AnxietyNCT02667782
Feasibility Study on the Use of Mindfulness-based Intervention for Family Carers of People With Dementia
A study testing Mindfulness-Based Stress Reduction (MBSR) and Mindfulness-Based Cognitive Therapy (MBCT) in people with Anxiety and Depression, run by The Hong Kong Polytechnic University at 2 sites in Hong Kong.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Anxiety, Depression, Dependency Burden
- What is being tested?
- Mindfulness-Based Stress Reduction (MBSR) and Mindfulness-Based Cognitive Therapy (MBCT)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 53 participants
- Where
- 2 sitesHong Kong
- Study dates
- 18 Feb 2016to 30 Sep 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- is the primary carer
- of an adult with a confirmed diagnosis of dementia.
Who cannot join
- 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).
Trial locations and contacts
2 sites in 1 country.
Hong Kong2 sites
School of Nursing, The Hong Kong Polytechnic University
Hong Kong
Community care centres
Kowloon
About this study
Official title: Use of a Mindfulness-based Intervention for Family Carers of People With Dementia in the Community: A Feasibility Study
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.
Read the 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.
- Conditions
- Anxiety, Depression, Dependency Burden, Stress, Psychological
- Being tested
- Mindfulness-Based Stress Reduction (MBSR), Mindfulness-Based Cognitive Therapy (MBCT)
- Keywords
- Mindfulness-based interventions, Dementia, Caregiving, Burden, Stress, Anxiety, Depression, Community care
- Medical subject headings
- Anxiety Disorders, Depression, Stress, Psychological, Dementia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mindfulness-Based Stress Reduction (MBSR)Behavioural
Recruited subjects that are randomly allocated into the MBSR group will have an intensive face-to-face (F-T-F) teaching-learning program that is focused on stress reduction. After that, there will be some regular telephone follow-ups for a closed group of 10-15 participants. Subjects would receive four consecutive weekly F-T-F sessions, then a weekly telephone follow-up for three months in combination with an F-T-F session once a month. The Interventionist will be an experienced mindfulness therapist who is qualified to deliver both MBSR and MBCT.
Mindfulness-Based Cognitive Therapy (MBCT)Behavioural
Recruited subjects that are randomly allocated into the MBCT group will have an intensive face-to-face (F-T-F) teaching-learning program that is focused on cognitive therapy. After that, there will be some regular telephone follow-ups for a closed group of 10-15 participants. Subjects would receive four consecutive weekly F-T-F sessions, then a weekly telephone follow-up for three months in combination with an F-T-F session once a month. The Interventionist will be an experienced mindfulness therapist who is qualified to deliver both MBSR and MBCT.
| Study group | Role | What they receive |
|---|---|---|
| Mindfulness-Based Stress Reduction | Experimental | Mindfulness-Based Stress Reduction (MBSR) is developed by Jon Kabat-Zinn in 1979 (Kabat-Zinn, 1990). It is an eight-week Program that includes practices such as gentle mindful movement (awareness of the body), a body scan (to systematically nurture awareness of the body region by region), and sitting meditation (awareness of the breath to include the four foundations of mindfulness, namely, body, feeling tone, mental state, and mental content) (Cullen, 2011). Receives: Behavioral: Mindfulness-Based Stress Reduction (MBSR) |
| Mindfulness-Based Cognitive Therapy | Experimental | Mindfulness-Based Cognitive Therapy (MBCT), developed by Zindel Segal, Mark Williams and John Teasdale, employs a cognitive theoretical framework (Cullen, 2011; Segal, Williams, \& Teasdale, 2002). It is also delivered as an eight-session group treatment. The first four sessions teach the fundamental concepts and skills of the practice of mindfulness. The remaining four sessions teach the individual how to notice his/her own thoughts and the impact of such thoughts on his/her own physical and emotional experiences. Receives: Behavioral: Mindfulness-Based Cognitive Therapy (MBCT) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change of Perceived Stress Scale (PSS)
Comparisons of changes of Perceived Stress Scale will be considered as follows:
- T0 - T1
- T0 - T2
- T0 - T3
- T1 - T2
- T1 - T3
- T2 - T3
Measured: [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).
