iCBT and ABM for Reducing Depressive Symptoms in Firefighters

Depression Clinical Trial

Official title:

Combining Internet-Delivered Cognitive Behavioral Therapy and Attention Bias Modification for Depression in Firefighters

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05741684
• Other study ID #: XF001
• Status: Completed
• Phase: N/A
• 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
• Study type: Interventional

Clinical Trial Summary

The study aimed to examine the impact of a combined internet-delivered Cognitive Behavioral Therapy (iCBT) and Attention Bias Modification (ABM) intervention to reduce depressive symptoms in firefighters. The study was a randomized controlled trial carried out in Kunming, China, and involved the recruitment of 138 active firefighters as participants. The intervention lasted for an 8-week duration, during which participants participated in ABM exercises on alternating days and concurrently underwent four modules of iCBT courses delivered through a smartphone application.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 138
• Est. completion date: December 1, 2022
• Est. primary completion date: June 30, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 50 Years

Eligibility

Inclusion Criteria:

• being an active firefighter and aged between 18 and 50

• having a score greater than zero on the Patient Health Questionnaire-9 (PHQ-9)

• with no history of severe depression

Exclusion Criteria:

• having suicidal ideation or intent

• having an active psychotic disorder other than depression

• prior participation in a cognitive-behavioral intervention

• concurrent participation in another study.

Related Conditions & MeSH terms

• Depression

Intervention

Behavioral:
• Internet-delivered Cognitive Behavioral Therapy
iCBT was administered in an unguided fashion without human therapeutic support. Participants were instructed to progress through the eight core modules over an 8-week period. The modules comprised psychoeducational content centered around CBT, aimed at promoting the development of skills such as self-monitoring of emotions, cognitive distancing, cognitive reframing/restructuring, problem-solving, and mindfulness. In the event of technical difficulties during the intervention, participants were able to seek assistance.
• Attention Bias Modification
The Dot-Probe Paradigm was utilized within the Attention Bias Modification procedure. The training sessions were comprised of 96 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.

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	Patient Health Questionnaire-9	The Patient Health Questionnaire-9 (PHQ-9) was utilized to assess symptoms of depression. The PHQ-9 is a self-report 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 self-report 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	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