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

NCT04564014 | Unknown

• 1 other identifier: 17180791
• Study Type: interventional
• Target: 427
• Locations: 1 country
• Sites: 1

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.

Conditions

Depression; Anxiety

Outcome Measures

Primary Outcomes (4)

• 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

• 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]

• 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

• 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]

Study Arms (2)

ISSS Intervention

EXPERIMENTAL

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.

Behavioral: ISSS; Other: Education Materials

Wait-list control group

ACTIVE COMPARATOR

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

Behavioral: ISSS; Other: Education Materials

Interventions

ISSS BEHAVIORAL

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.

ISSS Intervention; Wait-list control group

Education Materials OTHER

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.

ISSS Intervention; Wait-list control group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• being local Secondary school teachers
• being able to read and understand Chinese
• having access to the Internet
• item Patient Health Questionnaire (PHQ) and/or 7-item Generalized Anxiety Disorder (GAD) score \>=5

You may not qualify if:

• 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

Sponsors & Collaborators

• Chinese University of Hong Kong: lead

Study Sites (1)

Man Kwan QualiEd College

Hong Kong, Hong Kong

RECRUITING

MeSH Terms

Conditions

Depression; Anxiety Disorders

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior; Mental Disorders

Study Officials

• Xue Yang, PhD

  JC School of Public Health and Primary Care, Faculty of Medicine, CUHK

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Xue Yang, PhD

CONTACT

+852 2252 8740; sherryxueyang@cuhk.edu.hk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research Assistant Professor

Study Record Dates

• First Submitted: September 22, 2020
• First Posted: September 25, 2020
• Study Start: January 17, 2022
• Primary Completion: June 9, 2023
• Study Completion: June 9, 2023
• Last Updated: March 31, 2022

Record last verified: 2022-03

Data Sharing

• IPD Sharing: Will not share

Locations

HK (1)