Clinical trial NCT04288622: 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
Overall status: COMPLETED
Phase: NA
Conditions: Women at Risk of Common Mental Disorders
Keywords: Experience Sampling Method
At risk
Depression
Women
Randomized Controlled Trials
Feedback
Anxiety
Lead sponsor: The University of Hong Kong
Sponsor class: OTHER
First posted: 2020-02-28
Enrollment: 124
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Severity of depressive symptoms
timeFrame: At week 32
measure: Severity of anxiety symptoms
timeFrame: At week 32
Secondary outcomes:
Other outcomes:
Locations:
city: Hong Kong
country: Hong Kong
facility: University of Hong Kong
Study officials:
affiliation: The University of Hong Kong
name: Yi Nam Suen, PhD
role: PRINCIPAL_INVESTIGATOR
References: