A Randomized Controlled Trial of an Internet-based Self-help Skill Strengthening (ISSS) Selective Intervention for Secondary School Teachers With Emotional Problems
Trial Snapshot
- Phase
- Not Applicable
- Enrollment
- 427
- Locations
- 1
- Primary Endpoint
- Change from baseline depression six months after the interventions]
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double (Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
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.
Intervention: ISSS (Behavioral)
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.
Intervention: Education Materials (Other)
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.
Intervention: ISSS (Behavioral)
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.
Intervention: Education Materials (Other)
Outcomes
Primary Outcomes
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.
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.
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.
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.
Secondary Outcomes
No secondary outcomes reported
Investigators
Dr. Xue YANG
Research Assistant Professor
Chinese University of Hong Kong