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

Primary Purpose

Women at Risk of Common Mental Disorders

Status
Completed
Phase
Not Applicable
Locations
Hong Kong
Study Type
Interventional
Intervention
Weekly standardised, personalised feedback
Sponsored by
The University of Hong Kong
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Women at Risk of Common Mental Disorders focused on measuring Experience Sampling Method, At risk, Depression, Women, Randomized Controlled Trials, Feedback, Anxiety

Eligibility Criteria

18 Years - 64 Years (Adult)FemaleDoes not accept healthy volunteers

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.

Sites / Locations

  • University of Hong Kong

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

No Intervention

No Intervention

Arm Label

ESM-derived personalised feedback (ESM-F) group

ESM group

Control (CON) group

Arm Description

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.

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.

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.

Outcomes

Primary Outcome Measures

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.
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.

Secondary Outcome Measures

Full Information

First Posted
February 26, 2020
Last Updated
May 22, 2022
Sponsor
The University of Hong Kong
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1. Study Identification

Unique Protocol Identification Number
NCT04288622
Brief Title
ESM-derived Personalised Feedback for Women at Risk of Common Mental Disorder
Official 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
Study Type
Interventional

2. Study Status

Record Verification Date
May 2022
Overall Recruitment Status
Completed
Study Start Date
March 1, 2020 (Actual)
Primary Completion Date
August 30, 2021 (Actual)
Study Completion Date
December 31, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
The University of Hong Kong

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Women at Risk of Common Mental Disorders
Keywords
Experience Sampling Method, At risk, Depression, Women, Randomized Controlled Trials, Feedback, Anxiety

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
124 (Actual)

8. Arms, Groups, and Interventions

Arm Title
ESM-derived personalised feedback (ESM-F) group
Arm Type
Experimental
Arm Description
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.
Arm Title
ESM group
Arm Type
No Intervention
Arm Description
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.
Arm Title
Control (CON) group
Arm Type
No Intervention
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Weekly standardised, personalised feedback
Intervention Description
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 Outcome Measure Information:
Title
Severity of depressive symptoms
Description
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.
Time Frame
At week 32
Title
Severity of anxiety symptoms
Description
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.
Time Frame
At week 32

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
64 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yi Nam Suen, PhD
Organizational Affiliation
The University of Hong Kong
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Hong Kong
City
Hong Kong
Country
Hong Kong

12. IPD Sharing Statement

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

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