Secondary outcomes (3)
Change of Hospital Anxiety and Depression Scale (HADS)
Comparisons of changes of Hospital Anxiety and Depression Scale will be considered as follows:
- T0 - T1
- T0 - T2
- T0 - T3
- T1 - T2
- T1 - T3
- T2 - T3
Measured: 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)
Comparisons of changes of Center for Epidemiologic Studies Depression Scale will be considered as follows:
- T0 - T1
- T0 - T2
- T0 - T3
- T1 - T2
- T1 - T3
- T2 - T3
Measured: 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)
Comparisons of changes of Zarit Burden Inventory will be considered as follows:
- T0 - T1
- T0 - T2
- T0 - T3
- T1 - T2
- T1 - T3
- T2 - T3
Measured: At baseline (T0), 2 months (mid-point of intervention; T1), 4 months (immediately post- intervention; T2), and 7 months (follow-up assessment; T3).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jan 2016 (estimated)
- Study start18 Feb 2016
- Primary completion30 Sep 2017
- Study completion30 Sep 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for AnxietyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Care provider, Outcomes assessor
- Enrolment
- 53 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Hong Kong Polytechnic University
- Sponsor type
- University, hospital or other
- Collaborators
- Griffith University
- Responsible party
- Principal investigator, Wai-Tong Chien, The Hong Kong Polytechnic University
- Investigators
- Wai Tong Chien, PhD, Principal investigator, School of Nursing, The Hong Kong Polytechnic UniversityWendy Moyle, PhD, Principal investigator, Griffith UniversityDaphne Cheung, PhD, Principal investigator, School of Nursing, The Hong Kong Polytechnic University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02667782
- Sponsor's protocol ID
- 1-ZVG9
- Status last verified
- Feb 2018
- First submitted
- 21 Jan 2016
- Last updated
- 22 Feb 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Cullen M. (2011). Mindfulness- Based Interventions: an Emerging Phenomenon. Mindfulness. 2(3):186-93.
Cohen, S. and Williamson, G. Perceived Stress in a Probability Sample of the United States. Spacapan, S. and Oskamp, S. (Eds.) The Social Psychology of Health. Newbury Park, CA: Sage, 1988
Zigmond AS, Snaith RP. The hospital anxiety and depression scale. Acta Psychiatr Scand. 1983 Jun;67(6):361-70. doi: 10.1111/j.1600-0447.1983.tb09716.x.
PubMed 6880820Radloff, L. S. (1977). The CES-D scale: A self report depression scale for research in the general population. Applied Psychological Measurements, 1, 385-401.
Zarit SH, Reever KE, Bach-Peterson J. Relatives of the impaired elderly: correlates of feelings of burden. Gerontologist. 1980 Dec;20(6):649-55. doi: 10.1093/geront/20.6.649. No abstract available.
PubMed 7203086Baer RA, Smith GT, Hopkins J, Krietemeyer J, Toney L. Using self-report assessment methods to explore facets of mindfulness. Assessment. 2006 Mar;13(1):27-45. doi: 10.1177/1073191105283504.
PubMed 16443717Segal Z. V., Williams J. M. G., & Teasdale J. D. (2002). Mindfulness-based cognitive therapy for depression: A new approach to preventing relapse. New York: Guilford.
Kabat-Zinn, J. (1990). Full Catastrophe Living: How to Cope with Stress, Pain and Illness Using Mindfulness Meditation. New York, NY: Delacorte.
Study at a glance
From the registry record, last updated by the sponsor on 22 Feb 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Use of a Mindfulness-based Intervention for Family Carers of People With Dementia in the Community: A Feasibility Study
- ClinicalTrials.gov ID
- NCT02667782
- Acronym / sponsor ID
- 1-ZVG9
- Conditions
- Anxiety, Depression, Dependency Burden, Stress, Psychological
- Keywords
- Mindfulness-based interventions, Dementia, Caregiving, Burden, Stress, Anxiety, Depression, Community care
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 53 participants (actual)
- Lead sponsor
- The Hong Kong Polytechnic UniversityUniversity, hospital or other
- Collaborators
- Griffith University
- Study start
- 18 Feb 2016 (actual)
- Primary completion
- 30 Sep 2017 (actual)
- Study completion
- 30 Sep 2017 (actual)
- First posted
- 29 Jan 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Mindfulness-Based Stress Reduction | Experimental | Behavioral: Mindfulness-Based Stress Reduction (MBSR)Mindfulness-Based Stress Reduction (MBSR) is developed by Jon Kabat-Zinn in 1979 (Kabat-Zinn, 1990). It is an eight-week Program that includes practices such as gentle mindful movement (awareness of the body), a body scan (to systematically nurture awareness of the body region by region), and sitting meditation (awareness of the breath to include the four foundations of mindfulness, namely, body, feeling tone, mental state, and mental content) (Cullen, 2011). |
| Mindfulness-Based Cognitive Therapy | Experimental | Behavioral: Mindfulness-Based Cognitive Therapy (MBCT)Mindfulness-Based Cognitive Therapy (MBCT), developed by Zindel Segal, Mark Williams and John Teasdale, employs a cognitive theoretical framework (Cullen, 2011; Segal, Williams, \& Teasdale, 2002). It is also delivered as an eight-session group treatment. The first four sessions teach the fundamental concepts and skills of the practice of mindfulness. The remaining four sessions teach the individual how to notice his/her own thoughts and the impact of such thoughts on his/her own physical and emotional experiences. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- is the primary carer
- of an adult with a confirmed diagnosis of dementia.
