NCT04389242

Brief 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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
205

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jan 2019

Longer than P75 for not_applicable

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

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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
3 days until next milestone

First Posted

Study publicly available on registry

May 15, 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

Psychological Distress

Outcome Measures

Primary Outcomes (1)

  • General Health Questionnaire-12 (GHQ-12)

    12 item rating scale for psychological distress.

    3 months

Secondary Outcomes (5)

  • Beck Depression Inventory-II (BDI-II)

    3 months

  • Beck Anxiety Inventory (BAI)

    3 months

  • Chinese Automatic Thoughts Questionnaire (CATQ)

    3 months

  • Chinese Affect Scale (CAS)

    3 months

  • Electronic Learning Satisfaction Scale (ELSS) (administered at post-test only))

    2 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, one face-to-face session and one telephone follow-up with a certified CBT therapist.

Other: REST Online（Reduce Stress Tour Online）

app-based cognitive behavioral intervention

EXPERIMENTAL

Application-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, one face-to-face session and one telephone follow-up with a certified CBT therapist.

Other: REST Online（Reduce Stress Tour Online）

Wait-list control group

OTHER

No intervention will be provided when the experimental groups are 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.

Other: REST Online（Reduce Stress Tour Online）

Interventions

REST Online（Reduce Stress Tour Online）OTHER

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.

Wait-list control groupapp-based cognitive behavioral interventionweb-based cognitive behavioral intervention

Eligibility Criteria

Age18 Years - 40 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Chinese nationality
  • Has mild to moderate level of psychological distress
  • Receive no face-to-face counselling since program commencement

You may not qualify if:

  • Has low/high level of psychological distress
  • Has one or more psychosis
  • Has suicidal risk in the past 3 months

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Jiayan Pan

Hong Kong, Hong Kong

Location

Study Officials

  • Jiayan Pan, PhD

    Hong Kong Baptist University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Online Cognitive Behavioral Therapy
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

May 12, 2020

First Posted

May 15, 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

HK(1)