SchizophreniaNCT05808244
Tele-group Cognitive Behavioural Family Intervention for People With Schizophrenia and Their Families (Feasibility tgCBFI)
A study testing tgCBFI and Usual psychiatric care in people with Schizophrenia and Psychosis, run by The Hong Kong Polytechnic University at 1 site in Hong Kong.
Trial summary
This mixed-method study aims to examine the feasibility of delivering tgCBFI programme to dyads of people with schizophrenia and their family caregivers, and generate preliminary evidence on the effectiveness of tgCBFI in reducing expressed emotion. The research questions are as follows. 1. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Schizophrenia, Psychosis
- What is being tested?
- tgCBFI and Usual psychiatric care
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteHong Kong
- Study dates
- 30 Jun 2023to 22 Sep 2024
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Service users
- diagnosis of schizophrenia-spectrum disorders, based on ICD-10 made by the treating clinicians
- aged 18 to 64
- able to communicate in Cantonese
- Family caregivers
- aged 18 or above
- able to communicate in Cantonese
- live with service users
Who cannot join
- Service users
- have co-morbidity of learning disability, organic/neurological conditions, or substance misuse disorder
- live in hostel
- Family caregivers
- -have active psychiatric conditions
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomised Controlled Study on Feasibility of Tele-group Cognitive Behavioural Family Intervention (tgCBFI) for People With Schizophrenia and Their Families
This mixed-method study aims to examine the feasibility of delivering tgCBFI programme to dyads of people with schizophrenia and their family caregivers, and generate preliminary evidence on the effectiveness of tgCBFI in reducing expressed emotion. The research questions are as follows.
- What are the feasibility, acceptability, and safety of conducting a tele-group CBFI programme for people with schizophrenia and their family caregivers?
- What effect does tgCBFI have on the expressed emotion experienced by adults with schizophrenia and the caregiving experience of their family caregivers at posttreatment and 12-week after completion of the programme?
- What effect does tgCBFI have on the positive and negative symptoms of adults with schizophrenia and the perceived care burden and level of mood disturbance of their family caregivers at posttreatment, and 12-week after completion of the programme?
- Conditions
- Schizophrenia, Psychosis
- Being tested
- tgCBFI, Usual psychiatric care
- Medical subject headings
- Schizophrenia, Psychotic Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
tgCBFIBehavioural
Six weekly sessions CBT-based family intervention programme
Usual psychiatric careBehavioural
Integrated community psychiatric care with medical follow-up
| Study group | Role | What they receive |
|---|---|---|
| tgCBFI | Experimental | Not described Receives: Behavioral: tgCBFI; Behavioral: Usual psychiatric care |
| Usual psychiatric care | Active comparator | Not described Receives: Behavioral: Usual psychiatric care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Level of service satisfaction of service users and family caregivers
Measured: Immediate posttreatment
Feasibility, acceptability, and safety of the programme
Measured: Throughout the whole programme
Secondary outcomes (5)
Perceived expressed emotion of service users
Measured: up to 12-week follow up
Positive and negative symptoms of service users
Measured: up to 12-week follow up
Mood disturbance of family caregivers
Measured: up to 12-week follow up
Perceived care burden of family caregivers
Measured: up to 12-week follow up
Qualitative feedback from service users and family caregivers
Measured: Immediate posttreatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Apr 2023
- Study start30 Jun 2023
- Primary completion22 Sep 2024
- Study completion22 Sep 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for SchizophreniaStudies of the same condition, open and under way.
- More trials run by The Hong Kong Polytechnic UniversityThe sponsor's other registered studies.
- 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
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Hong Kong Polytechnic University
- Sponsor type
- University, hospital or other
- Collaborators
- The University of Hong Kong, Kowloon Hospital, Hong Kong, Nethersole Institute of Continuing Holistic Health Education
- Responsible party
- Principal investigator, Dennis Chak Fai Ma, The Hong Kong Polytechnic University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05808244
- Sponsor's protocol ID
- HSEARS20221011011
- Status last verified
- Jul 2026
- First submitted
- 29 Mar 2023
- Last updated
- 24 Jul 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Ma DCF, Tang CK, Chan CIY, Ho GWK, Leung SF, Wong FKN, Ngan F, Yeung LT, Bressington D, Chan SKW. Tele-Group Cognitive Behavioural Family Intervention for Schizophrenia-Spectrum Disorders and Their Caregivers: A Feasibility Randomised Controlled Trial. Healthcare (Basel). 2026 Jul 22;14(14):2231. doi: 10.3390/healthcare14142231.
