Clinical trial NCT04980326: A Scalable Psychological Intervention to Reduce Psychological Distress Among Healthcare Workers
Official title: A Scalable Low-intensity Psychological Intervention to Reduce Psychological Distress Among Healthcare Workers Involved in the First COVID-19 Outbreak in Spain: a Randomized Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Psychological Distress
Depression
Anxiety
Keywords: COVID-19
Healthcare workers
Psychological Distress
Depression
Anxiety
Problem Management Plus (PM+)
Doing What Matters (DWM)
Stepped-care
Lead sponsor: Instituto de Investigación Hospital Universitario La Paz
Sponsor class: OTHER
Collaborators: name: Universidad Autonoma de Madrid
name: Hospital Universitario La Paz
name: Parc Sanitari Sant Joan de Déu
name: Fundació Sant Joan de Déu
name: European Commission
name: VU University of Amsterdam
name: World Health Organization
First posted: 2021-07-28
Enrollment: 232
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Participants will be allocated to the experimental or the control arm with a 1:1 ratio. Participants in the experimental arm will first received the step 1 of the stepped-care program, namely the Doing What Matters self-guided program. If they still report significant levels of psychological distress, as measured by the K-10 scale, 1 week after DWM, they will be invited to step 2, an individual intervention namely Problem Management Plus (PM+). If they do not report significant levels of psychological distress, they will not receive further interventions, but will be asked to complete the remaining assessments.
Primary purpose: SUPPORTIVE_CARE

Brief summary: Rationale: The COVID-19 pandemic has impacted the mental health of healthcare workers (HCWs). 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 HCWs.

Objective: The main objective is to evaluate the implementation and (cost-)effectiveness of the culturally and contextually adapted DWM/PM+ stepped-care programs amongst health care workers during the COVID-19 pandemic in terms of mental distress, resilience, wellbeing, health inequalities, and costs to health systems.

Study design: Phase 2 (intervention study): pragmatic implementation trial with a single-blinded, randomized, parallel-group design. Phase 3: qualitative process evaluation consisting of individual interviews and focus group discussions (FGDs).

Study population: Study phase 2: Health care workers with self-reported elevated psychological distress. Study phase 3: study participants with different trajectories through the trial (completers, non-completers, drop-outs, etc.), family members/close persons of participants, professionals, and facilitators of the DWM and PM+ intervention.

Intervention- study phase 2: 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+) in addition to CAU. 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: Phase 2: Screening for in- and exclusion criteria will be interviewer-administered, in-person or through (video) calls. Online assessments will take place at baseline, at 2 weeks after having received DWM, at 1 week and at 2 months after having received PM+. The main study parameter will be the decrease in symptoms of anxiety and depression 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). Phase 3: Through FGDs and interviews at the end of the study, the feasibility of scaling-up the implementation on the stepped-care DWM/PM+ intervention.


Eligibility criteria: Inclusion criteria:

* 18 years or older;
* Living in Madrid or Barcelona
* Having elevated levels of psychological distress (Kessler Psychological Distress Scale (K10) \>15.9).
* Written/digital informed consent before entering the study.

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, not being on a stable dose during the past 2 months 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: Change: 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: Change: Baseline, 6 weeks, 12 weeks, and 20 weeks
measure: Client Service Receipt Inventory (CSRI) - RESPOND adaptation
timeFrame: Change: Baseline, 6 weeks, 12 weeks, and 20 weeks
measure: Stressor Reactivity
timeFrame: Change: Baseline, 6 weeks, 12 weeks, and 20 weeks
Other outcomes:
measure: Satisfaction with the intervention
timeFrame: 20 weeks
measure: Positive Appraisal Style
timeFrame: Change: Baseline, 6 weeks, 12 weeks, and 20 weeks
Locations:
city: Sant Boi De Llobregat
country: Spain
facility: Parc Sanitari Sant Joan de Déu
state: Barcelona
city: Madrid
country: Spain
facility: Hospital Universitario La Paz
Study officials:
affiliation: Universidad Autonoma de Madrid
name: José Luis Ayuso-Mateos, MD, PhD
role: STUDY_CHAIR
affiliation: Hospital Universitario La Paz
name: María Fe Bravo-Ortiz, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Parc Sanitari Sant Joan de Déu
name: Josep Maria Haro, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Mediavilla R, McGreevy KR, Felez-Nobrega M, Monistrol-Mula A, Bravo-Ortiz MF, Bayon C, Rodriguez-Vega B, Nicaise P, Delaire A, Sijbrandij M, Witteveen AB, Purgato M, Barbui C, Tedeschi F, Melchior M, van der Waerden J, McDaid D, Park AL, Kalisch R, Petri-Romao P, Underhill J, Bryant RA, Haro JM, Ayuso-Mateos JL; RESPOND Consortium. Effectiveness of a stepped-care programme of internet-based psychological interventions for healthcare workers with psychological distress: Study protocol for the RESPOND healthcare workers randomised controlled trial. Digit Health. 2022 Oct 5;8:20552076221129084. doi: 10.1177/20552076221129084. eCollection 2022 Jan-Dec.