A Scalable Psychological Intervention to Reduce Psychological Distress Among Healthcare Workers

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

232 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-11-03

Study Completion Date

2022-08-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Psychological Distress Depression Anxiety

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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 Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

SINGLE

Outcome Assessors

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.

Study Groups

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

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.

Group Type EXPERIMENTAL

Doing What Matters (DWM)

Intervention Type 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.

Problem Management Plus (PM+)

Intervention Type 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.

Psychological First Aid (PFA)

Intervention Type BEHAVIORAL

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

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.

Group Type ACTIVE_COMPARATOR

Psychological First Aid (PFA)

Intervention Type BEHAVIORAL

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

Interventions

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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, 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.

Intervention Type 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.

Intervention Type BEHAVIORAL

Psychological First Aid (PFA)

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

Intervention Type BEHAVIORAL

Other Intervention Names

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Doing What Matters in Times of Stress Self Help Plus SH+ DWM PM+ PFA

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No