Chronic IllnessNCT03048565
A Trial of an Online Mindfulness Based Programme for Informal Caregivers of People With Chronic Illnesses
A study testing MBSR in people with Chronic Illness, run by University of Dublin, Trinity College at 2 sites in Ireland.
Trial summary
This is a pilot feasibility study testing a mindfulness based intervention with caregivers of people with chronic illnesses Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Chronic Illness
- What is being tested?
- MBSR
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 11 participants
- Where
- 2 sitesIreland
- Study dates
- 13 Sep 2017to 4 Oct 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
- Be 18 years of age and over
- Provide unpaid care to an adult or child with a chronic illness
- Not suffer from a severe mental illness
- Be ready to commit to the course at this point in their lives.
Who cannot join
- Caregivers who are under the age of 18 years.
- Caregivers who have a serious mental illness, such as severe anxiety/depression.
- Caregivers who are in receipt of current and regular treatment from a psychologist or psychiatrist.
- Caregivers with an active or recent physical addiction to alcohol or drugs.
- Caregivers who are already engaged in similar research.
- Caregivers who have already participated in mindfulness based stress reduction (MBSR) or MBCT training.
Trial locations and contacts
2 sites in 1 country.
Ireland2 sites
Trinity College Dublin
Dublin, dublin 2
Trinity College Dubliln
Dublin
About this study
Official title: An Exploratory Randomised Pilot Trial Examining the Potential Effectiveness of an Online Mindfulness Based Stress Reduction Programme for Informal Caregivers of People With Chronic Illnesses.
This is a pilot feasibility study testing a mindfulness based intervention with caregivers of people with chronic illnesses
Read the detailed description
The primary aim of the project is to pilot test the delivery of an online Mindfulness Based Stress Reduction (MBSR) programme to informal caregivers of people with chronic illnesses in one region in Ireland so as to determine the feasibility of delivering the intervention to caregivers in Ireland.
A two-group randomised pilot-feasibility trial comparing the online MBSR programme (intervention) with no programme (control). The MBSR programme is delivered online over 8 weeks. Weekly email and telephone contact will be maintained with participants in the intervention group for the duration of the delivery of the intervention. Participants are encouraged to practice mindfulness exercises and homework between sessions. The online programme was developed by a trained mindfulness teacher and a mindfulness teacher will conduct the weekly email and telephone call to participants in the intervention group. The study sample are caregivers in the Dublin region who are members of Family Carers' Ireland. A total of 80 caregivers will be recruited to the study, 40 per group, based on 1:1 randomisation using a computer-randomised number generator.
Baseline (pre-intervention) and post intervention participant outcome data (stress, mindfulness and QoL) will be collected using self-reported validated scales administered to participants by post, with stamped-addressed envelopes provided for return. Other pilot measures (i.e. study processes) will be monitored and assessed by the research team to determine potential refinement needs. Feasibility outcome data will be collected by the research team (including time to recruit, attendance at classes, willingness of participants to be randomised) and by the participants (expenses diary) during the study period, using predesigned data collection forms. Mean differences with 95% confidence intervals will be calculated to determine any significant differences between the groups on the outcomes of stress, mindfulness and QoL.
- Conditions
- Chronic Illness
- Being tested
- MBSR
- Keywords
- mindfulness, caregivers
- Medical subject headings
- Chronic Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MBSRBehavioural
Mindfulness is a skill that helps people manage their thoughts so that the stressful impact of unhelpful thoughts can be limited. The aim of the mindfulness based intervention in this study is to help caregivers manage stressful thoughts and events and help them respond to life stressors in a positive way.
| Study group | Role | What they receive |
|---|---|---|
| Usual care | No intervention | No intervention |
| Mindfulness based Stress Reduction | Experimental | This is an active intervention The MBSR programme is delivered online with weekly telephone and email contact from a trained mindfulness teacher. Participants are encouraged to practice mindfulness exercises and homework between sessions. The online programme was developed be a trained mindfulness teacher. Receives: Behavioral: MBSR |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change over time in Calgary Symptoms of Stress Inventory (C-SOSI)
Response to stressful situations
Measured: up to 2 weeks and 6 months post-intervention
Change over time in Perceived Stress Scale
perceived stress
Measured: up to 2 weeks and 6 months post-intervention
Change over time in Cognitive and Affective Mindfulness Scale Revised (CAMS-R)
Mindfulness
Measured: up to 2 weeks and 6 months post-intervention
Change over time in The Adult Carer Quality of Life Questionnaire
Quality of Life
Measured: up to 2 weeks and 6 months post-intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Feb 2017 (estimated)
- Study start13 Sep 2017
- Primary completion4 Oct 2017
- Study completion4 Oct 2017
Why it stopped: recruitment challenges
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic IllnessStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 11 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Dublin, Trinity College
- Sponsor type
- University, hospital or other
- Collaborators
- Family Carers Ireland
- Responsible party
- Principal investigator, Margarita Corry, University of Dublin, Trinity College
- Investigators
- Margarita Corry, Principal investigator, University of Dublin, Trinity College
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03048565
- Sponsor's protocol ID
- 12
- Status last verified
- May 2018
- First submitted
- 6 Feb 2017
- Last updated
- 4 May 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 4 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Exploratory Randomised Pilot Trial Examining the Potential Effectiveness of an Online Mindfulness Based Stress Reduction Programme for Informal Caregivers of People With Chronic Illnesses.
