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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05754164
Other study ID # XF002
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date April 1, 2022
Est. completion date December 1, 2022

Study information

Verified date February 2023
Source Adai Technology (Beijing) Co., Ltd.
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The study aimed to examine the effect of Attention Control Training (ACT) intervention on reducing PTSD symptoms in firefighters. The study was a randomized controlled trial carried out in Kunming, China, and involved the recruitment of 180 active firefighters as participants. The intervention lasted for an 8-week duration, during which participants participated in ACT exercises delivered through a smartphone application.


Recruitment information / eligibility

Status Completed
Enrollment 180
Est. completion date December 1, 2022
Est. primary completion date June 30, 2022
Accepts healthy volunteers No
Gender Male
Age group 18 Years to 50 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Behavioral:
Attention Control Training
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.

Locations

Country Name City State
China Kunming Training Corps of the National Fire and Rescue Administration Kunming Yunnan

Sponsors (2)

Lead Sponsor Collaborator
Adai Technology (Beijing) Co., Ltd. Kungming Training Corps of National Fire and Rescue Administration

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary Posttraumatic Stress Disorder Checklist-Civilian Version 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
Primary Posttraumatic Stress Disorder Checklist-Civilian Version 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
Primary Patient Health Questionnaire-9 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
Primary Patient Health Questionnaire-9 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
Primary Generalized Anxiety Disorder 7-item scale 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
Primary Generalized Anxiety Disorder 7-item scale 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
Primary Attention Bias Score 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
Primary Attention Bias Score 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
Primary Attention Bias Variability 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
Primary Attention Bias Variability 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
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