SchizophreniaNCT04065360
Group Cognitive Behavioural Family Intervention (CBFI) for People With Schizophrenia and Their Families
A study testing Group Cognitive behavioural family intervention (CBFI) and Usual group psychoeducation in people with Schizophrenia and Psychosis, run by Hospital Authority, Hong Kong at 1 site in Hong Kong.
Trial summary
Cognitive behavioural family intervention (CBFI) is a brief psychosocial intervention that incorporates the model of cognitive behavioural therapy (CBT) into the family context. It builds upon the current trend of family interventions/psychoeducation with refocusing on the cognitive model within the family… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Schizophrenia, Psychosis
- What is being tested?
- Group Cognitive behavioural family intervention (CBFI) and Usual group psychoeducation
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteHong Kong
- Study dates
- Jan 2021to Dec 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Service users
- Diagnosis of schizophrenia-spectrum disorders, based on clinical judgement by the treating clinicians
- Aged 18-65
- Able to communicate in Cantonese
- Family caregivers
- Aged above 18
Show all 9Show fewer
- Living with service users
- Able to communicate in Cantonese
- Nominated by the service users
Who cannot join
- Service users
- Having co-morbidity of learning disability
- Organic/neurological conditions
- Substance misuse disorder
- Family caregivers
- Having active psychiatric conditions
- Looking after more than one family member suffering from chronic physical or mental illnesses
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effectiveness of Group Cognitive Behavioural Family Intervention (CBFI) for People With Schizophrenia and Their Families: A Mixed-method Study
Cognitive behavioural family intervention (CBFI) is a brief psychosocial intervention that incorporates the model of cognitive behavioural therapy (CBT) into the family context. It builds upon the current trend of family interventions/psychoeducation with refocusing on the cognitive model within the family interpersonal relationship. Existing literature indicates that CBFI may be effective in improving positive and negative symptoms of people diagnosed with schizophrenia immediately following the programme. This mixed-method is to evaluate the feasibility and effectiveness of a CBFI programme for people with schizophrenia and their families in a local context. The findings may accumulate more evidence that CBFI is a brief and effective psychosocial intervention that is adapted to Hong Kong clinical settings.
- Conditions
- Schizophrenia, Psychosis
- Being tested
- Group Cognitive behavioural family intervention (CBFI), Usual group psychoeducation
- Keywords
- Schizophrenia, Psychosis, Family intervention, Cognitive behavioural therapy, CBT
- 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.
Group Cognitive behavioural family intervention (CBFI)Behavioural
four-week, four-session CBT-based family intervention programme
Usual group psychoeducationBehavioural
Treatment as usual in the institution studied
| Study group | Role | What they receive |
|---|---|---|
| Cognitive behavioural family intervention | Experimental | Not described Receives: Behavioral: Group Cognitive behavioural family intervention (CBFI) |
| Usual group psychoeducation | Active comparator | Not described Receives: Behavioral: Usual group psychoeducation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Qualitative feedback from the clinicians of the concerned wards
Programme evaluation interview
Measured: Immediate posttreatment
Secondary outcomes (7)
Positive symptoms of service users
Psychotic Symptoms Rating Scales (PSYRATS); 11-item hallucination subscale ranging from 0 to 44; 6-item delusion subscale ranging from 0 to 24
Measured: Immediate posttreatment
Negative symptoms of service users
Brief Negative Symptom Scale (BNSS); 13-item ranging from 0 to 78
Measured: Immediate posttreatment
Expressed emotion by service users
Concise Chinese Level of Expressed Emotion Scale (CCLEES); 12-item ranging from 12 to 48
Measured: Immediate posttreatment
Caregiving experience by family caregivers
Chinese version of Experience of Caregiving Inventory (CECI); 66-item ranging from 0 to 264
Measured: Immediate posttreatment
Perceived care burden by family caregivers
Family Burden Interview Schedule (FBIS); 25-item ranging from 0 to 50
Measured: Immediate posttreatment
Mood disturbance by family caregivers
Hospital Anxiety and Depression Scale (HADS); 7-item depression subscale ranging from 0 to 21; 7-item anxiety subscale ranging from 0 to 21
Measured: Immediate posttreatment
Qualitative feedback from the service users and their families
Semi-structured focus group interview
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 posted22 Aug 2019
- Study startJan 2021 (estimated)
- Primary completionOct 2021 (estimated)
- Study completionDec 2022 (estimated)
Why it stopped: Due to COVID-19 pandemic
