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

NCT ID: NCT03048565

Last Updated: 2018-05-04

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 11 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-09-13
• Study Completion Date: 2017-10-04

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.

Conditions

Chronic Illness

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Usual care

No intervention

Group Type: NO_INTERVENTION

No interventions assigned to this group

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.

Group Type: EXPERIMENTAL

MBSR

Intervention Type: BEHAVIORAL

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.

Interventions

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.

Intervention Type: BEHAVIORAL

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Family Carers Ireland

UNKNOWN

Sponsor Role: collaborator

University of Dublin, Trinity College

OTHER

Sponsor Role: lead

Responsible Party

Margarita Corry

Assistant Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Margarita Corry

Role: PRINCIPAL_INVESTIGATOR

University of Dublin, Trinity College

Locations

Trinity College Dublin

Dublin, , Ireland

Trinity College Dubliln

Dublin, , Ireland

Countries

Ireland

Other Identifiers

12

Identifier Type: -

Identifier Source: org_study_id