Emoji-based Attention Bias Modification Training for Depressive Young Adults

NCT05415306 | Unknown

• 1 other identifier: FRGS/1/2021/SKK06/UTAR/02/4
• Study Type: interventional
• Target: 120
• Locations: 0 countries
• Sites: N/A

Brief Summary

Globally, the rates of young adults and college students reporting symptoms of depression have been rising over the past decade. There are major obstacles being faced in mental healthcare that prevents many individuals from receiving sufficient and quality mental healthcare services. Current treatments for depression are not able to target the underlying factors causing the disorder. In addition, individuals with depressive symptoms face issues with accessibility and social stigma. Hence, there has been increasing interest in behavioural and cognitive mental health interventions with the potential for remote applications. This study aims to evaluate the feasibility and acceptability of using an emoji-based attention bias modification training paradigm on depressive symptom severity compared with a deep breathing practice protocol, a sham training protocol and a control group. It is expected that participants who undergo the attention bias modification training and deep breathing training paradigms will have reduced depressive symptom scores, changes in attention bias indices, and changes in event-related potential component measures compared to participants who did not undergo the interventions.

Conditions

Depressive Symptoms; Mood Disorders

Keywords

Attention; Attention Bias Modification

Outcome Measures

Primary Outcomes (4)

• Attention Bias Index

  The participant response times from the ABM task will be collected and used to obtain an attention bias index which is calculated using the formula: Attention bias index = ½ \[RpLe - RpRe) + (LpRe - LpLe)\] where R is right position, L is left position, p is the position of the probe, and e is the position of the emotional (positive/negative) stimulus. A positive score indicates a bias toward emotional stimuli, while a negative score indicates a bias away from emotional stimuli. A score of 0 indicates no bias in either direction. The higher the score value, the stronger the bias.

  Up to 14 days

• Post-Intervention Event-related Potentials

  Participants' EEG signal will be obtained using a 32-channel EEG system. EEG power in all bands and the event-related potential waveform will be extracted from the signal. ERP measures are widely adopted as an objective measure of the time course of attention during the dot-probe task.

  Day 14

• Change from Baseline Patient Health Questionnaire-9 (PHQ-9) Score at 14 days

  The PHQ-9 is a self-administered instrument for screening and monitoring the severity of depression. The PHQ-9 uses the following scale: a score of 0 to 4 indicates a severity of "None", 5 to 9 indicates "Mild", 10 to 14 indicates "Moderate', 15 to 19 indicates "Moderately Severe", and 20 to 27 indicates "Severe".

  Baseline and Day 14

• Change from Baseline Depression, Anxiety and Stress Scale-21 (DASS-21) Score at 14 days

  The DASS-21 is a questionnaire designed to assess the dimensions of depression, anxiety and stress. It consists of 21 self-report items. Depression severity is measured on the DASS-21 as follows: a score of 0 to 4 is labelled "Normal", 5 to 6 is "Mild", 7 to 10 is "Moderate", 11 to 13 is "Severe", and 14 and above is "Extremely Severe".

  Baseline and Day 14

Secondary Outcomes (3)

• Heart Rate Variability

  Day 1, Day 14

• Hair Cortisol

  Day 1

• Pre-Intervention Event-Related Potentials

  Baseline

Study Arms (4)

Attention Bias Modification Training

EXPERIMENTAL

Participants randomized to the ABMT group will undergo active attention bias modification training. The emoji-based ABMT protocol will be adapted from the attention bias modification task from Browning et al., 2012. The stimuli used during the task are pictures of emoji displaying emotional expressions that have valences that are either positive, neutral, or negative. The positive, negative and neutral emojis will be chosen from the outcome of a preliminary rating questionnaire.

Behavioral: Attention Bias Modification

Sham Training

SHAM COMPARATOR

Participants in the sham control group will receive a sham version of the ABMT task. This condition is identical to the active ABM condition except for the location of the probe, which replaces the positive, negative, and neutral stimuli with equal probability. This control procedure is not expected to modify any underlying biases present.

Behavioral: Sham Training

Deep-breathing training

ACTIVE COMPARATOR

The protocol for the deep breathing practice will be adapted from the procedure outlined in (Cheng et al., 2019). Participants randomized to the deep breathing group will undergo mindful deep breathing practice. Participants will be required to follow an instructional video and perform mindful deep breathing. The video guide will be sent to each participant in the deep breathing group, and they will be instructed to perform the exercise once a day at any time of their choice for the 14-day period.

Behavioral: Deep-breathing training

No-intervention control

NO INTERVENTION

Participants in the no-intervention control group will not be required to undergo any intervention.

Interventions

Attention Bias Modification BEHAVIORAL

Attention bias modification (ABM) is a procedure for treatment of depression, with the intention of supplementing cognitive behavioural therapy (CBT) or as a treatment on its own. ABM procedures modify attention biases in emotional disorders, resulting in subjects learning to deploy their attention toward the more positive stimuli (Jonassen et al., 2018). A computerized attention bias modification intervention for depression involves repeatedly redirecting the attention of the subject away from emotionally relevant threat cues, and towards neutral (non-threatening) stimuli (Amir et al., 2009). The location of the probe will replace the relatively positive stimulus in the pair with 100% probability.

Attention Bias Modification Training

Deep-breathing training BEHAVIORAL

In most deep breathing studies, participants are required to alter their breathing pattern to a specific frequency for a specific duration of time. In the present study, participants will be required to perform deep-breathing at a rate of 6 breaths per minute for 9 minutes.

Deep-breathing training

Sham Training BEHAVIORAL

This condition is identical to the Attention Bias Modification condition with the except of the location of the probe, which replaces the positive, negative, and neutral stimuli with equal probability. This control procedure is not expected to modify any underlying biases present.

Sham Training

Eligibility Criteria

• Age: 18 Years - 30 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Aged between 18 and 30 years old
• Give informed consent

You may not qualify if:

• Past or present diagnosis of other major psychiatric disorders (e.g., suicidality, substance dependence, psychosis)
• Recently started psychotropic or medical prescriptions within the previous two weeks
• Visual impairments that cannot be corrected with contact lenses or glasses

Sponsors & Collaborators

• Universiti Tunku Abdul Rahman: lead

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Related Links

• WHO Mental Disorders Fact Sheet

MeSH Terms

Conditions

Depression; Mood Disorders

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior; Mental Disorders

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: May 24, 2022
• First Posted: June 13, 2022
• Study Start: July 1, 2022
• Primary Completion: July 1, 2023
• Study Completion: September 1, 2024
• Last Updated: June 13, 2022

Record last verified: 2022-06

Data Sharing

• IPD Sharing: Will not share