Schizophrenia and Related DisordersNCT07121166
Tele-group Cognitive Behavioural Family Intervention for Individuals With Schizophrenia and Their Families (Definitive tgCBFI)
A study testing tgCBFI programme and Treatment as Usual (TAU) in people with Schizophrenia and Related Disorders, run by The Hong Kong Polytechnic University at 6 sites in Hong Kong.
Trial summary
This mixed-method study comprises a RCT with a twelve-week post-intervention follow-up and focus group interviews. The RCT study aims to examine the effectiveness of delivering the tgCBFI programme to dyads of people with schizophrenia and their family caregivers, while the focus group interviews aim to qualitatively… Read more about this study
- Who is it for?
- Ages 18 to 64 years
- Conditions the study is for
- Schizophrenia and Related Disorders
- What is being tested?
- tgCBFI programme and Treatment as Usual (TAU)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 6 sitesHong Kong
- Study dates
- 1 Sep 2025to 31 Jul 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 64 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- current diagnosis of schizophrenia-spectrum disorders, based on ICD-10 made by the treating clinicians,
- aged 18-64, and
- able to read and write Chinese
- aged 18 or above,
- able to read and write Chinese,
- live with service users, and
- nominated by the service users
Who cannot join
- having co-morbidity of learning disability, organic/neurological conditions, or substance use disorder, and
- living in a hostel
- Family caregivers
- having active psychiatric conditions
Trial locations and contacts
6 sites in 1 country. Contact the study team or a site near you to ask about taking part.
6 sites in 1 country
Hong Kong6 sites, 6 recruiting
- Recruiting
ALOHA (Eastern)
Chai Wan
25054287
- Recruiting
Kowloon Hospital
Kowloon City
31297111
- Recruiting
Kwai Chung Hospital
Kwai Chung
27523000
- Recruiting
United Christian Hospital
Kwun Tong
23799611
- Recruiting
Queen Mary Hospital
Pokfulam
22553838
- Recruiting
ALOHA (Wong Tai Sin)
Tsz Wan Shan
23223794
About this study
Official title: Effectiveness of a Tele-group Cognitive Behavioural Family Intervention (tgCBFI) for People With Schizophrenia and Their Families: a Mixed-method Study
This mixed-method study comprises a RCT with a twelve-week post-intervention follow-up and focus group interviews. The RCT study aims to examine the effectiveness of delivering the tgCBFI programme to dyads of people with schizophrenia and their family caregivers, while the focus group interviews aim to qualitatively study the benefits of the tgCBFI programme from the service users and their family caregivers to provide a more in-depth understanding and complement the quantitative data. The main questions it aims to answer are: Does this online tgCBFI programme reduce the expressed emotion experienced and positive and negative symptoms of individuals with schizophrenia? Does this online tgCBFI programme reduce the perceived care burden and level of mood disturbances of family caregivers?
Read the detailed description
Recent network meta-analyses revealed that family interventions were superior to other psychosocial interventions in relapse prevention of people with schizophrenia. The current approaches to family intervention for schizophrenia are to provide support and offer psychoeducation and skill training for family caregivers, such as family psychoeducation and mutual support groups, and work with the whole family, stressing family structure, interaction, and dynamics, such as systemic therapy. A previous meta-analysis revealed that familial expressed emotion (EE), particularly critical comments, is a robust predictor of schizophrenic relapse, and it is one of the therapeutic foci of the family intervention to benefit the recovery of service users with schizophrenia. A proposed cognitive model of caregiving suggested that cognitive reappraisal, including reattribution of self-control on caregiving and reattribution of service users' control on illness progression, is one of the recommended therapeutic components to assist family caregivers in relieving their mood disturbances as well as negative expressed emotion. A framework of cognitive behavioural therapy (CBT) for service users with psychosis and their family caregivers has also been suggested to improve the clinical outcomes of the service users and extend the individual CBT to the family group. Built upon these two mainstream approaches of behavioural and structural family interventions, cognitive behavioural family intervention (CBFI) focuses on cognitive appraisals in family relationships between service users and their families, aligning with the proposed cognitive model of caregiving in resolving the two negative attrition-emotion pathways. A previous meta-analysis indicates that CBFI is superior to treatment as usual (TAU) in reducing the severity of positive and negative symptoms of people with schizophrenia immediately following the intervention. Recent systematic reviews supported that telepsychiatry/telehealth is a feasible and acceptable approach for people with severe mental illness and their family caregivers. This tgCBFI programme is a brief, novel group CBT-based family intervention using a telehealth delivery mode (i.e., via Zoom) to care for people with schizophrenia and their family caregivers in the community.
