EMI Therapy for Depression in Hong Kong

Mild to Moderate Depression Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06430476
• Other study ID #: EMI_depression
• Status: Recruiting
• Phase: N/A
• Start date: May 31, 2024
• Est. completion date: August 31, 2024

Study information

• Verified date: April 2024
• Source: The University of Hong Kong
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 80
• Est. completion date: August 31, 2024
• Est. primary completion date: August 31, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 16 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Depression
• Depressive Disorder
• Mild to Moderate Depression

Intervention

Other:
• EMI
A phone-based intervention containing exercises meant to reduce ruminative thoughts carried out on an experience sampling platform m-Path
• EMA
A phone-based exercise containing relaxation videos carried out on an experience sampling platform m-Path

Locations

Country	Name	City	State
Hong Kong	University of Hong Kong	Hong Kong

Sponsors (1)

Lead Sponsor	Collaborator
The University of Hong Kong

Country where clinical trial is conducted

Hong Kong, 

References & Publications (5)

American Psychiatric Association. (2013). Diagnostic and statistical manual of mental disorders (5th ed.). https://doi.org/10.1176/appi.books.9780890425596

Devilly GJ, Borkovec TD. Psychometric properties of the credibility/expectancy questionnaire. J Behav Ther Exp Psychiatry. 2000 Jun;31(2):73-86. doi: 10.1016/s0005-7916(00)00012-4. — View 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. — View Citation

Morosini PL, Magliano L, Brambilla L, Ugolini S, Pioli R. Development, reliability and acceptability of a new version of the DSM-IV Social and Occupational Functioning Assessment Scale (SOFAS) to assess routine social functioning. Acta Psychiatr Scand. 2000 Apr;101(4):323-9. — View 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

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Hamilton Depression Rating Scale (HDRS) - 17 items	Gold standard for measuring depressive symptoms, score ranges from 0 (minimum) to 53 (maximum); higher score indicates more severe depressive symptoms.	T0 (baseline); T1 (immedately after intervention); T2 (one-month after intervention follow-up)
Primary	Ecological 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.	During intervention
Secondary	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.	T0 (baseline); T1 (immedately after intervention); T2 (one-month after intervention follow-up)
Secondary	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	T0 (baseline); T1 (immedately after intervention); T2 (one-month after intervention follow-up)
Secondary	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	T0 (baseline); T1 (immedately after intervention); T2 (one-month after intervention follow-up)
Secondary	Short Form Health Survey (SF-12)	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	T0 (baseline); T1 (immedately after intervention); T2 (one-month after intervention follow-up)
Secondary	General Self Efficacy Scale	Measures self-reported self-efficacy; score ranges from 10 (minimum) to 40 (maximum), with higher scores indicating more self-efficacy	T0 (baseline); T1 (immedately after intervention); T2 (one-month after intervention follow-up)
Secondary	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.	T0 (baseline); T1 (immedately after intervention); T2 (one-month after intervention follow-up)
Secondary	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.	T0 (baseline); T1 (immedately after intervention); T2 (one-month after intervention follow-up)
Secondary	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.	T1 (immedately after intervention); T2 (one-month after intervention follow-up)
Secondary	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.	T1 (immedately after intervention); T2 (one-month after intervention follow-up)
Secondary	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.	T0 (baseline); T1 (immedately after intervention); T2 (one-month after intervention follow-up)
Secondary	Credibility Expectancy Questionnaire (CEQ) - Chinese translated	A four-question self-rated scale; measures intervention expectancy and credibility of intervention used; score ranges from 1 - 9 for questions 1-3 in the and from 0% to 100% for the last question. A higher value or percentage indicates higher agreement with the statement in the question.	Immediately after first day of intervention