Ignite Creation Date:
2024-05-06 @ 11:41 AM
Last Modification Date:
2024-10-26 @ 12:48 PM
Study NCT ID:
NCT03571347
Status:
COMPLETED
Last Update Posted:
2022-11-07
First Post:
2018-06-18
Brief Title:
Self Help Plus for Asylum Seekers and Refugees in Europe
Sponsor:
Universita di Verona
Organization:
Universita di Verona
Study Overview
Official Title:
Refugee Emergency DEFining and Implementing Novel Evidence-based Psychosocial Interventions
Status:
COMPLETED
Status Verified Date:
2022-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
REDEFINE
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 ie 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 11 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 MINI 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
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 11 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 MINI 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
Detailed Description:
Asylum seekers and refugees will be randomized to receive the SH intervention or Enhanced Treatment as Usual The SH has been developed by WHO and collaborators working in the humanitarian field with expertise in global mental health and psychosocial interventions SH consists of a pre-recorded audio course delivered by facilitators in a group setting and complemented with an illustrated self-help book SH was designed to be relevant for large adversity-affected populations it is transdiagnostic easily adaptable to different cultures and languages and both meaningful and safe for people with and without mental disorders The format of SH is innovative in that it seeks to ensure that key intervention components are delivered as intended without the burden of extensive facilitator training SH programme is based on acceptance and commitment therapy ACT a form of cognitive-behavioral therapy with distinct features SH programme has two components a pre-recorded course and an illustrated self-help book Pre-recorded audio material culturally adapted is delivered across five 2-hour sessions to groups of up to 30 people The audio material imparts key information about stress management and guides participants through individual exercises and small group discussions To augment the audio recordings an illustrated self-help book reviews all essential content and concepts 19 Written manuals help briefly-trained non-specialist facilitators to conduct the course using the pre-recorded audio The SH intervention will be delivered by briefly-trained non-specialist facilitators
The control intervention will receive Enhanced Treatment as Usual
The control intervention will receive Enhanced Treatment as Usual
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None