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…
ID
Bron
Verkorte titel
Aandoening
Common mental disorders;
Depression;
Anxiety;
Posttraumatic stress disorder
Ondersteuning
Onderzoeksproduct en/of interventie
Uitkomstmaten
Primaire uitkomstmaten
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).
Achtergrond van het onderzoek
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 labour 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 arising from the COVID-19 pandemic, addressing the needs of many people in a way that maximises 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 non-specialist helpers, 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 (DWM/PM+).
The main objective is to evaluate the implementation and (cost-)effectiveness of the culturally and contextually adapted DWM/PM+ stepped-care programs amongst labour migrants living in the Netherlands during the COVID-19 pandemic in terms of mental health outcomes, resilience, wellbeing, health inequalities, and costs to health systems.
Study participants include adult labour migrants with self-reported elevated psychological distress (K10 >15.9) (n=212).
The primary outcome will be the decrease in symptoms of anxiety and depression from baseline to two-month follow-up, measured through the PHQ-Anxiety and Depression Score (PHQ-ADS), i.e. the sum score of the Patient Health Questionnaire (PHQ-9) and General Anxiety Disorder-7 (GAD-7).
Doel van het onderzoek
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.
Onderzoeksopzet
- T0: Screening for eligibility including psychological distress
- T1: Baseline assessment
- T2: 2 weeks post DWM intervention assessment
- T3: 1-week post PM+ intervention assessment
- T4: 2-months post PM+ intervention assessment
Onderzoeksproduct en/of interventie
The study has two arms:
1. Control group: participants receive care-as-usual (CAU) and Psychological First Aid (PFA).
2. Treatment group: participants receive care-as-usual (CAU), Psychological First Aid (PFA), and a stepped care intervention consisting of Doing What Matters in times of stress (DWM) (step 1) and conditionally, if participants still meet criteria for psychological distress (K10 >15.9) 2 weeks after having received DWM, Problem Management Plus (PM+).
PFA is given at the start of the RCT, which means that participants in the treatment group receive it before the start of the stepped-care DWM/PM+ intervention.
Care-as-usual (CAU):
All participants are allowed to receive any care-as-usual. CAU ranges from community care to specialized psychological treatments, but only care provided by the general practitioner or the assistant of the general practitioner with a specialization in mental health care (POH-GGZ) is fully covered by the basic health insurance package; it does not completely cover mental health service costs. Labour migrants who signed up for the basic health insurance package (which is obligated for everyone who plans to stay for more than 4 months or who needs to pay wage taxes due to work conducted in the Netherlands) have access to the health system like any other Dutch citizen with a standard insurance package.
Psychological First Aid (PFA):
All participants will be offered individual Psychological First Aid (PFA) through teleconferencing. PFA is a WHO developed support strategy that involves humane, supportive and practical help for individuals living in a serious humanitarian crisis. PFA does not necessarily involve a discussion of the event(s) that cause the distress but aims particularly at five basic elements that are crucial to promote in the aftermath of crises, i.e. a sense of safety, calm, self- and community efficacy, connectedness, and hope (Hobfoll et al., 2007; Sijbrandij et al., 2020). PFA consists of a conversation (approximately 30-45 minutes) that a helper has with a participant which can be provided remotely (e.g. videoconferencing or telephone).
PFA has various themes; in PFA, the helper provides non-intruding practical care and support, listen to needs and concerns, helps people to address basic needs (e.g. information), listens to people without pressuring them to talk, comforts people and helps them to feel calm, helps people to connect to information, services, and social support, and protects people from further harm (WHO, 2011).
Doing What Matters in times of stress (DWM):
DWM is a self-help, stress management, illustrated guide that is part of Self-Help Plus (SH+), a psychosocial intervention developed by the WHO (Purgato et al., 2019). The illustrated DWM guide comprises the core information from the SH+ course and is accompanied by audio files to support regular practice of exercises which enhance stress reduction and adaptive coping and resilience (WHO, 2020).
SH+ and DWM are based on acceptance and commitment therapy (ACT), a modern form of cognitive-behavioural therapy with a strong focus on mindfulness practices and includes exercises which aim to enhance stress reduction and build social support, adaptive coping and resilience (Epping-Jordan et al., 2016).
SH+ has been implemented with different populations of refugees in Europe, Turkey (Purgato et al., 2019) and Northern Uganda (Tol et al., 2020). DWM can be delivered individually with support from a briefly trained, non-specialized helper.
In RESPOND, the DWM pre-recorded audios and the illustrated stress management guide will be adapted to an online application (app) (in a previous, qualitative phase). This way, people can use the self-help online app in their own time. The five weekly sessions in the app will follow the 5 chapters of the book (grounding, unhooking, acting on your values, being kind and making room). Participants will receive a weekly, 15-minute call from a non-specialized helper, trained to support and motivate individuals using the app.
Problem Management Plus (PM+):
PM+ is a brief, transdiagnostic, scalable, psychological intervention program, developed by the WHO, that aims to reduce symptoms of depression, anxiety, PTSD, and related conditions (Dawson et al., 2015). It is based on problem-solving and cognitive behavioural therapy (CBT) techniques that are empirically supported and formally recommended by the WHO (Dua et al., 2011).