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SchizophreniaStudies 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
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospital Authority, Hong Kong
- Sponsor type
- Other government
- Collaborators
- The University of Hong Kong
- Responsible party
- Principal investigator, Chak Fai Ma, Hospital Authority, Hong Kong
- Investigators
- Chak Fai Ma, MSc, Principal investigator, Kwai Chung Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04065360
- Sponsor's protocol ID
- CBFI
- Status last verified
- Mar 2023
- First submitted
- 17 Aug 2019
- Last updated
- 31 Mar 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Group Cognitive Behavioural Family Intervention (CBFI) for People With Schizophrenia and Their Families: A Mixed-method Study
- ClinicalTrials.gov ID
- NCT04065360
- Acronym / sponsor ID
- CBFI
- Conditions
- Schizophrenia, Psychosis
- Keywords
- Schizophrenia, Psychosis, Family intervention, Cognitive behavioural therapy, CBT
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Due to COVID-19 pandemic
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Hospital Authority, Hong KongOther government
- Collaborators
- The University of Hong Kong
- Study start
- Jan 2021 (estimated)
- Primary completion
- Oct 2021 (estimated)
- Study completion
- Dec 2022 (estimated)
- First posted
- 22 Aug 2019 (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.
Cognitive behavioural family intervention (CBFI) is a brief psychosocial intervention that incorporates the model of cognitive behavioural therapy (CBT) into the family context. It builds upon the current trend of family interventions/psychoeducation with refocusing on the cognitive model within the family interpersonal relationship. Existing literature indicates that CBFI may be effective in improving positive and negative symptoms of people diagnosed with schizophrenia immediately following the programme. This mixed-method is to evaluate the feasibility and effectiveness of a CBFI programme for people with schizophrenia and their families in a local context. The findings may accumulate more evidence that CBFI is a brief and effective psychosocial intervention that is adapted to Hong Kong clinical settings.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cognitive behavioural family intervention | Experimental | Behavioral: Group Cognitive behavioural family intervention (CBFI) |
| Usual group psychoeducation | Active comparator | Behavioral: Usual group psychoeducation |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Service users
- Diagnosis of schizophrenia-spectrum disorders, based on clinical judgement by the treating clinicians
- Aged 18-65
- Able to communicate in Cantonese
- Family caregivers
Key exclusion criteria (7 listed)
- Service users
- Having co-morbidity of learning disability
- Organic/neurological conditions
- Substance misuse disorder
- Family caregivers
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 |
|---|---|---|
| Group Cognitive behavioural family intervention (CBFI)four-week, four-session CBT-based family intervention programme | Behavioural | Cognitive behavioural family intervention |
| Usual group psychoeducationTreatment as usual in the institution studied | Behavioural | Usual group psychoeducation |
Primary outcome
Qualitative feedback from the clinicians of the concerned wards
Time frame: Immediate posttreatment
Programme evaluation interview
7 secondary outcomes
Positive symptoms of service users
Time frame: Immediate posttreatment
Negative symptoms of service users
Time frame: Immediate posttreatment
Expressed emotion by service users
Time frame: Immediate posttreatment
Caregiving experience by family caregivers
Time frame: Immediate posttreatment
Perceived care burden by family caregivers
Time frame: Immediate posttreatment
Mood disturbance by family caregivers
Time frame: Immediate posttreatment
Qualitative feedback from the service users and their families
Time frame: Immediate posttreatment
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Mar 2023.
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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.
Chak Fai Ma, MSc principal investigator
Kwai Chung Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Group Cognitive behavioural family intervention (CBFI) and Usual group psychoeducation in people with Schizophrenia and Psychosis, run by Hospital Authority, Hong Kong 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 9 inclusion and 7 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: withdrawn, as of the sponsor's last update on 31 Mar 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 was withdrawn before enrolling participants, so there are no results.
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?
Qualitative feedback from the clinicians of the concerned wards (time frame: Immediate posttreatment). 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 31 Mar 2023.