A Scalable Psychological Intervention to Reduce Psychological Distress Among Healthcare Workers (RESPOND-HCW)

Instituto de Investigación Hospital Universitario La Paz

Status: Completed

Conditions: Depression; Anxiety; Psychological Distress

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

Study type: Interventional

Funder types: Other

Identifiers

NCT04980326

RESPOND WP4 RCT

Details and patient eligibility

About

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.

Enrollment: 232 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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232 participants in 2 patient groups

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

Experimental group

Description:

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.

Treatment:

Behavioral: Psychological First Aid (PFA)

Behavioral: Problem Management Plus (PM+)

Behavioral: Doing What Matters (DWM)

Psychological First Aid (PFA)

Active Comparator group

Description:

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.

Treatment:

Behavioral: Psychological First Aid (PFA)