Effects of Mindfulness and Self-regulation Training on Anxiety, Depression, PTSD, and Leadership

NCT07084233 | Completed

• 1 other identifier: STUDY00009491
• Study Type: interventional
• Target: 174
• Locations: 1 country
• Sites: 1

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.

Conditions

Anxiety; Depression Disorder; PTSD - Post Traumatic Stress Disorder

Keywords

anxiety; depression; post-traumatic stress disorder; sleep quality; self-regulation; mindfulness; trauma-informed; resilience

Outcome Measures

Primary Outcomes (3)

• 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.

  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.

  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.

  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

  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

  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]

Study Arms (2)

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.

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.

Interventions

Mindfulness based, trauma informed, self-regulation skills training BEHAVIORAL

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.

MMFT arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Ukrainian speaker resident in Ukraine

You may not qualify if:

• Under 18 years of age

Sponsors & Collaborators

• Georgetown University: lead
• Ukrainian Catholic University: collaborator

Study Sites (1)

Ukrainian Catholic University

Lviv, Ukraine

Location

Related Publications (2)

• 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.

  PMID: 39419189 BACKGROUND

• Stanley, EA. (2019). Widen the Window: Training Your Brain and Body to Thrive during Stress and Recover from Trauma. Avery Books.

  BACKGROUND

MeSH Terms

Conditions

Anxiety Disorders; Combat Disorders; Depression; Stress Disorders, Post-Traumatic; Sleep Initiation and Maintenance Disorders; Self-Control

Condition Hierarchy (Ancestors)

Mental Disorders; Stress Disorders, Traumatic; Trauma and Stressor Related Disorders; Behavioral Symptoms; Behavior; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Social Behavior

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: The trial statistician (JQ) conducted the pre-specified primary and secondary outcome analyses with the two arms identified only by uninformative codes and was unmasked to the identity of the arms after those analyses were complete, when the manuscript was being prepared. Analyses undertaken after unmasking are identified as post hoc in the Methods and in Webtable 2 (protocol-outcome reporting table).
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 16, 2025
• First Posted: July 24, 2025
• Study Start: July 22, 2025
• Primary Completion: August 18, 2025
• Study Completion: September 18, 2025
• Last Updated: September 29, 2026

Record last verified: 2026-09

Data Sharing

• IPD Sharing: Will not share

Locations

UA (1)