- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06910748
An Online Guided Self-help Intervention to Improve Common Mental Health Problems Among Medical Professionals (EMPOWER)
E-training for Medical Professionals On Wellbeing and Effective Resolutions (E.M.P.O.W.E.R.) - An Online Guided Self-help Intervention to Improve Common Mental Health Problems Among Medical Professionals : A Randomized Controlled Trial
Study Overview
Status
Conditions
Detailed Description
Despite the high prevalence of common mental health problems among medical professionals (MPs), their help-seeking for mental health support is low. Existing interventions are empirically effective but practically challenging to be applied in Hong Kong given the long intervention hours and fixed schedule. New interventions are needed to cater for the unique needs of local MPs.
Objectives: An online guided self-help intervention for MPs, E-training for Medical Professionals On Wellbeing and Effective Resolutions (the EMPOWER program), will be developed based on Problem Solving Therapy (PST) and Acceptance and Commitment Therapy (ACT), which are both transdiagnostic low-intensity interventions recommended by the World Health Organization. Targeted at local MPs aged 18-60 with depression and/or anxiety symptoms, the intervention aims to reduce their symptoms through strengthening coping skills for work-related problems. A randomized controlled trial (RCT) will be conducted to evaluate (1) the intervention's efficacy in reducing depression/anxiety compared with an active control (education pamphlets); (2) its efficacy in improving the levels of PTSD symptoms, well-being, burnout, and work performance versus active control; (3) the potential mediators/mechanisms explaining any between-group differences.
Method: 120 participants will be recruited online. The EMPOWER group will receive four 30-min self-paced weekly intervention sessions. The active control group will receive four weekly education pamphlets. Data will be collected at baseline, immediately post-intervention and 1-month follow-up. The group effect will be examined by comparing the mean improvement scores and remission rates on the outcome variables among the two groups. The potential mediation effects of problem solving and psychological flexibility between the two groups and the outcomes will also be tested.
Expected outcomes: The investigators expect (1) greater reductions in depression and/or anxiety as well as levels of PTSD, well-being, burnout, and work performance for the EMPOWER group at post-treatment and 1-month follow-up than active control, and that (2) the EMPOWER program will reduce depression and/or anxiety through enhancement in problem solving and psychological flexibility.
Implications: Findings can help to identify a cost-effective, flexible, and readily accessible mental health intervention for local MPs.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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China
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Hong Kong, China, Hong Kong, No postal code
- JC School of Public Health and Primary Care, Faculty of Medicine, CUHK
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- (1) being a frontline medical professional 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.
Exclusion Criterion:
- actively suicidal.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: The EMPOWER program
The intervention group will receive 4 weekly sessions (the EMPOWER program).
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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.
ACT strategies were also incorporated throughout the program to facilitate behavioral change.
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|
Active Comparator: Education materials
The active control group receive education materials about mental health, depression, anxiety and available community resources but not the EMPOWER program during the intervention period.
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The active 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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change from baseline depression immediately after the interventions
Time Frame: immediately after the interventions
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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
Time Frame: 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
Time Frame: 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
Time Frame: 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
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 1007627352
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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