Clinical trial NCT05526235: A Scalable Psychological Intervention to Reduce Psychological Distress Among Workers of Assisted Living Facilities
Official title: Reducing the Psychosocial Impact of the Covid-19 Pandemic on Workers of Assisted Living Facilities
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Depression
Anxiety
Psychological Distress
Lead sponsor: Fundació Sant Joan de Déu
Sponsor class: OTHER
Collaborators: name: VU University of Amsterdam
name: Universidad Autonoma de Madrid
First posted: 2022-09-02
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: The current study is a randomized controlled trial (RCT) that aims to evaluate the effectiveness of a stepped-care program (Doing What Matters \[DWM\] and Problem Management Plus \[PM+\]) in reducing anxiety and depression symptoms amongst long-term care workers (LTCWs), following changes in care due to the COVID-19 pandemic.

Detailed description: Background: The COVID-19 pandemic has impacted the mental health of long-term care workers (LTCWs). 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 LTCWs.

Objective: To evaluate the implementation of a stepped-care program (DWM; PM+) amongst LTCWs following changes in care due to the COVID-19 pandemic in terms of mental distress, resilience and wellbeing.

Study design: A randomized controlled implementation trial with a single-blinded, parallel-group design.

Study population: Long-term care workers (including workers of assisted living facilities and home care) 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).

Eligibility criteria: Inclusion Criteria:

* 18 years or older;
* Having elevated levels of psychological distress (Kessler Psychological Distress Scale (K10) \>15.9).
* Written/digital informed consent before entering the study.
* Being a worker in a long-term care facility or a home care worker in the community of Catalonia.

Exclusion Criteria:

* Having acute medical conditions (requiring hospitalization)
* 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 specialized psychological treatment (e.g., Eye movement desensitization and reprocessing, Cognitive behavioral therapy)
* In case of current psychotropic medication use, being on an unstable dose for at least 2 months.

Primary outcomes:
measure: Patient Health Questionnaire Anxiety and Depression Scale (PHQ-ADS)
timeFrame: Change from baseline to 20 weeks
Secondary outcomes:
measure: Patient Health Questionnaire Anxiety and Depression Scale (PHQ-ADS)
timeFrame: Change: Baseline, 6 weeks, and 12 weeks
measure: Patient Health Questionnaire (PHQ-9)
timeFrame: Baseline, 6 weeks, 12 weeks, and 20 weeks
measure: Generalized Anxiety Disorder (GAD-7) scale
timeFrame: Change: Baseline, 6 weeks, 12 weeks, and 20 weeks
measure: Posttraumatic Stress Disorder (PTSD) Checklist for Diagnostic and Statistical Manual of Mental Disorders (DSM-5) (PCL-5) - 8-item version
timeFrame: Change: Baseline, 6 weeks, 12 weeks, and 20 weeks
measure: EuroQol 5-dimensional descriptive system - 5-level version (EQ-5D-5L)
timeFrame: Baseline, 6 weeks, 12 weeks, and 20 weeks
measure: Client Service Receipt Inventory (CSRI) - adaptation
timeFrame: Change: Baseline, 6 weeks, 12 weeks, and 20 weeks
Other outcomes:
Locations:
city: Sant Boi de Llobregat
country: Spain
facility: Parc Sanitari Sant Joan de Déu
state: Barcelona
Study officials:
affiliation: Fundació Sant Joan de Déu
name: Josep Maria Haro, MD,PhD
role: PRINCIPAL_INVESTIGATOR
References: