Psychological DistressRESPOND-HCWNCT04980326

A Scalable Psychological Intervention to Reduce Psychological Distress Among Healthcare Workers

A study testing Doing What Matters (DWM), Problem Management Plus (PM+) and Psychological First Aid (PFA) in people with Psychological Distress and Depression, run by Instituto de Investigación Hospital Universitario La Paz at 2 sites in Spain.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial 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. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Psychological Distress, Depression, Anxiety
What is being tested?: Doing What Matters (DWM), Problem Management Plus (PM+) and Psychological First Aid (PFA)
Type of treatment: Lifestyle or therapy programme
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 232 participants
Where: 2 sitesSpain
Study dates: 3 Nov 2021to 31 Aug 2022
Phase: Interventional
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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.

Who cannot join

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.

Trial locations and contacts

2 sites in 1 country.

Spain2 sites

Hospital Universitario La Paz
Madrid, 28046
Parc Sanitari Sant Joan de Déu
Sant Boi de Llobregat, Barcelona, 08830

Other trials in Spain

About this study

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

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
Being tested: Doing What Matters (DWM), Problem Management Plus (PM+), Psychological First Aid (PFA)
Keywords: COVID-19, Healthcare workers, Psychological Distress, Depression, Anxiety, Problem Management Plus (PM+), Doing What Matters (DWM), Stepped-care
Medical subject headings: Depression, Anxiety Disorders, COVID-19

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Doing What Matters (DWM)Behavioural
Also called Doing What Matters in Times of Stress, Self Help Plus, SH+, 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, 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.
Problem Management Plus (PM+)Behavioural
Also called 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.
Psychological First Aid (PFA)Behavioural
Also called PFA
PFA is a brief intervention consisting of providing basic information for peer support in times of emotional distress

Study groups in NCT04980326
Study group	Role	What they receive
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. Receives: 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. Receives: Behavioral: Psychological First Aid (PFA)

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: Change from baseline to 20 weeks

Secondary outcomes (7)

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.
Measured: Change: Baseline, 6 weeks, and 12 weeks
Patient Health Questionnaire (PHQ-9)
The PHQ-9 is a 9-item self-reported instrument that measures depression symptoms. 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 27, with higher scores indicating higher levels of depression.
Measured: Change: Baseline, 6 weeks, 12 weeks, and 20 weeks
Generalized Anxiety Disorder (GAD-7) scale
The GAD-7 is a 7-item self-reported instrument that measures anxiety symptoms. 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 21, with higher scores indicating higher levels of anxiety.
Measured: 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
The PCL-5 is a self-reported instrument that measures PTSD symptoms. Respondents are asked how much each symptom has bothered them over the past 4 weeks, with response options of "not at all", "a little bit", "moderately", "quite a bit", and "extremely". Items are rated on a 0-4 scale. The scale can range from 0 to 32 for the 8-item version, with higher scores indicating higher levels of PTSD symptoms.
Measured: Change: Baseline, 6 weeks, 12 weeks, and 20 weeks
EuroQol 5-dimensional descriptive system - 5-level version (EQ-5D-5L)
The EQ-5D-5L measures quality of life and consists of two parts, the EQ-5D and the EQ VAS. Part 1, the EQ-5D, rates the level of impairment across five dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems and extreme problems. The labels for the 5L followed the format "no problems," "slight problems," "moderate problems," "severe problems," and "unable to"/"extreme problems" for all dimensions. For mobility, the description of "confined to bed" has been changed to "unable to walk about.". Part 2, the EQ-VAS, is a visual analogue scale. The endpoints of the scale are called 'The best health you can imagine' and 'The worst health you can imagine' and the current health status of that day needs to be indicated, after which the number checked on the scale also needs to be written down. Higher scores indicate worst qualitive of life.
Measured: Change: Baseline, 6 weeks, 12 weeks, and 20 weeks
Client Service Receipt Inventory (CSRI) - RESPOND adaptation
The CSRI was developed for the collection of data on service utilization (e.g. use of health system, other services, time out of employment and other usual activities, need for informal care) and related characteristics of people with mental disorders, as the basis for calculating the costs of care for mental health cost-effectiveness research. The RESPOND-adapted version consists of a 13-item self-reported instrument that asks about the number and duration of contacts with healthcare professionals (physicians, mental health specialists, and nurses) in the past two months.
Measured: Change: Baseline, 6 weeks, 12 weeks, and 20 weeks
Stressor Reactivity
Stressor reactivity (SR) is a proxy of resilience. SR scores are calculated based on the individual's association between stressor exposure, as measured by a checklist of daily hassles, and mental health, as measured by the Patient Health Questionnaire (PHQ-9) and the Generalised Anxiety Disorder (GAD-7) questionnaire. Residuals of individuals' regression lines are used to assess individual deviation from the normative SR (i.e., the SR in the RESPOND sample).
Measured: Change: Baseline, 6 weeks, 12 weeks, and 20 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

