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Clinical Trials/NCT02667782
NCT02667782
Completed
Not Applicable

Use of a Mindfulness-based Intervention for Family Carers of People With Dementia in the Community: A Feasibility Study

The Hong Kong Polytechnic University2 sites in 1 country53 target enrollmentFebruary 18, 2016

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Anxiety
Sponsor
The Hong Kong Polytechnic University
Enrollment
53
Locations
2
Primary Endpoint
Change of Perceived Stress Scale (PSS)
Status
Completed
Last Updated
8 years ago

Overview

Brief Summary

The aim of this study is to examine which mindfulness-based intervention protocol, MBCT or MBSR, is more suited for use among local carers of people with dementia (PWD), as measured by better mental health outcomes in PWD such as reductions in stress and improvements in mental well-being.

Detailed Description

60 subjects will be recruited in the community and randomized into either the MBCT or MBSR group. Both MBSR and MBCT will be delivered through a face-to-face teaching session followed by regular telephone follow-ups. The primary outcome measures of the dementia caregivers will be stress with Perceived Stress Scale (PSS; Cohen \& Williamson, 1988). The secondary outcome measures of the dementia caregiver will be 1) anxiety with Hospital Anxiety and Depression Scale (HADS; Zigmon \& Snaith, 1983), 2) depression with Center for Epidemiologic Studies Depression Scale (CESD; Radloff, 1977), and 3) burden with Zarit Burden Inventory (ZBI; Zarit, Reever, \& Bach-Peterson, 1980). The control measure will be their level of mastery of the five facets mindfulness with Five Facets Mindfulness Questionnaire (FFMQ; Baer, Smith, Hopkins, Krietemeyer, \& Toney, 2006). Focus group interviews with each group of participants will be conducted post-intervention to explore their experiences and perceptions. Data will be collected at baseline (T0), at 2 months (the mid-point of the intervention; T1), 4 months (immediately after the intervention; T2), and 7 months (the follow-up assessment; T3). Adherence rates, response rates, and drop-out rates will be collected and analyzed. The triangulation of both qualitative and quantitative data will be performed to determine the suitability and benefits of MBSR and MBCT for carers of PWD in the local setting.

Registry
clinicaltrials.gov
Start Date
February 18, 2016
End Date
September 30, 2017
Last Updated
8 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Wai-Tong Chien

Professor

The Hong Kong Polytechnic University

Eligibility Criteria

Inclusion Criteria

  • Not provided

Exclusion Criteria

  • has a major active psychiatric illness such as bipolar disorder or schizophrenia.
  • is currently undergoing cancer treatment.
  • has severe chronic pain (lasting more than six months).

Outcomes

Primary Outcomes

Change of Perceived Stress Scale (PSS)

Time Frame: [Time Frame: At baseline (T0), 2 months (mid-point of intervention; T1), 4 months (immediately post- intervention; T2), and 7 months (follow-up assessment; T3).

Comparisons of changes of Perceived Stress Scale will be considered as follows: 1. T0 - T1 2. T0 - T2 3. T0 - T3 4. T1 - T2 5. T1 - T3 6. T2 - T3

Secondary Outcomes

  • Change of Hospital Anxiety and Depression Scale (HADS)(At baseline (T0), 2 months (mid-point of intervention; T1), 4 months (immediately post- intervention; T2), and 7 months (follow-up assessment; T3).)
  • Zarit Burden Inventory (ZBI)(At baseline (T0), 2 months (mid-point of intervention; T1), 4 months (immediately post- intervention; T2), and 7 months (follow-up assessment; T3).)
  • Center for Epidemiologic Studies Depression Scale (CESD)(At baseline (T0), 2 months (mid-point of intervention; T1), 4 months (immediately post- intervention; T2), and 7 months (follow-up assessment; T3).)

Study Sites (2)

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