iCBT and ABM for Reducing Depressive Symptoms in Firefighters

Sponsor
Adai Technology (Beijing) Co., Ltd. (Other)
Overall Status
Completed
CT.gov ID
NCT05741684
Collaborator
Kungming Training Corps of National Fire and Rescue Administration (Other)
138
1
2
8
17.2

Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Internet-delivered Cognitive Behavioral Therapy
  • Behavioral: Attention Bias Modification
N/A

Study Design

Study Type:
Interventional
Actual Enrollment :
138 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Combining Internet-Delivered Cognitive Behavioral Therapy and Attention Bias Modification for Depression in Firefighters
Actual Study Start Date :
Apr 1, 2022
Actual Primary Completion Date :
Jun 30, 2022
Actual Study Completion Date :
Dec 1, 2022

Arms and Interventions

Arm Intervention/Treatment
Experimental: iCBT and ABM

A combined internet-delivered Cognitive Behavioral Therapy (iCBT) and Attention Bias Modification (ABM) intervention to reduce depressive symptoms in firefighters.

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.

Behavioral: 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.

No Intervention: Control

No intervention

Outcome Measures

Primary Outcome Measures

  1. Patient Health Questionnaire-9 [Baseline]

    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

  2. Patient Health Questionnaire-9 [Immediately Post-intervention]

    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

  3. Attention Bias Score [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.

  4. Attention Bias Score [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.

  5. Attention Bias Variability [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.

  6. Attention Bias Variability [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 50 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Kunming Training Corps of the National Fire and Rescue Administration Kunming Yunnan China

Sponsors and Collaborators

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

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Adai Technology (Beijing) Co., Ltd.
ClinicalTrials.gov Identifier:
NCT05741684
Other Study ID Numbers:
  • XF001
First Posted:
Feb 23, 2023
Last Update Posted:
Feb 23, 2023
Last Verified:
Feb 1, 2023
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Feb 23, 2023