Group Cognitive Behavioural Family Intervention (CBFI) for People With Schizophrenia and Their Families

NCT04065360 | Withdrawn DMC

• 1 other identifier: CBFI
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief 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 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

Keywords

Schizophrenia; Psychosis; Family intervention; Cognitive behavioural therapy; CBT

Outcome Measures

Primary Outcomes (1)

• Qualitative feedback from the clinicians of the concerned wards

  Programme evaluation interview

  Immediate posttreatment

Secondary Outcomes (7)

• Positive symptoms of service users

  Immediate posttreatment

• Negative symptoms of service users

  Immediate posttreatment

• Expressed emotion by service users

  Immediate posttreatment

• Caregiving experience by family caregivers

  Immediate posttreatment

• Perceived care burden by family caregivers

  Immediate posttreatment

Study Arms (2)

Cognitive behavioural family intervention

EXPERIMENTAL

Behavioral: Group Cognitive behavioural family intervention (CBFI)

Usual group psychoeducation

ACTIVE COMPARATOR

Behavioral: Usual group psychoeducation

Interventions

Group Cognitive behavioural family intervention (CBFI) BEHAVIORAL

four-week, four-session CBT-based family intervention programme

Cognitive behavioural family intervention

Usual group psychoeducation BEHAVIORAL

Treatment as usual in the institution studied

Usual group psychoeducation

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• Living with service users
• Able to communicate in Cantonese
• Nominated by the service users

You may not qualify if:

• 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

Sponsors & Collaborators

• Hospital Authority, Hong Kong: lead
• The University of Hong Kong: collaborator

Study Sites (1)

Kwai Chung Hospital

Hong Kong, Hong Kong

Location

MeSH Terms

Conditions

Schizophrenia; Psychotic Disorders

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders

Study Officials

• Chak Fai Ma, MSc

  Kwai Chung Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Registered Nurse (Psychiatric)

Study Record Dates

• First Submitted: August 17, 2019
• First Posted: August 22, 2019
• Study Start: January 1, 2021
• Primary Completion: October 1, 2021
• Study Completion: December 1, 2022
• Last Updated: March 31, 2023

Record last verified: 2023-03

Locations

HK (1)