PubMed 42512747
Study at a glance
From the registry record, last updated by the sponsor on 24 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomised Controlled Study on Feasibility of Tele-group Cognitive Behavioural Family Intervention (tgCBFI) for People With Schizophrenia and Their Families
- ClinicalTrials.gov ID
- NCT05808244
- Acronym / sponsor ID
- HSEARS20221011011
- Conditions
- Schizophrenia, Psychosis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- The Hong Kong Polytechnic UniversityUniversity, hospital or other
- Collaborators
- The University of Hong Kong, Kowloon Hospital, Hong Kong, Nethersole Institute of Continuing Holistic Health Education
- Study start
- 30 Jun 2023 (actual)
- Primary completion
- 22 Sep 2024 (actual)
- Study completion
- 22 Sep 2024 (actual)
- First posted
- 11 Apr 2023 (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.
This mixed-method study aims to examine the feasibility of delivering tgCBFI programme to dyads of people with schizophrenia and their family caregivers, and generate preliminary evidence on the effectiveness of tgCBFI in reducing expressed emotion. The research questions are as follows.
- What are the feasibility, acceptability, and safety of conducting a tele-group CBFI programme for people with schizophrenia and their family caregivers?
- What effect does tgCBFI have on the expressed emotion experienced by adults with schizophrenia and the caregiving experience of their family caregivers at posttreatment and 12-week after completion of the programme?
- What effect does tgCBFI have on the positive and negative symptoms of adults with schizophrenia and the perceived care burden and level of mood disturbance of their family caregivers at posttreatment, and 12-week after completion of the programme?
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| tgCBFI | Experimental | Behavioral: tgCBFI, Behavioral: Usual psychiatric care |
| Usual psychiatric care | Active comparator | Behavioral: Usual psychiatric care |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Service users
- diagnosis of schizophrenia-spectrum disorders, based on ICD-10 made by the treating clinicians
- aged 18 to 64
- able to communicate in Cantonese
- Family caregivers
Key exclusion criteria (5 listed)
- Service users
- have co-morbidity of learning disability, organic/neurological conditions, or substance misuse disorder
- live in hostel
- Family caregivers
- -have active psychiatric conditions
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 |
|---|---|---|
| tgCBFISix weekly sessions CBT-based family intervention programme | Behavioural | tgCBFI |
| Usual psychiatric careIntegrated community psychiatric care with medical follow-up | Behavioural | Usual psychiatric care, tgCBFI |
Primary outcome
Level of service satisfaction of service users and family caregivers
Time frame: Immediate posttreatment
Feasibility, acceptability, and safety of the programme
Time frame: Throughout the whole programme
5 secondary outcomes
Perceived expressed emotion of service users
Time frame: up to 12-week follow up
Positive and negative symptoms of service users
Time frame: up to 12-week follow up
Mood disturbance of family caregivers
Time frame: up to 12-week follow up
Perceived care burden of family caregivers
Time frame: up to 12-week follow up
Qualitative feedback from service users and family caregivers
Time frame: Immediate posttreatment
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 24 Jul 2026.
- Derived from this study: PubMed 42512747Ma DCF, Tang CK, Chan CIY, Ho GWK, Leung SF, Wong FKN, Ngan F, Yeung LT, Bressington D, Chan SKW. Tele-Group Cognitive Behavioural Family Intervention for Schizophrenia-Spectrum Disorders and Their Caregivers: A Feasibility Randomised Controlled Trial. Healthcare (Basel). 2026 Jul 22;14(14):2231. doi: 10.3390/healthcare14142231.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing tgCBFI and Usual psychiatric care in people with Schizophrenia and Psychosis, run by The Hong Kong Polytechnic 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 8 inclusion and 5 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 24 Jul 2026. 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?
Level of service satisfaction of service users and family caregivers (time frame: Immediate posttreatment). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05808244, which also lists 1 linked publication.
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 24 Jul 2026.