ESM-derived Personalised Feedback for Women at Risk of Common Mental Disorder

A Randomised Controlled Trial Using Experience Sampling Method as a Way to Improve Depressive and Anxiety Symptoms in Women at Risk of Common Mental Disorder in Hong Kong

This study aims to examine the effectiveness of Experience Sampling Method (ESM) derived personalised feedback for women at risk of common mental disorder in Hong Kong, in reducing individuals depressive and anxiety symptoms.

Study Overview

• Status: Completed
• Conditions: Women at Risk of Common Mental Disorders
• Intervention / Treatment: Other: Weekly standardised, personalised feedback

Detailed Description

Women who are at-risk for common mental disorders and have completed the online screening for Jockey Club Mental Wellness Project for Women (JCWow) will be recruited. This study aims to test the effectiveness of ESM-derived personalized feedback in reducing symptoms of depression and anxiety using a randomised controlled trial. After given written consent, the participants will be required to undergo a 5 days baseline ESM data collection (week 0). Upon completion of baseline data collection, they will be randomly assigned to the intervention (ESM-F), active reference (ESM) or control (CON) group. The participants in the intervention group will participate in an ESM procedure (three days per week over a 6-week period) using through SMS system (week 1 - 6). This group will receive weekly standardised feedback on personalised patterns of positive affect. The active reference group will also participate in the same ESM procedure without a weekly feedback. The control group will not be required to undergo this 6-week data collection procedure. At week 7, all three groups will undergo another 5 days of post-intervention ESM data collection in order to examine the naturalistic and interventional changes on the depressive symptoms. From week 8 onwards, the participants will be contacted 5 times (week 8, 12, 16, 20 and 32) via telephone to follow-up their condition. After 32 weeks, both active reference and control group will receive the report.

• Study Type: Interventional
• Enrollment (Actual): 124
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Hong Kong
  • Hong Kong, Hong Kong
    • University of Hong Kong

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 64 years (ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

Inclusion Criteria:

• Women within the age range of 18-64
• Identified as at-risk for depressive disorders (iDD) using the Depression Subscale (scored 10 or above) in DASS-21
• Willing to provide written informed consent
• Understand Cantonese and can read or write Chinese
• Use a smartphone

Exclusion Criteria:

• Those mental conditions that require other treatment priorities (e.g., major depression, suicidal risk, substance abuse, current or past episodes of psychotic disorder, personality disorders).
• Those medical conditions that severely limit participation, comprehension, or adherence to treatment (e.g., epilepsy, dementia, terminal medical illness).
• Those who are receiving structured psychotherapy or counselling.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: ESM-derived personalised feedback (ESM-F) group; Participants will be required to participate in an ESM data collection procedure. Participants will be required to complete a beep-questionnaire 3 days a week, over a 6-week period. The mobile app will be programmed to emit a beep 10 times per day at random intervals between 7.30 and 22.30. At each beep, participants will use the app to digitally complete a brief beep-questionnaire, which covers current affect, current context and activities. Moreover, participants will receive weekly standardized feedback on personalized patterns of positive affect.	Other: Weekly standardised, personalised feedback; The ESM-F group will receive standardised ESM-derived feedback immediately followed the weekly ESM data collection procedure, totalling 6 times in the entire intervention period. The feedback will be provided by the researcher in the format of written report and verbal explanation. The feedback on participants' momentary affective state in specific daily life contexts and the association with depressive symptoms will be given. The changes in positive affect level and the number of depressive complaints over the course of the ESM intervention will be shown.
NO_INTERVENTION: ESM group; Participant will be required to participate in the same ESM data collection procedure as the ESM-F group. The personalised feedback report will be given to the participant after the whole study period (32 weeks) instead of weekly during data collection process.
NO_INTERVENTION: Control (CON) group; Participants will not be required to participate in the 6-week ESM data collection procedure. They will also receive the personalised feedback report based on the ESM data collected at baseline and week 7.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Severity of depressive symptoms	Measured by the Depression Subscale in Depression Anxiety Stress Scales (DASS-21). The subscale consists of 7 items, each with 4 options of responses (from 0-3), the total score of the subscale is calculated by summing up the item score of the 7 items and double it. It ranges from 0 to 42. Higher score indicates more severe level of depressive symptoms.	At week 32
Severity of anxiety symptoms	Measured by the Anxiety Subscale in Depression Anxiety Stress Scales (DASS-21). The subscale consists of 7 items, each with 4 options of responses (from 0-3), the total score of the subscale is calculated by summing up the item score of the 7 items and double it. It ranges from 0 to 42. Higher score indicates more severe level of anxiety symptoms.	At week 32

Collaborators and Investigators

• Sponsor: The University of Hong Kong

Study record dates

Study Major Dates

• Study Start (ACTUAL): March 1, 2020
• Primary Completion (ACTUAL): August 30, 2021
• Study Completion (ACTUAL): December 31, 2021

Study Registration Dates

• First Submitted: February 26, 2020
• First Submitted That Met QC Criteria: February 26, 2020
• First Posted (ACTUAL): February 28, 2020

Study Record Updates

• Last Update Posted (ACTUAL): May 24, 2022
• Last Update Submitted That Met QC Criteria: May 22, 2022
• Last Verified: May 1, 2022

More Information

Terms related to this study

• Keywords: Depression; Anxiety; Women; Randomized Controlled Trials; At risk; Feedback; Experience Sampling Method
• Additional Relevant MeSH Terms: Schizophrenia Spectrum and Other Psychotic Disorders; Psychotic Disorders; Mental Disorders
• Other Study ID Numbers: ESM iCMD RCT

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No