NCT03048565

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
• Phase: N/A
• Study type: Interventional
• Enrollment: 11 (actual)
• Sponsor: University of Dublin, Trinity College · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

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.

Conditions

• Chronic Illness

Interventions

Type	Name	Description
BEHAVIORAL	MBSR	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.

Timeline

• Start date: 2017-09-13
• Primary completion: 2017-10-04
• Completion: 2017-10-04
• First posted: 2017-02-09
• Last updated: 2018-05-04

Locations

2 sites across 1 country: Ireland