A Scalable Psychological Intervention to Reduce Psychological Distress Among Workers of Assisted Living Facilities

NCT05526235 | Recruiting

• 1 other identifier: 202114
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

Brief Summary

The current study is a randomized controlled trial (RCT) that aims to evaluate the effectiveness of a stepped-care program (Doing What Matters \[DWM\] and Problem Management Plus \[PM+\]) in reducing anxiety and depression symptoms amongst long-term care workers (LTCWs), following changes in care due to the COVID-19 pandemic.

Conditions

Depression; Anxiety; Psychological Distress

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 (6)

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

  Change: Baseline, 6 weeks, and 12 weeks

• Patient Health Questionnaire (PHQ-9)

  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)

  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 first receive Psychological First Aid (PFA). PFA consists of a 15-min call that assess the immediate concerns and needs of an individual in order to connect individuals to help and resources. Afterwards participants will receive the stepped-care program consisting of Doing What Matters (DWM) (step 1) and Problem Management Plus (PM+) (step 2). Step 2 will only be provided if the participant still has elevated levels of psychological distress (i.e. during the second quantitative assessment at 2 weeks after DWM). Participants will also be allowed to continue with their mental health interventions (CAU), as long as they meet eligibility criteria. Interventions: Behavioral: Doing What Matters (DWM) Behavioral: Problem Management Plus (PM+) Behavioral: Psychological First Aid (PFA)

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 PFA. Participants will also be allowed to continue with their mental health interventions (CAU), as long as they meet eligibility criteria. Intervention: Behavioral: Psychological First Aid (PFA)

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, has been adapted for use on a smartphone or other device with internet access. 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, DWM, SH+

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 a 15-min call that assess the immediate concerns and needs of an individual in order to connect individuals to help and resources.

Also known as: PFA

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

Eligibility Criteria

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

You may qualify if:

• years or older;
• Having elevated levels of psychological distress (Kessler Psychological Distress Scale (K10) \>15.9).
• Written/digital informed consent before entering the study.
• Being a worker in a long-term care facility or a home care worker in the community of Catalonia.

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, being on an unstable dose for at least 2 months.

Sponsors & Collaborators

• Fundació Sant Joan de Déu: lead
• VU University of Amsterdam: collaborator
• Universidad Autonoma de Madrid: collaborator

Study Sites (1)

Parc Sanitari Sant Joan de Déu

Sant Boi de Llobregat, Barcelona, 08930, Spain

RECRUITING

MeSH Terms

Conditions

Depression; Anxiety Disorders

Interventions

Psychological First Aid

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior; Mental Disorders

Intervention Hierarchy (Ancestors)

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

Study Officials

• Josep Maria Haro, MD,PhD

  Fundació Sant Joan de Déu

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Mireia Felez-Nobrega, PhD

CONTACT

936406350; mireia.felez@sjd.es

Leticia González Spinoglio, MSc

CONTACT

936406350; leticia.gonzalez@sjd.es

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 21, 2022
• First Posted: September 2, 2022
• Study Start: September 27, 2022
• Primary Completion: May 1, 2024
• Study Completion: September 1, 2024
• Last Updated: April 26, 2024

Record last verified: 2024-04

Locations

ES (1)