Clinical trial NCT06430476: EMI Therapy for Depression in Hong Kong
Official title: Ecological Momentary Intervention (EMI) as Augmentative Therapy for Depression in Clinical Sample in Hong Kong
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Mild to Moderate Depression
Keywords: Depression
Ecological momentary intervention
Rumination
Hong Kong
Lead sponsor: The University of Hong Kong
Sponsor class: OTHER
First posted: 2024-05-28
Enrollment: 80
Sex: ALL
Minimum age (years): 16
Maximum age (years): 65
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: EMA arm: participants will receive three ecological momentary assessment (EMA) prompts daily with the prompts spread out throughout the day. Within each prompt, participants will answer 14 questions regarding affect, suicidality, and rumination. Afterwards, they will be shown a video clip extracted from a popular and longstanding soap opera in Chinese that lasts between three to four minutes. Each prompt would take around 8 minutes to complete. In total, participants will complete 70 EMA prompts during the intervention period.

EMI arm: participants will receive two EMA prompts and one EMI prompt daily. The EMA prompts would be identical to the ones in the EMA arm without the video clip at the end. The EMI prompt would contain an interactive task designed to counter ruminative thoughts.
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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

Eligibility criteria: Inclusion Criteria:

* Aged 16-65 years
* Cantonese-speaking ethnic Chinese
* Diagnosis of major depressive episode (MDE) established by the Structured Clinical Interview for Diagnostic and Statistical Manual of Mental Disorder 5th Edition (DSM-V)
* 17-item Hamilton Depression Rating Scale (HDRS) ≥ 14 at screening and at baseline (i.e. moderate to severe depression)
* Having a smartphone with Internet access and iOS or Android operating system.

Exclusion Criteria:

* Patients who could not read Chinese, are unable to provide informed consents
* Comorbid with other Axis I diagnoses (especially schizoaffective disorder)
* With an unstable medical condition or current substance abuse
* Have a score of ≥4 on any one of the three items on Positive and Negative Syndrome Scale (P1 Delusion, P2 Conceptual disorganization, P3 Hallucination)
* Marked risk of self-harm or suicide that could not be safely managed in an outpatient clinic setting
* Currently receiving any other weekly psychosocial therapy
* Unable to use a smartphone-based application due to cognitive impairment or learning disability or inadequate vision.

Primary outcomes:
measure: Ecological Momentary Assessment (EMA) outcomes
timeFrame: During intervention
measure: Montgomery-Åsberg Depression Rating Scale (MADRS)
timeFrame: T0 (baseline); T1 (immedately after intervention); T2 (one-month after intervention follow-up)
Secondary outcomes:
measure: Hamilton Depression Rating Scale (HDRS) - 17 items
timeFrame: T0 (baseline); T1 (immedately after intervention); T2 (one-month after intervention follow-up)
measure: Social and Occupational Functioning Assessment scale (SOFAS)
timeFrame: T0 (baseline); T1 (immedately after intervention); T2 (one-month after intervention follow-up)
measure: Role Functioning Scale (RFS)
timeFrame: T0 (baseline); T1 (immedately after intervention); T2 (one-month after intervention follow-up)
measure: Global Functioning: Social Scale and Role Scale
timeFrame: T0 (baseline); T1 (immedately after intervention); T2 (one-month after intervention follow-up)
measure: WHO-5 Well-being Index
timeFrame: T0 (baseline); T1 (immedately after intervention); T2 (one-month after intervention follow-up)
measure: General Self Efficacy Scale
timeFrame: T0 (baseline); T1 (immedately after intervention); T2 (one-month after intervention follow-up)
measure: Rumination Response Scale (RRS)
timeFrame: T0 (baseline); T1 (immedately after intervention); T2 (one-month after intervention follow-up)
measure: Beck Scale for Suicidal Ideation
timeFrame: T0 (baseline); T1 (immedately after intervention); T2 (one-month after intervention follow-up)
measure: System Usability Scale - Chinese version
timeFrame: T1 (immedately after intervention); T2 (one-month after intervention follow-up)
measure: Clinical Global Impression Scale
timeFrame: T1 (immedately after intervention); T2 (one-month after intervention follow-up)
Other outcomes:
Locations:
city: Hong Kong
country: Hong Kong
facility: University of Hong Kong
Study officials:
References:
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citation: Wang, Y., Lei, T., & Liu, X. (2020). Chinese System Usability Scale: Translation, Revision, Psychological Measurement. International Journal of Human-Computer Interaction, 36(10), 953-963. https://doi.org/10.1080/10447318.2019.1700644
citation: American Psychiatric Association. (2013). Diagnostic and statistical manual of mental disorders (5th ed.). https://doi.org/10.1176/appi.books.9780890425596
citation: Mestdagh M, Verdonck S, Piot M, Niemeijer K, Kilani G, Tuerlinckx F, Kuppens P, Dejonckheere E. m-Path: an easy-to-use and highly tailorable platform for ecological momentary assessment and intervention in behavioral research and clinical practice. Front Digit Health. 2023 Oct 18;5:1182175. doi: 10.3389/fdgth.2023.1182175. eCollection 2023.
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