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Internet-based Self-help Skill Strengthening (ISSS) for Secondary School Teachers

Primary Purpose

Depression, Anxiety

Status
Recruiting
Phase
Not Applicable
Locations
Hong Kong
Study Type
Interventional
Intervention
ISSS
Education Materials
Sponsored by
Chinese University of Hong Kong
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Depression

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Man Kwan QualiEd CollegeRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

ISSS Intervention

Wait-list control group

Arm Description

The intervention group will receive 5 weekly ISSS sessions in addition to the information about mental health, depression, anxiety and available treatment and community resources also recived by the control group.

Members will receive information about mental health, depression, anxiety and available treatment and community resources but not ISSS during the intervention period.

Outcomes

Primary Outcome Measures

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.
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.
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.
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.

Secondary Outcome Measures

Full Information

First Posted
September 22, 2020
Last Updated
March 16, 2022
Sponsor
Chinese University of Hong Kong
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1. Study Identification

Unique Protocol Identification Number
NCT04564014
Brief Title
Internet-based Self-help Skill Strengthening (ISSS) for Secondary School Teachers
Official Title
A Randomized Controlled Trial of an Internet-based Self-help Skill Strengthening (ISSS) Selective Intervention for Secondary School Teachers With Emotional Problems
Study Type
Interventional

2. Study Status

Record Verification Date
March 2022
Overall Recruitment Status
Recruiting
Study Start Date
January 17, 2022 (Actual)
Primary Completion Date
June 9, 2023 (Anticipated)
Study Completion Date
June 9, 2023 (Anticipated)

3. Sponsor/Collaborators

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

4. Oversight

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

5. Study Description

Brief Summary
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.
Detailed Description
Secondary teachers are under great stress and have prevalent mental/emotional health problems with limited coping resources and treatment. Selective intervention with an ISSS program is potentially useful as it is effective in preventing clinical/severe mental disorders and enhancing cost-effectiveness in health promotion. Objective: This randomized controlled trial (RCT) develops an Internet-based guided self-help intervention for secondary school teachers. The primary objective is to evaluate the relative efficacy of an Internet-based self-help skill strengthening (ISSS) program in reducing levels of depression and/or anxiety among secondary school teachers that have depressive symptoms and anxiety symptoms versus a wait-list control (WLC) group at post-treatment time and the 6-month follow-up. Subjects and methods: The study design is two-armed RCT. The participants are secondary school teachers (n=427) with at least mild levels of depression ( Patient Health Questionnaire score >=15) and/or anxiety(Generalized Anxiety Disorder score>=20) identified through screening. Evaluation involves surveys at baseline, end of intervention, and 6 months afterwards. In addition to information received by the wait-list control group, the intervention group receives a carefully designed ISSS program with 5 sessions. The control group will participate in the ISSS program after the 6-month follow-up. Trained e-Coaches with a master degree in psychology or counseling will support and provide feedback to the participants. Outcomes and measures: The primary outcomes are depression and anxiety. Secondary outcomes include perceived stress, self-efficacy, job performance and well-being. Measures of potential mediators (problem-solving and time management) include: the General Self-Efficacy Scale (GSE),the Performance Maintenance Scale (PMS), the World Health Organization Well-Being Index (WHO-5), theProblem Solving Inventory (PSI), and the Time Management Behavior Scale (TMBS). Data analysis: Intention-to-treat (ITT) analysis will be performed. ANOVA and Chi-square tests will be conducted to test between-group differences in baseline characteristics. Pearson's correlation analyses will be used to test inter-correlations among all outcome variables and mediators. ANCOVA will be used to test changes in outcome variables at post-test or follow-up with pre-scores controlled. Mean improvement scores will be computed by calculating Cohen's d for ISSS as compared to WLC. Remission rates will be calculated (based on percentage of individuals dropping below PHQ-9 and/or GAD-7 cut-offs). Binary logistic regression will be used for odds ratios between the remission rates in ISSS with WLC. PHQ and GAD will be compared in two groups using ANCOVA. Post-test/follow-up score will be compared among two conditions, with pre-scores as covariates, to examine the group effect. The potential mediation effects of problem solving and time management between intervention conditions and emotional problems will be tested by using Structural Equation Modeling (SEM) and bootstrapping analysis. Implications: The findings may lead to an evidence-based selective intervention online program for the improvement of secondary teachers' mental/emotional health, a problem with scare coping resources and treatment. Enhancement of teachers' mental/emotional health, related knowledge and coping ability (problem solving, time management) would also benefit students.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Depression, Anxiety

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
InvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
427 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
ISSS Intervention
Arm Type
Experimental
Arm Description
The intervention group will receive 5 weekly ISSS sessions in addition to the information about mental health, depression, anxiety and available treatment and community resources also recived by the control group.
Arm Title
Wait-list control group
Arm Type
Active Comparator
Arm Description
Members will receive information about mental health, depression, anxiety and available treatment and community resources but not ISSS during the intervention period.
Intervention Type
Behavioral
Intervention Name(s)
ISSS
Intervention Description
The ISSS aims to help participants acquire problem-solving (e.g., interpersonal problems) and time management based on the treatment manual of the therapy. Video introductions for each session and example teacher characters who depict the targeted problems and demonstrate implementation of coping/management techniques in a variety of situations. ISSS will use metaphors, daily examples, and lively narrative stories to enhance motivation for participation and understanding of the intervention contents. Session 2-5 will assign exercise and homework. Within 48 hours, participants will receive personalized written feedback (e.g., suggestions) from an e-Coach on the exercises they have completed. Participants can contact e-Coaches via the online system if they have any questions regarding the contents. Questions that beyond the contents will be referred to the health psychologist (PI) by e-Coaches.
Intervention Type
Other
Intervention Name(s)
Education Materials
Intervention Description
Participants will recieve education materials addressing the following issues: (1) introduction to mental health and mental illness; (2) signs and symptoms of depression; (3) treatment of depression and available community resources; (4) signs and symptoms of anxiety; (3) treatment of anxiety and available community resources. The education materials will be carefully developed by the health psychologists and clinical psychologist of the research team who are very experienced in education intervention for mental and emotional health.
Primary Outcome Measure Information:
Title
Change from baseline depression immediately after the interventions
Description
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.
Time Frame
immediately after the interventions
Title
Change from baseline depression six months after the interventions]
Description
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.
Time Frame
six months after the interventions]
Title
Change from baseline anxiety immediately after the interventions
Description
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.
Time Frame
immediately after the interventions
Title
Change from baseline anxiety at 6 months
Description
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.
Time Frame
six months after the interventions]

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Xue Yang, PhD
Phone
+852 2252 8740
Email
sherryxueyang@cuhk.edu.hk
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Xue Yang, PhD
Organizational Affiliation
JC School of Public Health and Primary Care, Faculty of Medicine, CUHK
Official's Role
Principal Investigator
Facility Information:
Facility Name
Man Kwan QualiEd College
City
Hong Kong
Country
Hong Kong
Individual Site Status
Recruiting
Facility Contact:
Phone
+852 2706 6969

12. IPD Sharing Statement

Plan to Share IPD
No

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Internet-based Self-help Skill Strengthening (ISSS) for Secondary School Teachers

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