- Conditions
- Schizophrenia and Related Disorders
- Being tested
- tgCBFI programme, Treatment as Usual (TAU)
- Keywords
- CBT, family intervention, schizophrenia, telehealth
- Medical subject headings
- Schizophrenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
tgCBFI programmeBehavioural
a six-week online group intervention programme for dyads of service users and caregivers
Treatment as Usual (TAU)Behavioural
Integrated community psychiatric care with psychiatric outpatient follow-up
| Study group | Role | What they receive |
|---|---|---|
| tgCBFI group | Experimental | Participants in this group will receive a six-week online group intervention programme and integrated community psychiatric care with psychiatric outpatient follow-up. Receives: Behavioral: tgCBFI programme |
| Treatment as Usual (TAU) group | Active comparator | Participants in this group will receive integrated community psychiatric care with psychiatric outpatient follow-up Receives: Behavioral: Treatment as Usual (TAU) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Expressed emotion experienced by the service users as assessed by the Concise Chinese Level of Expressed Emotion Scale (CCLEES)
It has twelve items using a four-point Likert scale with three subscales. The total score ranges from 12 to 48, and a higher score indicates a higher level of familial expressed emotion.
Measured: From enrollment to twelve-week post-intervention follow-up
Secondary outcomes (5)
Positive and negative symptoms of service users as assessed by the Positive and Negative Syndrome Scale (PANSS)
It has thirty items using a seven-point Likert scale with three subscales. The subscale scores of positive and negative symptoms range from 7 to 49, while that of general psychopathology ranges from 16 to 112. A higher score indicates a higher level of severity of psychiatric symptoms.
Measured: From enrollment to twelve-week post-intervention follow-up
Perceived care burden of family caregivers as assessed by the Family Burden Interview Schedule (FBIS)
It has 25 items using a three-point Likert scale with six subscales. The total score ranges from 0 to 50. A higher score indicates a higher level of perceived family care burden.
Measured: From enrollment to twelve-week post-intervention follow-up
Mood disturbances of family caregivers as assessed by the Hospital Anxiety and Depression Scale (HADS)
It comprises fourteen items using a four-point Likert scale with two subscales. The subscale scores of depression and anxiety range from 0 to 21. A higher score indicates a higher level of mood disturbance.
Measured: From enrollment to twelve-week post-intervention follow-up
Service satisfaction of participants from the tgCBFI group as assessed by the Client Satisfaction Questionnaire (CSQ-8)
It consists of eight items using a four-point Likert scale. The total score ranges from 8 to 32. A higher score indicates a higher level of service satisfaction.
Measured: within one week after the intervention
Qualitative feedback from the participants in the tgCBFI group as assessed by focus group interviews
For each interview, a group of eight participants will be interviewed for up to 45 minutes
Measured: within one month after the intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Aug 2025
- Study start1 Sep 2025
- Primary completion31 May 2028 (estimated)
- Study completion31 Jul 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Schizophrenia and Related DisordersStudies 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
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The Hong Kong Polytechnic University
- Sponsor type
- University, hospital or other
- Collaborators
- health bureau, hong kong
- Responsible party
- Principal investigator, Dennis Chak Fai Ma, The Hong Kong Polytechnic University
- Investigators
- Dennis Chak Fai Ma, PhD, Principal investigator, School of Nursing, The Hong Kong Polytechnic University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07121166
- Sponsor's protocol ID
- HSEARS20241014006
- Status last verified
- Jul 2026
- First submitted
- 6 Aug 2025
- Last updated
- 24 Jul 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: IPD will be available upon reasonable request to the corresponding author after the study articles are published.
