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Completed

NCT Number: NCT03567083

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

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.

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Key information

Conditions

Anxiety Anxiety Disorders Behavior Behavioral Symptoms Depression Mental Disorders Posttraumatic Stress Disorder Stress Disorders, Post-Traumatic Stress Disorders, Traumatic Trauma and Stressor Related Disorders

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

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

Istanbul, Sultanbeyli, 34930, Turkey (Türkiye)

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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)

Exclusion criteria

  • 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)

Treatment and study plan

Problem Management Plus (PM+)

Behavioral

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).

Primary outcomes

  1. 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)

    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.

Secondary outcomes

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

    Time frame: 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)

    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.

  2. Psychological Outcome Measures (PSYCHLOPS)

    Time frame: 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)

    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.

  3. Client Service Receipt Inventory (CSRI)

    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)

    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.

  4. Access to health care: own questionnaire

    Time frame: 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)

    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.

Sponsors and collaborators

Lead sponsor

Istanbul Sehir University

Other

Collaborators

  • European Commission

Registry information

Official study title

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

Acronym: STRENGTHS

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Jun 25, 2018
Registry last updated
May 19, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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