Mild to Moderate DepressionNCT06430476
EMI Therapy for Depression in Hong Kong
A study testing EMI and EMA in people with Mild to Moderate Depression, run by The University of Hong Kong at 1 site in Hong Kong.
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. Read more about this study
- Who is it for?
- Ages 16 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Mild to Moderate Depression
- What is being tested?
- EMI and EMA
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteHong Kong
- Study dates
- 30 Jun 2024to 31 Aug 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 to 65 years
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Hong Kong1 site, 1 recruiting
- Recruiting
University of Hong Kong
Hong Kong
Ka Ying Heidi Lo, 2255 4486, lokaying@hku.hk
About this study
Official title: Ecological Momentary Intervention (EMI) as Augmentative Therapy for Depression in Clinical Sample in Hong Kong
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.
Read the 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
- Conditions
- Mild to Moderate Depression
- Being tested
- EMI, EMA
- Keywords
- Depression, Ecological momentary intervention, Rumination, Hong Kong
- Medical subject headings
- Depression, Rumination Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EMIOther
A phone-based intervention containing exercises meant to reduce ruminative thoughts carried out on an experience sampling platform m-Path
EMAOther
A phone-based exercise containing relaxation videos carried out on an experience sampling platform m-Path
| Study group | Role | What they receive |
|---|---|---|
| EMA | Active comparator | 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. Receives: Other: EMA |
| EMI | Experimental | 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. Receives: Other: EMI |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: T0 (baseline); T1 (immedately after intervention); T2 (one-month after intervention follow-up)
Secondary outcomes (10)
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.
Measured: 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.
Measured: 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
Measured: T0 (baseline); T1 (immedately after intervention); T2 (one-month after intervention follow-up)
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
Measured: 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
Measured: 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
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: T1 (immedately after intervention); T2 (one-month after intervention follow-up)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 May 2024
- Study start30 Jun 2024
- Primary completion31 Aug 2025 (estimated)
- Study completion31 Aug 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Mild to Moderate DepressionStudies of the same condition, open and under way.
- More trials run by The University of Hong KongThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The University of Hong Kong
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06430476
- Sponsor's protocol ID
- EMI_depression
- Status last verified
- Apr 2024
- First submitted
- 14 May 2024
- Last updated
- 11 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 10782554Wang, 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
American Psychiatric Association. (2013). Diagnostic and statistical manual of mental disorders (5th ed.). https://doi.org/10.1176/appi.books.9780890425596
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.
PubMed 37920867Devilly 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.
PubMed 11132119
Study at a glance
From the registry record, last updated by the sponsor on 11 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ecological Momentary Intervention (EMI) as Augmentative Therapy for Depression in Clinical Sample in Hong Kong
- ClinicalTrials.gov ID
- NCT06430476
- Acronym / sponsor ID
- EMI_depression
- Conditions
- Mild to Moderate Depression
- Keywords
- Depression, Ecological momentary intervention, Rumination, Hong Kong
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- The University of Hong KongUniversity, hospital or other
- Study start
- 30 Jun 2024 (actual)
- Primary completion
- 31 Aug 2025 (estimated)
- Study completion
- 31 Aug 2025 (estimated)
- First posted
- 28 May 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| EMA | Active comparator | Other: EMAEcological 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. |
| EMI | Experimental | Other: EMIEMI 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. |
Who may qualify
- Ages
- 16 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| EMIA phone-based intervention containing exercises meant to reduce ruminative thoughts carried out on an experience sampling platform m-Path | Other | EMI |
| EMAA phone-based exercise containing relaxation videos carried out on an experience sampling platform m-Path | Other | EMA |
Primary outcome
Ecological Momentary Assessment (EMA) outcomes
Time frame: During intervention
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.
Montgomery-Åsberg Depression Rating Scale (MADRS)
Time frame: T0 (baseline); T1 (immedately after intervention); T2 (one-month after intervention follow-up)
Measuring change in depressive symptoms; score ranges from 0 (minimum) to 60 (maximum); higher score indicates more severe depressive symptoms.
10 secondary outcomes
Hamilton Depression Rating Scale (HDRS) - 17 items
Time frame: T0 (baseline); T1 (immedately after intervention); T2 (one-month after intervention follow-up)
Social and Occupational Functioning Assessment scale (SOFAS)
Time frame: T0 (baseline); T1 (immedately after intervention); T2 (one-month after intervention follow-up)
Role Functioning Scale (RFS)
Time frame: T0 (baseline); T1 (immedately after intervention); T2 (one-month after intervention follow-up)
Global Functioning: Social Scale and Role Scale
Time frame: T0 (baseline); T1 (immedately after intervention); T2 (one-month after intervention follow-up)
WHO-5 Well-being Index
Time frame: T0 (baseline); T1 (immedately after intervention); T2 (one-month after intervention follow-up)
General Self Efficacy Scale
Time frame: T0 (baseline); T1 (immedately after intervention); T2 (one-month after intervention follow-up)
Rumination Response Scale (RRS)
Time frame: T0 (baseline); T1 (immedately after intervention); T2 (one-month after intervention follow-up)
Beck Scale for Suicidal Ideation
Time frame: T0 (baseline); T1 (immedately after intervention); T2 (one-month after intervention follow-up)
System Usability Scale - Chinese version
Time frame: T1 (immedately after intervention); T2 (one-month after intervention follow-up)
Clinical Global Impression Scale
Time frame: T1 (immedately after intervention); T2 (one-month after intervention follow-up)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Dec 2024.
- Background: PubMed 10782554Morosini 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.
- BackgroundWang, 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
- BackgroundAmerican Psychiatric Association. (2013). Diagnostic and statistical manual of mental disorders (5th ed.). https://doi.org/10.1176/appi.books.9780890425596
- Background: PubMed 37920867Mestdagh 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.
- Background: PubMed 11132119Devilly 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing EMI and EMA in people with Mild to Moderate Depression, run by The University of Hong Kong at 1 site in Hong Kong.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 11 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Hong Kong. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Ecological Momentary Assessment (EMA) outcomes (time frame: During intervention). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06430476, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Dec 2024.