- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05741684
iCBT and ABM for Reducing Depressive Symptoms in Firefighters
February 21, 2023 updated by: Adai Technology (Beijing) Co., Ltd.
Combining Internet-Delivered Cognitive Behavioral Therapy and Attention Bias Modification for Depression in Firefighters
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
138
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
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Yunnan
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Kunming, Yunnan, China
- Kunming Training Corps of the National Fire and Rescue Administration
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 50 years (Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
No Intervention: Control
No intervention
|
|
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Experimental: iCBT and ABM
A combined internet-delivered Cognitive Behavioral Therapy (iCBT) and Attention Bias Modification (ABM) intervention to reduce depressive symptoms in firefighters.
|
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.
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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Patient Health Questionnaire-9
Time Frame: 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
|
Baseline
|
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Patient Health Questionnaire-9
Time Frame: 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
|
Immediately Post-intervention
|
|
Attention Bias Score
Time Frame: 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.
|
Baseline
|
|
Attention Bias Score
Time Frame: 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.
|
Immediately Post-intervention
|
|
Attention Bias Variability
Time Frame: 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.
|
Baseline
|
|
Attention Bias Variability
Time Frame: 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.
|
Immediately Post-intervention
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
April 1, 2022
Primary Completion (Actual)
June 30, 2022
Study Completion (Actual)
December 1, 2022
Study Registration Dates
First Submitted
February 12, 2023
First Submitted That Met QC Criteria
February 21, 2023
First Posted (Estimate)
February 23, 2023
Study Record Updates
Last Update Posted (Estimate)
February 23, 2023
Last Update Submitted That Met QC Criteria
February 21, 2023
Last Verified
February 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- XF001
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
IPD Plan Description
Data not available due to privacy and ethical considerations
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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