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Effects of a Modified Mindfulness-based Cognitive Therapy for Family Caregivers of People With Dementia

NCT03354819 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 113

Last updated 2019-08-07

No results posted yet for this study

Summary

Caring for people with dementia (PWD) poses many challenges which may cause high levels of caregiver stress. This study aims to investigate the effects of a modified Mindfulness-based Cognitive Therapy for stress reduction in the family caregivers of PWD. A prospective, single-blind, parallel-group randomized controlled trial (RCT) of 76 family caregivers of PWD will be recruited and randomized to either the MBCT or the control groups.The primary outcomes (stress) and secondary outcomes (anxiety, depression, burden, quality of life and resilience) will be measured at immediate post-intervention (T1) and at 3 months follow up (T2) which will be compared with the baseline (T0). Mixed repeated measure MANOVA will be performed to assess the effects of time, group, and time-group interaction on all outcome measurements.To understand the therapeutic components and identify the strengths, limitations, and difficulties of the MBCT program, process evaluation will be conducted through focus group interviews with 15 participants from the MBI group. It is hypothesized that the MBCT group will have a significantly greater reduction of stress (primary outcome) and improvement in the secondary outcomes, namely depression, anxiety, and burden, at T1 and/or T2 than the control group.

Conditions

Interventions

BEHAVIORAL

Modified MBCT

Compared with the original protocol of Mindfulness-based Cognitive Therapy (Segal et al., 2002), the modified MBCT protocol in this pilot study has the following changes: Outline: Session 1 Awareness and automatic pilot: Session 2 Living in our head Session 3 Gathering the scattered mind Session 4 Recognizing aversion \& allowing Session 5 Thoughts are not facts Session 6 Take care of myself Session 7 Maintaining and extending new learning

BEHAVIORAL

SIRE on dementia

The SIRE program includes routine education sessions on dementia care, caregiver skills training, and group sharing on caregiving tasks. Outline: 1. Overview of dementia 2. Pharmacological and non-pharmacological treatment of dementia 3. BPSD in dementia care 4. Person center care 5. Advance planning in people with dementia 6. Principle of mindfulness 7. Non-pharmacological intervention on stress reduction

Sponsors & Collaborators

  • The Hong Kong Polytechnic University

    lead OTHER

Principal Investigators

  • Justina Liu, PhD · The Hong Kong Polytechnic Univeristy

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2017-12-23
Primary Completion
2019-05-23
Completion
2019-06-23

Countries

  • Hong Kong

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03354819 on ClinicalTrials.gov