Ignite Creation Date:
2024-06-16 @ 11:49 AM
Last Modification Date:
2024-10-26 @ 3:30 PM
Study NCT ID:
NCT06430476
Status:
RECRUITING
Last Update Posted:
2024-06-05
First Post:
2024-05-14
Brief Title:
EMI Therapy for Depression in Hong Kong
Sponsor:
The University of Hong Kong
Organization:
The University of Hong Kong
Study Overview
Official Title:
Ecological Momentary Intervention EMI as Augmentative Therapy for Depression in Clinical Sample in Hong Kong
Status:
RECRUITING
Status Verified Date:
2024-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 ones 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 participants computed rumination score ie 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
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 ones 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 participants computed rumination score ie 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None