NCT03048565

Brief Summary

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

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
11

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Sep 2017

Shorter than P25 for not_applicable

Geographic Reach
1 country

2 active sites

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 6, 2017

Completed
3 days until next milestone

First Posted

Study publicly available on registry

February 9, 2017

Completed
7 months until next milestone

Study Start

First participant enrolled

September 13, 2017

Completed
21 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 4, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 4, 2017

Completed
Last Updated

May 4, 2018

Status Verified

May 1, 2018

Enrollment Period

21 days

First QC Date

February 6, 2017

Last Update Submit

May 3, 2018

Conditions

Keywords

mindfulnesscaregivers

Outcome Measures

Primary Outcomes (4)

  • 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 Outcomes (1)

  • Caregiver MBCT Programme Evaluation Form

    up to 2 weeks post-intervention

Study Arms (2)

Usual care

NO INTERVENTION

No intervention

Mindfulness based Stress Reduction

EXPERIMENTAL

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

Interventions

MBSRBEHAVIORAL

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.

Mindfulness based Stress Reduction

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Trinity College Dublin

Dublin, dublin 2, Ireland

Location

Trinity College Dubliln

Dublin, Ireland

Location

MeSH Terms

Conditions

Chronic Disease

Condition Hierarchy (Ancestors)

Disease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Margarita Corry

    University of Dublin, Trinity College

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

February 6, 2017

First Posted

February 9, 2017

Study Start

September 13, 2017

Primary Completion

October 4, 2017

Study Completion

October 4, 2017

Last Updated

May 4, 2018

Record last verified: 2018-05

Locations