3 Nov 202131 Aug 2022

First posted28 Jul 2021
Study start3 Nov 2021
Primary completion31 Aug 2022
Study completion31 Aug 2022

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (3)Papers the sponsor has linked to this study.
Other trials for Psychological DistressStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Supportive care
Allocation: Randomised
Intervention model: Parallel groups
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.
Masking: Single blind
Who is masked: Outcomes assessor
Enrolment: 232 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04980326
Sponsor's protocol ID: RESPOND WP4 RCT
Acronym: RESPOND-HCW
Status last verified: Nov 2021
First submitted: 16 Jul 2021
Last updated: 4 Jun 2025
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No

Publications

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.
PubMed 39430699
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.
PubMed 37263708
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.
PubMed 36211795

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 4 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

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
ClinicalTrials.gov ID: NCT04980326
Acronym / sponsor ID: RESPOND-HCW / RESPOND WP4 RCT
Conditions: Psychological Distress, Depression, Anxiety
Keywords: COVID-19, Healthcare workers, Psychological Distress, Depression, Anxiety, Problem Management Plus (PM+), Doing What Matters (DWM), Stepped-care
Study type: Interventional
Recruitment status: Completed
Enrolment: 232 participants (actual)
Lead sponsor: Instituto de Investigación Hospital Universitario La PazUniversity, hospital or other
Collaborators: Universidad Autonoma de Madrid, Hospital Universitario La Paz, Parc Sanitari Sant Joan de Déu, Fundació Sant Joan de Déu, European Commission, VU University of Amsterdam, World Health Organization
Study start: 3 Nov 2021 (actual)
Primary completion: 31 Aug 2022 (actual)
Study completion: 31 Aug 2022 (actual)
First posted: 28 Jul 2021 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Supportive care
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind (outcomes assessor)
Number of arms: 2
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.

Arm	Type	Receives
Stepped-care program (Step 1: DWM; Step 2: PM+)	Experimental	Behavioral: Doing What Matters (DWM), Behavioral: Problem Management Plus (PM+), Behavioral: Psychological First Aid (PFA)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.
Psychological First Aid (PFA)	Active comparator	Behavioral: Psychological First Aid (PFA)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.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (4 listed)

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.

Key exclusion criteria (6 listed)

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)

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Doing What Matters (DWM)Also: Doing What Matters in Times of Stress, Self Help Plus, SH+, DWMThe 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.	Behavioural	Stepped-care program (Step 1: DWM; Step 2: PM+)
Problem Management Plus (PM+)Also: 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.	Behavioural	Stepped-care program (Step 1: DWM; Step 2: PM+)
Psychological First Aid (PFA)Also: PFAPFA is a brief intervention consisting of providing basic information for peer support in times of emotional distress	Behavioural	Psychological First Aid (PFA), Stepped-care program (Step 1: DWM; Step 2: PM+)

Primary outcome

Patient Health Questionnaire Anxiety and Depression Scale (PHQ-ADS)
Time frame: Change from baseline to 20 weeks
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.

7 secondary outcomes

Patient Health Questionnaire Anxiety and Depression Scale (PHQ-ADS)
Time frame: Change: Baseline, 6 weeks, and 12 weeks
Patient Health Questionnaire (PHQ-9)
Time frame: Change: Baseline, 6 weeks, 12 weeks, and 20 weeks
Generalized Anxiety Disorder (GAD-7) scale
Time frame: 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
Time frame: Change: Baseline, 6 weeks, 12 weeks, and 20 weeks
EuroQol 5-dimensional descriptive system - 5-level version (EQ-5D-5L)
Time frame: Change: Baseline, 6 weeks, 12 weeks, and 20 weeks
Client Service Receipt Inventory (CSRI) - RESPOND adaptation
Time frame: Change: Baseline, 6 weeks, 12 weeks, and 20 weeks
Stressor Reactivity
Time frame: Change: Baseline, 6 weeks, 12 weeks, and 20 weeks

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 4 Jun 2025.
Derived from this study: PubMed 39430699Mediavilla 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.
Derived from this study: PubMed 37263708Mediavilla 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.
Derived from this study: PubMed 36211795Mediavilla 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.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

José Luis Ayuso-Mateos, MD, PhD study chair

Universidad Autonoma de Madrid

María Fe Bravo-Ortiz, MD, PhD principal investigator

Hospital Universitario La Paz

Josep Maria Haro, MD, PhD principal investigator

Parc Sanitari Sant Joan de Déu

2 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 4 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Patient Health Questionnaire Anxiety and Depression Scale (PHQ-ADS) (time frame: Change from baseline to 20 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04980326, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Jun 2025.