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PTSDNCT05754164

Attention Control Training for the Prevention of PTSD in Firefighters

A study of PTSD, run by Adai Technology (Beijing) Co., Ltd. at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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. Read more about this study

Who is it for?
Ages 18 to 50 years, men only
Conditions the study is for
PTSD
Could I receive a placebo?
No, everyone receives an active treatment
How many people
180 participants
Where
1 siteChina
Study dates
1 Apr 2022to 1 Dec 2022
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 50 years
  • Men only
  • No healthy volunteers
  • Adult

Who may be able to join

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

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country.

China1 site
  • Kunming Training Corps of the National Fire and Rescue Administration

    Kunming, Yunnan

Other trials in China

About this study

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.

Conditions
PTSD
Being tested
Attention Control Training
Keywords
PTSD, Attention Control Training
Medical subject headings
Stress Disorders, Post-Traumatic

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Attention Control TrainingBehavioural

    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.

Study groups in NCT05754164
Study groupRoleWhat they receive
Attention Control TrainingExperimentalThe 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.
Receives: Behavioral: Attention Control Training
ControlNo interventionNot described

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: Baseline

  2. 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.

    Measured: Immediately Post-intervention

  3. 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

    Measured: Baseline

  4. 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

    Measured: Immediately Post-intervention

  5. 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.

    Measured: Baseline

  6. 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.

    Measured: Immediately Post-intervention

  7. 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.

    Measured: Baseline

  8. 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.

    Measured: Immediately Post-Intervention

  9. 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.

    Measured: Baseline

  10. 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.

    Measured: Immediately Post-Intervention

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted3 Mar 2023
  2. Study start1 Apr 2022
  3. Primary completion30 Jun 2022
  4. Study completion1 Dec 2022

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
180 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05754164
Sponsor's protocol ID
XF002
Status last verified
Feb 2023
First submitted
22 Feb 2023
Last updated
3 Mar 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study of PTSD, run by Adai Technology (Beijing) Co., Ltd. at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 3 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Posttraumatic Stress Disorder Checklist-Civilian Version (time frame: Baseline). The study lists 10 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Mar 2023.

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