EMI Therapy for Depression in Hong Kong

NCT06430476 | Recruiting

• 1 other identifier: EMI_depression
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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.

Conditions

Mild to Moderate Depression

Keywords

Depression; Ecological momentary intervention; Rumination; Hong Kong

Outcome Measures

Primary Outcomes (2)

• 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

• 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 Outcomes (10)

• Hamilton Depression Rating Scale (HDRS) - 17 items

  T0 (baseline); T1 (immedately after intervention); T2 (one-month after intervention follow-up)

• Social and Occupational Functioning Assessment scale (SOFAS)

  T0 (baseline); T1 (immedately after intervention); T2 (one-month after intervention follow-up)

• Role Functioning Scale (RFS)

  T0 (baseline); T1 (immedately after intervention); T2 (one-month after intervention follow-up)

• Global Functioning: Social Scale and Role Scale

  T0 (baseline); T1 (immedately after intervention); T2 (one-month after intervention follow-up)

• WHO-5 Well-being Index

  T0 (baseline); T1 (immedately after intervention); T2 (one-month after intervention follow-up)

Study Arms (2)

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.

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.

Other: EMI

Interventions

EMI OTHER

A phone-based intervention containing exercises meant to reduce ruminative thoughts carried out on an experience sampling platform m-Path

EMI

EMA OTHER

A phone-based exercise containing relaxation videos carried out on an experience sampling platform m-Path

EMA

Eligibility Criteria

• Age: 16 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)
• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• The University of Hong Kong: lead

Study Sites (1)

University of Hong Kong

Hong Kong, Hong Kong

RECRUITING

Related Publications (5)

• 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.

  PMID: 10782554 BACKGROUND

• 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

  BACKGROUND

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

  BACKGROUND

• 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.

  PMID: 37920867 BACKGROUND

• 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.

  PMID: 11132119 BACKGROUND

MeSH Terms

Conditions

Depression; Rumination Syndrome

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior; Gastrointestinal Diseases; Digestive System Diseases; Feeding and Eating Disorders; Mental Disorders

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: 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. Participants will also be instructed not to reveal their exercise components (i.e., relaxation exercises or rumination exercises) to the trained research assistants, who will also be responsible for obtaining outcomes. 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: May 14, 2024
• First Posted: May 28, 2024
• Study Start: June 30, 2024
• Primary Completion: August 31, 2025
• Study Completion: August 31, 2025
• Last Updated: December 11, 2024

Record last verified: 2024-04

Locations

HK (1)