Ignite Creation Date:
2025-12-25 @ 2:54 AM
Ignite Modification Date:
2025-12-31 @ 12:12 PM
Study NCT ID:
NCT07084233
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-08-15
First Post:
2025-07-16
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effects of Mindfulness and Self-regulation Training on Anxiety, Depression, PTSD, and Leadership
Sponsor:
Georgetown University
Organization:
Study Overview
Official Title:
Effects of Mindfulness and Self-regulation Training on Anxiety, Depression, PTSD, and Leadership: a Randomized Controlled Trial in Ukraine
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2025-08
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:
None
Brief Summary:
The goal of this study is to measure the effects of Mindfulness-based Mind Fitness Training (MMFT) on anxiety, depression, post-traumatic stress disorder, sleep quality, and leadership.
Detailed Description:
Globally, depressive disorders were the second highest cause of years lost to disability in 2021, having increased 36.5% since 2010, and anxiety disorders were sixth. Furthermore, 4% of the global population has had post-traumatic stress disorder at some point in their lives. In conflict-affected settings, such as Ukraine, the prevalence of these disorders can be especially high: 47% depression, 54% anxiety, and over 50% PTSD. Given this high mental illness burden, widespread disruption caused by Russian attacks, and a historically under-resourced mental health care system. Ukraine is an ideal setting to test novel digital mental health interventions (DMHIs) that can be delivered either standalone or by non-clinicians, and that may hold potential for other populations stressed and traumatized by armed conflict, natural disasters, and displacement.
Recent meta-analyses show that DMHIs reduce symptomology associated with anxiety disorders, depression, and PTSD. However, effects vary as a result of several factors, including populations targeted, level of support provided, and technology used. Furthermore, investigation of underlying mechanisms has mostly examined internet-based cognitive behavioral therapy, leaving the mechanisms active in other therapeutic approaches poorly understood.
The investigators propose to test a DMHI called Mindfulness-based Mind Fitness Training (MMFT) in the Ukrainian context. MMFT was designed with two goals in mind: (1) to improve self-regulation and resilience by widening individuals' windows of tolerance to stress arousal; and (2) to do so in a trauma/dysregulation-informed manner. MMFT cultivates two core skills, attentional control and tolerance for challenging experience, through (1) an understanding of the neurobiology of stress, trauma, and resilience; (2) mindfulness skills training; (3) body-based self-regulation skills training, drawn from body-based trauma therapies such as sensorimotor psychotherapy and Somatic Experiencing; and (4) concrete applications for daily life. MMFT's body-based self-regulation exercises, as well as its unique exercise sequence to gradually cultivate interoceptive awareness, make it distinct from other mindfulness-based interventions. This focus on grounding and gradual cultivation of interoceptive awareness is particularly important for populations with significant prior exposure to prolonged or overwhelming stress, so that they do not inadvertently become re-traumatized. A small pilot in early 2024, suggests MMFT is applicable and feasible in wartime Ukraine.
The investigators will randomize 200 participants in a 1:1 ratio to (i) a three-week MMFT course, or (ii) a waitlisted control group. Immediately prior to the course, all participants will complete a baseline questionnaire on demographics, anxiety, depression, post-traumatic stress disorder, sleep quality, and leadership. Three weeks later, after group (i) has completed the course, both groups will complete a similar endline questionnaire. Intention-to-treat analysis will be used to test for an effect of MMFT on anxiety, depression, post-traumatic stress disorder, sleep quality, and leadership.
The secondary objective of the study is to qualitatively understand participant experience of the sessions and of the three MMFT exercises, including their attitudes towards these sessions and their experience of the impacts. A small subset of the MMFT group (\~10 participants) will be randomly selected to take part in a one-time in-depth interview, lasting 30-60 minutes. Interview content will cover participant experience with the intervention, their reaction to the content and to the MMFT trainers, discussion of any barriers or challenges that they faced, and descriptions of any changes that they notice.
Recent meta-analyses show that DMHIs reduce symptomology associated with anxiety disorders, depression, and PTSD. However, effects vary as a result of several factors, including populations targeted, level of support provided, and technology used. Furthermore, investigation of underlying mechanisms has mostly examined internet-based cognitive behavioral therapy, leaving the mechanisms active in other therapeutic approaches poorly understood.
The investigators propose to test a DMHI called Mindfulness-based Mind Fitness Training (MMFT) in the Ukrainian context. MMFT was designed with two goals in mind: (1) to improve self-regulation and resilience by widening individuals' windows of tolerance to stress arousal; and (2) to do so in a trauma/dysregulation-informed manner. MMFT cultivates two core skills, attentional control and tolerance for challenging experience, through (1) an understanding of the neurobiology of stress, trauma, and resilience; (2) mindfulness skills training; (3) body-based self-regulation skills training, drawn from body-based trauma therapies such as sensorimotor psychotherapy and Somatic Experiencing; and (4) concrete applications for daily life. MMFT's body-based self-regulation exercises, as well as its unique exercise sequence to gradually cultivate interoceptive awareness, make it distinct from other mindfulness-based interventions. This focus on grounding and gradual cultivation of interoceptive awareness is particularly important for populations with significant prior exposure to prolonged or overwhelming stress, so that they do not inadvertently become re-traumatized. A small pilot in early 2024, suggests MMFT is applicable and feasible in wartime Ukraine.
The investigators will randomize 200 participants in a 1:1 ratio to (i) a three-week MMFT course, or (ii) a waitlisted control group. Immediately prior to the course, all participants will complete a baseline questionnaire on demographics, anxiety, depression, post-traumatic stress disorder, sleep quality, and leadership. Three weeks later, after group (i) has completed the course, both groups will complete a similar endline questionnaire. Intention-to-treat analysis will be used to test for an effect of MMFT on anxiety, depression, post-traumatic stress disorder, sleep quality, and leadership.
The secondary objective of the study is to qualitatively understand participant experience of the sessions and of the three MMFT exercises, including their attitudes towards these sessions and their experience of the impacts. A small subset of the MMFT group (\~10 participants) will be randomly selected to take part in a one-time in-depth interview, lasting 30-60 minutes. Interview content will cover participant experience with the intervention, their reaction to the content and to the MMFT trainers, discussion of any barriers or challenges that they faced, and descriptions of any changes that they notice.
Study Oversight
Has Oversight DMC:
False
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?: