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AnxietySTRENGTHSNCT03567083

Implementation of Problem Management Plus (PM+) in Adult Syrian Refugees in Turkey: Pilot

A study testing Problem Management Plus (PM+) in people with Anxiety and Depression, run by Istanbul Sehir University at 1 site in Turkey (Türkiye).

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

To implement Problem Management Plus (PM+) in Syrian refugees with this pilot study in Turkey with the aim of informing the definitive RCT about drop-out rates and estimated effect sizes. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Anxiety, Depression, Posttraumatic Stress Disorder
What is being tested?
Problem Management Plus (PM+)
Could I receive a placebo?
No, everyone receives an active treatment
How many people
46 participants
Where
1 siteTurkey (Türkiye)
Study dates
23 Jun 2018to 21 Jan 2019
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Adults of 18 years or above
  • Syrian under temporary protection status
  • Arabic-speaking
  • Elevated levels of psychological distress (K10 >15.9) and reduced psychosocial functioning (WHODAS 2.0 >16)

Who cannot join

  • Acute medical conditions
  • 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)
  • Severe mental disorder (psychotic disorders, substance-dependence)
  • Severe cognitive impairment (e.g., severe intellectual disability or dementia)

Trial locations and contacts

1 site in 1 country.

Turkey (Türkiye)1 site

  • Refugee and Asylum Seekers Assistance and Solidarity Association's (RASASA)

    Istanbul, Sultanbeyli, 34930

Other trials in Turkey (Türkiye)

About this study

Official title: STRENGTHS: Fostering Responsive Mental Health Systems in the Syrian Refugee Crisis - The Turkey Site

To implement Problem Management Plus (PM+) in Syrian refugees with this pilot study in Turkey with the aim of informing the definitive RCT about drop-out rates and estimated effect sizes.

Read the detailed description

The STRENGTHS (Syrian REfuGees MeNTal HealTH Care Systems) study is a 5-year study that started in January 2017 with funding from the European Commission Horizon 2020 scheme and Turkey is one of the sites that this study will be conducted. The main aim of STRENGTHS in Turkey is to evaluate the feasibility, acceptability, effectiveness and cost-effectiveness of the culturally adapted psychological intervention Problem Management Plus (PM+) intervention for adult Syrian refugees in Turkey.

The current trial registration is for the pilot trial to investigate the feasibility and acceptability (e.g., obtain estimates of drop-out rates), to inform a full-scale, definitive randomized controlled trial. Study participants (n=60) will consist of adult Syrian refugees (18 years and older) in Turkey with self-reported functional impairment (WHODAS 2.0 >16) and elevated psychological distress (K10 >15.9). Participants will be randomly allocated either to the treatment group who will receive five sessions of PM+ or to the enhanced care-as-usual (E-CAU) group. Participants in the comparison group will receive E-CAU only. The primary outcome will be the decrease in psychological distress from baseline to three-month post-intervention assessment, measured through the Hopkins Symptoms Checklist (HSCL-25).

Being tested
Problem Management Plus (PM+)
Keywords
Refugees, Mental Health Problems
Medical subject headings
Anxiety Disorders, Depression, Stress Disorders, Post-Traumatic

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Problem Management Plus (PM+)Behavioural

    This intervention is based on the WHO treatment guidelines for conditions related to stress (WHO, 2013). It is a 5-session intervention that is delivered by trained non-specialized workers or lay people, and is available in individual and group delivery formats for both children and adults. PM+ includes evidence-based techniques such as; problem solving, stress management, behavioral activation, and accessing social support. It has proved to be effective by two randomized controlled trials (RCTs) in Kenya and Pakistan (Bryant, Dawson, Schafer, Sijbrandij, \& van Ommeren, 2016; Rahman, Hamdani, Awan, Bryant, Dawson, Khan, Mukhtar-ul-Haq Azeemi, et al., 2016).

Study groups in NCT03567083
Study groupRoleWhat they receive
E-CAU with Problem Management Plus (PM+)Experimental30 participants will be randomly assigned to E-CAU with PM+ group. The PM+ is developed by the World Health Organization (WHO) especially for the communities who are exposed to adversity. PM+ (Dawson et al., 2015) belongs to a set of programs which are low-intensity, shorter, less expensive and trans-diagnostic (i.e., not condition-specific, but targeted at a broader set of symptoms of common mental disorders) programs to reduce common mental health symptoms (including depression, anxiety and stress symptoms) and improve psychosocial functioning.
Receives: Behavioral: Problem Management Plus (PM+)
Enhanced care as usual (E-CAU) onlyNo intervention30 participants will be randomly assigned to E-CAU group. CAU ranges from the free health services government provides to Refugee and Asylum Seekers Assistance and Solidarity Association's (RASASA) mental health services which are provided by the Psychological Support Unit (MHPSS Support Unit) which includes counselling as well. The enhanced care arm (CAU, with the addition of a referral document), is to be used as a benchmark for measuring the effectiveness of STRENGTHS's intervention, which is Problem Management Plus (PM+).

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Hopkins Symptom Checklist-25 (HSCL-25)

    The aim is to measure the change in psychological distress. Sub-scales can be calculated for depression (13 items) and anxiety symptoms (10 items). There are two items related to somatic symptoms. The items are rated on a 1-4 point Likert scale, with a well-validated cut-off score of 1.75. The current study will primarily look at the total score in which the lower values represent a better outcome. Furthermore, aim is to examine changes in caseness in depression, a cut-off score for the depression sub-scale of 2.1 will be used.

