NCT03587896 2018.
| Study name | Implementation of Self Help Plus in adult Syrian refugees in Turkey (RE‐DEFINE) |
| Methods | Randomised controlled trial |
| Participants |
Inclusion criteria 1. Age 18 or above 2. Able to speak and understand 1 Arabic 3. Asylum seeker or refugee or person under temporary protection 4. Presence of psychological distress, as shown by a score ≥ 3 on the 12‐item GHQ‐12 5. Both oral and written informed consent to enter the study Exclusion criteria 1. Presence of any mental disorders according to DSM‐5 and ICD‐10, as shown by a positive MINI 2. Acute medical condition contraindicating study participation 3. Clinical evidence of imminent suicide risk or suicide risk scored as ‘moderate or high’ (or a positive suicidality behaviour disorder) by the MINI (section Suicidality) 4. Clinical evidence that decision‐making capacity is impaired |
| Interventions |
Intervention SH+ programme A pre‐recorded audio course delivered by briefly trained, non‐specialist facilitators with a refugee or migrant background in a group setting of up to 30 people across five 2‐hour sessions complemented by an illustrated self‐help book. Based on acceptance and commitment therapy, SH+ includes techniques that aim to help people cope with stress, respond compassionately to themselves and others, and live in accordance with their values Control Enhanced treatment as usual Social support and/or care following local regulations; baseline and follow‐up assessments; information about freely available health and social services, and community networks that provide support to refugees and asylum seekers |
| Outcomes | 1. Psychological distress (GHQ‐12) 2. Psychiatric diagnosis (MINI) 3. Symptoms of PTSD (PCL‐5) 4. Depressive symptoms (PHQ‐9) 5. Subjective well‐being (WHO‐5) 6. Health‐related quality of life (EQ‐5D‐3L) 7. Self‐defined psychosocial goals (PSYCHLOPS) 8. Post‐migration stress difficulties (post‐migration living difficulties ‐ PMLDs) 9. Psychological functioning (WHODAS 2.0) 10. Cost‐effectiveness (CSSRI‐EU) |
| Starting date | 1 September 2018 |
| Contact information | marianna.purgato@univr.it |
| Notes | Terminated due to logistical reasons |