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.

University of Dublin, Trinity College2 sites in 1 country11 target enrollmentSeptember 13, 2017

ConditionsChronic Illness

Overview

Phase: N/A
Intervention: Not specified
Conditions: Chronic Illness
Sponsor: University of Dublin, Trinity College
Enrollment: 11
Locations: 2
Primary Endpoint: Change over time in Calgary Symptoms of Stress Inventory (C-SOSI)
Status: Terminated
Last Updated: 8 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

September 13, 2017

End Date

October 4, 2017

Last Updated

8 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

University of Dublin, Trinity College

Responsible Party

Principal Investigator

Margarita Corry

Assistant Professor

University of Dublin, Trinity College

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.