    Measured: Change from baseline assessment, at 1 week post-intervention assessment (6 weeks after baseline), and change from post-assessment at 3 month post-intervention assessment (4-4.5 months after baseline)

Secondary outcomes (4)

  1. PTSD Checklist for DSM-5 (PCL-5)

    The aim is to measure the change in PTSD symptoms. PCL-5 is a 20-item checklist corresponding with the 20 DSM-5 PTSD symptoms. Items are rated on a 0-4 scale and add up to a total severity score of 80, with higher scores indicating worse symptomatology. The current study will primarily look at the total score in which the lower values represent a better outcome.

    Measured: Change from baseline assessment, at 1 week post-intervention assessment (6 weeks after baseline), and change from post intervention assessment at 3 month post-intervention assessment (4-4.5 months after baseline)

  2. Psychological Outcome Measures (PSYCHLOPS)

    The aim is to assess the change in self-identified problems. PSYCHLOPS consists of four questions. It contains three domains: 2 questions on problems, 1 question on function, and 1 question on well-being. Participants are asked to give free text responses to the problem and function domains. Responses are scored on a 0-5 scale producing a maximum score of 20 (six points per domain). The current study will primarily look at the total score in which the lower values represent a better outcome.

    Measured: Change from baseline assessment, at 1 week post-intervention assessment (6 weeks after baseline), and change from post intervention assessment at 3 month post-intervention assessment (4-4.5 months after baseline)

  3. Client Service Receipt Inventory (CSRI)

    The aim is to measure the change in the cost of care. CSRI was developed for the collection of data on service utilization, and related characteristics of people with mental disorders, as the basis for calculating the costs of care for mental health cost-effectiveness research. The current study will look at the change in the cost of care.

    Measured: Change from baseline assessment, at 1 week post-intervention assessment (6 weeks after baseline), and change from post-assessment at 3 month post-intervention assessment (4-4.5 months after baseline)

  4. Access to health care: own questionnaire

    The aim is to assess the change in access to health care. The questionnaire will include 70 questions on perceived access to health care. 57 of those questions will be two-way closed ended questions (yes or no) with the addition of the items "don't know" and "refused to answer". 13 of these questions are asking the type of help received (counselling/psychotherapy, psychological support, and medicines) with the addition of the items "don't know" and "refused to answer". The current study will look at the change in the access to health care.

    Measured: Change from baseline assessment, at 1 week post-intervention assessment (6 weeks after baseline), and change from the post-intervention assessment at 3 month post-intervention assessment (4-4.5 months after baseline)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted25 Jun 2018
  2. Study start23 Jun 2018
  3. Primary completion21 Jan 2019
  4. Study completion21 Jan 2019

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
46 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03567083
Sponsor's protocol ID
10/2017No:1
Acronym
STRENGTHS
Status last verified
May 2021
First submitted
8 Jun 2018
Last updated
19 May 2021
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: The STRENGTHS project is consisted of various partners from different sites (such as the Netherlands, Jordan, Germany etc.). It is planned that the individual sites will be sharing their data with the researchers who are from these project partners. In addition to this, the partners will use the same Study Protocol while adapting it to their site.

Publications

  • Dawson KS, Bryant RA, Harper M, Kuowei Tay A, Rahman A, Schafer A, van Ommeren M. Problem Management Plus (PM+): a WHO transdiagnostic psychological intervention for common mental health problems. World Psychiatry. 2015 Oct;14(3):354-7. doi: 10.1002/wps.20255. No abstract available.

    PubMed 26407793

  • Dawson KS, Schafer A, Anjuri D, Ndogoni L, Musyoki C, Sijbrandij M, van Ommeren M, Bryant RA. Feasibility trial of a scalable psychological intervention for women affected by urban adversity and gender-based violence in Nairobi. BMC Psychiatry. 2016 Nov 18;16(1):410. doi: 10.1186/s12888-016-1117-x.

    PubMed 27863515

  • Rahman A, Hamdani SU, Awan NR, Bryant RA, Dawson KS, Khan MF, Azeemi MM, Akhtar P, Nazir H, Chiumento A, Sijbrandij M, Wang D, Farooq S, van Ommeren M. Effect of a Multicomponent Behavioral Intervention in Adults Impaired by Psychological Distress in a Conflict-Affected Area of Pakistan: A Randomized Clinical Trial. JAMA. 2016 Dec 27;316(24):2609-2617. doi: 10.1001/jama.2016.17165.

    PubMed 27837602

  • Acarturk C, Uygun E, Ilkkursun Z, Yurtbakan T, Kurt G, Adam-Troian J, Senay I, Bryant R, Cuijpers P, Kiselev N, McDaid D, Morina N, Nisanci Z, Park AL, Sijbrandij M, Ventevogel P, Fuhr DC. Group problem management plus (PM+) to decrease psychological distress among Syrian refugees in Turkey: a pilot randomised controlled trial. BMC Psychiatry. 2022 Jan 4;22(1):8. doi: 10.1186/s12888-021-03645-w.

    PubMed 34983461

Questions about this trial

What is this clinical trial studying?

A study testing Problem Management Plus (PM+) in people with Anxiety and Depression, run by Istanbul Sehir University at 1 site in Turkey (Türkiye).

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 19 May 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Hopkins Symptom Checklist-25 (HSCL-25) (time frame: Change from baseline assessment, at 1 week post-intervention assessment (6 weeks after baseline), and change from post-assessment at 3 month post-intervention assessment (4-4.5 months after baseline)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03567083, which also lists 4 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 May 2021.

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