Clinical Trials Logo

Clinical Trial Details — Status: Withdrawn

Administrative data

NCT number NCT04065360
Other study ID # CBFI
Secondary ID
Status Withdrawn
Phase N/A
First received
Last updated
Start date January 2021
Est. completion date December 2022

Study information

Verified date March 2023
Source Hospital Authority, Hong Kong
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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 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.


Recruitment information / eligibility

Status Withdrawn
Enrollment 0
Est. completion date December 2022
Est. primary completion date October 2021
Accepts healthy volunteers No
Gender All
Age group 18 Years to 65 Years
Eligibility Inclusion Criteria: 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 Exclusion Criteria: 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

Study Design


Intervention

Behavioral:
Group Cognitive behavioural family intervention (CBFI)
four-week, four-session CBT-based family intervention programme
Usual group psychoeducation
Treatment as usual in the institution studied

Locations

Country Name City State
Hong Kong Kwai Chung Hospital Hong Kong

Sponsors (2)

Lead Sponsor Collaborator
Hospital Authority, Hong Kong The University of Hong Kong

Country where clinical trial is conducted

Hong Kong, 

Outcome

Type Measure Description Time frame Safety issue
Primary Qualitative feedback from the clinicians of the concerned wards Programme evaluation interview Immediate posttreatment
Secondary 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 Immediate posttreatment
Secondary Negative symptoms of service users Brief Negative Symptom Scale (BNSS); 13-item ranging from 0 to 78 Immediate posttreatment
Secondary Expressed emotion by service users Concise Chinese Level of Expressed Emotion Scale (CCLEES); 12-item ranging from 12 to 48 Immediate posttreatment
Secondary Caregiving experience by family caregivers Chinese version of Experience of Caregiving Inventory (CECI); 66-item ranging from 0 to 264 Immediate posttreatment
Secondary Perceived care burden by family caregivers Family Burden Interview Schedule (FBIS); 25-item ranging from 0 to 50 Immediate posttreatment
Secondary 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 Immediate posttreatment
Secondary Qualitative feedback from the service users and their families Semi-structured focus group interview Immediate posttreatment
See also
  Status Clinical Trial Phase
Recruiting NCT05039489 - A Study on the Brain Mechanism of cTBS in Improving Medication-resistant Auditory Hallucinations in Schizophrenia N/A
Completed NCT05111548 - Brain Stimulation and Cognitive Training - Efficacy N/A
Completed NCT05321602 - Study to Evaluate the PK Profiles of LY03010 in Patients With Schizophrenia or Schizoaffective Disorder Phase 1
Completed NCT04503954 - Efficacy of Chronic Disease Self-management Program in People With Schizophrenia N/A
Completed NCT02831231 - Pilot Study Comparing Effects of Xanomeline Alone to Xanomeline Plus Trospium Phase 1
Completed NCT05517460 - The Efficacy of Auricular Acupressure on Improving Constipation Among Residents in Community Rehabilitation Center N/A
Completed NCT03652974 - Disturbance of Plasma Cytokine Parameters in Clozapine-Resistant Treatment-Refractory Schizophrenia (CTRS) and Their Association With Combination Therapy Phase 4
Recruiting NCT04012684 - rTMS on Mismatch Negativity of Schizophrenia N/A
Recruiting NCT04481217 - Cognitive Factors Mediating the Relationship Between Childhood Trauma and Auditory Hallucinations in Schizophrenia N/A
Completed NCT00212784 - Efficacy and Safety of Asenapine Using an Active Control in Subjects With Schizophrenia or Schizoaffective Disorder (25517)(P05935) Phase 3
Completed NCT04092686 - A Clinical Trial That Will Study the Efficacy and Safety of an Investigational Drug in Acutely Psychotic People With Schizophrenia Phase 3
Completed NCT01914393 - Pediatric Open-Label Extension Study Phase 3
Recruiting NCT03790345 - Vitamin B6 and B12 in the Treatment of Movement Disorders Induced by Antipsychotics Phase 2/Phase 3
Recruiting NCT05956327 - Insight Into Hippocampal Neuroplasticity in Schizophrenia by Investigating Molecular Pathways During Physical Training N/A
Terminated NCT03261817 - A Controlled Study With Remote Web-based Adapted Physical Activity (e-APA) in Psychotic Disorders N/A
Terminated NCT03209778 - Involuntary Memories Investigation in Schizophrenia N/A
Completed NCT02905604 - Magnetic Stimulation of the Brain in Schizophrenia or Depression N/A
Recruiting NCT05542212 - Intra-cortical Inhibition and Cognitive Deficits in Schizophrenia N/A
Completed NCT04411979 - Effects of 12 Weeks Walking on Cognitive Function in Schizophrenia N/A
Terminated NCT03220438 - TMS Enhancement of Visual Plasticity in Schizophrenia N/A