STRENGTHS: Fostering responsive mental health systems in the Syrian refugee crisis

ISRCTN ISRCTN11862037
DOI https://doi.org/10.1186/ISRCTN11862037
Secondary identifying numbers NL7552
Submission date
22/08/2022
Registration date
23/08/2022
Last edited
31/01/2023
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Mental and Behavioural Disorders
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year

Plain English summary of protocol

Background and study aims
Syrian refugees are at risk for common mental disorders (CMDs), such as depression, anxiety and post-traumatic stress disorder (PTSD). However, access to mental health care can be limited due to barriers such as long waitlists and communication difficulties. The World Health Organization (WHO) developed a brief, transdiagnostic psychological intervention (Problem Management Plus; PM+) for communities affected by adversity.

We aim to investigate the effectiveness of PM+ in reducing symptoms of CMDs among Syrian refugees in the Netherlands.

Who can participate?
Syrian refugees (18 years and above) living in the Netherlands with self-reported distress (K10 >15) and functional impairment (WHODAS 2.0 >16) are invited to participate. Participants with acute medical conditions, imminent suicide risk/acute needs/protection risks, a severe mental disorder, or severe cognitive impairment are excluded and referred to appropriate services. Participants currently enrolled in a specialized psychological treatment program are also excluded.

What does the study involve?
Included participants complete a baseline assessment with questionnaires on mental health, psychosocial functioning, severe stressors and health care use. After baseline, participants are randomized into the PM+ treatment group (PM+/CAU) or into the CAU control group. After the intervention period, participants are re-assessed at 1-week post-assessment (i.e., 6 weeks after baseline), 3-month follow-up (i.e., 4.5 months after baseline), and 12-month follow-up (i.e., 12-months after baseline).

What are the possible benefits and risks of participating?
Problem Management Plus (PM+) may reduce psychological distress, but it is not certain. If you are allocated to the CAU control group, you will not benefit from participating in this study. However, your participation can contribute to a better understanding of the effect of short-term psychological interventions for Syrian refugees in reducing psychological distress.

A potential risk of participating int he study is that you may experience (temporary) distress or anxiety because you are asked about your feelings. You can always skip questions if you prefer. In case you will be allocated to the PM+/CAU treatment group, you may temporarily experience distress or anxiety during the PM+ sessions. Our PM+ helpers are well-trained to support you, and may also refer you to specialist care.

Where is the study run from?
The study is conducted by the Vrije Universiteit Amsterdam and I-psy mental health care (Almere).

When is the study starting and how long is it expected to run for?
March 2019 to December 2022.

Who is funding the study?
Horizon 2020 Framework Programme for Research and Innovation (2014-2020).

Who is the main contact?
Ms. Anne de Graaff (a.m.de.graaff@vu.nl)
Prof. dr. Marit Sijbrandij (e.m.sijbrandij@vu.nl)

Study website

Contact information

Prof Marit Sijbrandij
Principal Investigator

Van der Boechorststraat 7
Amsterdam
1081BT
Netherlands

ORCiD logoORCID ID 0000-0001-5430-9810
Phone +31 (0)205988360
Email e.m.sijbrandij@vu.nl
Miss Anne de Graaff
Public

Van der Boechorststraat 7
Amsterdam
1081BT
Netherlands

ORCiD logoORCID ID 0000-0001-6686-4432
Phone +31 (0)205983833
Email a.m.de.graaff@vu.nl

Study information

Study designSingle-blind two-arm randomized controlled trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Community
Study typeTreatment
Participant information sheet http://strengths-project.eu/en/participants/
Scientific titleImplementation of Problem Management Plus in Syrian refugees: a randomized controlled trial RCT
Study acronymSTRENGTHS
Study objectivesProblem Management Plus (PM+) will reduce psychological distress among Syrian refugees in the Netherlands three months after receipt of the intervention.
Ethics approval(s)Approved 06/09/2017, Research Ethics Review Committee at VU Medical Center (BS7, kamer H-565, Amsterdam, Netherlands; +31 (0)20 -4445585; metc@vumc.nl), ref: NL61361.029.17
Health condition(s) or problem(s) studiedCommon mental disorders; Depression; Anxiety; Posttraumatic stress disorder
InterventionProblem Management Plus (PM+):
PM+ consists of five weekly in-person sessions of 90 minutes each with a non-specialist helper. The intervention is based on cognitive-behavioral therapy and problem solving, and incudes four evidence-based strategies: stress management (slow breathing exercise; session 1), problem-solving (session 2), behavioural activation (re-engaging with pleasant and task-oriented activities; session 3), and accessing social support (session 4). Homework practice is scheduled following each session and discussed in the next session. Psychoeducation is delivered in session 1 and relapse prevention discussed in session 5. In the current trial, the non-specialist helpers were Arabic (and Dutch or English) speaking. The non-specialist helpers received 8-day training on common mental disorders, basic counselling skills, delivery of intervention strategies, and self-care, followed by a practice-case. Helpers met weekly for group-supervision by a PM+ supervisor. PM+ trainers and supervisors were mental health professionals who had received 5-day training covering elements of training of helpers, and training and supervision skills.

