Clinical trial NCT04564014: 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
Overall status: UNKNOWN
Phase: NA
Conditions: Depression
Anxiety
Lead sponsor: Chinese University of Hong Kong
Sponsor class: OTHER
First posted: 2020-09-25
Enrollment: 427
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Change from baseline depression immediately after the interventions
timeFrame: immediately after the interventions
measure: Change from baseline depression six months after the interventions]
timeFrame: six months after the interventions]
measure: Change from baseline anxiety immediately after the interventions
timeFrame: immediately after the interventions
measure: Change from baseline anxiety at 6 months
timeFrame: six months after the interventions]
Secondary outcomes:
Other outcomes:
Locations:
city: Hong Kong
country: Hong Kong
facility: Man Kwan QualiEd College
Study officials:
affiliation: JC School of Public Health and Primary Care, Faculty of Medicine, CUHK
name: Xue Yang, PhD
role: PRINCIPAL_INVESTIGATOR
References: