Please select the arm or intervention descriptions that belong to the clinical trial below.
Title: Refugee Emergency: DEFining and Implementing Novel Evidence-based Psychosocial Interventions
Brief Summary: Background The flow of asylum seekers and refugees moving to European and bordering countries has progressively increased in the last years. This population is exposed to physical and mental challenges before and during displacement, and suffer continuing hardships after arrival in a High-Income Country. As a consequence, asylum seekers and refugees are extremely vulnerable to some common mental health conditions, i.e., post-traumatic stress disorder, anxiety, depression and other forms of disabling psychological distress. The World Health Organization has developed a new 5-session self-help intervention called Self-Help Plus (SH+) for managing stress and coping with adversity. SH+ has been evaluated in RCTs in low- and middle-income countries, however, there is no rigorous evidence on its cost-effectiveness in preventing the onset of mental disorders in HIC.

Objectives To evaluate the effectiveness and cost-effectiveness of the SH+ in asylum seekers and refugees with psychological distress resettled in six sites of five European countries (Italy, Austria, Germany, Finland, and two sites in the UK), as compared with enhanced treatment as usual (ETAU). The primary outcome is the reduction in the incidence of any mental disorders. Secondary outcomes are mental health symptoms, psychological functioning, well-being, drop-out rates, and economic outcomes.

Design This is a multicentre parallel-group randomized controlled trial, in which participants will have an equal probability (1:1) of being randomly allocated to the SH+ or the ETAU.

Methodology Asylum seekers and refugees who screen positive at the General Health Questionnaire (≥ 3) and without a formal diagnosis of any psychiatric disorders according to the M.I.N.I. International Neuropsychiatric Interview will enter the study. After random allocation they will receive the SH+ or the ETAU. Assessments will be performed by masked assessors immediately after intervention, at 6 months, and a 12 months after randomization.

Time frame The recruitment phase will last 12 months. After the screening, eligible participants will be assessed at baseline, post-intervention, and at 6- and 12-month follow-up. The SH+ delivery will be conducted in around 5 weeks.

Expected outcomes A reduction in the incidence of psychiatric diagnoses at 6-month follow-up, and a general improvement in mental health symptoms, psychological functioning, well-being, and economic outcomes at each assessment.


Options:
A: Arm Label: 1; Type: EXPERIMENTAL; Interventions: Behavioral: Stepping Stones | Arm Label: 2; Type: ACTIVE_COMPARATOR; Interventions: Behavioral: stepping Stones short | Intervention Type: BEHAVIORAL; Name: Stepping Stones; Assigned to Arm(s): 1 | Intervention Type: BEHAVIORAL; Name: stepping Stones short; Assigned to Arm(s): 2
B: Arm Label: Philani Intervention Program; Type: EXPERIMENTAL; Interventions: Behavioral: Philani Intervention Program | Arm Label: Standard Care; Type: NO_INTERVENTION; Interventions: N/A | Intervention Type: BEHAVIORAL; Name: Philani Intervention Program; Assigned to Arm(s): Philani Intervention Program
C: Arm Label: Self Help Plus; Type: EXPERIMENTAL; Interventions: Behavioral: Self Help Plus | Arm Label: Enhanced Treatment As Usual; Type: OTHER; Interventions: Other: Enhanced Treatment As Usual | Intervention Type: BEHAVIORAL; Name: Self Help Plus; Assigned to Arm(s): Self Help Plus | Intervention Type: OTHER; Name: Enhanced Treatment As Usual; Assigned to Arm(s): Enhanced Treatment As Usual
D: Arm Label: Family intervention; Type: EXPERIMENTAL; Interventions: Behavioral: Family intervention | Arm Label: Waitlist control; Type: NO_INTERVENTION; Interventions: N/A | Intervention Type: BEHAVIORAL; Name: Family intervention; Assigned to Arm(s): Family intervention

Answer: C