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RESPOND: Improving the Preparedness of Health Systems to Reduce Mental Health and Psychosocial Concerns Resulting From the COVID-19 Pandemic (RESPOND)

Primary Purpose

Psychological Distress

Status
Recruiting
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
Stepped-care DWM/PM+
Psychological First Aid + usual care (CAU)
Sponsored by
Universita di Verona
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Psychological Distress focused on measuring mental health, psychological symptoms, resilience, wellbeing

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 18 years or older;
  • Living in Italy as asylum seeker, refugee, or migrant
  • Having elevated levels of psychological distress (Kessler Psychological Distress Scale (K10) >15.9).
  • Sufficient mastery (written and spoken) of one of the languages the DWM/PM+ intervention is being delivered in (e.g. English, Italian).
  • Oral and written informed consent before entering the study.

Exclusion Criteria:

  • Planning to permanently move back to their home country before the last quantitative assessment at 2 months after PM+;
  • 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 receiving specialized psychological treatment (e.g. Eye Movement Desensitization and Reprocessing - EMDR; Cognitive behavioural therapy - CBT);
  • In case of current psychotropic medication use: being on an unstable dose for at least 2 months

Sites / Locations

  • Università di VeronaRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Other

Arm Label

Psychological First Aid + Stepped-care intervention (DWM/PM+)

Psychological First Aid + usual care

Arm Description

All participants will be offered individual Psychological First Aid (PFA), a WHO developed support strategy that involves humane, supportive and practical help for individuals suffering from serious humanitarian crises. The treatment group will receive the stepped-care program consisting of DWM (step 1) and Problem Management Plus (PM+). The DWM program has been developed by WHO and collaborators working in the humanitarian field. DWM was designed to be relevant for large segments of adversity-affected populations: it is intended to be transdiagnostic, and easily adaptable to different cultures and languages. PM+ is a new, brief, psychological intervention program based on cognitive-behavioral therapy (CBT) techniques that are empirically supported.

All participants will be offered individual Psychological First Aid (PFA), a WHO developed support strategy that involves humane, supportive and practical help for individuals suffering from serious humanitarian crises. In addition, both the groups will receive care-as-usual (CAU); they will be allowed to receive any usual care. CAU may include community care, social/legal support, and psychoeducation.

Outcomes

Primary Outcome Measures

Patient Health Questionnaire - Anxiety and Depression (PHQ-ADS)
Decrease in symptoms of depression and anxiety. The total score ranges from 0 to 48, with higher scores indicating higher levels of depression and anxiety symptomatology.

Secondary Outcome Measures

Patient Health Questionnaire (PHQ-9)
Level of depression The total score ranges from 0 to 27, with higher scores indicating higher levels of depression symptomatology.
Generalized Anxiety Disorder checklist (GAD-7)
Level of anxiety The total score ranges from 0 to 21, with higher scores indicating higher levels of anxiety symptomatology.
PTSD Checklist for DSM-5 (PCL-5)
Severity of posttraumatic stress disorder The total score ranges from 0 to 32, with higher scores indicating higher levels of PTSD symptomatology.
EuroQol five dimension five level checklist for quality of life EU European Union (EQ-5D-5L)
Quality of life
Mainz Inventory of MIcrostressorS (MIMIS) and stressful events
Resilience based on exposure to stressful (general- and COVID-19 related-) events (MIMIS)
Client Service Receipt Inventory (CSRI)
Cost of care: impact on use of health system, other services, time out of employment and other usual activities and need for informal care

Full Information

First Posted
August 5, 2021
Last Updated
December 14, 2021
Sponsor
Universita di Verona
Collaborators
VU University of Amsterdam, Universidad Autonoma de Madrid, London School of Economics and Political Science, Sorbonne University, Mainz University
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1. Study Identification

Unique Protocol Identification Number
NCT04993534
Brief Title
RESPOND: Improving the Preparedness of Health Systems to Reduce Mental Health and Psychosocial Concerns Resulting From the COVID-19 Pandemic
Acronym
RESPOND
Official Title
RESPOND: Improving the Preparedness of Health Systems to Reduce Mental Health and Psychosocial Concerns Resulting From the COVID-19 Pandemic. A Randomized Controlled Trial in Italy
Study Type
Interventional

