NCT05754164

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
180

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Apr 2022

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2022

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2022

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2022

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

February 22, 2023

Completed
9 days until next milestone

First Posted

Study publicly available on registry

March 3, 2023

Completed
Last Updated

March 3, 2023

Status Verified

February 1, 2023

Enrollment Period

3 months

First QC Date

February 22, 2023

Last Update Submit

February 22, 2023

Conditions

Keywords

PTSDAttention Control Training

Outcome Measures

Primary Outcomes (10)

  • 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

  • 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

  • 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

  • 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

  • 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

  • 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

  • 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

  • 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

  • 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

  • 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

Study Arms (2)

Attention Control Training

EXPERIMENTAL

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.

Behavioral: Attention Control Training

Control

NO INTERVENTION

Interventions

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.

Attention Control Training

Eligibility Criteria

Age18 Years - 50 Years
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • being an active firefighter and aged between 18 and 50
  • with no history of severe PTSD

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kunming Training Corps of the National Fire and Rescue Administration

Kunming, Yunnan, China

Location

MeSH Terms

Conditions

Stress Disorders, Post-Traumatic

Condition Hierarchy (Ancestors)

Stress Disorders, TraumaticTrauma and Stressor Related DisordersMental Disorders

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 22, 2023

First Posted

March 3, 2023

Study Start

April 1, 2022

Primary Completion

June 30, 2022

Study Completion

December 1, 2022

Last Updated

March 3, 2023

Record last verified: 2023-02

Data Sharing

IPD Sharing
Will not share

Locations