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A Trial of an Online Mindfulness Based Programme for Informal Caregivers of People With Chronic Illnesses
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.
1 other identifier
interventional
11
1 country
2
Brief Summary
This is a pilot feasibility study testing a mindfulness based intervention with caregivers of people with chronic illnesses
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Sep 2017
Shorter than P25 for not_applicable
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 6, 2017
CompletedFirst Posted
Study publicly available on registry
February 9, 2017
CompletedStudy Start
First participant enrolled
September 13, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 4, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
October 4, 2017
CompletedMay 4, 2018
May 1, 2018
21 days
February 6, 2017
May 3, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (4)
Change over time in Calgary Symptoms of Stress Inventory (C-SOSI)
Response to stressful situations
up to 2 weeks and 6 months post-intervention
Change over time in Perceived Stress Scale
perceived stress
up to 2 weeks and 6 months post-intervention
Change over time in Cognitive and Affective Mindfulness Scale Revised (CAMS-R)
Mindfulness
up to 2 weeks and 6 months post-intervention
Change over time in The Adult Carer Quality of Life Questionnaire
Quality of Life
up to 2 weeks and 6 months post-intervention
Other Outcomes (1)
Caregiver MBCT Programme Evaluation Form
up to 2 weeks post-intervention
Study Arms (2)
Usual care
NO INTERVENTIONNo intervention
Mindfulness based Stress Reduction
EXPERIMENTALThis 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.
Interventions
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.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University of Dublin, Trinity Collegelead
- Family Carers Irelandcollaborator
Study Sites (2)
Trinity College Dublin
Dublin, dublin 2, Ireland
Trinity College Dubliln
Dublin, Ireland
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Margarita Corry
University of Dublin, Trinity College
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Assistant Professor
Study Record Dates
First Submitted
February 6, 2017
First Posted
February 9, 2017
Study Start
September 13, 2017
Primary Completion
October 4, 2017
Study Completion
October 4, 2017
Last Updated
May 4, 2018
Record last verified: 2018-05