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
- Effectiveness of a Tele-group Cognitive Behavioural Family Intervention (tgCBFI) for People With Schizophrenia and Their Families: a Mixed-method Study
- ClinicalTrials.gov ID
- NCT07121166
- Acronym / sponsor ID
- HSEARS20241014006
- Conditions
- Schizophrenia and Related Disorders
- Keywords
- CBT, family intervention, schizophrenia, telehealth
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- The Hong Kong Polytechnic UniversityUniversity, hospital or other
- Collaborators
- health bureau, hong kong
- Study start
- 1 Sep 2025 (actual)
- Primary completion
- 31 May 2028 (estimated)
- Study completion
- 31 Jul 2028 (estimated)
- First posted
- 13 Aug 2025 (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 comprises a RCT with a twelve-week post-intervention follow-up and focus group interviews. The RCT study aims to examine the effectiveness of delivering the tgCBFI programme to dyads of people with schizophrenia and their family caregivers, while the focus group interviews aim to qualitatively study the benefits of the tgCBFI programme from the service users and their family caregivers to provide a more in-depth understanding and complement the quantitative data. The main questions it aims to answer are: Does this online tgCBFI programme reduce the expressed emotion experienced and positive and negative symptoms of individuals with schizophrenia? Does this online tgCBFI programme reduce the perceived care burden and level of mood disturbances of family caregivers?
Detailed description
Recent network meta-analyses revealed that family interventions were superior to other psychosocial interventions in relapse prevention of people with schizophrenia. The current approaches to family intervention for schizophrenia are to provide support and offer psychoeducation and skill training for family caregivers, such as family psychoeducation and mutual support groups, and work with the whole family, stressing family structure, interaction, and dynamics, such as systemic therapy. A previous meta-analysis revealed that familial expressed emotion (EE), particularly critical comments, is a robust predictor of schizophrenic relapse, and it is one of the therapeutic foci of the family intervention to benefit the recovery of service users with schizophrenia. A proposed cognitive model of caregiving suggested that cognitive reappraisal, including reattribution of self-control on caregiving and reattribution of service users' control on illness progression, is one of the recommended therapeutic components to assist family caregivers in relieving their mood disturbances as well as negative expressed emotion. A framework of cognitive behavioural therapy (CBT) for service users with psychosis and their family caregivers has also been suggested to improve the clinical outcomes of the service users and extend the individual CBT to the family group. Built upon these two mainstream approaches of behavioural and structural family interventions, cognitive behavioural family intervention (CBFI) focuses on cognitive appraisals in family relationships between service users and their families, aligning with the proposed cognitive model of caregiving in resolving the two negative attrition-emotion pathways. A previous meta-analysis indicates that CBFI is superior to treatment as usual (TAU) in reducing the severity of positive and negative symptoms of people with schizophrenia immediately following the intervention. Recent systematic reviews supported that telepsychiatry/telehealth is a feasible and acceptable approach for people with severe mental illness and their family caregivers. This tgCBFI programme is a brief, novel group CBT-based family intervention using a telehealth delivery mode (i.e., via Zoom) to care for people with schizophrenia and their family caregivers in the community.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| tgCBFI group | Experimental | Behavioral: tgCBFI programmeParticipants in this group will receive a six-week online group intervention programme and integrated community psychiatric care with psychiatric outpatient follow-up. |
| Treatment as Usual (TAU) group | Active comparator | Behavioral: Treatment as Usual (TAU)Participants in this group will receive integrated community psychiatric care with psychiatric outpatient follow-up |
Who may qualify
- Ages
- 18 to 64 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- current diagnosis of schizophrenia-spectrum disorders, based on ICD-10 made by the treating clinicians,
- aged 18-64, and
- able to read and write Chinese
- aged 18 or above,
- able to read and write Chinese,
Key exclusion criteria (4 listed)
- having co-morbidity of learning disability, organic/neurological conditions, or substance use disorder, and
- living in a hostel
- Family caregivers
- having 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 |
|---|---|---|
| tgCBFI programmea six-week online group intervention programme for dyads of service users and caregivers | Behavioural | tgCBFI group |
| Treatment as Usual (TAU)Integrated community psychiatric care with psychiatric outpatient follow-up | Behavioural | Treatment as Usual (TAU) group |
Primary outcome
Expressed emotion experienced by the service users as assessed by the Concise Chinese Level of Expressed Emotion Scale (CCLEES)
Time frame: From enrollment to twelve-week post-intervention follow-up
It has twelve items using a four-point Likert scale with three subscales. The total score ranges from 12 to 48, and a higher score indicates a higher level of familial expressed emotion.
