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: Home Care; Type: ACTIVE_COMPARATOR; Interventions: Behavioral: Home based, flexible, stepped care intervention | Arm Label: Wait-list; Type: OTHER; Interventions: Behavioral: Home based, flexible, stepped care intervention after 6 months. Families will be free to choose any health care they desire during the waiting period. | Intervention Type: BEHAVIORAL; Name: Home based, flexible, stepped care intervention; Assigned to Arm(s): Home Care | Intervention Type: BEHAVIORAL; Name: Home based, flexible, stepped care intervention after 6 months. Families will be free to choose any health care they desire during the waiting period.; Assigned to Arm(s): Wait-list
B: Arm Label: Care as usual; Type: NO_INTERVENTION; Interventions: N/A | Arm Label: Collaborations in Health (COACH); Type: EXPERIMENTAL; Interventions: Behavioral: Collaborations in Health (COACH) | Intervention Type: BEHAVIORAL; Name: Collaborations in Health (COACH); Assigned to Arm(s): Collaborations in Health (COACH)
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: CAMH training; Type: EXPERIMENTAL; Interventions: Other: CAMH training | Arm Label: No CAMH training; Type: NO_INTERVENTION; Interventions: N/A | Intervention Type: OTHER; Name: CAMH training; Assigned to Arm(s): CAMH training

Answer: C