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

NCT ID: NCT05808244

Last Updated: 2023-04-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-04-30

Study Completion Date

2024-02-29

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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. What are the feasibility, acceptability, and safety of conducting a tele-group CBFI programme for people with schizophrenia and their family caregivers?
2. 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?
3. 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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Schizophrenia Psychosis

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

tgCBFI

Group Type EXPERIMENTAL

tgCBFI

Intervention Type BEHAVIORAL

Six weekly sessions CBT-based family intervention programme

Usual psychiatric care

Intervention Type BEHAVIORAL

Integrated community psychiatric care with medical follow-up

Usual psychiatric care

Group Type ACTIVE_COMPARATOR

Usual psychiatric care

Intervention Type BEHAVIORAL

Integrated community psychiatric care with medical follow-up

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

tgCBFI

Six weekly sessions CBT-based family intervention programme

Intervention Type BEHAVIORAL

Usual psychiatric care

Integrated community psychiatric care with medical follow-up

Intervention Type BEHAVIORAL

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

The University of Hong Kong

OTHER

Sponsor Role collaborator

Queen Mary Hospital, Hong Kong

OTHER

Sponsor Role collaborator

Kowloon Hospital, Hong Kong

OTHER

Sponsor Role collaborator

Nethersole Institute of Continuing Holistic Health Education

UNKNOWN

Sponsor Role collaborator

The Hong Kong Polytechnic University

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Dennis Chak Fai Ma

Clinical Associate (Mental Health)

Responsibility Role PRINCIPAL_INVESTIGATOR

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Dennis Chak Fai Ma

Role: CONTACT

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

tgCBFI

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Peer-led Psycho-education for Schizophrenia
NCT03246932 ACTIVE_NOT_RECRUITING NA