5 secondary outcomes
Positive and negative symptoms of service users as assessed by the Positive and Negative Syndrome Scale (PANSS)
Time frame: From enrollment to twelve-week post-intervention follow-up
Perceived care burden of family caregivers as assessed by the Family Burden Interview Schedule (FBIS)
Time frame: From enrollment to twelve-week post-intervention follow-up
Mood disturbances of family caregivers as assessed by the Hospital Anxiety and Depression Scale (HADS)
Time frame: From enrollment to twelve-week post-intervention follow-up
Service satisfaction of participants from the tgCBFI group as assessed by the Client Satisfaction Questionnaire (CSQ-8)
Time frame: within one week after the intervention
Qualitative feedback from the participants in the tgCBFI group as assessed by focus group interviews
Time frame: within one month after the intervention
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jul 2026.
- Individual participant dataSharing planned: Yes. IPD will be available upon reasonable request to the corresponding author after the study articles are published.
Related trials for Schizophrenia and Related Disorders
RecruitingPhase 3
A Study to Evaluate the Long-term Safety and Tolerability of Xanomeline and Trospium Chloride for the Treatment of Psychiatric Disorders in Children and Adolescents
Schizophrenia, Autism-Related Irritability
Not yet recruitingObservational study
Sleep Monitoring for Early Detection of Relapse in People With Schizophrenia or Bipolar Disorder Receiving Usual Treatment
Bipolar Disorder (BD), SCHIZOPHRENIA 1 (Disorder)
Not yet recruitingPhase 1
Pharmacokinetics and Relative Bioavailability of Intranasal vs Intramuscular Olanzapine in Healthy Adult Participants
Healthy Adult Participants
Recruiting
REACH Study (Recovery Environments: Assessing Cognitive & Brain Health in Community Mental Health)
Schizophrenia, Schizo Affective Disorder
RecruitingPhase 3
Safety and Tolerability Trial of Lumateperone in Pediatric Patients With Schizophrenia, Bipolar Disorder or Autism Spectrum Disorder
Schizophrenia, Bipolar Disorder
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.
Dennis Chak Fai Ma, PhD principal investigator
School of Nursing, The Hong Kong Polytechnic University
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing tgCBFI programme and Treatment as Usual (TAU) in people with Schizophrenia and Related Disorders, run by The Hong Kong Polytechnic University at 6 sites 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 7 inclusion and 4 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: looking for participants now, 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 6 sites 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Dennis Chak Fai Ma, PhD (852-27666555, dennis.cf.ma@polyu.edu.hk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Expressed emotion experienced by the service users as assessed by the Concise Chinese Level of Expressed Emotion Scale (CCLEES) (time frame: From enrollment to twelve-week post-intervention follow-up). 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 24 Jul 2026.