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History of Changes for Study: NCT02444312
Trial of Benefit Finding in Caregivers: The Building Resources in Caregivers (BRiC) Study (BRiC)
Latest version (submitted October 5, 2015) on ClinicalTrials.gov
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Study Record Versions
Version A B Submitted Date Changes
1 May 13, 2015 None (earliest Version on record)
2 October 5, 2015 Recruitment Status, Study Status, Study Design and Contacts/Locations
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Study NCT02444312
Submitted Date:  May 13, 2015 (v1)

Open or close this module Study Identification
Unique Protocol ID: BRiC2015
Brief Title: Trial of Benefit Finding in Caregivers: The Building Resources in Caregivers (BRiC) Study (BRiC)
Official Title: A Randomised Controlled Trial of Benefit Finding in Caregivers: The Building Resources in Caregivers (BRiC) Study Protocol
Secondary IDs:
Open or close this module Study Status
Record Verification: May 2015
Overall Status: Not yet recruiting
Study Start: June 2015
Primary Completion: September 2015 [Anticipated]
Study Completion: September 2015 [Anticipated]
First Submitted: May 11, 2015
First Submitted that
Met QC Criteria:
May 13, 2015
First Posted: May 14, 2015 [Estimate]
Last Update Submitted that
Met QC Criteria:
May 13, 2015
Last Update Posted: May 14, 2015 [Estimate]
Open or close this module Sponsor/Collaborators
Sponsor: University of Limerick
Responsible Party: Principal Investigator
Investigator: Brenda O'Connell
Official Title: Ms. Brenda O'Connell
Affiliation: University of Limerick
Collaborators: Carolan Research Institute
Care Alliance Ireland
Open or close this module Oversight
U.S. FDA-regulated Drug:
U.S. FDA-regulated Device:
Data Monitoring: No
Open or close this module Study Description
Brief Summary: A randomised controlled trial that will compare the effects of a brief benefit -finding writing intervention with an active control condition on quality of life and psychological health among informal caregivers.
Detailed Description: A double-blind, randomized controlled parallel group study design with an equal 1:1 allocation ratio will be employed. This study will compare the effect of a brief benefit finding writing intervention with a control condition among caregivers. Caregivers currently caring for people with mental and physical disabilities will be randomised into a two-week, a) a benefit writing group or b) a control writing group. Caregivers will complete self-report measures relating to their care-recipient and themselves (e.g., illness type, and sociodemographics) and psychometric measures of benefit finding (primary outcome), psychological distress and quality of life(secondary outcomes). These will be assessed via online software at baseline, immediate post-test and at 3 month follow-up. Additionally, expectations and fidelity indices will be assessed and qualitative commentary on participation experiences gathered.
Open or close this module Conditions
Conditions: Quality of Life
Psychological Distress
Keywords: Caregiving
Benefit Finding
Writing Intervention
Open or close this module Study Design
Study Type: Interventional
Primary Purpose: Treatment
Study Phase: Not Applicable
Interventional Study Model: Parallel Assignment
Number of Arms: 2
Masking: Triple (Care Provider, Investigator, Outcomes Assessor)
Allocation: Randomized
Enrollment: 96 [Anticipated]
Open or close this module Arms and Interventions
Arms Assigned Interventions
Experimental: Benefit-finding Writing Activity
For two weeks, on six days of their choice, caregivers will be instructed to write about their thoughts and feelings in a diary/ notebook about the benefits of caring.
Behavioral: Benefit-finding Writing Activity
Caregivers will be instructed to write about the benefits of caring, considering things such as improved social relationship, appreciation of life and loved ones, and the positive consequences with respect to these.
Active Comparator: Neutral Writing activity
For two weeks, on six days of their choice, caregivers will be instructed to write about a neutral topic.
Behavioral: Neutral Writing Activity
The control group will be instructed to write number of things about the weather that day. Although the sentences can be as long or as short as they like, they will be encouraged to try and aim for about 3 or 4 sentences at least.
Open or close this module Outcome Measures
Primary Outcome Measures:
1. Benefit Finding (Adapted version of the 17-item Benefit Finding Scale; Antoni et al., 2001)
[ Time Frame: Baseline, immediate post-intervention (two weeks), and 3 months ]

Used to assess change in benefit-finding levels over the course of the intervention and follow-up
Secondary Outcome Measures:
1. Caregiver Quality of Life (40 item Adult Carer Quality of Life Questionnaire; Joseph, Becker, Elwick, & Silburn, 2012)
[ Time Frame: Baseline, immediate post-intervention (two weeks), and 3 months ]

This measures quality of life in eight separate domains: support for caring; caring choice; caring stress; money matters; personal growth; sense of value; ability to care; and carer satisfaction. Used to assess change in quality of life levels over the course of the intervention and follow-up
2. Psychological Distress (Hospital and Anxiety Depression Scale; Zigmond & Snaith, 1983)
[ Time Frame: Baseline, immediate post-intervention (two weeks), and 3 months ]

Used to assess change in psychological distress levels over the course of the intervention and follow-up, and as a moderator
Open or close this module Eligibility
Minimum Age: 18 Years
Maximum Age:
Sex: All
Gender Based:
Accepts Healthy Volunteers: Yes
Criteria:

Inclusion Criteria:

  • Must be over the age of 18
  • Must identify as caring for a family member, friend or relative
  • Must be living in Ireland

Exclusion Criteria:

  • If the person cared for is living in institutional care
Open or close this module Contacts/Locations
Central Contact Person: Stephen Gallagher, PhD
Telephone: +353 (0)61 234899
Email: stephen.gallagher@ul.ie
Central Contact Backup: Charles Brand, MSc
Email: charles.brand@ul.ie
Study Officials: Stephen Gallagher, PhD
Study Director
University of Limerick, Department of Psychology
Charles Brand, MSc
Principal Investigator
University of Limerick
Brenda H O' Connell, B.A
Principal Investigator
University of Limerick
Locations:
Open or close this module IPDSharing
Plan to Share IPD:
Open or close this module References
Citations:
Links:
Available IPD/Information:

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