A Scalable Psychological Intervention to Reduce Psychological Distress Among Healthcare Workers

NCT04980326 | Completed

• 1 other identifier: RESPOND WP4 RCT
• Study Type: interventional
• Target: 232
• Locations: 1 country
• Sites: 2

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.

Conditions

Psychological Distress; Depression; Anxiety

Keywords

COVID-19; Healthcare workers; Psychological Distress; Depression; Anxiety; Problem Management Plus (PM+); Doing What Matters (DWM); Stepped-care

Outcome Measures

Primary Outcomes (1)

• Patient Health Questionnaire Anxiety and Depression Scale (PHQ-ADS)

  The PHQ-ADS is a 16-item self-reported instrument that combines the nine-item Patient Health Questionnaire depression scale and seven-item Generalized Anxiety Disorder scale-as a composite measure of depression and anxiety. Respondents are asked how much each symptom has bothered them over the past 2 weeks, with response options of "not at all", "several days", "more than half the days", and "nearly every day", scored as 0, 1, 2, and 3. The scale can range from 0 to 48, with higher scores indicating higher levels of depression and anxiety symptomatology.

  Change from baseline to 20 weeks

Secondary Outcomes (7)

• Patient Health Questionnaire Anxiety and Depression Scale (PHQ-ADS)

  Change: Baseline, 6 weeks, and 12 weeks

• Patient Health Questionnaire (PHQ-9)

  Change: Baseline, 6 weeks, 12 weeks, and 20 weeks

• Generalized Anxiety Disorder (GAD-7) scale

  Change: Baseline, 6 weeks, 12 weeks, and 20 weeks

• Posttraumatic Stress Disorder (PTSD) Checklist for Diagnostic and Statistical Manual of Mental Disorders (DSM-5) (PCL-5) - 8-item version

  Change: Baseline, 6 weeks, 12 weeks, and 20 weeks

• EuroQol 5-dimensional descriptive system - 5-level version (EQ-5D-5L)

  Change: Baseline, 6 weeks, 12 weeks, and 20 weeks

Other Outcomes (2)

• Satisfaction with the intervention

  20 weeks

• Positive Appraisal Style

  Change: Baseline, 6 weeks, 12 weeks, and 20 weeks

Study Arms (2)

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

EXPERIMENTAL

The treatment group will receive the stepped-care program consisting of Doing What Matters (DWM) (step 1) and Problem Management Plus (PM+) (step 2) in addition to Psychological First Aid (PFA) and care-as-usual (CAU). Step 2 will only be provided if the participant still has elevated levels of psychological distress at 2 weeks after DWM, i.e. during the second quantitative assessment at 2 weeks after DWM. Participants allocated to the experimental arm will also receive training in PFA, which consists of a 30-min call that covers basic aspects about peer support in times of stress. Participants will also be allowed to continue with their mental health interventions (CAU), as long as they meet eligibility criteria.

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

Psychological First Aid (PFA)

ACTIVE COMPARATOR

Participants allocated to the control arm will also receive training in PFA, which consists of a 30-min call that covers basic aspects about peer support in times of stress. Participants will also be allowed to continue with their mental health interventions (CAU), as long as they meet eligibility criteria.

Behavioral: Psychological First Aid (PFA)

Interventions

Doing What Matters (DWM) BEHAVIORAL

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, will be adapted for use on a smartphone or other device with internet access during Phase 1 of RESPOND. 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.

Also known as: Doing What Matters in Times of Stress, Self Help Plus, SH+, DWM

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

Problem Management Plus (PM+) BEHAVIORAL

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.

Also known as: PM+

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

Psychological First Aid (PFA) BEHAVIORAL

PFA is a brief intervention consisting of providing basic information for peer support in times of emotional distress

Also known as: PFA

Psychological First Aid (PFA); Stepped-care program (Step 1: DWM; Step 2: PM+)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Instituto de Investigación Hospital Universitario La Paz: lead
• Universidad Autonoma de Madrid: collaborator
• Hospital Universitario La Paz: collaborator
• Parc Sanitari Sant Joan de Déu: collaborator
• Fundació Sant Joan de Déu: collaborator
• European Commission: collaborator
• VU University of Amsterdam: collaborator
• World Health Organization: collaborator

Study Sites (2)

Parc Sanitari Sant Joan de Déu

Sant Boi de Llobregat, Barcelona, 08830, Spain

Location

Hospital Universitario La Paz

Madrid, 28046, Spain

Location

Related Publications (3)

• Mediavilla R, Garcia-Vazquez B, McGreevy KR, Underhill J, Bayon C, Bravo-Ortiz MF, Munoz-Sanjose A, Haro JM, Monistrol-Mula A, Nicaise P, Petri-Romao P, McDaid D, Park AL, Melchior M, Vuillermoz C, Turrini G, Compri B, Purgato M, Roos R, Witteveen AB, Sijbrandij M, Bryant RA, Fuhr D, Ayuso-Mateos JL. Beyond effectiveness in eHealth trials: Process evaluation of a stepped-care programme to support healthcare workers with psychological distress (RESPOND-HCWs). Digit Health. 2024 Oct 18;10:20552076241287678. doi: 10.1177/20552076241287678. eCollection 2024 Jan-Dec.

  PMID: 39430699 DERIVED

• Mediavilla R, Felez-Nobrega M, McGreevy KR, Monistrol-Mula A, Bravo-Ortiz MF, Bayon C, Gine-Vazquez I, Villaescusa R, Munoz-Sanjose A, Aguilar-Ortiz S, Figueiredo N, Nicaise P, Park AL, Petri-Romao P, Purgato M, Witteveen AB, Underhill J, Barbui C, Bryant R, Kalisch R, Lorant V, McDaid D, Melchior M, Sijbrandij M, Haro JM, Ayuso-Mateos JL; RESPOND Consortium. Effectiveness of a mental health stepped-care programme for healthcare workers with psychological distress in crisis settings: a multicentre randomised controlled trial. BMJ Ment Health. 2023 Jun;26(1):e300697. doi: 10.1136/bmjment-2023-300697.

  PMID: 37263708 DERIVED

• 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.

  PMID: 36211795 DERIVED

Related Links

• RESPOND Project website

MeSH Terms

Conditions

Depression; Anxiety Disorders; COVID-19

Interventions

Psychological First Aid

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior; Mental Disorders; Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Emergency Services, Psychiatric; Mental Health Services; Behavioral Disciplines and Activities

Study Officials

• José Luis Ayuso-Mateos, MD, PhD

  Universidad Autonoma de Madrid

  STUDY CHAIR

• María Fe Bravo-Ortiz, MD, PhD

  Hospital Universitario La Paz

  PRINCIPAL INVESTIGATOR

• Josep Maria Haro, MD, PhD

  Parc Sanitari Sant Joan de Déu

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Outcomes assessor will not know whether a single participant was allocated to the experimental or to the control arm. That will be done by assigning random values toe the variable "arm" in the dataset.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: July 16, 2021
• First Posted: July 28, 2021
• Study Start: November 3, 2021
• Primary Completion: August 31, 2022
• Study Completion: August 31, 2022
• Last Updated: June 4, 2025

Record last verified: 2021-11

Locations

ES (2)