NCT04388800

Brief Summary

The purpose of this study is to develop a culturally and linguistically appropriate online cognitive behavioral intervention program-- with therapist guidance -- for Hong Kong Chinese adults suffering from major depressive disorder with mild to moderate depressive symptoms, and examine the effectiveness of this program in reducing their depressive symptoms and improving their mental health. The 3- and 6-month maintenance effect after 3 months and 6 months will also be tested.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
402

participants targeted

Target at P75+ for not_applicable depression

Timeline
Completed

Started Jan 2019

Typical duration for not_applicable depression

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2019

Completed
1.4 years until next milestone

First Submitted

Initial submission to the registry

May 12, 2020

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 14, 2020

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2022

Completed
Last Updated

September 22, 2023

Status Verified

September 1, 2023

Enrollment Period

3.5 years

First QC Date

May 12, 2020

Last Update Submit

September 20, 2023

Conditions

Keywords

online cognitive behavioral interventionHong Kong Chinesedepression

Outcome Measures

Primary Outcomes (2)

  • Beck Depression Inventory-II (BDI-II)

    21-item rating scale for depressive symptoms

    6 months

  • Patient Health Questionnaire-9 (PHQ-9)

    9-item rating scale for depressive symptoms.

    6 months

Secondary Outcomes (5)

  • General Health Questionnaire-12 (GHQ-12)

    6 months

  • Beck Anxiety Inventory (BAI)

    6 months

  • Chinese Automatic Thoughts Questionnaire (CATQ)

    6 months

  • Chinese Affect Scale (CAS)

    6 months

  • Negative effects Questionnaire (NEQ) (administered at post-test only)

    6 months

Study Arms (3)

web-based cognitive behavioral intervention

EXPERIMENTAL

The web-based program is consisted of 8 online modules, forum, internal messaging, reminder, online assessment and online booking. Each online module contains mood check, animation briefing and debriefing, case demonstration videos, session review and exercise. Blended mode is adopted to deliver service, which includes the online program, two face-to-face session and 2 telephone follow-ups with a clinical psychologist.

Other: Confront and Navigate Depression Online (CANDO)

app-based cognitive behavioral intervention

EXPERIMENTAL

App-based cognitive behavioral intervention program The App-based program is consisted of 8 online modules, forum, internal messaging, reminder, online assessment and online booking. Each online module contains mood check, animation briefing and debriefing, case demonstration videos, session review and exercise. Blended mode is adopted to deliver service, which includes the online program, two face-to-face session and 2 telephone follow-ups with a clinical psychologist

Other: Confront and Navigate Depression Online (CANDO)

Wait-list control group

NO INTERVENTION

No intervention will be provided when the experimental group is receiving services, but the access to the app-based program will be delivered to the wait-list control group after the two experimental groups complete the service.

Interventions

This study adopts a blended mode of service delivery, which included both online and offline intervention. The online intervention includes 8 weekly online model, animation briefing and debriefing, case demonstration video, exercise, forum, internal messaging, reminder, online assessment, session review and online booking system. The offline intervention includes two face-to-face sessions and two telephone follow-ups.

app-based cognitive behavioral interventionweb-based cognitive behavioral intervention

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Hong Kong resident
  • Has mild to moderate depressive symptoms
  • No suicidal risk in the past 3 months
  • Receive no face-to-face counselling since program commencement
  • Has access to a computer/smartphone with internet access
  • Has a valid email address

You may not qualify if:

  • Has severe or no depressive symptoms
  • Has suicidal risk in the past 3 months
  • Currently receiving other psychological treatment
  • Suffer from severe psychiatric conditions, such as bipolar disorder or schizophrenia
  • Has no computer or smartphone with internet access
  • Has no valid email address

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Jiayan Pan

Hong Kong, Hong Kong

Location

Related Publications (1)

  • Pan JY, Rafi J. Culturally Adapted Guided Internet-Based Cognitive Behavioral Therapy for Hong Kong People With Depressive Symptoms: Randomized Controlled Trial. J Med Internet Res. 2025 Feb 25;27:e64303. doi: 10.2196/64303.

MeSH Terms

Conditions

Depression

Condition Hierarchy (Ancestors)

Behavioral SymptomsBehavior

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: randomized controlled trial
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

May 12, 2020

First Posted

May 14, 2020

Study Start

January 1, 2019

Primary Completion

June 30, 2022

Study Completion

June 30, 2022

Last Updated

September 22, 2023

Record last verified: 2023-09

Data Sharing

IPD Sharing
Will not share

Locations