- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07426341
Mindfulness-based Writing Expression Training Among Military Personnel
The Effectiveness of Mindfulness-based Writing Expression Training on Stress and Cognitive Flexibility Among Military Personnel
The goal of this clinical trial is to learn if mindfulness-based writing expression training works to improve stress and cognitive flexibility among military personnel. The main questions it aims to answer are:
- Does the mindfulness-based writing expression training lower the scores of the perceived stress scale and of the cognitive flexibility inventory?
- Researchers will compare the mindfulness-based writing expression training to the regular mental health education to see if the mindfulness-based writing expression training works to relieve stress and enhance cognitive flexibility among military personnel.
Participants will:
The intervention group received five sessions of mindfulness-based expressive writing training.
The control group carried out activities according to the daily mental health education training without any additional intervention.
All participants completed assessments of cognitive flexibility and perceived stress using the Cognitive Flexibility Questionnaire and the Perceived Stress Scale, administered both prior to and following the randomized controlled trial.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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-
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Chongqing, China
- Army Medical University
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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Experimental: Mindfulness-based writing expression training group
The intervention group received five sessions of mindfulness-based expressive writing training.
Each session lasts for 40 to 60 minutes, including 10 minutes of mindfulness meditation, 20 to 30 minutes of writing expression, and 10 to 20 minutes of discussion and sharing.
This is done once a day for 5 consecutive days.
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Each intervention session followed a standardized protocol comprising: (1) a 5-minute guided mindfulness breathing exercise; (2) 20-30 minutes of expressive writing; (3) 10-20 minutes of facilitated group sharing and discussion; and (4) a concluding 5-minute guided mindfulness breathing exercise.
|
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Active Comparator: control group
The control group carried out regular mental health education activities during the same period, each session lasting 40 to 60 minutes, once a day for 5 consecutive days.
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Regular mental health education covers: common psychological problems among active-duty military personnel, methods for stress relief, and techniques for identifying and handling abnormal psychological conditions.
40 to 60 minutes each day, for a total of 5 days.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
perceived stress
Time Frame: Baseline: The perceived stress level of military personnel is evaluated one day before the intervention. After 5 sessions intervention, the same scale is used again to assess the perceived stress of the military personnel immediately afterwards.
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The Perceived Stress Scale (PSS) is used to measure the participants' perceived stress levels over the previous month.
This scale contains 14 items, including 7 measuring loss of control and 7 measuring perceived tension, with responses ranging from 0 (never) to 4 (always).
Notably, items 4, 5, 6, 7, 9, 10, and 13 are scored in reverse order.
The total scores ranged between 0 and 56, with higher scores indicating increased levels of stress.
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Baseline: The perceived stress level of military personnel is evaluated one day before the intervention. After 5 sessions intervention, the same scale is used again to assess the perceived stress of the military personnel immediately afterwards.
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cognitive flexibility
Time Frame: The cognitive flexibility level of military personnel is evaluated one day before the intervention. After 5 sessions intervention, the same scale is used again to assess the cognitive flexibility of the military personnel immediately afterwards.
|
The Cognitive Flexibility Inventory (CFI) is used to measure participants' cognitive flexibility levels.
It contains 20 items, which include 10 for control ability and 10 for alternatives, with responses ranging from 1 (strongly disagree) to 7 (completely agree).
Importantly, items 2, 4, 7, 9, 11 and 17 are scored in reverse order.
The total scores ranged between 20 and 140, with higher scores indicating higher cognitive flexibility levels.
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The cognitive flexibility level of military personnel is evaluated one day before the intervention. After 5 sessions intervention, the same scale is used again to assess the cognitive flexibility of the military personnel immediately afterwards.
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
anxiety
Time Frame: The anxiety level of military personnel was evaluated one day before the intervention. After 5 sessions intervention, the same scale was used again to assess the anxiety of the military personnel immediately afterwards.
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The anxiety levels of active-duty military personnel The participants' anxiety is measured by the Generalized Anxiety Disorder Scale (GAD-7).
It is a measure used to assess the severity of symptoms of generalized anxiety disorder.
This scale contains 7 items, the scores for each item, on the GAD range from 0 (not at all) to 3 (nearly every day), and the total score ranges from 0 to 21.
A higher total score indicates a higher level of anxiety.
GAD-7 score > 14 has been shown to indicate severe anxiety .
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The anxiety level of military personnel was evaluated one day before the intervention. After 5 sessions intervention, the same scale was used again to assess the anxiety of the military personnel immediately afterwards.
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depression
Time Frame: The depression level of military personnel is evaluated one day before the intervention. After 5 sessions intervention, the same scale is used again to assess the depression level of the military personnel immediately afterwards.
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The Patient Health Questionnaire (PHQ-9) is used to assess depression severity among military personnel.
The scale contains 9 items.
The response options for each item, of the PHQ-9 range from 0 (not at all) to 3 (nearly every day).
The total PHQ-9 score ranges from 0 to 27.
A higher total score indicates a higher level of depression.
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The depression level of military personnel is evaluated one day before the intervention. After 5 sessions intervention, the same scale is used again to assess the depression level of the military personnel immediately afterwards.
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posttraumatic growth
Time Frame: The posttraumatic growth level of military personnel is evaluated one day before the intervention. After 5 sessions intervention, the same scale is used again to assess the posttraumatic growth of the military personnel immediately afterwards.
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The Posttraumatic Growth Inventory (PTGI) is used to determine the positive changes that occur as a result of the traumatic events experienced by military personnel.
Participants are asked to rate the degree to which they have experienced the change described by each item.
The scale consists of 21 items in total and uses a 6-point Likert-type response scale ranging from 0 (almost never) to 5 (almost always).
The total score ranges from 0 to 105, and the higher the score is, the greater the level of posttraumatic growth.
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The posttraumatic growth level of military personnel is evaluated one day before the intervention. After 5 sessions intervention, the same scale is used again to assess the posttraumatic growth of the military personnel immediately afterwards.
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Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- ArmyMedUniversity
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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