Clinical trial NCT03048565: A Trial of an Online Mindfulness Based Programme for Informal Caregivers of People With Chronic Illnesses
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.
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Chronic Illness
Keywords: mindfulness
caregivers
Lead sponsor: University of Dublin, Trinity College
Sponsor class: OTHER
Collaborators: name: Family Carers Ireland
First posted: 2017-02-09
Enrollment: 11
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Change over time in Calgary Symptoms of Stress Inventory (C-SOSI)
timeFrame: up to 2 weeks and 6 months post-intervention
measure: Change over time in Perceived Stress Scale
timeFrame: up to 2 weeks and 6 months post-intervention
measure: Change over time in Cognitive and Affective Mindfulness Scale Revised (CAMS-R)
timeFrame: up to 2 weeks and 6 months post-intervention
measure: Change over time in The Adult Carer Quality of Life Questionnaire
timeFrame: up to 2 weeks and 6 months post-intervention
Secondary outcomes:
Other outcomes:
measure: Caregiver MBCT Programme Evaluation Form
timeFrame: up to 2 weeks post-intervention
Locations:
city: Dublin
country: Ireland
facility: Trinity College Dublin
city: Dublin
country: Ireland
facility: Trinity College Dubliln
Study officials:
affiliation: University of Dublin, Trinity College
name: Margarita Corry
role: PRINCIPAL_INVESTIGATOR
References: