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临床试验/NCT05415306
NCT05415306尚未招募不适用

An Emoji-based Attention Bias Modification Intervention for Depressive Symptom Severity in Young Adults

Universiti Tunku Abdul Rahman0 个研究点目标入组 120 人开始时间: 2022年7月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
尚未招募
入组人数
120
主要终点
Attention Bias Index

研究概览

简要总结

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.

详细描述

Depression is a common mental health disorder and is a major cause of disability worldwide. Despite the wide range of treatments currently available, many individuals with depression do not acquire treatment for the disorder. Some patients are concerned about possible negative effects of antidepressants, although there is also a high rate of discontinuation among patients on antidepressant regimens. Relapse is a common occurrence, where at least 50% of the patients who recover from the first episode of depression will experience at least one more depressive episode. The consistent preference for psychological treatments over medication gives particular relevance to research aimed at developing suitable behavioral and psychological treatments for depression.

Digital mental health interventions could potentially improve access to mental health services and help overcome the stigma associated with seeking traditional mental health services. Vulnerable young people, especially individuals in rural or low-resource areas and marginalized communities face unequal access to mental health services. In contrast, there is an unprecedented surge in access to digital technology platforms and mobile devices among young adults worldwide. The mental healthcare access gap can be addressed by the opportunities provided by digital technology to provide better care for youth and young adults. The young adult demographic is a critical target group because it is the group with the highest incidence and prevalence of mood disorders. Many people often find it challenging to communicate about mental health issues, but if left unresolved, these issues can lead to deterioration of mental well-being.

A growing majority of young adults have access to mobile devices and the Internet. Meta-analyses of computerized and Internet-based treatments for depression found that they significantly reduced depressive symptoms compared to control groups. However, some methodological limitations were reported by the analyses, such as lack of follow-up testing, skewed post-intervention data, and lack of participant feedback. A review by Lamb et al. (2019) on the efficacy and practicality of remote psychotherapy for depression and anxiety disorders, reported that interventions that were administered over the telephone, through video-conferencing, or online were generally effective. Remote psychotherapy was reported to improve accessibility and convenience, especially for individuals living in rural and remote areas or individuals with limited mobility.

The dot-probe paradigm is a behavioral task widely employed to measure attention and perception biases. The task can be adapted in different ways to accommodate the investigation of various conditions such as generalized anxiety disorders, eating disorders, and substance use disorders. In the dot-probe task, two stimuli appear on a screen simultaneously in two separate spatial locations. One of the stimuli has an emotional valence, while the other is neutral. The stimuli then are removed, and a dot-probe appears in one of the locations where the stimuli were previously displayed. The subject's response times are recorded and a faster response to the probe when it appears in the previous location of a threatening stimulus is interpreted as vigilance for threat, indicating attentional bias.

Individuals suffering from emotional disorders exhibit negative attentional biases. Notably, this negative attention bias can also be present in non-depressed individuals with high risk of developing depression, as well as individuals who have recovered from episodes of depression. In general, studies on healthy adults show that the prefrontal cortex plays a role in response inhibition, specifically the right inferior frontal cortex region. When presented with competing stimuli, certain responses need to be inhibited in order to make a decision. In the case of attention biases, the lateral prefrontal cortex contributes by modulating responses to emotional information. Deficits in response inhibition result in a bias towards certain emotional information.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Single (Participant)

入排标准

年龄范围
18 Years 至 30 Years(Adult)
性别
All
接受健康志愿者
是

入选标准

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

排除标准

  • •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

研究组 & 干预措施

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.

干预措施: Attention Bias Modification (Behavioral)

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.

干预措施: Sham Training (Behavioral)

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.

干预措施: Deep-breathing training (Behavioral)

No-intervention control

No Intervention

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

结局指标

主要结局

Attention Bias Index

时间窗: Up to 14 days

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.

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

时间窗: Baseline and Day 14

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".

Post-Intervention Event-related Potentials

时间窗: Day 14

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.

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

时间窗: Baseline and Day 14

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".

次要结局

  • Heart Rate Variability(Day 1, Day 14)
  • Pre-Intervention Event-Related Potentials(Baseline)
  • Hair Cortisol(Day 1)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Poh Foong Lee, PhD

Assistant Professor

Universiti Tunku Abdul Rahman

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