire, BTQ), hair biomarkers (cortisol concentrations (HCC), cortisone, dehydroepiandrosterone (sulfate) (DHEA(S)), progesterone, and testosterone concentrations), digital markers, treatment fidelity, satisfaction and acceptability of the intervention program, and implementation indicators (such as reach, dose, resource use, intervention implementation related costs). Study phase 3: Through FGDs and interviews at the end of the study, the feasibility of scaling-up the implementation on the stepped-care DWM/PM+ intervention within the Netherlands will be examined. | — |
Countries
Netherlands
Outcome results
None listed