AnxietyNCT07084233
Effects of Mindfulness and Self-regulation Training on Anxiety, Depression, PTSD, and Leadership
A study testing Mindfulness based, trauma informed, self-regulation skills training in people with Anxiety and Depression Disorder, run by Georgetown University at 1 site in Ukraine.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Anxiety, Depression Disorder, PTSD - Post Traumatic Stress Disorder
- What is being tested?
- Mindfulness based, trauma informed, self-regulation skills training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 174 participants
- Where
- 1 siteUkraine
- Study dates
- 22 Jul 2025to 18 Sep 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Ukrainian speaker resident in Ukraine
Who cannot join
- Under 18 years of age
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of Mindfulness and Self-regulation Training on Anxiety, Depression, PTSD, and Leadership: a Randomized Controlled Trial in Ukraine
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.
Read the 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.
- Being tested
- Mindfulness based, trauma informed, self-regulation skills training
- Keywords
- anxiety, depression, post-traumatic stress disorder, sleep quality, self-regulation, mindfulness, trauma-informed, resilience
- Medical subject headings
- Anxiety Disorders, Combat Disorders, Depression, Stress Disorders, Post-Traumatic, Sleep Initiation and Maintenance Disorders, Self-Control
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mindfulness based, trauma informed, self-regulation skills trainingBehavioural
The study intervention, MMFT, consists of 7.5 hours of live, online courses, in three sessions, over three weeks. The entire intervention group (n=100) will participate in each session simultaneously, with four trainers and two translators.
Session 1 (3 hours): This session will introduce three mind fitness exercises. Session 2 (3 hours): This session will begin with mind fitness practice and discussion about participants' experience with the exercises during the previous two weeks.
Session 3 (1.5 hours): This session is for participants to integrate course content at an experiential level-no new content will be offered. The session will include some guided practice, but mostly focus on answering questions from participants and/or providing guidance to participants for how to navigate challenges with practice.
During the three weeks participants are in the course, they will be asked to practice the MMFT techniques for 5-60 minutes per day.
| Study group | Role | What they receive |
|---|---|---|
| MMFT arm | Experimental | This arm will begin the three-week Mindfulness Mind Fitness Training course shortly after enrolling. This course consists of 7.5 hours of live, online, group instruction. Receives: Behavioral: Mindfulness based, trauma informed, self-regulation skills training |
| Waitlist-control | No intervention | This arm will receive no intervention of any kind during the study. Once the study is complete, they will be able to enroll in the same MMFT course that the intervention arm received. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Depression
Change in PHQ-9 (Patient Health Questionnaire-9) over three weeks. This 9-item self-report scale asks how often, over the past two weeks, respondents experienced core depressive symptoms; each item is rated 0-3 ("Not at all" to "Nearly every day") and summed for a total severity score ranging from 0 to 27.
Measured: T1 (time of enrollment) [i.e. immediately prior to randomization]; T2 (three weeks post-randomization) [i.e. immediately post completion of intervention in the intervention group]
Post-traumatic stress disorder symptoms
Change in post-traumatic stress over three weeks. The PCL-5 self-report measure uses a Likert scale (0-4) to quantify the extent to which the respondent is bothered by 20 PTSD-related symptoms that are summed for a total severity score of 0 to 80.
Measured: T1 (time of enrollment) [i.e. immediately prior to randomization]; T2 (three weeks post-randomization) [i.e. immediately post completion of intervention in the intervention group]
Anxiety
Change in GAD-7 (Generalized Anxiety Disorder-7) over three weeks. This 7-item self-report measure uses the same 0-3 Likert scale to capture the frequency of common anxiety symptoms in the past two weeks, yielding a total score of 0 to 21 that reflects overall anxiety severity.
