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Completed

NCT Number: NCT04288622

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

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.

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Key information

Age range

18 year–64 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

University of Hong Kong

Hong Kong

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Weekly standardised, personalised feedback

Other

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.

Primary outcomes

  1. Severity of depressive symptoms

    Time frame: At week 32

    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.

  2. Severity of anxiety symptoms

    Time frame: At week 32

    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.

Sponsors and collaborators

Lead sponsor

The University of Hong Kong

Other

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Feb 28, 2020
Registry last updated
May 24, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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