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.

This is a pilot feasibility study testing a mindfulness based intervention with caregivers of people with chronic illnesses

Study Overview

• Status: Terminated
• Conditions: Chronic Illness
• Intervention / Treatment: Behavioral: MBSR

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 Type: Interventional
• Enrollment (Actual): 11
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Ireland
  • Dublin, Ireland, dublin 2
    • Trinity College Dublin
  • Dublin, Ireland
    • Trinity College Dubliln

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Usual care; No intervention
Experimental: Mindfulness based Stress Reduction; 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.	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.

What is the study measuring?

Primary Outcome Measures

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Caregiver MBCT Programme Evaluation Form	programme evaluation	up to 2 weeks post-intervention

Collaborators and Investigators

• Sponsor: University of Dublin, Trinity College
• Collaborators: Family Carers Ireland
• Investigators: Principal Investigator: Margarita Corry, University of Dublin, Trinity College

Study record dates

Study Major Dates

• Study Start (Actual): September 13, 2017
• Primary Completion (Actual): October 4, 2017
• Study Completion (Actual): October 4, 2017

Study Registration Dates

• First Submitted: February 6, 2017
• First Submitted That Met QC Criteria: February 8, 2017
• First Posted (Estimate): February 9, 2017

Study Record Updates

• Last Update Posted (Actual): May 4, 2018
• Last Update Submitted That Met QC Criteria: May 3, 2018
• Last Verified: May 1, 2018

More Information

Terms related to this study

• Keywords: mindfulness; caregivers
• Additional Relevant MeSH Terms: Pathologic Processes; Disease Attributes; Chronic Disease
• Other Study ID Numbers: 12 (Israel lung Association)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No