Recruitment

Recruitment Status
Active, not recruiting
Estimated Enrollment
600

Summary

Conditions
Stress Psychological
Type
Interventional
Phase
Not Applicable
Design
Allocation: RandomizedIntervention Model: Parallel AssignmentIntervention Model Description: RE-DEFINE is a prospective, multicentre, randomized, parallel-group trial that will follow study participants over a period of 12-months. Asylum seekers and refugees with psychological distress, but without a mental disorder according to the MINI International Neuropsychiatric Interview (M.I.N.I.) for DSM-V and ICD-10, will be randomly assigned to the Self Help Plus intervention or to enhanced treatment as usual (ETAU).Masking: Single (Outcomes Assessor)Masking Description: Participants, facilitators, and research staff involved in the screening and baseline assessment will not be blind to the interventions provided during the trial. Outcomes assessors will be kept blind to the study conditions.Primary Purpose: Prevention

Participation Requirements

Age
Between 18 years and 125 years
Gender
Both males and females

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 ...

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.

Tracking Information

NCT #
NCT03571347
Collaborators
  • World Health Organization
  • VU University of Amsterdam
  • University of Vienna
  • University of Ulm
  • The International Federation of Red Cross and Red Crescent Societies
  • University of Turku
  • University of Liverpool
  • University of York
Investigators
Not Provided