Tele-group Cognitive Behavioural Family Intervention (tgC... | NCT05808244

Studies
Tele-group Cognitive Behavioural Family Intervention (tgCBFI) for People With Schizophrenia and Their Families

NCT05808244

Sponsor

The Hong Kong Polytechnic University

Status

Unknown status

Last Update Posted

Apr 11, 2023Actual

Enrollment

60Estimated

Phase

Not Applicable

Conditions

Schizophrenia
Psychosis

Interventions

tgCBFI
Usual psychiatric care

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2023

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Not yet recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 2023Estimated

Primary Completion Date

Jan 2024Estimated

Completion Date

Feb 2024Estimated

First Submitted Date

Mar 29, 2023

First Submission Date that Met QC Criteria

Mar 29, 2023

First Posted Date

Apr 11, 2023Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 29, 2023

Last Update Posted Date

Apr 11, 2023Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Dennis Chak Fai Ma, Clinical Associate (Mental Health), The Hong Kong Polytechnic UniversityPrincipal Investigator

Lead Sponsor

The Hong Kong Polytechnic UniversityOTHER

Collaborators

Name	Class
The University of Hong Kong	OTHER
Queen Mary Hospital, Hong Kong	OTHER
Kowloon Hospital, Hong Kong	OTHER
Nethersole Institute of Continuing Holistic Health Education

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief 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.

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?

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

60Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
tgCBFI	Experimental		Behavioral: tgCBFI Behavioral: Usual psychiatric care
Usual psychiatric care	Active Comparator		Behavioral: Usual psychiatric care

Interventions

Name	Type	Description	Arm Group Labels	Other Names
tgCBFI	Behavioral	Six weekly sessions CBT-based family intervention programme	tgCBFI

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Level of service satisfaction of service users and family caregivers		Immediate posttreatment
Feasibility, acceptability, and safety of the programme		Throughout the whole programme

Secondary Outcomes

Measure	Description	Time Frame
Perceived expressed emotion of service users		up to 12-week follow up
Positive and negative symptoms of service users		up to 12-week follow up
Mood disturbance of family caregivers

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

Service users

have co-morbidity of learning disability, organic/neurological conditions, or substance misuse disorder
live in hostel

Family caregivers

-have active psychiatric conditions

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Dennis Chak Fai Ma	Contact			dennis.cf.ma@polyu.edu.hk

Overall Officials

Not provided

Locations

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D012559	Schizophrenia
D011618	Psychotic Disorders

Ancestor Terms

ID	Term
D019967	Schizophrenia Spectrum and Other Psychotic Disorders
D001523	Mental Disorders

Browse Leaves

Not provided

Browse Branches

Not provided