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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.

Status
Terminated
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03048565
Enrollment
11
Registered
2017-02-09
Start date
2017-09-13
Completion date
2017-10-04
Last updated
2018-05-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic Illness

Keywords

mindfulness, caregivers

Brief summary

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.

Interventions

BEHAVIORALMBSR

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.

Sponsors

Family Carers Ireland
CollaboratorUNKNOWN
University of Dublin, Trinity College
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

Inclusion criteria

* 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.

Exclusion criteria

* 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.

Design outcomes

Primary

MeasureTime frameDescription
Change over time in Calgary Symptoms of Stress Inventory (C-SOSI)up to 2 weeks and 6 months post-interventionResponse to stressful situations
Change over time in Perceived Stress Scaleup to 2 weeks and 6 months post-interventionperceived stress
Change over time in Cognitive and Affective Mindfulness Scale Revised (CAMS-R)up to 2 weeks and 6 months post-interventionMindfulness
Change over time in The Adult Carer Quality of Life Questionnaireup to 2 weeks and 6 months post-interventionQuality of Life

Other

MeasureTime frameDescription
Caregiver MBCT Programme Evaluation Formup to 2 weeks post-interventionprogramme evaluation

Countries

Ireland

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026