A Trial of an Online Mindfulness Based Programme for Informal Caregivers of People With Chronic Illnesses

Not Applicable

Terminated

• Conditions: Chronic Illness
• Interventions: Behavioral: MBSR

• Registration Number: NCT03048565
• Lead Sponsor: University of Dublin, Trinity College

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.

Study Timeline

• Study First Submitted: 2017-02-06
• Study First Submitted QC: 2017-02-08
• Study First Posted: 2017-02-09
• Study Start: 2017-09-13
• Primary Completion: 2017-10-04
• Study Completion: 2017-10-04
• Status Verified: 2018-05
• Last Update Submitted: 2018-05-03
• Last Update Posted: 2018-05-04

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 11

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.

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Mindfulness based Stress Reduction	MBSR	This 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.

Primary Outcome Measures

Name	Time	Method
Change over time in Calgary Symptoms of Stress Inventory (C-SOSI)	up to 2 weeks and 6 months post-intervention	Response to stressful situations
Change over time in Perceived Stress Scale	up to 2 weeks and 6 months post-intervention	perceived stress
Change over time in Cognitive and Affective Mindfulness Scale Revised (CAMS-R)	up to 2 weeks and 6 months post-intervention	Mindfulness
Change over time in The Adult Carer Quality of Life Questionnaire	up to 2 weeks and 6 months post-intervention	Quality of Life

Trial Locations

Locations (2)

Trinity College Dubliln; 🇮🇪 Dublin, Ireland

Trinity College Dublin; 🇮🇪 Dublin, Ireland