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

Primary Purpose

Chronic Illness

Status
Terminated
Phase
Not Applicable
Locations
Ireland
Study Type
Interventional
Intervention
MBSR
Sponsored by
University of Dublin, Trinity College
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Chronic Illness focused on measuring mindfulness, caregivers

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Trinity College Dublin
  • Trinity College Dubliln

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

Usual care

Mindfulness based Stress Reduction

Arm Description

No intervention

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.

Outcomes

Primary Outcome Measures

Change over time in Calgary Symptoms of Stress Inventory (C-SOSI)
Response to stressful situations
Change over time in Perceived Stress Scale
perceived stress
Change over time in Cognitive and Affective Mindfulness Scale Revised (CAMS-R)
Mindfulness
Change over time in The Adult Carer Quality of Life Questionnaire
Quality of Life

Secondary Outcome Measures

Full Information

First Posted
February 6, 2017
Last Updated
May 3, 2018
Sponsor
University of Dublin, Trinity College
Collaborators
Family Carers Ireland
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1. Study Identification

Unique Protocol Identification Number
NCT03048565
Brief Title
A Trial of an Online Mindfulness Based Programme for Informal Caregivers of People With Chronic Illnesses
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.
Study Type
Interventional

2. Study Status

Record Verification Date
May 2018
Overall Recruitment Status
Terminated
Why Stopped
recruitment challenges
Study Start Date
September 13, 2017 (Actual)
Primary Completion Date
October 4, 2017 (Actual)
Study Completion Date
October 4, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Dublin, Trinity College
Collaborators
Family Carers Ireland

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Illness
Keywords
mindfulness, caregivers

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
11 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Usual care
Arm Type
No Intervention
Arm Description
No intervention
Arm Title
Mindfulness based Stress Reduction
Arm Type
Experimental
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
MBSR
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change over time in Calgary Symptoms of Stress Inventory (C-SOSI)
Description
Response to stressful situations
Time Frame
up to 2 weeks and 6 months post-intervention
Title
Change over time in Perceived Stress Scale
Description
perceived stress
Time Frame
up to 2 weeks and 6 months post-intervention
Title
Change over time in Cognitive and Affective Mindfulness Scale Revised (CAMS-R)
Description
Mindfulness
Time Frame
up to 2 weeks and 6 months post-intervention
Title
Change over time in The Adult Carer Quality of Life Questionnaire
Description
Quality of Life
Time Frame
up to 2 weeks and 6 months post-intervention
Other Pre-specified Outcome Measures:
Title
Caregiver MBCT Programme Evaluation Form
Description
programme evaluation
Time Frame
up to 2 weeks post-intervention

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Margarita Corry
Organizational Affiliation
University of Dublin, Trinity College
Official's Role
Principal Investigator
Facility Information:
Facility Name
Trinity College Dublin
City
Dublin
ZIP/Postal Code
dublin 2
Country
Ireland
Facility Name
Trinity College Dubliln
City
Dublin
Country
Ireland

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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

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