- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05754164
Attention Control Training for the Prevention of PTSD in Firefighters
Study Overview
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Yunnan
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Kunming, Yunnan, China
- Kunming Training Corps of the National Fire and Rescue Administration
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- being an active firefighter and aged between 18 and 50
- with no history of severe PTSD
Exclusion Criteria:
- having suicidal ideation or intent
- having an active psychotic disorder other than PTSD
- prior participation in a cognitive-behavioral intervention
- concurrent participation in another study.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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No Intervention: Control
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Experimental: Attention Control Training
The Dot-Probe Paradigm was utilized within the Attention Bias Modification procedure.
The training sessions were comprised of 80 trials, which included facial expression photos depicting happiness, neutrality, and sadness, sourced from four male and four female actors.
A fixed cross (+) was presented on the computer screen's center for a duration of 500 milliseconds before each stimulus display, followed by the presentation of two images portraying distinct emotional expressions, which persisted for 500 milliseconds.
After the disappearance of the images, an arrow appeared in the location where they had been displayed, and participants were instructed to select the arrow that corresponded with the presented arrow.
In the ABM procedure, the arrow was consistently presented following the display of a more positive facial expression, such that in the instance of a sad-neutral face pair, the arrow would always appear in the location of the neutral facial expression image.
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Mobile app-based attention control training is an effective training method that can help people improve their ability to control attention.
It is generally recommended to undergo 4 weeks of training, with 3-4 sessions per week and one day between each session.
The specific operational method of this training may vary depending on different applications, but generally, training is presented in the form of a series of tasks.
These tasks may involve aspects such as focusing attention, inhibiting interference, and reacting quickly.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Attention Bias Score
Time Frame: Baseline
|
To quantify attention bias, response times (RTs) were analyzed in accordance with the established procedure to calculate the attention bias score (ABS).
Trials characterized by inaccurate responses or RTs of exceptional brevity (<150ms) or prolonged duration (>1200ms) were disregarded.
The computation of attention bias entailed determining the discrepancy between the mean RT in response to relatively positive stimuli and the mean RT in response to relatively negative stimuli.
A preference for happy faces was indicated by an average RT for happy facial expressions that were shorter than the average RT for neutral or sad facial expressions.
|
Baseline
|
|
Attention Bias Variability
Time Frame: Baseline
|
To quantify attention-bias variability (ABV), the experimental data were divided into 8 segments, and attention-bias scores were computed for each segment.
Subsequently, the standard deviation of attention-bias scores across segments was determined, and this value was divided by all trials ABS to account for ABS variability.
|
Baseline
|
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Posttraumatic Stress Disorder Checklist-Civilian Version
Time Frame: Baseline
|
The PCL-C scale (Posttraumatic Stress Disorder Checklist-Civilian Version) is a self-report questionnaire that assesses symptoms of post-traumatic stress disorder (PTSD) in adults who have experienced a traumatic event. The PCL-C is based on the DSM-IV criteria for PTSD and includes 17 items that correspond to the three symptom clusters of PTSD: re-experiencing, avoidance/numbing, and hyperarousal. The PCL-C scale is widely used in both clinical and research settings to screen for and assess PTSD symptoms. It is a quick and easy-to-administer tool that can help healthcare professionals identify individuals who may need further evaluation and treatment for PTSD. The PCL-C can also be used to monitor the severity of PTSD symptoms over time and to evaluate the effectiveness of PTSD treatments. |
Baseline
|
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Posttraumatic Stress Disorder Checklist-Civilian Version
Time Frame: Immediately Post-intervention
|
The PCL-C scale (Posttraumatic Stress Disorder Checklist-Civilian Version) is a self-report questionnaire that assesses symptoms of post-traumatic stress disorder (PTSD) in adults who have experienced a traumatic event. The PCL-C is based on the DSM-IV criteria for PTSD and includes 17 items that correspond to the three symptom clusters of PTSD: re-experiencing, avoidance/numbing, and hyperarousal. The PCL-C scale is widely used in both clinical and research settings to screen for and assess PTSD symptoms. It is a quick and easy-to-administer tool that can help healthcare professionals identify individuals who may need further evaluation and treatment for PTSD. The PCL-C can also be used to monitor the severity of PTSD symptoms over time and to evaluate the effectiveness of PTSD treatments. |
Immediately Post-intervention
|
|
Patient Health Questionnaire-9
Time Frame: Baseline
|
The Patient Health Questionnaire-9 (PHQ-9) was utilized to assess symptoms of depression.
The PHQ-9 is a selfreport questionnaire comprising 9 items, with a score range of 0-27, measuring depression-related symptoms experienced in the past two weeks
|
Baseline
|
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Patient Health Questionnaire-9
Time Frame: Immediately Post-intervention
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The Patient Health Questionnaire-9 (PHQ-9) was utilized to assess symptoms of depression.
The PHQ-9 is a selfreport questionnaire comprising 9 items, with a score range of 0-27, measuring depression-related symptoms experienced in the past two weeks
|
Immediately Post-intervention
|
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Generalized Anxiety Disorder 7-item scale
Time Frame: Baseline
|
The GAD-7 scale (Generalized Anxiety Disorder 7-item scale) is a self-report questionnaire used to assess symptoms of generalized anxiety disorder (GAD) in adults. The GAD-7 includes seven items that correspond to the DSM-IV criteria for GAD, such as feeling nervous, anxious or on edge, worrying too much, and having trouble relaxing. The GAD-7 is a brief and easy-to-use tool that has been validated in various settings, including primary care, psychiatric clinics, and community-based samples. It is designed to help healthcare professionals screen for and assess the severity of GAD symptoms in their patients. |
Baseline
|
|
Generalized Anxiety Disorder 7-item scale
Time Frame: Immediately Post-intervention
|
The GAD-7 scale (Generalized Anxiety Disorder 7-item scale) is a self-report questionnaire used to assess symptoms of generalized anxiety disorder (GAD) in adults. The GAD-7 includes seven items that correspond to the DSM-IV criteria for GAD, such as feeling nervous, anxious or on edge, worrying too much, and having trouble relaxing. The GAD-7 is a brief and easy-to-use tool that has been validated in various settings, including primary care, psychiatric clinics, and community-based samples. It is designed to help healthcare professionals screen for and assess the severity of GAD symptoms in their patients. |
Immediately Post-intervention
|
|
Attention Bias Score
Time Frame: Immediately Post-Intervention
|
To quantify attention bias, response times (RTs) were analyzed in accordance with the established procedure to calculate the attention bias score (ABS).
Trials characterized by inaccurate responses or RTs of exceptional brevity (<150ms) or prolonged duration (>1200ms) were disregarded.
The computation of attention bias entailed determining the discrepancy between the mean RT in response to relatively positive stimuli and the mean RT in response to relatively negative stimuli.
A preference for happy faces was indicated by an average RT for happy facial expressions that were shorter than the average RT for neutral or sad facial expressions.
|
Immediately Post-Intervention
|
|
Attention Bias Variability
Time Frame: Immediately Post-Intervention
|
To quantify attention-bias variability (ABV), the experimental data were divided into 8 segments, and attention-bias scores were computed for each segment.
Subsequently, the standard deviation of attention-bias scores across segments was determined, and this value was divided by all trials ABS to account for ABS variability.
|
Immediately Post-Intervention
|
Collaborators and Investigators
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
Additional Relevant MeSH Terms
Other Study ID Numbers
- XF002
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
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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