- ClinicalTrials.gov ID
- NCT03048565
- Acronym / sponsor ID
- 12
- Conditions
- Chronic Illness
- Keywords
- mindfulness, caregivers
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: recruitment challenges
- Enrolment
- 11 participants (actual)
- Lead sponsor
- University of Dublin, Trinity CollegeUniversity, hospital or other
- Collaborators
- Family Carers Ireland
- Study start
- 13 Sep 2017 (actual)
- Primary completion
- 4 Oct 2017 (actual)
- Study completion
- 4 Oct 2017 (actual)
- First posted
- 9 Feb 2017 (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.
This is a pilot feasibility study testing a mindfulness based intervention with caregivers of people with chronic illnesses
Detailed description
The primary aim of the project is to pilot test the delivery of an online Mindfulness Based Stress Reduction (MBSR) programme to informal caregivers of people with chronic illnesses in one region in Ireland so as to determine the feasibility of delivering the intervention to caregivers in Ireland.
A two-group randomised pilot-feasibility trial comparing the online MBSR programme (intervention) with no programme (control). The MBSR programme is delivered online over 8 weeks. Weekly email and telephone contact will be maintained with participants in the intervention group for the duration of the delivery of the intervention. Participants are encouraged to practice mindfulness exercises and homework between sessions. The online programme was developed by a trained mindfulness teacher and a mindfulness teacher will conduct the weekly email and telephone call to participants in the intervention group. The study sample are caregivers in the Dublin region who are members of Family Carers' Ireland. A total of 80 caregivers will be recruited to the study, 40 per group, based on 1:1 randomisation using a computer-randomised number generator.
Baseline (pre-intervention) and post intervention participant outcome data (stress, mindfulness and QoL) will be collected using self-reported validated scales administered to participants by post, with stamped-addressed envelopes provided for return. Other pilot measures (i.e. study processes) will be monitored and assessed by the research team to determine potential refinement needs. Feasibility outcome data will be collected by the research team (including time to recruit, attendance at classes, willingness of participants to be randomised) and by the participants (expenses diary) during the study period, using predesigned data collection forms. Mean differences with 95% confidence intervals will be calculated to determine any significant differences between the groups on the outcomes of stress, mindfulness and QoL.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Usual care | No intervention | –No intervention |
| Mindfulness based Stress Reduction | Experimental | Behavioral: MBSRThis is an active intervention The MBSR programme is delivered online with weekly telephone and email contact from a trained mindfulness teacher. Participants are encouraged to practice mindfulness exercises and homework between sessions. The online programme was developed be a trained mindfulness teacher. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Be 18 years of age and over
- Provide unpaid care to an adult or child with a chronic illness
- Not suffer from a severe mental illness
- Be ready to commit to the course at this point in their lives.
Key exclusion criteria (6 listed)
- Caregivers who are under the age of 18 years.
- Caregivers who have a serious mental illness, such as severe anxiety/depression.
- Caregivers who are in receipt of current and regular treatment from a psychologist or psychiatrist.
- Caregivers with an active or recent physical addiction to alcohol or drugs.
- Caregivers who are already engaged in similar research.
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 |
|---|---|---|
| MBSRMindfulness is a skill that helps people manage their thoughts so that the stressful impact of unhelpful thoughts can be limited. The aim of the mindfulness based intervention in this study is to help caregivers manage stressful thoughts and events and help them respond to life stressors in a positive way. | Behavioural | Mindfulness based Stress Reduction |
Primary outcome
Change over time in Calgary Symptoms of Stress Inventory (C-SOSI)
Time frame: up to 2 weeks and 6 months post-intervention
Response to stressful situations
Change over time in Perceived Stress Scale
Time frame: up to 2 weeks and 6 months post-intervention
perceived stress
Change over time in Cognitive and Affective Mindfulness Scale Revised (CAMS-R)
Time frame: up to 2 weeks and 6 months post-intervention
Mindfulness
Change over time in The Adult Carer Quality of Life Questionnaire
Time frame: up to 2 weeks and 6 months post-intervention
Quality of Life
Results and safety
The study was stopped early (reason given: recruitment challenges). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 May 2018.
- Individual participant dataSharing planned: Undecided
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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.
Margarita Corry principal investigator
University of Dublin, Trinity College
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing MBSR in people with Chronic Illness, run by University of Dublin, Trinity College at 2 sites in Ireland.
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 4 inclusion and 6 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: stopped early, as of the sponsor's last update on 4 May 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 Ireland. 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 was stopped early (reason given: recruitment challenges). Results are not available in the source record.
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 over time in Calgary Symptoms of Stress Inventory (C-SOSI) (time frame: up to 2 weeks and 6 months post-intervention). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 4 May 2018.