NCT05526235

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

Reducing the Psychosocial Impact of the Covid-19 Pandemic on Workers of Assisted Living Facilities

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 150 (estimated)
• Sponsor: Fundació Sant Joan de Déu · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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).

Conditions

• Depression
• Anxiety
• Psychological Distress

Interventions

Type	Name	Description
BEHAVIORAL	Doing What Matters (DWM)	The original DWM program consists of a self-help guide called 'Doing What Matters in Times of Stress', that is complemented with pre-recorded audio exercises. The audio material imparts key information about stress management and guides participants through individual exercises. Additionally, participants are guided by a briefly trained helper. In this study, DWM will be delivered as an online intervention. The DWM intervention, i.e. both the audio recordings and the self-help guide, has been adapted for use on a smartphone or other device with internet access. The format of DWM is innovative in that it seeks to ensure that key intervention components are delivered as intended through the use of pre-recorded audio, without the burden of extensive training and supervision. In the online application tool a new module is released every week so participants will be asked to go through the entire DWM intervention within 5 weeks with weekly guidance from a helper.
BEHAVIORAL	Problem Management Plus (PM+)	PM+ is a new, brief, psychological intervention program based on cognitive behavioral therapy (CBT) techniques. The manual involves the following empirically supported elements: problem solving plus stress management, behavioral activation, facing fears, and accessing social support. Across the five 90-minute sessions participants may talk to trained non-professional. PM+ has four core features, and it is brief. In this study, the delivery mode of the PM+ intervention will be flexible, with remote delivery in phases of the pandemic when physical distancing rules apply. This is a future-oriented attempt towards a more holistic mental health care system that can flexibly switch between modes of delivery (e.g. remotely (e.g. Zoom) or face-to), depending on the needs and the specific containment measures that apply, and the specific preferences and needs of the participant.
BEHAVIORAL	Psychological First Aid (PFA)	PFA is a brief intervention consisting of a 15-min call that assess the immediate concerns and needs of an individual in order to connect individuals to help and resources.

Timeline

• Start date: 2022-09-27
• Primary completion: 2024-05-01
• Completion: 2024-09-01
• First posted: 2022-09-02
• Last updated: 2024-04-26

Locations

1 site across 1 country: Spain