NCT04380259

Mindfulness-Based Trauma Recovery for Refugees (MBTR-R)

Completed Phase 1, PHASE2 Last updated 8 May 2020

What this trial tests

Phase 1, PHASE2 trial testing Mindfulness-Based Trauma Recovery for Refugees (MBTR-R) in Stress Disorders, Post-Traumatic in 158 participants. Completed in 18 May 2019.

Timeline

10 May 2018

Primary endpoint
18 May 2019

18 May 2019

Quick facts

Lead sponsor	University of Haifa
Phase	Phase 1, PHASE2
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	158
Start date	10 May 2018
Primary completion	18 May 2019
Estimated completion	18 May 2019
Sites	1 location across Israel

Drugs / interventions tested

• Mindfulness-Based Trauma Recovery for Refugees (MBTR-R)

Conditions studied

• Stress Disorders, Post-Traumatic — all drugs for Stress Disorders, Post-Traumatic →
• Stress Related Disorder — all drugs for Stress Related Disorder →

Sponsor

University of Haifa

Who can join

Adults 18 to 65, any sex, with Stress Disorders, Post-Traumatic or Stress Related Disorder. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Worldwide, refugees and asylum seekers suffer at high rates from trauma- and stress-related mental health problems. The investigators thus developed Mindfulness-Based Trauma Recovery for Refugees (MBTR-R) - a 9-week, mindfulness- and compassion-based, trauma-sensitive and socio-culturally adapted, group intervention for refugees and asylum seekers. The overarching aims of the study were to, first, test whether MBTR-R is an efficacious and safe mental health intervention for traumatized refugees and asylum seekers with respect to stress- and trauma-related mental health outcomes; and, second, to test theorized mechanisms of action of MBTR-R. Accordingly, the investigators conducted a randomized waitlist-controlled trial among a community sample of female and male Eritrean asylum seekers in an urban post-displacement setting in the Middle East (Israel).

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Prevalence and prevention of suicidal ideation among asylum seekers in a high-risk urban post-displacement setting.
   Aizik-Reebs A, Yuval K, Beyene Kesete Y, Lurie I, et al · · 2022 · cited 5× · PMID 36245417 · DOI 10.1017/s2045796022000579