NCT06910748

Brief Summary

This randomized controlled trial (RCT) aims to evaluate the effectiveness of an internet-based guided self-help intervention developed based on Problem Solving Therapy, a transdiagnostic low-intensity intervention recommended by the World Health Organization, in improving medical professionals' mental health.

Trial Health

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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
120

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Dec 2022

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 20, 2022

Completed
2.3 years until next milestone

First Submitted

Initial submission to the registry

March 28, 2025

Completed
7 days until next milestone

First Posted

Study publicly available on registry

April 4, 2025

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 31, 2025

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 31, 2026

Completed
Last Updated

April 10, 2025

Status Verified

April 1, 2025

Enrollment Period

2.7 years

First QC Date

March 28, 2025

Last Update Submit

April 8, 2025

Conditions

Keywords

randomized controlled trialmedical professionalsinternet-basedself-helpinterventionmental healthdepressionanxiety

Outcome Measures

Primary Outcomes (4)

  • Change from baseline depression immediately after the interventions

    The outcome will be measured by the Patient Health Questionnaire (PHQ) consisting of 9 questions designed to correspond to the 9 diagnostic criteria for major depressive disorder listed in the Diagnostic and Statistical Manual of Mental Disorders (DSM-IV). Items are rated from 0 to 3 according to increased frequency of experiencing difficulties in each area covered. Scores are summed and can range from 0 to 27. Score 10 is often recommended as the cut-off score to detect major depressive disorder. Scores of 5, 10, 15, and 20 represent cut-off points for mild, moderate, moderately severe, and severe depression, respectively. The Chinese version has been validated.

    immediately after the interventions

  • Change from baseline depression 1 month after the interventions

    The outcome will be measured by the Patient Health Questionnaire (PHQ) consisting of 9 questions designed to correspond to the 9 diagnostic criteria for major depressive disorder listed in the Diagnostic and Statistical Manual of Mental Disorders (DSM-IV). Items are rated from 0 to 3 according to increased frequency of experiencing difficulties in each area covered. Scores are summed and can range from 0 to 27. Score 10 is often recommended as the cut-off score to detect major depressive disorder. Scores of 5, 10, 15, and 20 represent cut-off points for mild, moderate, moderately severe, and severe depression, respectively. The Chinese version has been validated.

    1 month after the interventions

  • Change from baseline anxiety immediately after the interventions

    The outcome will be measured by the Generalized Anxiety Disorder Scale (GAD), which is a 7-item instrument developed to identify likely cases of generalized anxiety disorder in primary care patients. Items are rated for the last two weeks, using a four-point rating scale for duration from 1 ("not at all") to 5 ("nearly every day"). A score of 10 or greater represents a cut point for identifying cases of generalized anxiety disorder, while cut points of 5, 10, 15, and 20 are interpreted as representing mild, moderate, moderately severe, and severe levels of anxiety. The Chinese version has been validated.

    Immediately after the interventions

  • Change from baseline anxiety 1 month after the interventions

    The outcome will be measured by the Generalized Anxiety Disorder Scale (GAD), which is a 7-item instrument developed to identify likely cases of generalized anxiety disorder in primary care patients. Items are rated for the last two weeks, using a four-point rating scale for duration from 1 ("not at all") to 5 ("nearly every day"). A score of 10 or greater represents a cut point for identifying cases of generalized anxiety disorder, while cut points of 5, 10, 15, and 20 are interpreted as representing mild, moderate, moderately severe, and severe levels of anxiety. The Chinese version has been validated.

    1 month after the interventions

Study Arms (2)

The EMPOWER program

EXPERIMENTAL

The intervention group will receive 4 weekly sessions (the EMPOWER program) in addition to the information about mental health, depression, anxiety and available treatment and community resources received by the waitlist control group.

Behavioral: E-training for Medical Professionals On Wellbeing and Effective Resolutions (E.M.P.O.W.E.R.)

Education materials

ACTIVE COMPARATOR

The waitlist control group receive education materials about mental health, depression, anxiety and available treatment and community resources but not the EMPOWER prgoram during the intervention period.

Other: Education Materials

Interventions

The EMPOWER programme aims to help participants acquire problem-solving skills adapted into the context of MPs' workplace and daily life to address their work-related, personal, and interpersonal problems, including self-neglect, work-life imbalance, patient communication problems, as well as stress during emerging public health crises. The session elements include video introduction, metaphors, daily examples, and narrative stories with prototype MP characters depicting the targeted problems to demonstrate how the taught problem-solving skills could be applied in a variety of situations. Brief exercise and homework will be assigned after each session and personalized written feedback will be provided.

The EMPOWER program

The waitlist control receive education materials covering (1) introduction of mental health problems; (2) signs, symptoms, causes, and consequences of anxiety and depression, and (3) treatment approaches and available community resources.

Education materials

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • (1) being a frontline doctor or nurse working in local public settings;
  • (2) at least 18 years of age;
  • (3) able to read and understand Chinese;
  • (4) have access to the Internet; and
  • (5) Patient Health Questionnaire (PHQ-9) and/or Generalized Anxiety Disorder (GAD-7) score\>=5, indicating at least mild levels of depression and/or anxiety.

You may not qualify if:

  • (1) currently taking psychotropic medication; and
  • (2) actively suicidal.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

JC School of Public Health and Primary Care, Faculty of Medicine, CUHK

Hong Kong, China, No postal code, Hong Kong

RECRUITING

MeSH Terms

Conditions

DepressionAnxiety DisordersPsychological Well-Being

Condition Hierarchy (Ancestors)

Behavioral SymptomsBehaviorMental DisordersPersonal Satisfaction

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

March 28, 2025

First Posted

April 4, 2025

Study Start

December 20, 2022

Primary Completion

August 31, 2025

Study Completion

March 31, 2026

Last Updated

April 10, 2025

Record last verified: 2025-04

Data Sharing

IPD Sharing
Will not share

Locations