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Background: The COVID-19 pandemic has impacted the mental health of workers of Assisted Living Facilities (ALFs). This study combines two low-intensity psychological interventions developed by the World Health Organization (Doing What Matters [DWM] and Problem Management Plus [PM+]) into a stepped-care program for workers of ALFs. Objective: To evaluate the implementation of an stepped-care program (DWM; PM+) amongst workers of ALFs during the COVID-19 pandemic in terms of mental distress, resilience and wellbeing. Study design: A randomized controlled implementation trial with an single-blinded, parallel-group design. Study population: Workers of ALFs with self-reported elevated psychological distress. Intervention-study: All participants (in both the treatment and the comparison group) will receive Psychological First Aid (PFA) and care as usual (CAU). In addition to PFA and CAU, the treatment group will receive the stepped-care intervention (DWM with or without PM+). The stepped-care intervention consists of DWM (step 1) and conditionally PM+ (step 2) if participants still meet criteria for psychological distress (Kessler Psychological Distress scale (K10) >15.9) 1 month after having received DWM. Main study parameters/endpoints: Screening for inclusion and exclusion criteria will be interviewer-administered through phone calls. All assessments will be online and will take place at baseline, 2 weeks after having received DWM, 1 week after having received PM+ and 2 months after PM+. The main study parameter will be the decrease of anxiety and depressive symptoms from baseline to two-month follow-up, 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).


Clinical Trial Description

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Study Design


Related Conditions & MeSH terms


NCT number NCT05526235
Study type Interventional
Source Fundació Sant Joan de Déu
Contact Mireia Felez-Nobrega, PhD
Phone 936406350
Email mireia.felez@sjd.es
Status Recruiting
Phase N/A
Start date September 27, 2022
Completion date September 2023

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