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

Chronic Illness Clinical Trial

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.

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03048565
• Other study ID #: 12
• Status: Terminated
• Phase: N/A
• Start date: September 13, 2017
• Est. completion date: October 4, 2017

Study information

• Verified date: May 2018
• Source: University of Dublin, Trinity College
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 11
• Est. completion date: October 4, 2017
• Est. primary completion date: October 4, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Chronic Disease
• Chronic Illness

Intervention

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.

Locations

Country	Name	City	State
Ireland	Trinity College Dubliln	Dublin
Ireland	Trinity College Dublin	Dublin

Sponsors (2)

Lead Sponsor	Collaborator
University of Dublin, Trinity College	Family Carers Ireland

Country where clinical trial is conducted

Ireland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Caregiver MBCT Programme Evaluation Form	programme evaluation	up to 2 weeks post-intervention
Primary	Change over time in Calgary Symptoms of Stress Inventory (C-SOSI)	Response to stressful situations	up to 2 weeks and 6 months post-intervention
Primary	Change over time in Perceived Stress Scale	perceived stress	up to 2 weeks and 6 months post-intervention
Primary	Change over time in Cognitive and Affective Mindfulness Scale Revised (CAMS-R)	Mindfulness	up to 2 weeks and 6 months post-intervention
Primary	Change over time in The Adult Carer Quality of Life Questionnaire	Quality of Life	up to 2 weeks and 6 months post-intervention