Measured: T1 (time of enrollment) [i.e. immediately prior to randomization]; T2 (three weeks post-randomization) [i.e. immediately post completion of intervention in the intervention group]
Secondary outcomes (2)
Sleep quality
Change in Pittsburgh Sleep Quality Index (PSQI) over three weeks. This self-report instrument assesses sleep quality over the past month by combining 19 items into seven component scores (e.g., latency, duration, disturbances), each rated 0-3; the components are summed for a global score of 0 to 21, with higher totals indicating poorer overall sleep quality.
Measured: T1 (time of enrollment) [i.e. immediately prior to randomization]; T2 (three weeks post-randomization) [i.e. immediately post completion of intervention in the intervention group]
Leadership character
Change in character dimensions of leadership over three weeks. Participants self-report how frequently they apply each of eleven dimensions.
Measured: T1 (time of enrollment) [i.e. immediately prior to randomization]; T2 (three weeks post-randomization) [i.e. immediately post completion of intervention in the intervention group]
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jul 2025
- Study start22 Jul 2025
- Primary completion18 Aug 2025
- Study completion18 Sep 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for AnxietyStudies of the same condition, open and under way.
- More trials run by Georgetown UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 174 participants (actual)
Sponsor and investigators
- Lead sponsor
- Georgetown University
- Sponsor type
- University, hospital or other
- Collaborators
- Ukrainian Catholic University
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07084233
- Sponsor's protocol ID
- STUDY00009491
- Status last verified
- Sep 2026
- First submitted
- 16 Jul 2025
- Last updated
- 29 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Plessen CY, Panagiotopoulou OM, Tong L, Cuijpers P, Karyotaki E. Digital mental health interventions for the treatment of depression: A multiverse meta-analysis. J Affect Disord. 2025 Jan 15;369:1031-1044. doi: 10.1016/j.jad.2024.10.018. Epub 2024 Oct 15.
PubMed 39419189Stanley, EA. (2019). Widen the Window: Training Your Brain and Body to Thrive during Stress and Recover from Trauma. Avery Books.
Study at a glance
From the registry record, last updated by the sponsor on 29 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Mindfulness and Self-regulation Training on Anxiety, Depression, PTSD, and Leadership: a Randomized Controlled Trial in Ukraine
- ClinicalTrials.gov ID
- NCT07084233
- Acronym / sponsor ID
- STUDY00009491
- Keywords
- anxiety, depression, post-traumatic stress disorder, sleep quality, self-regulation, mindfulness, trauma-informed, resilience
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 174 participants (actual)
- Lead sponsor
- Georgetown UniversityUniversity, hospital or other
- Collaborators
- Ukrainian Catholic University
- Study start
- 22 Jul 2025 (actual)
- Primary completion
- 18 Aug 2025 (actual)
- Study completion
- 18 Sep 2025 (actual)
- First posted
- 24 Jul 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| MMFT arm | Experimental | Behavioral: Mindfulness based, trauma informed, self-regulation skills trainingThis arm will begin the three-week Mindfulness Mind Fitness Training course shortly after enrolling. This course consists of 7.5 hours of live, online, group instruction. |
| Waitlist-control | No intervention | –This arm will receive no intervention of any kind during the study. Once the study is complete, they will be able to enroll in the same MMFT course that the intervention arm received. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Ukrainian speaker resident in Ukraine
Key exclusion criteria (1 listed)
- Under 18 years of age
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Mindfulness based, trauma informed, self-regulation skills trainingThe study intervention, MMFT, consists of 7.5 hours of live, online courses, in three sessions, over three weeks. The entire intervention group (n=100) will participate in each session simultaneously, with four trainers and two translators. Session 1 (3 hours): This session will introduce three mind fitness exercises. Session 2 (3 hours): This session will begin with mind fitness practice and discussion about participants' experience with the exercises during the previous two weeks. Session 3 (1.5 hours): This session is for participants to integrate course content at an experiential level-no new content will be offered. The session will include some guided practice, but mostly focus on answering questions from participants and/or providing guidance to participants for how to navigate challenges with practice. During the three weeks participants are in the course, they will be asked to practice the MMFT techniques for 5-60 minutes per day. | Behavioural | MMFT arm |
Primary outcome
Depression
Time frame: T1 (time of enrollment) [i.e. immediately prior to randomization]; T2 (three weeks post-randomization) [i.e. immediately post completion of intervention in the intervention group]
Change in PHQ-9 (Patient Health Questionnaire-9) over three weeks. This 9-item self-report scale asks how often, over the past two weeks, respondents experienced core depressive symptoms; each item is rated 0-3 ("Not at all" to "Nearly every day") and summed for a total severity score ranging from 0 to 27.