2. Study Status

Record Verification Date
December 2021
Overall Recruitment Status
Recruiting
Study Start Date
December 14, 2021 (Actual)
Primary Completion Date
May 2023 (Anticipated)
Study Completion Date
May 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Universita di Verona
Collaborators
VU University of Amsterdam, Universidad Autonoma de Madrid, London School of Economics and Political Science, Sorbonne University, Mainz University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
This randomized controlled trial will evaluate the implementation and (cost-)effectiveness of the culturally and contextually adapted Doing What Matters in times of stress (DWM) and Problem Management Plus (PM+) stepped-care programs amongst asylum seekers, refugees, and/or migrants living in Italy. Outcomes include mental health, resilience, wellbeing, health inequalities, and costs to health systems.
Detailed Description
Rationale: The ongoing COVID-19 pandemic has a major and potentially long-lasting effect on mental health and wellbeing across populations worldwide. Vulnerable groups, such as asylum seekers, refugees and migrants, are disproportionally affected by the COVID-19 pandemic. There is a high need for psychosocial interventions that can target the most prevalent mental health problems as a result of the COVID-19 pandemic, addressing the needs of many people in a way that maximizes the use of resources. The World Health Organization (WHO) has developed two scalable, low-intensity psychological interventions: Doing What Matters in times of stress (DWM; a self-help intervention) and Problem Management Plus (PM+; a face-to-face intervention). DWM and PM+ can be delivered by paraprofessionals, are applicable to a variety of mental health problems (depression, anxiety and PTSD), and can be adapted to different populations, cultures and languages. Both DWM and PM+ have been proven to be effective on their own. In this study, DWM and PM+ will be combined into a stepped-care intervention. This study is part of the larger EU H2020-RESPOND project, which aims to improve the preparedness of the European mental health care system in the face of future pandemics. Objective: The main objective is to evaluate the implementation and (cost-)effectiveness of the culturally and contextually adapted DWM/PM+ stepped-care programs amongst asylum seekers, refugees, and/or migrants living in Italy during the COVID-19 pandemic in terms of mental health outcomes, resilience, wellbeing, health inequalities, and costs to health systems. The main hypothesis is that the stepped-care DWM/PM+ intervention together with psychological first aid (PFA) in addition to care-as-usual (CAU) will be more effective in decreasing psychological distress and symptoms of mental health problems than PFA and CAU alone. We aim to conduct a randomized controlled trial (RCT) to assess the (cost-)effectiveness of the stepped-care DWM/PM+ intervention, and to identify (a) barriers and facilitators to treatment engagement and adherence and (b) opportunities for scaling up the implementation of the DWM/PM+ intervention within the existing health care system in Italy. Study design: pragmatic implementation trial with a single-blinded, randomized, parallel-group design. The final phase of the trial will consist of a qualitative process evaluation with individual interviews and focus group discussions (FGDs). The qualitative phase will include some participants in the randomized trial who completed DWM (n=2/4;), who completed PM+ (n=2/4), who dropped-out during DWM (n=2/4), and who dropped-out during PM+ (n=2/4); (b) local stakeholders (n=10/15) (c) facilitators of the DWM and PM+ intervention (both helpers and trainers/supervisors). Study population: Adult asylum seekers, refugees or migrants with self-reported elevated psychological distress (K10 >15.9) (n=212). Intervention: All participants (in both the treatment and the comparison group) will receive Psychological First Aid (PFA) and CAU. In addition to PFA and CAU, the treatment group will receive the stepped-care intervention (DWM with or without PM+). The stepped-care intervention consists of DWM (step 1), and conditionally PM+ (step 2) if participants still meet criteria for psychological distress (K10 >15.9) 2 weeks after having received DWM. DWM, i.e. a self-help book with pre-recorded audios, has been adapted as an online intervention (phase 1). PM+ consists of five sessions and will be delivered by trained peer-support helpers in person or via teleconferencing in individual or group format. In addition to PFA, the comparison group will receive CAU which ranges from community care to specialized psychological treatments, according to the needs and clinical characteristics of participants. Main study parameters/endpoints: Screening for inclusion and exclusion criteria will be interviewer-administered, inperson or through (video) calls. For all participants, 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 primary outcome 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). We expect to detect a Cohen's d effect size of 0.3 in the DWM/PM+ group at 2 months post-treatment. Additional health outcomes include level of anxiety (GAD-7) and depression (PHQ-9), symptoms of posttraumatic stress disorder (PCL-5), resilience (Mainz Inventory of Microstressors, MIMIS), quality of life (5-level EQ-5D version, EQ-5D-5L), and cost of care (Client Service Receipt Inventory, CSRI). Additional study parameters will include demographic data, COVID-19 related (exposure) variables, treatment fidelity, satisfaction and acceptability of the intervention program, and implementation indicators (such as reach, dose, resource use, intervention-related costs). Through FGDs and interviews at the end of the trial, the feasibility of scaling-up the implementation on the stepped-care DWM/PM+ intervention within asylum seekers, refugees, and migrants in Italy.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Psychological Distress
Keywords
mental health, psychological symptoms, resilience, wellbeing

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
212 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Psychological First Aid + Stepped-care intervention (DWM/PM+)
Arm Type
Experimental
Arm Description
All participants will be offered individual Psychological First Aid (PFA), a WHO developed support strategy that involves humane, supportive and practical help for individuals suffering from serious humanitarian crises. The treatment group will receive the stepped-care program consisting of DWM (step 1) and Problem Management Plus (PM+). The DWM program has been developed by WHO and collaborators working in the humanitarian field. DWM was designed to be relevant for large segments of adversity-affected populations: it is intended to be transdiagnostic, and easily adaptable to different cultures and languages. PM+ is a new, brief, psychological intervention program based on cognitive-behavioral therapy (CBT) techniques that are empirically supported.
Arm Title
Psychological First Aid + usual care
Arm Type
Other
Arm Description
All participants will be offered individual Psychological First Aid (PFA), a WHO developed support strategy that involves humane, supportive and practical help for individuals suffering from serious humanitarian crises. In addition, both the groups will receive care-as-usual (CAU); they will be allowed to receive any usual care. CAU may include community care, social/legal support, and psychoeducation.
Intervention Type
Behavioral
Intervention Name(s)
Stepped-care DWM/PM+
Intervention Description
The DWM program consists of a self-help guide 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. DWM includes five sections (or modules), each of which focuses on a specific skill. In this study, the DWM program will be delivered as an online intervention. The DWM intervention, i.e. both the audios and the self-help guide, have been adapted for use on a smartphone or other device with internet access. 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.
Intervention Type
Other
Intervention Name(s)
Psychological First Aid + usual care (CAU)
Intervention Description
All participants, both in the treatment and the comparison group, will be offered individual Psychological First Aid (PFA) through a face-to-face or teleconferencing meeting. In addition to PFA, both the treatment and the comparison group will receive care-as-usual (CAU); they will be allowed to receive any usual care. CAU may include community care, social/legal support, and psychoeducation.
Primary Outcome Measure Information:
Title
Patient Health Questionnaire - Anxiety and Depression (PHQ-ADS)
Description
Decrease in symptoms of depression and anxiety. The total score ranges from 0 to 48, with higher scores indicating higher levels of depression and anxiety symptomatology.
Time Frame
Two-month follow-up after the PM+ intervention ended
Secondary Outcome Measure Information:
Title
Patient Health Questionnaire (PHQ-9)
Description
Level of depression The total score ranges from 0 to 27, with higher scores indicating higher levels of depression symptomatology.
Time Frame
T1 (baseline), T2 (up to 2 weeks after DWM), T3 (up to 2 weeks after PM+), T4 (2 months after PM+)
Title
Generalized Anxiety Disorder checklist (GAD-7)
Description
Level of anxiety The total score ranges from 0 to 21, with higher scores indicating higher levels of anxiety symptomatology.
Time Frame
T1 (baseline), T2 (up to 2 weeks after DWM), T3 (up to 2 weeks after PM+), T4 (2 months after PM+)
Title
PTSD Checklist for DSM-5 (PCL-5)
Description
Severity of posttraumatic stress disorder The total score ranges from 0 to 32, with higher scores indicating higher levels of PTSD symptomatology.
Time Frame
T1 (baseline), T2 (up to 2 weeks after DWM), T3 (up to 2 weeks after PM+), T4 (2 months after PM+)
Title
EuroQol five dimension five level checklist for quality of life EU European Union (EQ-5D-5L)
Description
Quality of life
Time Frame
T1 (baseline), T2 (up to 2 weeks after DWM), T3 (up to 2 weeks after PM+), T4 (2 months after PM+)
Title
Mainz Inventory of MIcrostressorS (MIMIS) and stressful events
Description
Resilience based on exposure to stressful (general- and COVID-19 related-) events (MIMIS)
Time Frame
T1 (baseline), T2 (up to 2 weeks after DWM), T3 (up to 2 weeks after PM+), T4 (2 months after PM+)
Title
Client Service Receipt Inventory (CSRI)
Description
Cost of care: impact on use of health system, other services, time out of employment and other usual activities and need for informal care
Time Frame
T1 (baseline), T2 (up to 2 weeks after DWM), T3 (up to 2 weeks after PM+), T4 (2 months after PM+)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 18 years or older; Living in Italy as asylum seeker, refugee, or migrant Having elevated levels of psychological distress (Kessler Psychological Distress Scale (K10) >15.9). Sufficient mastery (written and spoken) of one of the languages the DWM/PM+ intervention is being delivered in (e.g. English, Italian). Oral and written informed consent before entering the study. Exclusion Criteria: Planning to permanently move back to their home country before the last quantitative assessment at 2 months after PM+; 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 receiving specialized psychological treatment (e.g. Eye Movement Desensitization and Reprocessing - EMDR; Cognitive behavioural therapy - CBT); In case of current psychotropic medication use: being on an unstable dose for at least 2 months
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Corrado Barbui, MD, Prof
Phone
+390458126418
Email
corrado.barbui@univr.it
First Name & Middle Initial & Last Name or Official Title & Degree
Marianna Purgato, PhD
Phone
+390458124884
Email
marianna.purgato@univr.it
Facility Information:
Facility Name
Università di Verona
City
Verona
State/Province
VR
ZIP/Postal Code
37134
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Corrado Barbui, MD, Prof
Phone
+390458126418
Email
corrado.barbui@univr.it
First Name & Middle Initial & Last Name & Degree
Marianna Purgato, PhD
Phone
+390458124884
Email
marianna.purgato@univr.it

12. IPD Sharing Statement

Learn more about this trial

RESPOND: Improving the Preparedness of Health Systems to Reduce Mental Health and Psychosocial Concerns Resulting From the COVID-19 Pandemic

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