NCT04761510

Mindfulness-SOS: Stress Reduction for Refugees

Completed NA Last updated 21 February 2021

What this trial tests

NA trial testing Mindfulness-SOS for Refugees in Stress Disorders, Post-Traumatic in 60 participants. Completed in 14 January 2021.

Timeline

14 September 2020

Primary endpoint
14 January 2021

14 January 2021

Quick facts

Lead sponsor	University of Haifa
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	60
Start date	14 September 2020
Primary completion	14 January 2021
Estimated completion	14 January 2021
Sites	1 location across Israel

Drugs / interventions tested

• Mindfulness-SOS for Refugees

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

The COVID-19 pandemic crisis is associated with a wide range of stressors for the general population. For forcibly displaced persons (FDPs), the turmoil of this crisis is magnified significantly, and elevated pre-existing post-migration stressors and trauma-related mental health problems are acutely amplified. In a recent randomized control trial, Mindfulness-Based Trauma Recovery for Refugees (MBTR-R) led to large acute stress-buffering effects among Eritrean asylum seekers in Israel. The investigators thus developed Mindfulness-SOS for Refugees - a brief internet-based mobile-supported adaptation of the MBTR-R mental health intervention program - specifically designed to mitigate acute stress and related mental health symptoms among FDPs. The investigators will conduct a nonrandomized single-group intervention trial of the efficacy, safety, utilization, and related feasibility of Mindfulness-SOS for Refugees among a traumatized chronically stressed sample of East African asylum seekers in an urban post-displacement setting in the Middle East (Israel). The study will be carried out during an acutely stressful period of time for this population due to a COVID-19 pandemic national lockdown.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

1. COVID 19 pandemic challenges and their management: A review of medicines, vaccines, patents and clinical trials with emphasis on psychological health issues.
   Mohapatra S, Ayash Kumar P, Farooq U, Jain P, et al · · 2022 · cited 3× · PMID 35645588 · DOI 10.1016/j.jsps.2022.05.004
2. Nonrandomized Open Trial of a Mindfulness- and Compassion-Based Selective Preventive Mobile Health Intervention for Forcibly Displaced People.
   Zohar Puris S, Yuval K, Gebremariam G, Goldberg SB, et al · · 2025 · PMID 41050629 · DOI 10.1007/s12671-025-02675-9