Stress Disorders, Post-Traumatic Clinical Trial
Official title:
Mindfulness-SOS: Stress Reduction for Refugees
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.
Brief Background: The COVID-19 pandemic is associated with a range of stressors and consequent mental health problems. For tens of millions of FDPs, stressors and sequelae of the pandemic are particularly magnified and severe, as their preexisting stress-related mental health problems are acutely exacerbated. In a recent randomized control trial prior to the COVID-19 pandemic, the investigators found significant therapeutic effects of MBTR-R - a 9-week, mindfulness- and compassion-based, trauma-sensitive, and socio-culturally adapted group intervention program designed for FDPs - for stress- and trauma-related mental health outcomes among Eritrean asylum seekers in Israel. In light of the COVID-19 pandemic, and to facilitate access, reach, and flexibility of mental health care among FDPs, the investigators 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. Study Aims: Broadly, the study aims are: I) to test the efficacy of the Mindfulness-SOS for Refugees intervention program on stress- and trauma-related mental health outcomes (e.g. posttraumatic stress, depression), II) to test intervention safety - including rates of clinically significant deterioration in primary outcomes in response to the intervention, III) to assess participant utilization of the Mindfulness-SOS for Refugees intervention program, IV) to test whether Mindfulness-SOS for Refugees will lead to changes in targeted processes or mechanisms of change including mindful awareness and self-compassion, and V) to test whether expected pre-to-post intervention change in the targeted processes will predict expected pre-to-post intervention change in stress- and trauma-related mental health outcomes. Study Overview: Accordingly, the investigators will conduct a nonrandomized single-group intervention trial among a community sample of traumatized and chronically stressed East African asylum seekers (N=60, 50% female), residing in Israel in an urban post-displacement setting, during the COVID-19 pandemic. Over the course of three successive months, participants will be recruited from the community via public flyers, social networks, local non-governmental- (NGOs), and municipal- organizations working with FDPs. Participants will be assigned to Mindfulness-SOS for Refugees - a brief internet-based mobile-supported intervention program, entailing 8 brief sessions as well as 9 mindfulness meditation practice exercises - delivered via audio recordings using participants' personal smartphones. Over the course of the Mindfulness-SOS for Refugees intervention program, participants will receive administrative guidance (e.g. technical support in case of mobile phone and internet platform-related difficulties and relevant information of the internet-based mobile-supported intervention program and assessment); as well as adherence-focused guidance (e.g. adherence monitoring including weekly brief check-in telephone calls and smartphone text-based nudges to remind and prompt weekly adherence and assessment), in the participants' mother tongue, Tigrinya. Stress- and trauma-related mental health outcomes and targeted change processes will be assessed via self-report questionnaires pre-intervention, brief weekly assessments, and post-intervention. In addition to participants' self-report, participant-level utilization of the Mindfulness-SOS for Refugees intervention program will be digitally monitored. Participants will be encouraged to complete 2 sessions per week and practice each day for 4 weeks but can choose to extend this up to 8 weeks. Post-intervention assessments will be carried out when participants will complete the 8 sessions of the internet-based mobile-supported intervention program (recommended 4 weeks, a maximum of 8 weeks post-baseline, or when participants will indicate that they are no longer interested in participating in the intervention program). The intervention program and assessments will be completed on participants' smartphones. ;
Status | Clinical Trial | Phase | |
---|---|---|---|
Recruiting |
NCT05620381 -
Health and Sleep Assessment After the Strasbourg Attacks of December 11, 2018
|
||
Completed |
NCT02856412 -
Improving Mind/Body Health and Functioning With Integrative Exercise
|
N/A | |
Recruiting |
NCT05400200 -
PTSD and Self-regulation: Coping, Emotional Regulation and Cognitive Control and Their Relationships to Symptom Management
|
N/A | |
Not yet recruiting |
NCT06088303 -
Enhancing PTSD Treatment Outcomes by Improving Patient-Provider Communication
|
N/A | |
Not yet recruiting |
NCT03652922 -
Propranolol Reactivation Mismatch (PRM) Treatment for PTSD
|
Phase 4 | |
Completed |
NCT02875912 -
Prospective Evaluation of Family Care Rituals in the ICU
|
N/A | |
Completed |
NCT01589575 -
Anxiety and Depression in Relatives of Critically Ill Patients: Spouses Versus Other Close Relatives
|
N/A | |
Completed |
NCT01291368 -
Sedation Influence on Delirium and Post-traumatic Stress-disorder as a Result of Hospitalization in Intensive Care
|
N/A | |
Completed |
NCT00990106 -
Augmentation Trial of Prazosin for Post-Traumatic Stress Disorder (PTSD)
|
N/A | |
Active, not recruiting |
NCT00657787 -
Development of a Post-Traumatic Stress Disorder (PTSD) Population Registry for Veterans
|
||
Completed |
NCT00835627 -
Treatment Trial for Psychogenic Nonepileptic Seizures
|
Phase 4 | |
Completed |
NCT00880152 -
Mindfulness Based Stress Reduction for Posttraumatic Stress Disorder: A Pilot Study
|
N/A | |
Completed |
NCT01365247 -
Concurrent Treatment for Substance Dependent Individuals With Post-Traumatic Stress Disorder (PTSD)
|
N/A | |
Completed |
NCT00419029 -
Motivational Interviewing to Engage Operations Enduring Freedom and Iraqi Freedom (OEF/OIF) Veterans in Mental Health Treatment
|
N/A | |
Completed |
NCT00514956 -
Effect of Emotional Freedom Technique and Diaphragmatic Breathing on Post Traumatic Stress Disorder (PTSD)
|
Phase 1 | |
Completed |
NCT00333710 -
Evaluating a Telehealth Treatment for Veterans With Hepatitis C and PTSD
|
N/A | |
Completed |
NCT01120847 -
Post Traumatic Stress Disorder (PTSD), Sleep Disordered Breathing And Genetics: Effects On Cognition
|
||
Completed |
NCT00069225 -
Brain Structure and Function Before and After Treatment for Post-Traumatic Stress Disorder
|
N/A | |
Completed |
NCT00055354 -
Acupuncture for the Treatment of Post-Traumatic Stress Disorder (PTSD)
|
N/A | |
Completed |
NCT00186212 -
Alternative Support for Rural and Isolated Women in an HMO
|
Phase 3 |