Clinical trial NCT05415306: Emoji-based Attention Bias Modification Training for Depressive Young Adults
Official title: An Emoji-based Attention Bias Modification Intervention for Depressive Symptom Severity in Young Adults
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Depressive Symptoms
Mood Disorders
Keywords: Attention
Attention Bias Modification
Lead sponsor: Universiti Tunku Abdul Rahman
Sponsor class: OTHER
First posted: 2022-06-13
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Maximum age (years): 30
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Detailed description: 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.

A common application of the dot-probe task is in attention bias modification (ABM), an experimental procedure for treatment of depression, with the intention of supplementing cognitive behavioural therapy (CBT) or as a treatment on its own. Besides treating emotional disorders, attention bias modification interventions are also being used to treat eating disorders, alcohol dependency, and social phobias. ABM procedures modify attention biases in emotional disorders, resulting in subjects learning to deploy their attention toward the more positive stimuli. 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. The effects of the attention bias training are assessed by examining the motivational outcomes on the subjects (i.e. depressive assessment scores). Studies examining the effects of ABM on depressive symptoms generally found reduced symptoms where the attentional biases were successfully modified.

Deep breathing is another promising approach to cognitive-behavioral interventions for mood disorders. Deep breathing exercises are known to decrease heart rate and stimulate parasympathetic relaxation. There are observable physical changes associated with breathing relaxation, such as reduced metabolism, muscle tension, brain activity and skin resistance. These effects are associated with lowered anxiety and depression, better quality of sleep, and enhanced concentration. This has led to a growing body of work regarding the use of deep breathing techniques to combat mental health symptoms associated with various physical and mental disorders. Deep breathing exercises have been employed in research on chronic cardiovascular disease, post-traumatic stress disorder (PTSD), pain management, depression, and anxiety.

In most deep breathing studies, the duration and frequency of the breathing patterns are notably different across different studies. In a study on the effect of deep breathing duration on depressive symptoms by Cheng et al. (2019), it was found that deep breathing for 5, 7 and 9 minutes produced higher activation of the parasympathetic nervous system compared to the control group. However, only deep breathing durations of 7 or 9 minutes produced significantly lower self-report depressive scores, with the 9-minute group achieving a larger effect size than the 7-minute group. As for breathing frequency, a rate of 6 breaths per minute has been extensively practiced in numerous studies as it has been found to result in significant differences in heart rate variability measures compared to other rates and natural breathing rates.

Attention bias modification paradigms and deep breathing exercises have potential as both standalone treatments for mood disorders and complementary regimens to pharmacotherapy. A meta-analysis has found that while psychotherapy and medication are both efficacious in improving depressive symptom severity, a combination of both provides significantly better outcomes for patients. The development of interventions such as attention bias modification and deep breathing training would contribute towards creating highly accessible tools for management and alleviation of depression symptoms. When administered in combination with other psychotherapy and antidepressant treatments, these remote interventions could improve the quality of the mental healthcare experience for patients and healthcare professionals.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

* 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

Primary outcomes:
measure: Attention Bias Index
timeFrame: Up to 14 days
measure: Post-Intervention Event-related Potentials
timeFrame: Day 14
measure: Change from Baseline Patient Health Questionnaire-9 (PHQ-9) Score at 14 days
timeFrame: Baseline and Day 14
measure: Change from Baseline Depression, Anxiety and Stress Scale-21 (DASS-21) Score at 14 days
timeFrame: Baseline and Day 14
Secondary outcomes:
measure: Heart Rate Variability
timeFrame: Day 1, Day 14
measure: Hair Cortisol
timeFrame: Day 1
measure: Pre-Intervention Event-Related Potentials
timeFrame: Baseline
Other outcomes:
Locations:
Study officials:
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