## Protocol Section
### Identification Module
**NCT ID:** NCT06430476

**Brief Title:** EMI Therapy for Depression in Hong Kong

**Official Title:** Ecological Momentary Intervention (EMI) as Augmentative Therapy for Depression in Clinical Sample in Hong Kong

#### Organization Study ID Info
**ID:** EMI_depression
#### Organization
**Class:** OTHER
**Full Name:** The University of Hong Kong
### Status Module
#### Completion Date
**Date:** 2024-08-31

**Type:** ESTIMATED

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-28

**Type:** ACTUAL

**Last Update Submit Date:** 2024-05-23

**Overall Status:** RECRUITING

#### Primary Completion Date
**Date:** 2024-08-31

**Type:** ESTIMATED

#### Start Date
**Date:** 2024-05-31

**Type:** ESTIMATED

**Status Verified Date:** 2024-04

#### Study First Post Date
**Date:** 2024-05-28
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-14
**Study First Submit QC Date:** 2024-05-23
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** OTHER

**Name:** The University of Hong Kong

#### Responsible Party

**Type:** SPONSOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

**Oversight Has DMC:** False

### Description Module

**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 (15). 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) (Morosini et al., 2000)
* 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

### Conditions Module

**Conditions:**

- Mild to Moderate Depression

**Keywords:**

- Depression

- Ecological momentary intervention

- Rumination

- Hong Kong

### Design Module

#### Design Info

**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.

##### Masking Info

**Masking:** QUADRUPLE

**Masking Description:** masking: Participants will be notified that they would engage in a diary recording activity for two weeks, but would be blinded to whether they were receiving the intervention or active control version. Trained research assistents would assess outcomes and the principal investigator would randomise participants to the two conditions based on anonymised IDs. Treatment provided to participants as usual by their usual care providers (e.g., doctors) would not be notified about the randomisation conditions.

**Who Masked:**

- PARTICIPANT

- CARE_PROVIDER

- INVESTIGATOR

- OUTCOMES_ASSESSOR

**Primary Purpose:** TREATMENT

#### Enrollment Info

**Count:** 40

**Type:** ESTIMATED

**Phases:**

- NA

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** Ecological momentary assessment (EMA) arm: participants will receive three ecological momentary assessment (EMA) prompts daily within three time blocks 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.

**Intervention Names:**

- Other: EMI

**Label:** EMA

**Type:** ACTIVE_COMPARATOR

#### Arm Group 2

**Description:** EMI arm: participants in this arm will receive two ecological momentary assessment (EMA) prompts and one econological momentary intervention (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. Examples of the interactive tasks include: mindfulness exercises (mindful walking), cognitive reappriasal, strengths recognition, etc. Each EMI prompt would last around 3-5 minutes.

**Intervention Names:**

- Other: EMI

**Label:** EMI

**Type:** EXPERIMENTAL

### Interventions

#### Intervention 1

**Arm Group Labels:**

- EMA

- EMI

**Description:** A phone-based intervention carried out on an experience sampling platform m-Path

**Name:** EMI

**Type:** OTHER

### Outcomes Module

#### Primary Outcomes

**Description:** Gold standard for measuring depressive symptoms, score ranges from 0 (minimum) to 53 (maximum); higher score indicates more severe depressive symptoms.

**Measure:** Hamilton Depression Rating Scale (HDRS) - 17 items

**Time Frame:** T0 (baseline); T1 (immedately after intervention); T2 (one-month after intervention follow-up)

**Description:** Measuring change in depressive symptoms; score ranges from 0 (minimum) to 60 (maximum); higher score indicates more severe depressive symptoms.

