Depression Clinical Trial
Official title:
A Randomized Controlled Trial of an Internet-based Self-help Skill Strengthening (ISSS) Selective Intervention for Secondary School Teachers With Emotional Problems
NCT number | NCT04564014 |
Other study ID # | 17180791 |
Secondary ID | |
Status | Recruiting |
Phase | N/A |
First received | |
Last updated | |
Start date | January 17, 2022 |
Est. completion date | June 9, 2023 |
This RCT develops an ISSS program for secondary teachers. The primary objective is to assess the efficacy of such an intervention in reducing depression/anxiety, compared with a WLC group.
Status | Recruiting |
Enrollment | 427 |
Est. completion date | June 9, 2023 |
Est. primary completion date | June 9, 2023 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - being local Secondary school teachers - being able to read and understand Chinese - having access to the Internet - 9-item Patient Health Questionnaire (PHQ) and/or 7-item Generalized Anxiety Disorder (GAD) score >=5 Exclusion Criteria: - currently taking psychotropic medication - being actively suicidal (as measured by item 9 of the PHQ with score >2) - having severe depression/anxiety (PHQ>=15/GAD score>=20) - being international Secondary school teachers |
Country | Name | City | State |
---|---|---|---|
Hong Kong | Man Kwan QualiEd College | Hong Kong |
Lead Sponsor | Collaborator |
---|---|
Chinese University of Hong Kong |
Hong Kong,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Change from baseline depression immediately after the interventions | The outcome will be measured by the Patient Health Questionnaire (PHQ) consisting of nine questions designed to correspond to the nine diagnostic criteria for major depressive disorder covered 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 | |
Primary | Change from baseline depression six months after the interventions] | The outcome will be measured by the Patient Health Questionnaire (PHQ) consisting of nine questions designed to correspond to the nine diagnostic criteria for major depressive disorder covered 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. | six months after the interventions] | |
Primary | Change from baseline anxiety immediately after the interventions | The outcome will be measured by the generalized Anxiety Disorder Scale (GAD) is a 7-item instrument developed to identify likely cases of generalized anxiety disorder in primary care patients and it is a widely-used screening tool of anxiety. 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 | |
Primary | Change from baseline anxiety at 6 months | The outcome will be measured by the generalized Anxiety Disorder Scale (GAD) is a 7-item instrument developed to identify likely cases of generalized anxiety disorder in primary care patients and it is a widely-used screening tool of anxiety. 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. |
six months after the interventions] |
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