Post-traumatic stress disorder symptoms
Time frame: T1 (time of enrollment) [i.e. immediately prior to randomization]; T2 (three weeks post-randomization) [i.e. immediately post completion of intervention in the intervention group]
Change in post-traumatic stress over three weeks. The PCL-5 self-report measure uses a Likert scale (0-4) to quantify the extent to which the respondent is bothered by 20 PTSD-related symptoms that are summed for a total severity score of 0 to 80.
Anxiety
Time frame: T1 (time of enrollment) [i.e. immediately prior to randomization]; T2 (three weeks post-randomization) [i.e. immediately post completion of intervention in the intervention group]
Change in GAD-7 (Generalized Anxiety Disorder-7) over three weeks. This 7-item self-report measure uses the same 0-3 Likert scale to capture the frequency of common anxiety symptoms in the past two weeks, yielding a total score of 0 to 21 that reflects overall anxiety severity.
2 secondary outcomes
Sleep quality
Time frame: T1 (time of enrollment) [i.e. immediately prior to randomization]; T2 (three weeks post-randomization) [i.e. immediately post completion of intervention in the intervention group]
Leadership character
Time frame: T1 (time of enrollment) [i.e. immediately prior to randomization]; T2 (three weeks post-randomization) [i.e. immediately post completion of intervention in the intervention group]
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Sep 2026.
- Background: PubMed 39419189Plessen CY, Panagiotopoulou OM, Tong L, Cuijpers P, Karyotaki E. Digital mental health interventions for the treatment of depression: A multiverse meta-analysis. J Affect Disord. 2025 Jan 15;369:1031-1044. doi: 10.1016/j.jad.2024.10.018. Epub 2024 Oct 15.
- BackgroundStanley, EA. (2019). Widen the Window: Training Your Brain and Body to Thrive during Stress and Recover from Trauma. Avery Books.
- Individual participant dataSharing planned: No
Related trials for Anxiety
Not yet recruiting
Effect of Stress Ball Use During Femoral Arterial Sheath Removal After Coronary Angiography
Femoral Arterial Sheath Removal, Stress Ball
Recruiting
Unified Protocol in Penitentiary Facilities
Depression Disorders, Anxiety
Not yet recruiting
Preventive and Personalized Digital Emotion Regulation Skills Intervention to Reduce Depression and Anxiety in Youths With Adverse Childhood Experiences
Adverse Childhood Experience, Depression / Major Depressive Disorder
Recruiting
Effect of a Brief Daily Digital Meditation on Well-Being in US Young Adults (BEGIN II)
Mental Health and General Well-being
Not yet recruitingObservational study
Functional Impact of Psychological Symptoms in Patients With Superior Semicircular Canal Dehiscence Syndrome (SSCD): a National Cross-sectional Study
Superior Semicircular Canal Dehiscence
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mindfulness based, trauma informed, self-regulation skills training in people with Anxiety and Depression Disorder, run by Georgetown University at 1 site in Ukraine.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Ukraine. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Depression (time frame: T1 (time of enrollment) [i.e. immediately prior to randomization]; T2 (three weeks post-randomization) [i.e. immediately post completion of intervention in the intervention group]). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07084233, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Sep 2026.