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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04389242
Other study ID # 12606118
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date January 1, 2019
Est. completion date June 30, 2022

Study information

Verified date September 2023
Source Hong Kong Baptist University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Brief summary: The objective of this study is to develop an internet-based cognitive behavioral intervention program (including an online platform and a smartphone application) for Chinese university students in Hong Kong, and examine its effectiveness in reducing psychological distress, anxiety/depression symptoms, and improving emotions and automatic thoughts. The 3-month maintenance effect will also be tested.


Description:

Previous research has provided evidence for the effectiveness of internet-based cognitive behavioral intervention in improving mental health, but most studies were done in Western countries. This study is intended to design a culturally appropriate online program especially for Chinese university students in Hong Kong. The program will include 8 weekly sessions and one face-to-face session and one telephone follow-up with a with certified CBT therapist. The effects on psychological distress, anxiety/depression, emotions, and automatic thoughts will be tested.


Recruitment information / eligibility

Status Completed
Enrollment 205
Est. completion date June 30, 2022
Est. primary completion date June 30, 2022
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 40 Years
Eligibility Inclusion Criteria: - Chinese nationality - Has mild to moderate level of psychological distress - Receive no face-to-face counselling since program commencement Exclusion Criteria: - Has low/high level of psychological distress - Has one or more psychosis - Has suicidal risk in the past 3 months

Study Design


Related Conditions & MeSH terms


Intervention

Other:
REST Online(Reduce Stress Tour Online)
Different cognitive behavioral skills are introduced and practiced in a 8 weekly online program, which includes animation briefing and debriefing, case demonstration video, exercise, forum, internal messaging, online assessment and reminder. One face-to-face session and one telephone follow-up provided by an experienced CBT therapist are also provided to clients.

Locations

Country Name City State
Hong Kong Jiayan Pan Hong Kong

Sponsors (3)

Lead Sponsor Collaborator
Hong Kong Baptist University Research Grants Council, Hong Kong, Stockholm University

Country where clinical trial is conducted

Hong Kong, 

Outcome

Type Measure Description Time frame Safety issue
Primary General Health Questionnaire-12 (GHQ-12) 12 item rating scale for psychological distress. 3 months
Secondary Beck Depression Inventory-II (BDI-II) 21-item rating scale for depressive symptoms. 3 months
Secondary Beck Anxiety Inventory (BAI) 21-item rating scale for cognitive and somatic symptoms of anxiety. 3 months
Secondary Chinese Automatic Thoughts Questionnaire (CATQ) 20-item rating scale for automatic thoughts. 3 months
Secondary Chinese Affect Scale (CAS) 20-item rating scale for affect state of Chinese-speaking people. 3 months
Secondary Electronic Learning Satisfaction Scale (ELSS) (administered at post-test only)) 17-item rating scale for satisfaction toward electronic learning 2 months
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