A Scalable Psychological Intervention to Reduce Psychological Distress Among Workers of Assisted Living Facilities (REPICAL)

Fundació Sant Joan de Déu

Status: Enrolling

Conditions: Depression; Anxiety; Psychological Distress

Treatments: Behavioral: Psychological First Aid (PFA); Behavioral: Doing What Matters (DWM); Behavioral: Problem Management Plus (PM+)

Study type: Interventional

Funder types: Other

Identifiers

NCT05526235

202114

Details and patient eligibility

About

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.

Full 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).

Enrollment: 150 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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150 participants in 2 patient groups

Stepped-care program (Step 1: DWM; Step 2: PM+)

Experimental group

Description:

The treatment group will first receive Psychological First Aid (PFA). PFA consists of a 15-min call that assess the immediate concerns and needs of an individual in order to connect individuals to help and resources. Afterwards participants will receive the stepped-care program consisting of Doing What Matters (DWM) (step 1) and Problem Management Plus (PM+) (step 2). Step 2 will only be provided if the participant still has elevated levels of psychological distress (i.e. during the second quantitative assessment at 2 weeks after DWM). Participants will also be allowed to continue with their mental health interventions (CAU), as long as they meet eligibility criteria. Interventions: Behavioral: Doing What Matters (DWM) Behavioral: Problem Management Plus (PM+) Behavioral: Psychological First Aid (PFA)

Treatment:

Behavioral: Problem Management Plus (PM+)

Behavioral: Doing What Matters (DWM)

Behavioral: Psychological First Aid (PFA)

Psychological First Aid (PFA)

Active Comparator group

Description:

Participants allocated to the control arm will also receive PFA. Participants will also be allowed to continue with their mental health interventions (CAU), as long as they meet eligibility criteria. Intervention: Behavioral: Psychological First Aid (PFA)

Treatment:

Behavioral: Psychological First Aid (PFA)