Cluster RCT of Cognitive Behavioral Therapy to Support Caregivers of Older Adults in Hong Kong

NCT06473012 | Completed

• 1 other identifier: 2023-0030-001
• Study Type: interventional
• Target: 255
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this cluster randomized controlled trial study is to compare the effectiveness of a novel psychosocial intervention based on Cognitive Behavioral Therapy, lifestyle intervention and effective communication skills in caregivers of older adults in Hong Kong. The main question\[s\] it aims to answer are: What is the impact of the 6-week psychosocial intervention on distress and burden among participants? Participants will participate in a 6-week psychosocial intervention. Researchers will compare the results between the intervention group and the active control group to see if participants in the intervention group have lower distress and burden.

Conditions

Caregiver Burden; Depressive Symptoms; Quality of Life; Self Efficacy; Resilience

Outcome Measures

Primary Outcomes (2)

• Patient Health Questionnaire (PHQ-9)

  The PHQ-9 is a self-report instrument used to assess depression symptoms, consisting of nine items that correspond to the diagnostic criteria for major depressive disorder. Participants will rate the frequency of symptoms experienced over the past two weeks, helping to determine the severity of depressive symptoms.

  3 months

• Generalized Anxiety Disorder (GAD-7)

  The GAD-7 is a widely used screening tool that measures the severity of generalized anxiety disorder by assessing the frequency of anxiety symptoms experienced over the past two weeks.

  3 months

Secondary Outcomes (5)

• Carer multidimensional assessment tool

  3 months

• Cantonese short version of the Zarit Burden Interview (CZBI)

  3 months

• The World Health Organization Quality of Life (WHOQoL-BREF)

  3 months

• Connor-Davidson Resilience Scale (CD-RISC-25)

  3 months

• Self-Care Self-Efficacy Scale (SCSES-10)

  3 months

Study Arms (2)

CBT Experimental Group

EXPERIMENTAL

Group intervention based on Cognitive Behavioral Therapy, lifestyle intervention, and effective communication.

Behavioral: Cognitive Behavioral Therapy for Caregivers of Older Adults

Active Control Group

ACTIVE COMPARATOR

The session focused on education about lifestyle and communication.

Behavioral: Control intervention for Caregivers of Older Adults

Interventions

Cognitive Behavioral Therapy for Caregivers of Older Adults BEHAVIORAL

Cognitive Behavioral Therapy Intervention for Caregivers of Older Adults is designed to be implemented in a group setting with 12 to 15 caregivers in a group. It consists of 6 weekly sessions, and each session lasts for 90 minutes to 120 minutes. The content of the intervention is based on lifestyle intervention, CBT and effective communication skills. Home practices will be assigned to the participants in between each weekly session.

CBT Experimental Group

Control intervention for Caregivers of Older Adults BEHAVIORAL

The control group receives 6 weekly education sessions on useful healthcare information (mental health, physical health, health ageing and dementia). Each session lasts for 90 minutes to 120 minutes.

Active Control Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• family member needs to be the identified adult primary caregiver to an older adult aged 60 years old or above who living in the community
• caregiver needs to score \< 50 using the Caregiver Self-Efficacy Scale (CSES-8) which represents significant insufficiency in self-efficacy
• report mild to moderate depressive symptoms: a total score ranged from 5 to 14 using the Patient Health Questionnaire (PHQ-9)
• report mild to moderate anxiety: a total score ranged from 5 to 14 using the Generalized Anxiety Disorder 7-item (GAD-7)
• living in designated clusters in Hong Kong

You may not qualify if:

• caregivers diagnosed with Alzheimer's disease or other types of dementia
• older family member with caregiving needs is receiving government-subvented service
• suffering from acute health conditions, such as conditions caused by a virus, infection, injury, misuse of drugs or medications, preventing the provision of caregiving support
• illiterate

Sponsors & Collaborators

• The University of Hong Kong: lead

Study Sites (1)

Sau Po Center on Ageing HKU

Hong Kong, Hong Kong

Location

Related Publications (1)

• Tsoi TCW, Kwok KYH, Chan WS, Tang VMY, Chandola T, Quan J, Lou VW. Low intensity cognitive behavioral therapy to improve psychological well-being among family carers of older adults in Hong Kong: a cluster randomized controlled trial study protocol. Trials. 2025 Dec 10;27(1):17. doi: 10.1186/s13063-025-09347-y.

  PMID: 41373055 DERIVED

MeSH Terms

Conditions

Caregiver Burden; Depression

Interventions

Cognitive Behavioral Therapy

Condition Hierarchy (Ancestors)

Stress, Psychological; Behavioral Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities

Study Officials

• Vivian Lou, PhD

  Sau Po Center on Ageing, HKU

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: A multi-site RCT with one intervention group and one control group is planned to be implemented. The intervention group will receive a novel group intervention based on cognitive behavioral therapy, lifestyle intervention, and effective communication skills. It is tailor-made for caregivers of older adults in Hong Kong identified with psychological symptoms or risks through empirically validated screening assessment. It is devised and administered with the consideration of the Hong Kong local culture.

Study Record Dates

• First Submitted: June 18, 2024
• First Posted: June 25, 2024
• Study Start: September 3, 2024
• Primary Completion: April 20, 2026
• Study Completion: April 20, 2026
• Last Updated: May 1, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: Between 2024 and 2026, the data will become available.
• Access Criteria: Upon request from the academic journals.

Locations

HK (1)