PM+ comprises 5 weekly, 90-minute sessions delivered by a trained, non-specialized helper. PM+ is available in individual and group delivery formats. It was originally designed for in-person delivery, but similarly to other psychological interventions, it can be adapted for delivery over the telephone or through video-conferencing. In RESPOND, PM+ will be delivered individually through video-conferencing.
Individual PM+ has been successfully implemented in Kenya (Bryant et al., 2017) and Pakistan (Rahman et al., 2016). Although PM+ was mainly developed for low and middle income countries, it is also being evaluated among refugees in the Netherlands (de Graaff et al., 2020).
For this study, we will adapt both the DWM and the PM+ intervention to the COVID-19 pandemic and to the context and culture of the target population, i.e. we will adapt examples and pictures used in the intervention (in a previous, qualitative phase).
References:
Bryant, R. A., Schafer, A., Dawson, K. S., Anjuri, D., Mulili, C., Ndogoni, L., ... & Van Ommeren, M. (2017). Effectiveness of a brief behavioural intervention on psychological distress among women with a history of gender-based violence in urban Kenya: a randomised clinical trial. PLoS medicine, 14(8), e1002371.
Dawson, K. S., Bryant, R. A., Harper, M., Tay, A. K., Rahman, A., Schafer, A., & Van Ommeren, M. (2015). Problem Management Plus (PM+): a WHO transdiagnostic psychological intervention for common mental health problems. World Psychiatry, 14(3), 354.
de Graaff, A. M., Cuijpers, P., McDaid, D., Park, A., Woodward, A., Bryant, R. A., ... & Sijbrandij, M. (2020). Peer-provided Problem Management Plus (PM+) for adult Syrian refugees: a pilot randomised controlled trial on effectiveness and cost-effectiveness. Epidemiology and Psychiatric Sciences, 29.
Dua, T., Barbui, C., Clark, N., Fleischmann, A., Poznyak, V., van Ommeren, M., ... & Saxena, S. (2011). Evidence-based guidelines for mental, neurological, and substance use disorders in low-and middle-income countries: summary of WHO recommendations. PLoS Med, 8(11), e1001122.
Epping‐Jordan, J. E., Harris, R., Brown, F. L., Carswell, K., Foley, C., García‐Moreno, C., ... & van Ommeren, M. (2016). Self‐Help Plus (SH+): a new WHO stress management package. World Psychiatry, 15(3), 295
Hobfoll, S.E.; Watson, P.; Bell, C.C.; Bryant, R.A.; Brymer, M.J.; Friedman, M.J.; Friedman, M.; Gersons, B.P.; de Jong, J.T.; Layne, C.M.; et al. Five essential elements of immediate and mid-term mass trauma intervention: Empirical evidence. Psychiatry 2007, 70, 283–315.
Purgato, M., Carswell, K., Acarturk, C., Au, T., Akbai, S., Anttila, M., ... & Van Ommeren, M. (2019). Effectiveness and cost-effectiveness of Self-Help Plus (SH+) for preventing mental disorders in refugees and asylum seekers in Europe and Turkey: study protocols for two randomised controlled trials. BMJ open, 9(5), e030259.
Rahman, A., Hamdani, S. U., Awan, N. R., Bryant, R. A., Dawson, K. S., Khan, M. F., ... & Van Ommeren, M. (2016). Effect of a multicomponent behavioral intervention in adults impaired by psychological distress in a conflict-affected area of Pakistan: a randomized clinical trial. Jama, 316(24), 2609-2617.
Sijbrandij, M., Horn, R., Esliker, R., O’may, F., Reiffers, R., Ruttenberg, L., ... & Ager, A. (2020). The effect of psychological first aid training on knowledge and understanding about psychosocial support principles: a cluster-randomized controlled trial. International journal of environmental research and public health, 17(2), 484.
Tol, W. A., Leku, M. R., Lakin, D. P., Carswell, K., Augustinavicius, J., Adaku, A., ... & van Ommeren, M. (2020). Guided self-help to reduce psychological distress in South Sudanese female refugees in Uganda: a cluster randomised trial. The Lancet Global Health, 8(2), e254-e263.
WHO (2011). Psychological first aid: Guide for field workers. Geneva: WHO
WHO (2020). Doing what matters in times of stress: an illustrated guide. Geneva: WHO
Publiek
Wetenschappelijk
Belangrijkste voorwaarden om deel te mogen nemen (Inclusiecriteria)
- 18 years or older
- Living in the Netherlands as labour 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. Polish, English).
Belangrijkste redenen om niet deel te kunnen nemen (Exclusiecriteria)
- Planning to permanently move back to their home country before the last quantitative assessment at 2 months after PM+
- Having acute medical conditions (requiring hospitalisation)
- 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 specialised psychological treatment (e.g. EMDR, CBT)
- In case of current psychotropic medication use: being on an unstable dose for at least 2 months or a change in dosage over the past 2 months.
Opzet
Deelname
Voornemen beschikbaar stellen Individuele Patiënten Data (IPD)
Toelichting
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In overige registers
Register | ID |
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NTR-new | NL9630 |
Ander register | METc VUmc : METc Protocol No: NL77644.029.21 |