Care as usual (CAU):
CAU includes all (mental) health services that individuals with a refugee background may access in the Netherlands, ranging from primary care services to specialist mental health care.

A randomization list with permuted block sizes (4-6-8) was generated in R by an independent researcher not involved in the rest of the study. Allocation concealment involved sealed opaque envelopes.
Intervention typeBehavioural
Primary outcome measurePsychological distress (Hopkins Symptom Checklist; HSCL-25) at screening/baseline, 1-week post-assessment, 3-month follow-up, 12-month follow-up
Secondary outcome measuresMeasured at screening/baseline, 1-week post-assessment, 3-month follow-up, 12-month follow-up unless noted:
1. Depression (HSCL-25 subscale)
2. Anxiety (HSCL-25 subscale)
3. Symptoms of post traumatic stress disorder (PTSD Checklist DSM-5; PCL-5)
4. Functional impairment (WHO Disability Assessment Schedule; WHODAS 2.0)
5. Self-identified problems (Psychological Outcomes Profiles; PSYCHLOPS)
6. Cost of care (Client Service Receipt Inventory; adapted CSRI)
7. Anger (Trait Anger Scale; STAS) at baseline and 1-week post assessment
8. Cortisol (hair cortisol concentrations) at baseline and 3-month follow up
Overall study start date01/03/2019
Completion date12/12/2022

Eligibility

Participant type(s)Patient
Age groupAdult
Lower age limit18 Years
SexBoth
Target number of participants184
Total final enrolment206
Key inclusion criteria1. Adults of 18 years or above
2. Syrian refugee
3. Arabic-speaking
4. Elevated levels of psychological distress (K10 >15) and reduced psychosocial functioning (WHODAS 2.0 >16)
Key exclusion criteria1. Acute medical conditions
2. Imminent suicide risk or expressed acute needs/protection risks (e.g., a young woman who expresses that she is at acute risk of being assaulted or killed)
3. Severe mental disorder (psychotic disorders, substance-dependence)
4. Severe cognitive impairment (e.g., severe intellectual disability or dementia)
5. Currently enrolled in a specialized psychological treatment program (e.g., EMDR, CBT)
Date of first enrolment07/03/2019
Date of final enrolment23/12/2021

Locations

Countries of recruitment

  • Netherlands

Study participating centres

Vrije Universiteit Amsterdam
Van der Boechorststraat 7
Amsterdam
1081BT
Netherlands
i-Pys mental health care
Metropolestraat 1c
Almere
1315 KK
Netherlands

Sponsor information

VU Amsterdam
University/education

Van der Boechorststraat 7
Amsterdam
1081BT
Netherlands

Phone +31 (0)205988951
Email a.van.straten@vu.nl
Website https://vu.nl/en
ROR logo "ROR" https://ror.org/008xxew50

Funders

Funder type

Government

Horizon 2020 Framework Programme
Government organisation / National government
Alternative name(s)
EU Framework Programme for Research and Innovation H2020, Horizon 2020, Rahmenprogramm Horizont 2020, Programa Marco Horizonte 2020, Programme-cadre Horizon 2020, Programma quadro Orizzonte 2020, Program ramowy Horyzont 2020, Horizont 2020, Horizonte 2020, Orizzonte 2020, Horyzont 2020, Horizon 2020 Framework Programme (H2020), H2020

Results and Publications

Intention to publish date31/12/2023
Individual participant data (IPD) Intention to shareYes
IPD sharing plan summaryStored in non-publicly available repository, Available on request
Publication and dissemination planPlanned publication in a high-impact peer-reviewed journal.
IPD sharing planThe Vrije Universiteit Amsterdam (VU) will keep a central data repository of all data collected in the STRENGTHS project. The data will be available upon reasonable request to the STRENGTHS consortium. Data access might not be granted to third parties when this would interfere with relevant data protection and legislation in the countries participating in this project and any applicable EU legislation regarding data protection. Interested researchers can contact Dr Marit Sijbrandij at e.m.sijbrandij@vu.nl to initiate the process.

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
Protocol article 20/01/2020 22/08/2022 Yes No

Editorial Notes

31/01/2023: The overall trial end date was changed from 31/12/2022 to 12/12/2022.
22/08/2022: Trial's existence confirmed by VUmc