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

March 16, 2022 updated by: Dr. Xue YANG, Chinese University of Hong Kong

A Randomized Controlled Trial of an Internet-based Self-help Skill Strengthening (ISSS) Selective Intervention for Secondary School Teachers With Emotional Problems

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.

Study Overview

Status

Recruiting

Conditions

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.

Study Type

Interventional

Enrollment (Anticipated)

427

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Hong Kong, Hong Kong
        • Recruiting
        • Man Kwan QualiEd College
        • Contact:
          • Phone Number: +852 2706 6969

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: ISSS Intervention
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.
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.
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.
Active Comparator: Wait-list control group
Members will receive information about mental health, depression, anxiety and available treatment and community resources but not ISSS during the intervention period.
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.
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.

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
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
Change from baseline depression six months after the interventions]
Time Frame: 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]
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) 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
Change from baseline anxiety at 6 months
Time Frame: six months 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.

six months after the interventions]

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 17, 2022

Primary Completion (Anticipated)

June 9, 2023

Study Completion (Anticipated)

June 9, 2023

Study Registration Dates

First Submitted

September 22, 2020

First Submitted That Met QC Criteria

September 22, 2020

First Posted (Actual)

September 25, 2020

Study Record Updates

Last Update Posted (Actual)

March 31, 2022

Last Update Submitted That Met QC Criteria

March 16, 2022

Last Verified

March 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 17180791

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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.

Clinical Trials on Depression

Clinical Trials on ISSS

Subscribe