**Measure:** Montgomery-Åsberg Depression Rating Scale (MADRS)

**Time Frame:** T0 (baseline); T1 (immedately after intervention); T2 (one-month after intervention follow-up)

#### Secondary Outcomes

**Description:** Reference (Morosini et al., 2000); 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.

**Measure:** Social and Occupational Functioning Assessment scale (SOFAS)

**Time Frame:** T0 (baseline); T1 (immedately after intervention); T2 (one-month after intervention follow-up)

**Description:** 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

**Measure:** Role Functioning Scale (RFS)

**Time Frame:** T0 (baseline); T1 (immedately after intervention); T2 (one-month after intervention follow-up)

**Description:** Measures social and role functioning; score ranges from 1 (minimum) to 10 (maximum); higher score indicates better social/role functioning

**Measure:** Global Functioning: Social Scale and Role Scale

**Time Frame:** T0 (baseline); T1 (immedately after intervention); T2 (one-month after intervention follow-up)

**Description:** Measures impacts of overall physical and emotional health on individuals' day to day living; score ranges from 0 (minimum) to 100 (maximum), higher score indicates better physical and mental health functioning

**Measure:** Short Form Health Survey (SF-12)

**Time Frame:** T0 (baseline); T1 (immedately after intervention); T2 (one-month after intervention follow-up)

**Description:** Measures self-reported self-efficacy; score ranges from 10 (minimum) to 40 (maximum), with higher scores indicating more self-efficacy

**Measure:** General Self Efficacy Scale

**Time Frame:** T0 (baseline); T1 (immedately after intervention); T2 (one-month after intervention follow-up)

**Description:** Measures self-reported rumination responses; score ranges from 10 (minimum) to 40 (maximum), with higher scores indicating higher levels of ruminative responses styles.

**Measure:** Rumination Response Scale (RRS)

**Time Frame:** T0 (baseline); T1 (immedately after intervention); T2 (one-month after intervention follow-up)

**Description:** Measures self-reported suicidal ideation; score ranges from 0 (minimum) to 38 (maximum), with higher scores indicating a greater risk of suicide.

**Measure:** Beck Scale for Suicidal Ideation

**Time Frame:** T0 (baseline); T1 (immedately after intervention); T2 (one-month after intervention follow-up)

**Description:** Reference: (Wang et al., 2019); 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.

**Measure:** System Usability Scale - Chinese version

**Time Frame:** T1 (immedately after intervention); T2 (one-month after intervention follow-up)

**Description:** 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.

**Measure:** Clinical Global Impression Scale

**Time Frame:** T1 (immedately after intervention); T2 (one-month after intervention follow-up)

### Eligibility Module

**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.

**Healthy Volunteers:** True

**Maximum Age:** 65 Years

**Minimum Age:** 16 Years

**Sex:** ALL

**Standard Ages:**

- CHILD

- ADULT

- OLDER_ADULT

### Contacts Locations Module

#### Locations

**Location 1:**

**City:** Hong Kong

**Contacts:**

***Contact 1:***

- **Email:** lokaying@hku.hk

- **Name:** Ka Ying Heidi Lo

- **Phone:** 2255 4486

- **Role:** CONTACT

***Contact 2:***

- **Email:** lokaying@hku.hk

- **Phone:** 2255 4486

- **Role:** CONTACT

**Country:** Hong Kong

**Facility:** University of Hong Kong

**Status:** RECRUITING

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000001526

- Term: Behavioral Symptoms

- ID: D000019964

- Term: Mood Disorders

- ID: D000001523

- Term: Mental Disorders

### Condition Browse Module - Browse Branches

- Abbrev: BXM

- Name: Behaviors and Mental Disorders

- Abbrev: All

- Name: All Conditions

- Abbrev: BC06

- Name: Digestive System Diseases

- Abbrev: Rare

- Name: Rare Diseases

### Condition Browse Module - Browse Leaves

- ID: M7058

- Name: Depression

- Relevance: HIGH

- As Found: Depression

- ID: M7061

- Name: Depressive Disorder

- Relevance: HIGH

- As Found: Depression

- ID: M2062

- Name: Rumination Syndrome

- Relevance: LOW

- As Found: Unknown

- ID: M4818

- Name: Behavioral Symptoms

- Relevance: LOW

- As Found: Unknown

- ID: M21835

- Name: Mood Disorders

- Relevance: LOW

- As Found: Unknown

- ID: M4815

- Name: Mental Disorders

- Relevance: LOW

- As Found: Unknown

- ID: M14473

- Name: Psychotic Disorders

- Relevance: LOW

- As Found: Unknown

- ID: T5077

- Name: Rumination Disorder

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000003863

- Term: Depression

- ID: D000003866

- Term: Depressive Disorder

### Misc Info Module

- Version Holder: 2024-05-31
