To determine if a two-week ecological momentary intervention (two EMA + one EMI daily) as augmentation to treatment as usual would reduce depressive symptoms, rumination levels, and functioning in subjects with mild to moderate depression, as compared to active controls receiving three EMA prompts daily.
Background: Major Depressive Disorder (MDD) is the leading contributors to disability-adjusted life years, with a burden comparable to that of cardiovascular disease. Among the core symptoms of MDD, rumination stands out as a particularly pernicious factor. Rumination is dysfunctional disturbing thinking; a maladaptive pattern of regulating thoughts and emotions characterized by a repetitive focus on negative thoughts, such as dwelling on negative memories and analyzing events without taking actions. Rumination amplifies negative cognitions and attenuates the effect of adapting problem-solving strategy, decreasing the motivation of patients to cope with stressful encounters and become more vulnerable to momentary low mood. Interventional strategies (such as Cognitive Bias Modification) targeting rumination involves increases one's ability to become aware of their own rumination and supporting them to adapt alternative thinking habits. Complementary techniques such as mindfulness and relaxation do not involve the reframing of negative thoughts but rather promote the acceptance of these thoughts, in this way, it allows one become more aware of distractions and repetitive past or future thinking events. The ESM, a structured self-report diary technique several times a day over a number of days using mobile devices zooming in on the micro-level of experience and behavior, presents a novel and promising approach to accurately track symptoms and experience by minimizing recall bias and capturing the natural fluctuations of symptom on a more immediate, granular level. The ESM-derived intervention (ESM-I), uses personalized mobile feedback to effectively treat depressive symptoms. Importantly, increasing evidence from randomised controlled trials (RCTs) have shown ESM-I as effective means to augment interventions in depression. While improving rumination is key the core depression symptom, ESM-I has yet to specifically target rumination, and the mechanisms by which ESM-I exert therapeutic effects warrant further investigation. Objectives: Our study aims to investigate the efficacy of a newly developed smartphone based 2-week Ecological Momentary Intervention (EMI) in comparison with an active control group receiving only ESM, as an innovative, online-based, accessible, and augmentative treatment for depression. This intervention is designed to be both timely and adaptive, targeting the core symptom of anhedonia in a clinical sample within Hong Kong. Design: This is a single-center, randomized, double-blind, sham-controlled trial with three assessment time points: Baseline (T0), post-intervention (T1) and 1-month post-intervention (T2). Ecological Momentary Assessment (EMA): After providing informed consent, participants will install the "m-path" smartphone-based application, which is an open-source ESM program developed by KU Leuven. Following a briefing and practise run, participants will be randomly prompted within designated 3-hour blocks three times daily to complete a 5-minute questionnaire assessing their momentary affect, rumination levels, and suicidality, using visual analogue scales ranging from 0 (lowest) to 100 (highest). There will be 14 EMA questions covering affect (8 questions), suicidality (2 questions), and rumination (4 questions). Ecological Momentary Intervention (EMI): Embedded within the last EMA survey, the EMI arm will include interactive tasks when a participant's computed rumination score (i.e., mean score of the four EMA rumination questions) reaches above the 80th percentile of their own cumulative score, or if the raw rumination score reach above 70 out of 100. The intervention comprises of short exercises (most can be completed within 1-3 minutes) rooted in cognitive bias modification (CBM) techniques. Participants will interact with instructions and multimedia formats based on CBM module framework based on reflection / brooding. Participants will continue treatment with their psychiatrists who will be blinded to group allocation. Variables: * Hamilton Depression Rating Scale (HDRS) * Montgomery-Åsberg Depression Rating Scale (MADRS) * Social and Occupational Functioning Assessment scale (SOFAS) * Role Functioning Scale (RFS) * Global Functioning: Social Scale and Role Scale * Short Form Health Survey (SF-12) * General Self Efficacy Scale * Rumination Response Scale (RRS) * System Usability Scale - Chinese version * Beck Scale for Suicidal Ideation
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
80
University of Hong Kong
Hong Kong, Hong Kong
RECRUITINGEcological Momentary Assessment (EMA) outcomes
Average score among the following aspects: positive and negative affect (four questions each), active and passive suicidality (one question each), rumination (four questions); score ranges from 0 (minimal) to 100 (maximum), with a higher score indicating a greater value of measured aspect.
Time frame: During intervention
Montgomery-Åsberg Depression Rating Scale (MADRS)
Measuring change in depressive symptoms; score ranges from 0 (minimum) to 60 (maximum); higher score indicates more severe depressive symptoms.
Time frame: T0 (baseline); T1 (immedately after intervention); T2 (one-month after intervention follow-up)
Hamilton Depression Rating Scale (HDRS) - 17 items
Measuring depressive symptoms, score ranges from 0 (minimum) to 53 (maximum); higher score indicates more severe depressive symptoms.
Time frame: T0 (baseline); T1 (immedately after intervention); T2 (one-month after intervention follow-up)
Social and Occupational Functioning Assessment scale (SOFAS)
Measures social and occupational functioning across work functioning, independent functioning, immediate and extended social network functioning; score ranges from 0 (minimum) to 100 (maximum), higher score indicates higher social and occupational functioning ability.
Time frame: T0 (baseline); T1 (immedately after intervention); T2 (one-month after intervention follow-up)
Role Functioning Scale (RFS)
Measures role functioning in four areas: work productivity, independent living, immediate and extended social network relationships; score ranges from 0 (minimum) to 7 (maximum) on each aspect, higher score indicates better role functioning
Time frame: T0 (baseline); T1 (immedately after intervention); T2 (one-month after intervention follow-up)
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Global Functioning: Social Scale and Role Scale
Measures social and role functioning; score ranges from 1 (minimum) to 10 (maximum); higher score indicates better social/role functioning
Time frame: T0 (baseline); T1 (immedately after intervention); T2 (one-month after intervention follow-up)
WHO-5 Well-being Index
Measures wellbeing at a primary care setting; score ranges from 0 (minimum) to 100 (maximum) and is calculated by summing the total score and multiply it by 4. Higher score indicates better wellbeing
Time frame: T0 (baseline); T1 (immedately after intervention); T2 (one-month after intervention follow-up)
General Self Efficacy Scale
Measures self-reported self-efficacy; score ranges from 10 (minimum) to 40 (maximum), with higher scores indicating more self-efficacy
Time frame: T0 (baseline); T1 (immedately after intervention); T2 (one-month after intervention follow-up)
Rumination Response Scale (RRS)
Measures self-reported rumination responses; score ranges from 10 (minimum) to 40 (maximum), with higher scores indicating higher levels of ruminative responses styles.
Time frame: T0 (baseline); T1 (immedately after intervention); T2 (one-month after intervention follow-up)
Beck Scale for Suicidal Ideation
Measures self-reported suicidal ideation; score ranges from 0 (minimum) to 38 (maximum), with higher scores indicating a greater risk of suicide.
Time frame: T0 (baseline); T1 (immedately after intervention); T2 (one-month after intervention follow-up)
System Usability Scale - Chinese version
to assess acceptability and feedback regarding conducting EMA and EMI on mPath platform; scores ranges from 10 (minimum) to 50 (maximum), with higher scores indicating higher perceived usability of the systems involved.
Time frame: T1 (immedately after intervention); T2 (one-month after intervention follow-up)
Clinical Global Impression Scale
Measures the severity of illness and global improvement following an intervention; scores ranges from 1 (normal/very much improved) to 7 (most severely ill/very much worse), with higher scores indicating worse outcome.
Time frame: T1 (immedately after intervention); T2 (one-month after intervention follow-up)