Key exclusion criteria (3 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Mindfulness-Based Stress Reduction (MBSR)Recruited subjects that are randomly allocated into the MBSR group will have an intensive face-to-face (F-T-F) teaching-learning program that is focused on stress reduction. After that, there will be some regular telephone follow-ups for a closed group of 10-15 participants. Subjects would receive four consecutive weekly F-T-F sessions, then a weekly telephone follow-up for three months in combination with an F-T-F session once a month. The Interventionist will be an experienced mindfulness therapist who is qualified to deliver both MBSR and MBCT. | Behavioural | Mindfulness-Based Stress Reduction |
| Mindfulness-Based Cognitive Therapy (MBCT)Recruited subjects that are randomly allocated into the MBCT group will have an intensive face-to-face (F-T-F) teaching-learning program that is focused on cognitive therapy. After that, there will be some regular telephone follow-ups for a closed group of 10-15 participants. Subjects would receive four consecutive weekly F-T-F sessions, then a weekly telephone follow-up for three months in combination with an F-T-F session once a month. The Interventionist will be an experienced mindfulness therapist who is qualified to deliver both MBSR and MBCT. | Behavioural | Mindfulness-Based Cognitive Therapy |
Primary outcome
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
3 secondary outcomes
Change of Hospital Anxiety and Depression Scale (HADS)
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).
Center for Epidemiologic Studies Depression Scale (CESD)
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).
Zarit Burden Inventory (ZBI)
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).
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Feb 2018.
- BackgroundCullen M. (2011). Mindfulness- Based Interventions: an Emerging Phenomenon. Mindfulness. 2(3):186-93.
- BackgroundCohen, S. and Williamson, G. Perceived Stress in a Probability Sample of the United States. Spacapan, S. and Oskamp, S. (Eds.) The Social Psychology of Health. Newbury Park, CA: Sage, 1988
- Background: PubMed 6880820Zigmond AS, Snaith RP. The hospital anxiety and depression scale. Acta Psychiatr Scand. 1983 Jun;67(6):361-70. doi: 10.1111/j.1600-0447.1983.tb09716.x.
- BackgroundRadloff, L. S. (1977). The CES-D scale: A self report depression scale for research in the general population. Applied Psychological Measurements, 1, 385-401.
- Background: PubMed 7203086Zarit SH, Reever KE, Bach-Peterson J. Relatives of the impaired elderly: correlates of feelings of burden. Gerontologist. 1980 Dec;20(6):649-55. doi: 10.1093/geront/20.6.649. No abstract available.
- Background: PubMed 16443717Baer RA, Smith GT, Hopkins J, Krietemeyer J, Toney L. Using self-report assessment methods to explore facets of mindfulness. Assessment. 2006 Mar;13(1):27-45. doi: 10.1177/1073191105283504.
- BackgroundSegal Z. V., Williams J. M. G., & Teasdale J. D. (2002). Mindfulness-based cognitive therapy for depression: A new approach to preventing relapse. New York: Guilford.
- BackgroundKabat-Zinn, J. (1990). Full Catastrophe Living: How to Cope with Stress, Pain and Illness Using Mindfulness Meditation. New York, NY: Delacorte.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Wai Tong Chien, PhD principal investigator
School of Nursing, The Hong Kong Polytechnic University
Wendy Moyle, PhD principal investigator
Griffith University
Daphne Cheung, PhD principal investigator
School of Nursing, The Hong Kong Polytechnic University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mindfulness-Based Stress Reduction (MBSR) and Mindfulness-Based Cognitive Therapy (MBCT) in people with Anxiety and Depression, run by The Hong Kong Polytechnic University at 2 sites in Hong Kong.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Feb 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Hong Kong. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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).). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02667782, which also lists 8 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Feb 2018.