Ignite Creation Date:
2025-12-24 @ 10:09 PM
Ignite Modification Date:
2026-02-28 @ 11:20 AM
Study NCT ID:
NCT05526235
Status:
RECRUITING
Last Update Posted:
2024-04-26
First Post:
2022-07-21
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Scalable Psychological Intervention to Reduce Psychological Distress Among Workers of Assisted Living Facilities
Sponsor:
Fundació Sant Joan de Déu
Organization:
Study Overview
Official Title:
Reducing the Psychosocial Impact of the Covid-19 Pandemic on Workers of Assisted Living Facilities
Status:
RECRUITING
Status Verified Date:
2024-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
REPICAL
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).
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).
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: