Psychological DistressREST OnlineNCT04389242
Online Cognitive Behavioral Intervention Program for Hong Kong University Students
A study testing REST Online（Reduce Stress Tour Online） in people with Psychological Distress, run by Hong Kong Baptist University at 1 site in Hong Kong.
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… Read more about this study
- Who is it for?
- Ages 18 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Psychological Distress
- What is being tested?
- REST Online（Reduce Stress Tour Online）
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 205 participants
- Where
- 1 siteHong Kong
- Study dates
- 1 Jan 2019to 30 Jun 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Chinese nationality
- Has mild to moderate level of psychological distress
- Receive no face-to-face counselling since program commencement
Who cannot join
- Has low/high level of psychological distress
- Has one or more psychosis
- Has suicidal risk in the past 3 months
Trial locations and contacts
1 site in 1 country.
About this study
Official title: An Evidence-based Program Evaluation of the Effectiveness of Internet-based Cognitive Behavioral Preventive Intervention in Reducing Psychological Distress for Chinese University Students in Hong Kong
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.
Read the detailed 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.
- Conditions
- Psychological Distress
- Being tested
- REST Online（Reduce Stress Tour Online）
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. Receives: Other: REST Online（Reduce Stress Tour Online） |
What is being measured
The primary outcome is the main question the study is designed to answer.
General Health Questionnaire-12 (GHQ-12)
12 item rating scale for psychological distress.
Measured: 3 months
Secondary outcomes (5)
Beck Depression Inventory-II (BDI-II)
21-item rating scale for depressive symptoms.
Measured: 3 months
Beck Anxiety Inventory (BAI)
21-item rating scale for cognitive and somatic symptoms of anxiety.
Measured: 3 months
Chinese Automatic Thoughts Questionnaire (CATQ)
20-item rating scale for automatic thoughts.
Measured: 3 months
Chinese Affect Scale (CAS)
20-item rating scale for affect state of Chinese-speaking people.
Measured: 3 months
Electronic Learning Satisfaction Scale (ELSS) (administered at post-test only))
17-item rating scale for satisfaction toward electronic learning
Measured: 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 May 2020
- Study start1 Jan 2019
- Primary completion30 Jun 2022
- Study completion30 Jun 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Psychological DistressStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Online Cognitive Behavioral Therapy
- Masking
- None (open label)
- Enrolment
- 205 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hong Kong Baptist University
- Sponsor type
- University, hospital or other
- Collaborators
- Stockholm University, Research Grants Council, Hong Kong
- Responsible party
- Principal investigator, Jiayan Pan, Hong Kong Baptist University
- Investigators
- Jiayan Pan, PhD, Principal investigator, Hong Kong Baptist University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04389242
- Sponsor's protocol ID
- 12606118
- Acronym
- REST Online
- Status last verified
- Sep 2023
- First submitted
- 12 May 2020
- Last updated
- 22 Sep 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Evidence-based Program Evaluation of the Effectiveness of Internet-based Cognitive Behavioral Preventive Intervention in Reducing Psychological Distress for Chinese University Students in Hong Kong
- ClinicalTrials.gov ID
- NCT04389242
- Acronym / sponsor ID
- REST Online / 12606118
- Conditions
- Psychological Distress
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 205 participants (actual)
- Lead sponsor
- Hong Kong Baptist UniversityUniversity, hospital or other
- Collaborators
- Stockholm University, Research Grants Council, Hong Kong
- Study start
- 1 Jan 2019 (actual)
- Primary completion
- 30 Jun 2022 (actual)
- Study completion
- 30 Jun 2022 (actual)
- First posted
- 15 May 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- Online Cognitive Behavioral Therapy
| Arm | Type | Receives |
|---|---|---|
| web-based cognitive behavioral intervention | Experimental | Other: REST Online（Reduce Stress Tour Online）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. |
| app-based cognitive behavioral intervention | Experimental | Other: REST Online（Reduce Stress Tour Online）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. |
| Wait-list control group | Other | Other: REST Online（Reduce Stress Tour Online）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. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Chinese nationality
- Has mild to moderate level of psychological distress
- Receive no face-to-face counselling since program commencement
Key exclusion criteria (3 listed)
- Has low/high level of psychological distress
- Has one or more psychosis
- Has suicidal risk in the past 3 months
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Other | Wait-list control group, app-based cognitive behavioral intervention, web-based cognitive behavioral intervention |
Primary outcome
General Health Questionnaire-12 (GHQ-12)
Time frame: 3 months
12 item rating scale for psychological distress.
5 secondary outcomes
Beck Depression Inventory-II (BDI-II)
Time frame: 3 months
Beck Anxiety Inventory (BAI)
Time frame: 3 months
Chinese Automatic Thoughts Questionnaire (CATQ)
Time frame: 3 months
Chinese Affect Scale (CAS)
Time frame: 3 months
Electronic Learning Satisfaction Scale (ELSS) (administered at post-test only))
Time frame: 2 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Sep 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jiayan Pan, PhD principal investigator
Hong Kong Baptist University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing REST Online（Reduce Stress Tour Online） in people with Psychological Distress, run by Hong Kong Baptist University at 1 site in Hong Kong.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Hong Kong. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
General Health Questionnaire-12 (GHQ-12) (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Sep 2023.